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betamethasone

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Description

Betamethasone is a potent synthetic glucocorticoid with anti-inflammatory and immunosuppressive properties. It is used to treat a variety of conditions, including inflammatory skin diseases, asthma, and autoimmune disorders. Betamethasone is synthesized through a multi-step process starting with a steroid precursor. It exerts its effects by binding to glucocorticoid receptors in cells, leading to the regulation of gene expression and the suppression of inflammatory mediators. Betamethasone is widely studied due to its therapeutic potential in numerous diseases and its complex pharmacological mechanisms. Research focuses on understanding its effects on different cell types, its safety profile, and its potential for developing novel therapeutic strategies.'

Betamethasone: A glucocorticoid given orally, parenterally, by local injection, by inhalation, or applied topically in the management of various disorders in which corticosteroids are indicated. Its lack of mineralocorticoid properties makes betamethasone particularly suitable for treating cerebral edema and congenital adrenal hyperplasia. (From Martindale, The Extra Pharmacopoeia, 30th ed, p724) [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID3003
CHEMBL ID1393513
CHEBI ID93851
SCHEMBL ID2757815
MeSH IDM0002437
PubMed CID9782
CHEMBL ID632
CHEBI ID3077
SCHEMBL ID4565
MeSH IDM0002437

Synonyms (226)

Synonym
9-fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione
HMS3267M14
BRD-A35108200-001-04-7
pregna-1,20-dione, 9-fluoro-11,17,21-trihydroxy-16-methyl-, (11.beta.,16.beta.)-
celestone
corticosterone, 1-dehydro-9-fluoro-17-hydroxy-16.beta.-methyl-
prednisolone, 9-fluoro-16.beta.-methyl-
hormezon
pregna-1,20-dione, 9-fluoro-11.beta.,17,21-trihydroxy-16.beta.-methyl-
.beta.-methasone
.beta.-methasone alcohol
9-fluoro-16.beta.-methylprednisolone
9.alpha.-fluoro-16.beta.-methylprednisolone
9-fluoro-11.beta.,21-trihydroxy-16.beta.-methylpregna-1,4-diene-3,20-dione
smr000339803
MLS000686794
gf120918a
AKOS001582690
MLS-0310139.0001
HMS3259J08
STL257060
NCGC00015161-02
FT-0603100
NC00707
AKOS021764260
SCHEMBL2757815
CHEMBL1393513
CHEBI:93851
9b-fluoro-1,10-dihydroxy-1-(2-hydroxyacetyl)-2,9a,11a-trimethyl-1h,2h,3h,3ah,3bh,4h,5h,7h,9ah,9bh,10h,11h,11ah-cyclopenta[a]phenanthren-7-one
FT-0666299
9-fluoro-11,17-dihydroxy-17-(2-hydroxy-1-oxoethyl)-10,13,16-trimethyl-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-3-one
Q27165596
FT-0700405
(2s,3s)-(-)-2,3-butanedioldi-p-tosylate
EN300-295509
MLS001066413
BIDD:PXR0047
MLS002153244
BRD-K39188321-001-03-9
AKOS008901360
betamethazone
betacorlan
betsolan
betamamallet
cidoten
betapredol
betasolon
becort
flubenisolone
celestene
nsc-39470
methazon
rinderon
betnelan
sch 4831
bebate
desacort-beta
betacortril
nsc39470
(11beta,16beta)-9-fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione
PRESTWICK_703
BPBIO1_000533
PRESTWICK2_000362
BSPBIO_000483
PRESTWICK3_000362
SMP1_000043
betamethasone cream
16-beta-methyl-1,4-pregnadiene-9-alpha-fluoro-11-beta,17-alpha,21-triol-3,20-dione
rinderon a
betametasona [inn-spanish]
betametasone [dcit]
einecs 206-825-4
pregna-1,4-diene-3,20-dione, 9-fluoro-11,17,21-trihydroxy-16-methyl-, (11beta,16beta)-
9-alpha-fluoro-16-beta-methyl-1,4-pregnadiene-11-beta,17-alpha,21-triol-3,20-dione
9-alpha-fluoro-16-beta-methylprednisolone
visubeta
betamethasonum [inn-latin]
beta-methasone
betamethasone alcohol
pregna-1,4-diene-3,20-dione, 9-fluoro-11beta,17,21-trihydroxy-16beta-methyl-
prednisolone, 9-fluoro-16beta-methyl-
hsdb 3015
9-fluoro-11-beta,17,21-trihydroxy-16-beta-methylpregna-1,4-diene-3,20-dione
brn 3176546
corticosterone, 1-dehydro-9-fluoro-17-hydroxy-16beta-methyl-
nsc 39470
bedifos
MLS001332616
C06848
betamethasone
378-44-9
(8s,9r,10s,11s,13s,14s,16s,17r)-9-fluoro-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13,16-trimethyl-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-3-one
pregna-1,4-diene-3,20-dione, 9-fluoro-11,17,21-trihydroxy-16-methyl-, (11.beta.,16.beta.)-
betamethasone, meets usp testing specifications
16beta-methyl-1,4-pregnadiene-9alpha-fluoro-11beta,17alpha,21-triol-3,20-dione
DB00443
betadexamethasone
smr000058601
9alpha-fluoro-16beta-methylprednisolone
beta-methasone alcohol
9-fluoro-16beta-methylprednisolone
MLS000859943 ,
rinderon (tn)
D00244
betamethasone (jp17/usp/inn)
NCGC00164401-01
PRESTWICK0_000362
PRESTWICK1_000362
SPBIO_002404
NCGC00164401-02
9-fluoro-11beta,17,21-trihydroxy-16beta-methylpregna-1,4-diene-3,20-dione
betamethasonum
CHEBI:3077 ,
betametasona
betamethasone, >=98%
B1837
9alpha-fluoro-11beta,17alpha,21-trihydroxy-16beta-methyl-1,4-pregnadiene-3,20-dione
CHEMBL632
sch-4831
D1961
HMS1569I05
NCGC00164401-03
HMS2096I05
tox21_301455
dtxsid3022667 ,
dtxcid002667
NCGC00255195-01
tox21_112115
BCP9000393
HMS2233I08
BCPP000345
unii-9842x06q6m
4-08-00-03501 (beilstein handbook reference)
betamethasone [usan:usp:inn:ban:jan]
ec 206-825-4
betamethasone, topical
9842x06q6m ,
betametasone
betamethasone [vandf]
9-fluoro-11.beta.,17,21-trihydroxy-16.beta.-methylpregna-1,4-diene-3,20-dione.
betamethasone [jan]
betamethasone [mi]
betamethasone [usp monograph]
betamethasone [who-ip]
dexamethasone impurity b [ep impurity]
betamethasone acetate impurity a [ep impurity]
betamethasone [usan]
betamethasonum [who-ip latin]
betamethasone [inn]
betamethasone dipropionate impurity a
betamethasone [mart.]
betamethasone [usp-rs]
betamethasone [ep monograph]
betamethasone [orange book]
betamethasone [ep impurity]
betamethasone [who-dd]
flosteron
betamethasone valerate impurity a [ep impurity]
S1500
AKOS015894863
gtpl7061
CCG-220362
HY-13570
CS-1897
SCHEMBL4565
tox21_112115_1
KS-5302
bdbm73823
cid_9782
9-fluoro-16beta-methyl-11beta,17,21-trihydroxypregna-1,4-diene-3,20-dione
W-106509
.beta.-corlan
9-.alpha.-fluoro-16-.beta.-methyl-1,4-pregnadiene-11-.beta.,17-.alpha.,21-triol-3,20-dione
9-.alpha.-fluoro-11-.beta.,17-.alpha.,21-trihydroxy-16-.beta.-methylpregna-1,4-diene-3,20-dione
desacort-.beta.
16-.beta.-methyl-1,4-pregnadiene-9-.alpha.-fluoro-11-.beta.,17-.alpha.,21-triol-3,20-dione
9-fluoro-11.beta.,17,21-trihydroxy-16.beta.-methylpregna-1,4-diene-3,20-dione
pregna-1,4-diene-3,20-dione, 9alpha-fluoro-11beta,17alpha,21-trihydroxy-16beta-methyl-
(11.beta.,16.beta.)-9-fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione
9-fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione, (11.beta.,16.beta.) #
pregna-1,4-diene-3,20-dione, 9-fluoro-11.beta.,17,21-trihydroxy-16.beta.-methyl-
9-.alpha.-fluoro-11-.beta.,17,21-trihydroxy-16-.beta.-methylpregna-1,4-diene-3,20-dione
(8s,9r,10s,11s,13s,14s,16s,17r)-9-fluoro-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13,16-trimethyl-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3h-cyclopenta[a]phenanthren-3-one
mfcd00062969
(1r,2s,10s,11s,13s,14r,15s,17s)-1-fluoro-14,17-dihydroxy-14-(2-hydroxyacetyl)-2,13,15-trimethyltetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadeca-3,6-dien-5-one
betamethasone, european pharmacopoeia (ep) reference standard
sr-01000780582
SR-01000780582-2
9a-fluoro-11b,17a,21-trihydroxy-16b-methylpregna-1,4-diene-3,20-dione
betamethasone, pharmaceutical impurity standard, >=95.0% (hplc)
betamethasone, vetranal(tm), analytical standard
betamethasone, united states pharmacopeia (usp) reference standard
betamethasone, pharmaceutical secondary standard; certified reference material
HMS3713I05
betamethasone, british pharmacopoeia (bp) reference standard
Q416132
ncs-39470
betamethasone (celestone)
betamethasone dipropionate ep impurity a
betamethasone; 9-fluoro-11?,17,21-trihydroxy-16?-methylpregna-1,4-diene-3,20-dione; (11?,16?)-9-fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione; 9?-fluoro-16?-methylprednisolone
betamethasone 100 microg/ml in acetonitrile
BCP02020
D88866
EN300-119511
(1r,2s,3as,3bs,9as,9br,10s,11as)-9b-fluoro-1,10-dihydroxy-1-(2-hydroxyacetyl)-2,9a,11a-trimethyl-1h,2h,3h,3ah,3bh,4h,5h,7h,9ah,9bh,10h,11h,11ah-cyclopenta[a]phenanthren-7-one
Z1521553714
mfcd00062929
betametasona (inn-spanish)
a07ea04
s01ba06
betamethasone (usp monograph)
s01cb04
c05aa05
betamethasone (ep monograph)
betamethasone (usan:usp:inn:ban:jan)
betamethasone (mart.)
r03ba04
d07ac01
s03ba03
s02ba07
dexamethasone impurity b (ep impurity)
betamethasonum (inn-latin)
betamethasone (ep impurity)
h02ab01
d07xc01
betamethasone (usp-rs)

Research Excerpts

Toxicity

The calcipotriol/betamethasone dipropionate two-compound product is safe and effective in the short-term treatment of psoriasis. Adverse effects related to neurotoxicity of intrathecal betameth asone were not observed in any patients.

ExcerptReferenceRelevance
" The data indicate that betamethasone exacerbates the toxic effects of paraquat."( Betamethasone effects on paraquat lung toxicity.
Boveris, A; Giulivi, C; Lavagno, C, 1991
)
0.28
" Eighteen percent of patients using mometasone reported adverse reactions but all were of limited duration and did not persist despite continued application of the drug."( Safety and efficacy of mometasone furoate cream in the treatment of steroid responsive dermatoses.
Cains, GD; Gilmore, SJ; Kelly, JW; Rallings, M, 1991
)
0.28
" No other adverse cutaneous effects were observed."( The safety of halobetasol 0.05% ointment in the treatment of psoriasis.
Freer, JP; Kalb, RE; Krochmal, L; Siskin, SB; Watson, WA, 1990
)
0.28
"A less frequently reported adverse side effect of local steroid injections has been described."( Perilymphatic atrophy of skin. An adverse side effect of intralesional steroid injections.
Kravette, MA, 1986
)
0.27
" Thus, toxic effects can be caused by preservatives or inadequate osmolarity of the vehicles alone."( Experimental and clinical observations of the intraocular toxicity of commercial corticosteroid preparations.
Arena, JE; Chandler, D; Hida, T; Machemer, R, 1986
)
0.27
"Fourteen patients suffering from rosacea treated by prolonged topical applications of fluorinated steroids showed adverse effects."( Adverse effect of topical fluorinated corticosteroids in rosacea.
Sneddon, I, 1969
)
0.25
"3 mg/kg/day, however, some dose-dependent symptoms such as suppression of body weight gain, emaciation, regressive changes in adrenals, lymphatic and hematopoietic tissues, decrease in circulating white blood cell and lymphocyte counts, which have been known as toxic effects of synthetic corticosteroids, were induced."( [Studies on toxicity of clobetasone-17-butyrate (II)--chronic toxicity in rats (author's transl)].
Aoishi, M; Bando, T; Ezaki, H; Hashimoto, K; Matsumoto, M; Moriwaki, T; Nagasawa, R; Okamura, C; Sato, N; Sutoh, M; Tamura, J; Tatami, A, 1980
)
0.26
" Adverse events were reported by 34."( Efficacy and safety of twice-daily augmented betamethasone dipropionate lotion versus clobetasol propionate solution in patients with moderate-to-severe scalp psoriasis.
Bressinck, R; Cornell, R; Katz, HI; Lindholm, JS; Morman, M; Pariser, DM; Pariser, RJ; Shavin, JS; Weiss, JS; Weng, W,
)
0.13
" Safety assessments included routine clinical laboratory evaluations, morning plasma cortisol levels, and reporting of adverse events."( A comparison of the safety, tolerability, and efficacy of fluticasone propionate ointment, 0.005%, and betamethasone-17,21-dipropionate ointment, 0.05%, in the treatment of eczema.
Delescluse, J; van der Endt, JD, 1996
)
0.29
"05%) was found to be safe and very effective by physicians in the treatment of infected dermatoses in 94."( Evaluation of safety and efficacy of supirocin-B (mupirocin 2% + betamethasone dipropionate 0.05%) in infected dermatoses--a post marketing study.
Desai, A; Janaki, VR; Mittal, RR; Savant, S; Sengupta, S, 2000
)
0.31
" Safety data showed the frequency of adverse events to be less in the combined formulation groups than in both the calcipotriol group and the vehicle group."( Efficacy and safety of a new combination of calcipotriol and betamethasone dipropionate (once or twice daily) compared to calcipotriol (twice daily) in the treatment of psoriasis vulgaris: a randomized, double-blind, vehicle-controlled clinical trial.
Chu, AC; Garcia-Diez, A; Guenther, L; Kragballe, K; Snellman, E; Springborg, J; Tegner, E; Van de Kerkhof, PC, 2002
)
0.31
" However, there are many reports in the literature of life-threatening adverse effects of these drugs."( [Herbal medicines and severe adverse effects: uvular angioedema caused by Echballium elaterium].
Cabrera, D; Caiozzi, G; Mardónez, JM; Saldías, F, 2002
)
0.31
" We conclude that although steroid injections are safe and effective for temporary relief of CTS, most patients will eventually require surgery for long-term control of their symptoms."( Intracarpal steroid injection is safe and effective for short-term management of carpal tunnel syndrome.
Armstrong, T; Borschel, L; Contreras, R; Devor, W, 2004
)
0.32
"5 million adverse drug reaction (ADR) reports for 8620 drugs/biologics that are listed for 1191 Coding Symbols for Thesaurus of Adverse Reaction (COSTAR) terms of adverse effects."( Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
Benz, RD; Contrera, JF; Kruhlak, NL; Matthews, EJ; Weaver, JL, 2004
)
0.32
"The calcipotriol/betamethasone dipropionate two-compound product Dovobet/Daivobet/Taclonex(LEO Pharma A/S, Ballerup, Denmark) has been shown to be safe and effective in the treatment of psoriasis for up to 8 weeks."( A 52-week randomized safety study of a calcipotriol/betamethasone dipropionate two-compound product (Dovobet/Daivobet/Taclonex) in the treatment of psoriasis vulgaris.
Austad, J; Barnes, L; Bibby, A; Cambazard, F; de la Brassinne, M; Fleming, C; Heikkilä, H; Jolliffe, D; Kragballe, K; Peyri, J; Svensson, A; Toole, J; Wozel, G, 2006
)
0.33
"Treatment with the two-compound product for up to 52 weeks appears to be safe and well tolerated whether used on its own or alternating every 4 weeks with calcipotriol treatment."( A 52-week randomized safety study of a calcipotriol/betamethasone dipropionate two-compound product (Dovobet/Daivobet/Taclonex) in the treatment of psoriasis vulgaris.
Austad, J; Barnes, L; Bibby, A; Cambazard, F; de la Brassinne, M; Fleming, C; Heikkilä, H; Jolliffe, D; Kragballe, K; Peyri, J; Svensson, A; Toole, J; Wozel, G, 2006
)
0.33
"To study the pharmacokinetics of different betamethasone doses and preparations used to enhance fetal lung maturation in the maternal and fetal circulation of sheep and the adverse effects on fetal blood pressure."( Kinetics of betamethasone and fetal cardiovascular adverse effects in pregnant sheep after different doses.
Coksaygan, T; Jusko, WJ; Nathanielsz, PW; Samtani, MN; Schwab, M, 2006
)
0.33
" Risk-benefit studies are needed to find the effective steroid dose with the least adverse effects."( Kinetics of betamethasone and fetal cardiovascular adverse effects in pregnant sheep after different doses.
Coksaygan, T; Jusko, WJ; Nathanielsz, PW; Samtani, MN; Schwab, M, 2006
)
0.33
"The calcipotriol/betamethasone dipropionate two-compound product is safe and effective in the short-term treatment of psoriasis."( Efficacy results of a 52-week, randomised, double-blind, safety study of a calcipotriol/betamethasone dipropionate two-compound product (Daivobet/Dovobet/Taclonex) in the treatment of psoriasis vulgaris.
Austad, J; Barnes, L; Bibby, A; Cambazard, F; de la Brassinne, M; Fleming, C; Heikkilä, H; Kragballe, K; Peyri Rey, J; Svensson, A; Toole, J; Williams, Z; Wozel, G, 2006
)
0.33
" During the 4-week study period, the analgesic efficacy and adverse effects related to intrathecal betamethasone were observed."( Intrathecal betamethasone for cancer pain in the lower half of the body: a study of its analgesic efficacy and safety.
Oishi, K; Sakamoto, S; Shingu, K; Taguchi, H, 2007
)
0.34
" Adverse effects related to neurotoxicity of intrathecal betamethasone, such as sensory and motor dysfunctions, were not observed in any patients."( Intrathecal betamethasone for cancer pain in the lower half of the body: a study of its analgesic efficacy and safety.
Oishi, K; Sakamoto, S; Shingu, K; Taguchi, H, 2007
)
0.34
"When conventional cancer pain treatments are not successful, intrathecal betamethasone may be useful, as it probably induces long-lasting analgesia without adverse effects and improves activities of daily living, especially in patients with vertebral bone metastases."( Intrathecal betamethasone for cancer pain in the lower half of the body: a study of its analgesic efficacy and safety.
Oishi, K; Sakamoto, S; Shingu, K; Taguchi, H, 2007
)
0.34
" Both treatments were safe and well tolerated."( Efficacy, safety and quality of life of calcipotriol/betamethasone dipropionate (Dovobet) versus calcipotriol (Daivonex) in the treatment of psoriasis vulgaris: a randomized, multicentre, clinical trial.
Andreassi, L; Ayala, F; Bongiorno, MR; Chimenti, S; Giannetti, A; Lisi, P; Martini, P; Peris, K; Peserico, A; Saraceno, R, 2007
)
0.34
"Effective and safe products are needed for long-term management of scalp psoriasis."( A study of the safety and efficacy of calcipotriol and betamethasone dipropionate scalp formulation in the long-term management of scalp psoriasis.
Bourcier, M; Cambazard, F; Clonier, F; Gupta, G; Kidson, P; Larsen, FG; Luger, TA; Shear, NH, 2008
)
0.35
" Incidences of adverse events possibly associated with long-term corticosteroid use were low in both the two-compound (2."( A study of the safety and efficacy of calcipotriol and betamethasone dipropionate scalp formulation in the long-term management of scalp psoriasis.
Bourcier, M; Cambazard, F; Clonier, F; Gupta, G; Kidson, P; Larsen, FG; Luger, TA; Shear, NH, 2008
)
0.35
" Mild-to-moderate adverse effects were reported."( A randomized, double-blind, placebo-controlled study comparing the efficacy and safety of paracetamol, serratiopeptidase, ibuprofen and betamethasone using the dental impaction pain model.
Chopra, D; Kakkar, AK; Mehra, P; Rehan, HS, 2009
)
0.35
" Secondary efficacy outcomes and adverse events were also evaluated."( Efficacy and safety of calcipotriol plus betamethasone dipropionate scalp formulation compared with calcipotriol scalp solution in the treatment of scalp psoriasis: a randomized controlled trial.
Hoffmann, V; Kragballe, K; Nordin, P; Ortonne, JP; Segaert, S; Tan, J, 2009
)
0.35
" Further evidence of the superiority of the two-compound scalp formulation over the scalp solution was demonstrated through greater improvements in clinical signs and fewer adverse events."( Efficacy and safety of calcipotriol plus betamethasone dipropionate scalp formulation compared with calcipotriol scalp solution in the treatment of scalp psoriasis: a randomized controlled trial.
Hoffmann, V; Kragballe, K; Nordin, P; Ortonne, JP; Segaert, S; Tan, J, 2009
)
0.35
" An understanding of structure-activity relationships (SARs) of chemicals can make a significant contribution to the identification of potential toxic effects early in the drug development process and aid in avoiding such problems."( Developing structure-activity relationships for the prediction of hepatotoxicity.
Fisk, L; Greene, N; Naven, RT; Note, RR; Patel, ML; Pelletier, DJ, 2010
)
0.36
" Adverse event incidences were similar between patients with and without prior anti-TNF therapy."( Efficacy and safety of adalimumab in patients with psoriasis previously treated with anti-tumour necrosis factor agents: subanalysis of BELIEVE.
Chimenti, S; Gniadecki, R; Goldblum, O; Kupper, H; Ortonne, JP; Reich, K; Sprøgel, P; Thaçi, D; Unnebrink, K, 2011
)
0.37
" They are mostly presented in the group of mood stabilizers and antiepileptic drugs, particularly the carbamazepine and lamotrigine, and can be manifested through the Stevens Johnson syndrome, Toxic Epidermal Necrolysis (TEN)/Lyell's syndrome with about 30% lethality."( Exanthema medicamentosum as a side effect of promazine.
Cvitanović, MZ; Hlevnjak, I; Lasić, D; Uglešić, B; Višić, V, 2011
)
0.37
" BASDAI, BASFI, VAS of the affected heel, the percentage of ASAS20 responders, CRP, ESR and any adverse events were recorded at baseline, 2, 4, 8 and 12 weeks after the treatment."( Efficacy and safety of ultrasound-guided local injections of etanercept into entheses of ankylosing spondylitis patients with refractory Achilles enthesitis.
Cao, J; Huang, Z; Li, T; Wang, M; Zheng, B; Zheng, R,
)
0.13
" In addition, there were no adverse events from the etanercept group, except for the mild acid bilges feeling during the injection procedure, while 1 patient from the betamethasone group developed mild local atrophoderma since the week 4 follow-up visit and the atrophoderma kept stable at the 2 subsequent visits."( Efficacy and safety of ultrasound-guided local injections of etanercept into entheses of ankylosing spondylitis patients with refractory Achilles enthesitis.
Cao, J; Huang, Z; Li, T; Wang, M; Zheng, B; Zheng, R,
)
0.13
"US-guided local injection of etanercept might be a highly effective, safe and well tolerated treatment for Achilles enthesitis in patients with AS."( Efficacy and safety of ultrasound-guided local injections of etanercept into entheses of ankylosing spondylitis patients with refractory Achilles enthesitis.
Cao, J; Huang, Z; Li, T; Wang, M; Zheng, B; Zheng, R,
)
0.13
" No adverse effects related to the study, including skin irritation, were observed or reported."( Evaluating the efficacy and safety of calcipotriene/betamethasone ointment occluded with a hydrogel patch: a 6-week bilaterally controlled, investigator-blinded trial.
Bhutani, T; Busse, KL; Koo, J; Patel, T, 2011
)
0.37
" Most adverse events (AEs) were mild-moderate severity."( Pooled safety analysis of calcipotriol plus betamethasone dipropionate gel for the treatment of psoriasis on the body and scalp.
Kragballe, K; van de Kerkhof, P, 2014
)
0.4
" Twenty-seven patients (35%) reported a total of 64 adverse events (AEs); most were mild (33/64) or moderate (22/64) in severity and there were no serious AEs."( Safety and efficacy of calcipotriol plus betamethasone dipropionate gel in the treatment of scalp psoriasis in adolescents 12-17 years of age.
Debarre, JM; Gooderham, M; Goodfield, M; Keddy-Grant, J; Kurvits, M; Xu, Z, 2014
)
0.4
" Sixteen patients (52%) experienced a total of 20 adverse events; 19 were considered unrelated to study treatment, 14 were mild, and none were serious or lesional or perilesional on the scalp."( Safety and efficacy of calcipotriene plus betamethasone dipropionate topical suspension in the treatment of extensive scalp psoriasis in adolescents ages 12 to 17 years.
Eichenfield, LF; Ganslandt, C; Kurvits, M; Schlessinger, J,
)
0.13
"Calcipotriol/betamethasone dipropionate combination in a non-alcoholic, lipophilic gel formulation (two-compound gel) has previously been demonstrated as a safe and effective treatment for scalp psoriasis in Caucasian, Hispanic/Latino, and Black/African American populations."( Calcipotriol plus betamethasone dipropionate gel compared with calcipotriol scalp solution in the treatment of scalp psoriasis: a randomized, controlled trial investigating efficacy and safety in a Chinese population.
Cui, P; Facy, P; Gao, T; Ge, M; Gu, J; Hao, F; Kurvits, M; Li, R; Ma, L; Sun, Q; Wang, G; Xu, J; Xu, Z; Yang, H; Yang, Q; Zheng, M, 2016
)
0.43
" The two-compound gel was associated with fewer adverse drug reactions than calcipotriol scalp solution (18."( Calcipotriol plus betamethasone dipropionate gel compared with calcipotriol scalp solution in the treatment of scalp psoriasis: a randomized, controlled trial investigating efficacy and safety in a Chinese population.
Cui, P; Facy, P; Gao, T; Ge, M; Gu, J; Hao, F; Kurvits, M; Li, R; Ma, L; Sun, Q; Wang, G; Xu, J; Xu, Z; Yang, H; Yang, Q; Zheng, M, 2016
)
0.43
" Safety was monitored by adverse events/calcium homeostasis."( Efficacy and Safety of Calcipotriene Plus Betamethasone Dipropionate Aerosol Foam in Patients With Psoriasis Vulgaris--a Randomized Phase III Study (PSO-FAST).
Bagel, J; Leonardi, C; Olesen, M; Pariser, D; Stein Gold, L; Xu, Z; Yamauchi, P; Østerdal, ML, 2015
)
0.42
" Adverse drug reactions were reported in 10 Cal/BD foam patients (3."( Efficacy and Safety of Calcipotriene Plus Betamethasone Dipropionate Aerosol Foam in Patients With Psoriasis Vulgaris--a Randomized Phase III Study (PSO-FAST).
Bagel, J; Leonardi, C; Olesen, M; Pariser, D; Stein Gold, L; Xu, Z; Yamauchi, P; Østerdal, ML, 2015
)
0.42
"Bleomycin induced flagellate dermatitis is an uncommon and unique adverse effect."( Bleomycin induced flagellate erythema in a patient with thalamic mixed germ cell tumour: Report of a rare adverse effect.
Biswas, A; Julka, PK, 2016
)
0.43
" Knee pain (Numeric Rating Scale [NRS]), Oxford Knee Score, overall treatment effect (Global Perceived Effect), analgesic drug use, and adverse events were compared between CRFA and IAS cohorts at 1, 3, and 6 months after intervention."( Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis.
Buvanendran, A; Choi, D; Davis, T; DePalma, M; Desai, M; Gupta, A; Hunter, C; Kapural, L; Lindley, D; Loudermilk, E; Patel, N; Soloman, M, 2018
)
0.48
" There were no procedure-related serious adverse events."( Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis.
Buvanendran, A; Choi, D; Davis, T; DePalma, M; Desai, M; Gupta, A; Hunter, C; Kapural, L; Lindley, D; Loudermilk, E; Patel, N; Soloman, M, 2018
)
0.48
"Derivatives of hydrocortisone, such as mometasone furoate, a (2') furoate-17 ester with chlorine substitutions at positions 9 and 21, have been designed to improve efficacy and reduce the incidence of adverse effects."( Comparative safety and efficacy of topical mometasone furoate with other topical corticosteroids.
Barnes, TM; Greive, KA; Spada, F, 2018
)
0.48
" Adverse events were similar between groups."( A randomized placebo-controlled trial of the efficacy and safety of a terbinafine, florfenicol and betamethasone topical ear formulation in dogs for the treatment of bacterial and/or fungal otitis externa.
Doucette, KP; Forster, SL; King, SB; Real, T, 2018
)
0.48
"The application of two doses of Osurnia, one week apart, is effective and safe to treat microbial otitis externa in dogs."( A randomized placebo-controlled trial of the efficacy and safety of a terbinafine, florfenicol and betamethasone topical ear formulation in dogs for the treatment of bacterial and/or fungal otitis externa.
Doucette, KP; Forster, SL; King, SB; Real, T, 2018
)
0.48
" Adverse events attributable to the ear medications were not noted."( A randomized, controlled, single-blinded, multicenter evaluation of the efficacy and safety of a once weekly two dose otic gel containing florfenicol, terbinafine and betamethasone administered for the treatment of canine otitis externa.
Doucette, KP; Forster, SL; King, SB; Seewald, W, 2018
)
0.48
"Administering an otic gel twice at a one-week interval is an effective, safe and convenient way to treat canine otitis externa."( A randomized, controlled, single-blinded, multicenter evaluation of the efficacy and safety of a once weekly two dose otic gel containing florfenicol, terbinafine and betamethasone administered for the treatment of canine otitis externa.
Doucette, KP; Forster, SL; King, SB; Seewald, W, 2018
)
0.48
" No adverse effects related to neurotoxicity were recorded."( Intrathecal betamethasone for cancer pain: A study of its analgesic efficacy and safety.
Masuzawa, M; Matsumoto, H; Oishi, K; Shingu, K; Taguchi, H, 2019
)
0.51
" Follow-up indexes included IgG4-RD responder index (IgG4-RD RI), serology and imaging, plasma cytokines and adverse drug effect."( Efficacy and safety of iguratimod plus corticosteroid as bridge therapy in treating mild IgG4-related diseases: A prospective clinical trial.
Chen, H; Fei, Y; Gong, Y; Li, J; Li, Y; Lin, W; Liu, X; Liu, Y; Liu, Z; Peng, L; Shen, M; Shi, Q; Wang, M; Zeng, X; Zhang, F; Zhang, P; Zhang, W; Zhang, X; Zhao, Y; Zhou, J, 2019
)
0.51
" Safety response criteria included adverse drug reactions [ADRs; any adverse event (AE) possibly or probably related to treatment as determined by the investigator; a primary response criterion] and AEs (a secondary response criterion)."( Safety and efficacy of topical, fixed-dose combination calcipotriene (0.005%) and betamethasone (0.064% as dipropionate) gel in adolescent patients with scalp and body psoriasis: a phase II trial.
Eichenfield, LF; Kurvits, M; Liljedahl, M; Marcoux, D, 2020
)
0.56
" To determine the efficacy, adverse events, and their influencing factors of fractional erbium: yttrium-aluminum-garnet (Er:YAG) laser-assisted topical delivery of corticosteroids in stable vitiligo."( Multi-Factors Associated With Efficacy and Adverse Events of Fractional Erbium:YAG Laser-Assisted Delivery of Topical Betamethasone for Stable Vitiligo: A Retrospective Analysis.
Deng, Y; Huang, C; Jian, D; Li, J; Li, P; Mao, M; Wang, B, 2020
)
0.56
" A common adverse event was hyperpigmentation (14."( Multi-Factors Associated With Efficacy and Adverse Events of Fractional Erbium:YAG Laser-Assisted Delivery of Topical Betamethasone for Stable Vitiligo: A Retrospective Analysis.
Deng, Y; Huang, C; Jian, D; Li, J; Li, P; Mao, M; Wang, B, 2020
)
0.56
" Primary objectives included treatment-emergent adverse events (TEAEs) and systemic calcium levels in the overall population, and HPA-axis function, change in calcium excretion and the calcium:creatinine ratio in the HPA-axis cohort."( Safety and efficacy of fixed-dose combination calcipotriol (50 μg/g) and betamethasone dipropionate (0.5 mg/g) cutaneous foam in adolescent patients (aged 12 to <17 years) with plaque psoriasis: results of a phase II, open-label trial.
Abramovits, W; Hoejen, MN; Liljedahl, M; Seyger, M; Teng, J, 2020
)
0.56
" Radiofrequency treatment is a new method to reduce KOA-related pain and partially improve knee joint dysfunction without adverse effect."( Comparing the Safety and Effectiveness of Radiofrequency Thermocoagulation on Genicular Nerve, Intraarticular Pulsed Radiofrequency with Steroid Injection in the Pain Management of Knee Osteoarthritis.
Ding, Y; Han, Z; Hong, T; Li, G; Wang, S; Yao, P, 2020
)
0.56
" Cal/BD foam plus apremilast appeared to be safe and well tolerated."( Efficacy and Safety of Calcipotriene 0.005%/Betamethasone Dipropionate 0.064% Foam With Apremilast for Moderate Plaque Psoriasis.
Kircik, LH; Schlesinger, TE; Tanghetti, E, 2020
)
0.56
" Incidence of adverse drug reactions (ADRs) of any type and adverse events (AEs) of concern associated with long-term corticosteroid use on the scalp were evaluated."( Comparison of safety and efficacy between calcipotriol plus betamethasone dipropionate gel and calcipotriol scalp solution as long-term treatment for scalp psoriasis in Chinese patients: a national, multicentre, prospective, randomized, active-controlled
Cao, S; Chen, K; Chen, Y; Cheng, H; Ding, Y; Fang, H; Han, X; He, L; He, Y; Huang, J; Li, M; Li, S; Li, W; Liu, L; Lu, Q; Lu, Y; Pan, W; Wang, J; Yan, G; Zhang, C; Zhang, J; Zheng, M; Zhu, W, 2020
)
0.56
" There was no significant difference in treatment-emergent adverse events (TEAEs) associated with long-term topical corticosteroid use on the scalp (1."( Comparison of safety and efficacy between calcipotriol plus betamethasone dipropionate gel and calcipotriol scalp solution as long-term treatment for scalp psoriasis in Chinese patients: a national, multicentre, prospective, randomized, active-controlled
Cao, S; Chen, K; Chen, Y; Cheng, H; Ding, Y; Fang, H; Han, X; He, L; He, Y; Huang, J; Li, M; Li, S; Li, W; Liu, L; Lu, Q; Lu, Y; Pan, W; Wang, J; Yan, G; Zhang, C; Zhang, J; Zheng, M; Zhu, W, 2020
)
0.56
"The Pregnancy-IVI algorithm is safe and effective when used following betamethasone in type 1 diabetes in pregnancy."( Efficacy and safety of the pregnancy-IVI, an intravenous insulin protocol for pregnancy, following antenatal betamethasone in type 1 and type 2 diabetes.
Addley, J; Brown, K; Delbridge, M; Rowe, CW; Watkins, B; Woods, A; Wynne, K, 2021
)
0.62
" This superior efficacy was not associated with an increased frequency or severity of adverse events, and there was no evidence for dysregulation of the hypothalamic-pituitary-adrenal axis or calcium homeostasis."( Efficacy and safety of fixed-dose combination calcipotriol/betamethasone dipropionate foam for the treatment of psoriasis.
Paul, C; Romiti, R; Stein Gold, L, 2021
)
0.62
" Efficacy was evaluated based on primary outcome indicators including skin lesion improvement and overall adverse reaction rate."( Clinical efficacy and safety of using calcipotriol-betamethasone compounding agent for psoriasis treatment: a systematic review and meta-analysis.
Ding, H; Dong, S; Feng, J; Li, N; Li, X; Ren, J; Sun, Z; Wang, H; Wang, S; Zhu, Q, 2022
)
0.72
" There was no adverse drug reaction reported with a frequency of >1%, associated with the CAL/BDP PAD-cream."( A pooled analysis of randomized, controlled, phase 3 trials investigating the efficacy and safety of a novel, fixed dose calcipotriene and betamethasone dipropionate cream for the topical treatment of plaque psoriasis.
Augustin, M; Gold, LS; Green, LJ; Pinter, A; Praestegaard, M; Selmer, J, 2022
)
0.72
" To assess what impact can be expected from this regulatory action, we analyzed reports of adverse drug events due to topical corticosteroids at a hospital-based pharmacovigilance center between January 2017 and August 2018."( Topical steroid containing combinations: Burden of adverse effects and why the recent regulatory action may not be enough.
Asati, DP; Chaudhary, D; Jhaj, R; Sadasivam, B,
)
0.13
"45%) were the corticosteroids most frequently associated with adverse events."( Topical steroid containing combinations: Burden of adverse effects and why the recent regulatory action may not be enough.
Asati, DP; Chaudhary, D; Jhaj, R; Sadasivam, B,
)
0.13
"Nearly half of the cutaneous adverse effects were due to topical steroid combinations which are still widely available over the counter."( Topical steroid containing combinations: Burden of adverse effects and why the recent regulatory action may not be enough.
Asati, DP; Chaudhary, D; Jhaj, R; Sadasivam, B,
)
0.13
" Overall, corticosteroids reduced inflammatory complications after 3MS and did not show any serious adverse effects."( Comparative efficacy and safety of different corticosteroids to reduce inflammatory complications after mandibular third molar surgery: a systematic review and network meta-analysis.
Canellas, JVDS; Ritto, FG; Tiwana, P, 2022
)
0.72
" Also, Methotrexate (MTX) can be used as an alternative and safe modality in LP."( Efficacy and safety of oral methotrexate versus oral mini pulse betamethasone therapy in the treatment of lichen planus: a comparative study.
Abd-Elsalam, S; Elwan, NM; Fawzy, MM; Gamal Alsakaan, NA, 2022
)
0.72
" The reported clinical and laboratory adverse effects were tolerable and didn't lead to the discontinuation of treatment."( Efficacy and safety of oral methotrexate versus oral mini pulse betamethasone therapy in the treatment of lichen planus: a comparative study.
Abd-Elsalam, S; Elwan, NM; Fawzy, MM; Gamal Alsakaan, NA, 2022
)
0.72
"OMP betamethasone and low dose MTX may be considered effective and safe lines of treatment for different types of LP and may represent good and safe alternative options for conventional daily corticosteroid therapy."( Efficacy and safety of oral methotrexate versus oral mini pulse betamethasone therapy in the treatment of lichen planus: a comparative study.
Abd-Elsalam, S; Elwan, NM; Fawzy, MM; Gamal Alsakaan, NA, 2022
)
0.72
" Topical latanoprost added to therapeutic efficacy of topical betamethason and minoxidil in treating patchy AA, suggesting it being beneficial and safe adjuvant therapy and add to efficacy of topical treatments without any adverse effects."( Comparison of efficacy, safety and satisfaction of latanoprost versus minoxidil, betamethasone and in combination in patients with alopecia areata: A blinded multiple group randomized controlled trial.
Behrangi, E; Ghassemi, M; Goodarzi, A; Jafari, M; Yazdanian, N, 2022
)
0.72
" Smartphone app images documented adverse events and mild local skin reactions, particularly erythema (75%), laser-induced swelling (28%), and crusting (27%)."( Investigating the efficacy and safety of calcipotriol/betamethasone dipropionate foam and laser microporation for psoriatic nail disease-A hybrid trial using a smartphone application, optical coherence tomography, and patient-reported outcome measures.
Bourlioux, M; Fuchs, CSK; Haedersdal, M; Mandel, VD; Nissen, CV; Ortner, VK; Philipsen, PA; Skak, K; Zibert, JR, 2022
)
0.72
" All adverse events were mild and deemed unrelated to treatment by the investigators."( Efficacy and Safety of Calcipotriene/Betamethasone Dipropionate Foam in the Treatment of Psoriasis in Skin of Color.
Alexis, A; Cices, A; Kaufman, B; Liu, J; Sanabria-Gonzalez, I, 2023
)
0.91
"Cal/BD foam was safe and well tolerated in plaque psoriasis patients with skin of color."( Efficacy and Safety of Calcipotriene/Betamethasone Dipropionate Foam in the Treatment of Psoriasis in Skin of Color.
Alexis, A; Cices, A; Kaufman, B; Liu, J; Sanabria-Gonzalez, I, 2023
)
0.91
"Antenatal glucocorticoids accelerate fetal lung maturation and reduce mortality in preterm babies but can trigger adverse effects on the cardiovascular system."( Molecular mechanisms underlying adverse effects of dexamethasone and betamethasone in the developing cardiovascular system.
Beck, C; Botting, KJ; Conlon, FG; Derks, JB; Garrud, TAC; Giussani, DA; Itani, N; Nicholas, LM; Niu, Y; Ozanne, SE; Skeffington, KL; Teulings, NEWD; Tong, W, 2023
)
0.91
"  Adverse event rates were similar between the subgroup with skin types IV to VI and the total study population for all treatment arms."( Efficacy, Convenience, and Safety of Calcipotriene-Betamethasone Dipropionate Cream in Skin of Color Patients With Plaque Psoriasis.
Bhatia, N; Callender, VD; Curcio, A; Feldman, SR; Gorodokin, B; Kircik, L; Kontzias, CL; Tissera, KA, 2023
)
0.91

Pharmacokinetics

The shorter half-life of betamethasone in twin pregnancy than in singleton pregnancy may cause it to be subtherapeutic for lung maturation. Achievement of steady-state betametasone dipropionate uptake into the stratum corneum was not commensurate with the maximal pharmacodyn.

ExcerptReferenceRelevance
" Drug uptake into the stratum corneum, measured by tapestripping, is correlated with the pharmacodynamic response of skin blanching, observed in the vasoconstrictor assay."( New approaches to assess topical corticosteroid bioequivalence: pharmacokinetic evaluation.
Pershing, LK, 1992
)
0.28
" Plasma levels of the steroids were measured and pharmacokinetic parameters were calculated."( Pharmacokinetics and pharmacodynamics of glucocorticoid suspensions after intra-articular administration.
Derendorf, H; Grüner, A; Gyselby, G; Haack, D; Möllmann, H, 1986
)
0.27
" Elimination half-life was inversely related to gestational age, and ranged from 22."( Pharmacokinetics and tissue distribution of metronidazole in the new born infant.
Baird-Lambert, J; Buchanan, N; Cvejic, M; Doyle, PE; Jager-Roman, E, 1982
)
0.26
" Pharmacokinetic evaluation of the data, obtained according to the one-compartment open model, indicated that there were no significant differences between the extent of absorption, and the first-order elimination rate constants."( Pharmacokinetic evaluation of betamethasone and its water soluble phosphate ester in humans.
Brien, R; Jordan, N; Loo, JC; McGilveray, IJ,
)
0.13
" Pharmacodynamic effects such as miosis and IOP reduction were investigated."( Pharmacokinetic and pharmacodynamic aspects of an ophthalmic pilocarpine nanoparticle-delivery-system.
Kreuter, J; Lambrecht, G; Mayer, D; Mutschler, E; Zimmer, A, 1994
)
0.29
" These results will complicate pharmacokinetic and pharmacodynamic analysis."( Comparative pharmacokinetics of two diastereoisomers dexamethasone and betamethasone in plasma and cerebrospinal fluid in rabbits.
Choisy, H; Lamiable, D; Leperre, A; Millart, H; Trenque, T; Vistelle, R, 1994
)
0.29
"Effective topical drug therapy requires drug delivery into the skin to produce the desired pharmacodynamic response."( Topical 0.050% betamethasone dipropionate. Pharmacokinetic and pharmacodynamic dose-response studies in humans.
Lambert, L; Pershing, LK; Shah, VP; Williams, RL; Wright, ED, 1994
)
0.29
" The maximal mean pharmacodynamic response reflected the mean drug uptake with all four methods."( Topical 0.050% betamethasone dipropionate. Pharmacokinetic and pharmacodynamic dose-response studies in humans.
Lambert, L; Pershing, LK; Shah, VP; Williams, RL; Wright, ED, 1994
)
0.29
" Achievement of steady-state betamethasone dipropionate uptake into the stratum corneum was not commensurate with the maximal pharmacodynamic response."( Topical 0.050% betamethasone dipropionate. Pharmacokinetic and pharmacodynamic dose-response studies in humans.
Lambert, L; Pershing, LK; Shah, VP; Williams, RL; Wright, ED, 1994
)
0.29
"We measured serial betamethasone and cortisol levels in 30 singleton and 21 twin pregnancies after the first dose of betamethasone and calculated the pharmacokinetic parameters for betamethasone including volume of distribution, half-life, and clearance."( Pharmacokinetics of betamethasone in twin and singleton pregnancy.
Auld, PA; Ballabh, P; Cooper, TB; Krauss, AN; Kumari, J; Lo, ES; Zervoudakis, I, 2002
)
0.31
"The half-life of betamethasone in mothers with twin pregnancies was significantly shorter than that in mothers with singleton pregnancies (7."( Pharmacokinetics of betamethasone in twin and singleton pregnancy.
Auld, PA; Ballabh, P; Cooper, TB; Krauss, AN; Kumari, J; Lo, ES; Zervoudakis, I, 2002
)
0.31
"The shorter half-life of betamethasone in twin pregnancy than in singleton pregnancy may cause the level of betamethasone to be subtherapeutic for lung maturation in twin pregnancy."( Pharmacokinetics of betamethasone in twin and singleton pregnancy.
Auld, PA; Ballabh, P; Cooper, TB; Krauss, AN; Kumari, J; Lo, ES; Zervoudakis, I, 2002
)
0.31
" A simple pharmacokinetic model, essentially a modification of the single compartment model with first-order absorption and elimination, is developed to describe the time course of glucose concentration and the associated insulin response."( Uising WinBUGS to fit nonlinear mixed models with an application to pharmacokinetic modelling of insulin response to glucose challenge in sheep exposed antenatally to glucocorticoids.
Challis, JR; Gurrin, LC; Hazelton, ML; Moss, TJ; Newnham, JP; Sloboda, DM, 2003
)
0.32
" The half-life of betamethasone in the fetal circulation was shorter after fetal injection (1."( Pharmacokinetics of betamethasone after maternal or fetal intramuscular administration.
Doherty, DA; Harding, R; Moss, TJ; Newnham, JP; Nitsos, I, 2003
)
0.32
" A comparison is also presented between several methods based on animal pharmacokinetic data, using the same set of proprietary compounds, and it lends further support for the use of this method, as opposed to methods that require the gathering of pharmacokinetic data in laboratory animals."( Prediction of human volume of distribution values for neutral and basic drugs. 2. Extended data set and leave-class-out statistics.
Gao, F; Lombardo, F; Obach, RS; Shalaeva, MY, 2004
)
0.32
" Area/Moment equations and compartmental models for estimating pharmacokinetic parameters from single dose data during pregnancy were developed."( Area/moment and compartmental modeling of pharmacokinetics during pregnancy: applications to maternal/fetal exposures to corticosteroids in sheep and rats.
Jusko, WJ; Nathanielsz, PW; Samtani, MN; Schwab, M, 2004
)
0.32
" We therefore designed a study to capture the true pharmacokinetic profiles of betamethasone from these fast acting and dual-release formulations."( Betamethasone pharmacokinetics after two prodrug formulations in sheep: implications for antenatal corticosteroid use.
Grant, A; Jusko, WJ; Lohle, M; Nathanielsz, PW; Samtani, MN, 2005
)
0.33
"In two separate trials, we studied the concomitant administration of atosiban with labetalol and betamethasone to determine any possibility of a clinically relevant pharmacokinetic interaction."( Pharmacokinetic interaction studies of atosiban with labetalol or betamethasone in healthy female volunteers.
Larsen, LS; Rasmussen, BB; Senderovitz, T, 2005
)
0.33
" Study 2 was an open-label, randomised, three-period crossover pharmacokinetic study."( Pharmacokinetic interaction studies of atosiban with labetalol or betamethasone in healthy female volunteers.
Larsen, LS; Rasmussen, BB; Senderovitz, T, 2005
)
0.33
" Pharmacokinetic parameters (AUC, C(max), t(max)) did not differ markedly between treatments and all 90% CIs for ratios between treatments were fully within limits (80-125%)."( Pharmacokinetic interaction studies of atosiban with labetalol or betamethasone in healthy female volunteers.
Larsen, LS; Rasmussen, BB; Senderovitz, T, 2005
)
0.33
" Observations collected in two population pharmacokinetic studies, in preterm neonates, investigating amikacin and vancomycin were used to estimate: i) the impact of ibuprofen administration on the clearance of these drugs; and ii) the difference between prophylactic and therapeutic administration of ibuprofen on this clearance."( Impact of ibuprofen administration on renal drug clearance in the first weeks of life.
Allegaert, K; Anderson, BJ; Rayyan, M, 2006
)
0.33
" pharmacokinetic data on 670 drugs representing, to our knowledge, the largest publicly available set of human clinical pharmacokinetic data."( Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
Lombardo, F; Obach, RS; Waters, NJ, 2008
)
0.35
"The goals of the study were to estimate the pharmacokinetic parameters of standard dose betamethasone in a large obstetrics population and evaluate the effect of maternal body size and multiple gestation on the pharmacokinetic parameters and their observed variability."( Betamethasone in pregnancy: influence of maternal body weight and multiple gestation on pharmacokinetics.
Della Torre, M; Fischer, JH; Hibbard, JU; Jeong, H, 2010
)
0.36
"This was a prospective pharmacokinetic study."( Betamethasone in pregnancy: influence of maternal body weight and multiple gestation on pharmacokinetics.
Della Torre, M; Fischer, JH; Hibbard, JU; Jeong, H, 2010
)
0.36
" The greatest effect on pharmacokinetic variability was observed with maternal lean body weight (LBW)."( Betamethasone in pregnancy: influence of maternal body weight and multiple gestation on pharmacokinetics.
Della Torre, M; Fischer, JH; Hibbard, JU; Jeong, H, 2010
)
0.36
" The main objectives of the current study were to evaluate the pharmacokinetic and pharmacodynamic features of DFBA when used as an ophthalmic agent, and to compare these features with those of other common ophthalmic agents, to determine which has the highest activity."( Pharmacokinetic features of difluprednate ophthalmic emulsion in rabbits as determined by glucocorticoid receptor-binding bioassay.
Kida, T; Sakaki, H; Tajika, T; Tsuzuki, M; Waki, M, 2011
)
0.37
" The validated method was successfully applied to determine the plasma concentrations of triamcinolone acetonide in healthy volunteers, in a pharmacokinetic study with nasal spray formulation."( Determination of triamcinolone in human plasma by a sensitive HPLC-ESI-MS/MS method: application for a pharmacokinetic study using nasal spray formulation.
Bellorio, KB; Brêtas, JM; Byrro, RM; César, IC; de Santana e Silva Cardoso, FF; de Sousa, WC; de Souza Teixeira, L; Gomes, SA; Mundim, IM; Pianetti, GA, 2011
)
0.37
" However, the pharmacokinetic properties of betamethasone in plasma after intramuscular injection of betamethasone sodium phosphate and betamethasone acetate dual-acting suspension need further investigation."( Pharmacokinetics of betamethasone after single-dose intramuscular administration of betamethasone phosphate and betamethasone acetate to healthy subjects.
Najib, NM; Salem, II, 2012
)
0.38
"The main aim of this study was to determine the pharmacokinetic parameters of betamethasone, betamethasone acetate, and betamethasone phosphate after the administration of a single intramuscular dose of the dual-acting suspension to healthy human volunteers."( Pharmacokinetics of betamethasone after single-dose intramuscular administration of betamethasone phosphate and betamethasone acetate to healthy subjects.
Najib, NM; Salem, II, 2012
)
0.38
" The plasma samples obtained in the second study were stabilized to enable pharmacokinetic profiling of betamethasone esters."( Pharmacokinetics of betamethasone after single-dose intramuscular administration of betamethasone phosphate and betamethasone acetate to healthy subjects.
Najib, NM; Salem, II, 2012
)
0.38
"The observed pharmacokinetic parameters suggested that the acetate ester, and not the phosphate ester, of betamethasone acts as a prodrug or reservoir for betamethasone, conferring on it sustained- and extended-release characteristics."( Pharmacokinetics of betamethasone after single-dose intramuscular administration of betamethasone phosphate and betamethasone acetate to healthy subjects.
Najib, NM; Salem, II, 2012
)
0.38
"Even though intra-articular injections play an important role in the treatment of joint-related lameness in horses, little is known about pharmacokinetic properties of substances used."( The isolated perfused equine distal limb as an ex vivo model for pharmacokinetic studies.
Friebe, M; Kietzmann, M; Stahl, J, 2013
)
0.39
"Co-administration of OBE001 and betamethasone to determine pharmacokinetic interactions was studied during an open-label, randomized, three-period crossover study."( Pharmacokinetic interactions of OBE001 and betamethasone in healthy female volunteers.
Chollet, A; Homery, MC; Lemaux, F; Patat, A; Pohl, O, 2015
)
0.42
"There was no effect on geometric mean Cmax after the second administration and AUCs of OBE001 [geometric mean ratio point estimate (90% CI): Cmax (Day2) 1·05 (0·98-1·12) and AUC(0-24 h )1·11 (0·99-1·23)/AUC(24 h-∞) 0·99 (0·93-1·06), respectively]; Cmax after the first administration together with betamethasone was increased by 12% [geometric mean ratio point estimates (90% CI): Cmax (Day1) 1·12 (0·96-1·32)]."( Pharmacokinetic interactions of OBE001 and betamethasone in healthy female volunteers.
Chollet, A; Homery, MC; Lemaux, F; Patat, A; Pohl, O, 2015
)
0.42
"AUC and Cmax of the betamethasone and OBE001 combination did not differ significantly between treatments."( Pharmacokinetic interactions of OBE001 and betamethasone in healthy female volunteers.
Chollet, A; Homery, MC; Lemaux, F; Patat, A; Pohl, O, 2015
)
0.42
" Plasma data were analyzed using compartmental pharmacokinetic modeling."( Pharmacokinetics of betamethasone in plasma, urine, and synovial fluid following intra-articular administration to exercised thoroughbred horses.
Harrison, LM; Knych, HK; Mckemie, DS; Stanley, SD, 2017
)
0.46
" The method was successfully applied to a preclinical pharmacokinetic (PK) study of the six GCs on female nude mice after a single oral dose of 1 mg/kg."( Development and validation of a LC-MS/MS method for simultaneous determination of six glucocorticoids and its application to a pharmacokinetic study in nude mice.
Guo, Y; Hao, C; Kong, D; Li, J; Tian, X; Xue, J; Yao, Q; Zhou, T, 2020
)
0.56
"Physiologically based pharmacokinetic (PBPK) models have been previously developed for betamethasone and buprenorphine for pregnant women."( Physiologically based pharmacokinetic modelling in pregnancy: Model reproducibility and external validation.
Haas, DM; Quinney, SK; Silva, LL; Silvola, RM, 2022
)
0.72
" time profiles, and comparison of pharmacokinetic parameters."( Physiologically based pharmacokinetic modelling in pregnancy: Model reproducibility and external validation.
Haas, DM; Quinney, SK; Silva, LL; Silvola, RM, 2022
)
0.72
"Minimal physiologically-based pharmacokinetic (mPBPK) models are an alternative to full physiologically-based pharmacokinetic (PBPK) models as they offer reduced complexity while maintaining the physiological interpretation of key model components."( Minimal physiologically-based hybrid model of pharmacokinetics in pregnant women: Application to antenatal corticosteroids.
Jobe, AH; Jusko, WJ; Krzyzanski, W; Milad, MA, 2023
)
0.91

Compound-Compound Interactions

This study was designed to compare the antiemetic effect of. betamethasone alone with that of betamETHasone combined with metoclopramide. We treated a 3-year-old child with severe AA with microneedling combined with compound betametasone. Treatment protocol with high energy of 1800 mJ/P of fractional Er:YAG laser followed by topical betametsone solution.

ExcerptReferenceRelevance
"An experimental dog model was used to reproduce the clinical picture of bilateral arteriole and choriocapillaris occlusion from a unilateral intracarotid injection of long-acting corticosteroids combined with other drugs including lidocaine, epinephrine, and penicillin."( Bilateral retinal artery and choriocapillaris occlusion following the injection of long-acting corticosteroid suspensions in combination with other drugs: II. Animal experimental studies.
McGrew, RN; White, HJ; Wilson, RS, 1978
)
0.26
"This study was designed to compare the antiemetic effect of betamethasone alone with that of betamethasone combined with metoclopramide."( [Antiemetic efficacy of betamethasone versus betamethasone combined with metoclopramide in cisplatin-treated cancer patients].
Kagami, Y; Narimatsu, N; Nishio, M; Sakurai, T; Tomita, M, 1989
)
0.28
"To investigate the effect of Grenz ray therapy alone compared with Grenz rays combined with a topical corticosteroid (betamethasone dipropionate) in psoriasis of the scalp, 40 patients were randomized into two groups."( Psoriasis of the scalp treated with Grenz rays or topical corticosteroid combined with Grenz rays. A comparative randomized trial.
Johannesson, A; Lindelöf, B, 1988
)
0.27
"A double-blind comparative trial of acyclovir (ACV) and adenine arabinoside (ARA-A) in combination with dilute betamethasone was carried out in 30 patients with herpetic disciform keratitis."( A double-blind comparative trial of acyclovir and adenine arabinoside in combination with dilute betamethasone in the management of herpetic disciform keratitis.
Collum, LM; Grant, DM, 1987
)
0.27
" It is concluded that steroids in combination with UVB should be used only during the initial period in order to achieve a more rapid alleviation of symptoms and to avoid the side effects."( The effect on psoriasis of clobetasol propionate used alone or in combination with UVB.
Larkö, O; Svartholm, H; Swanbeck, G, 1984
)
0.27
" When combined with dilute steroid, acyclovir heals herpetic disciform keratitis and preliminary results of a double-blind clinical trial suggest that it may be more effective and less toxic than adenine arabinoside in the treatment of this condition."( Comparison of the efficacy and toxicity of acyclovir and of adenine arabinoside when combined with dilute betamethasone in herpetic disciform keratitis: preliminary results of a double-blind trial.
Collum, LM; Logan, P; O'Connor, M, 1983
)
0.27
" The pathogenesis of cilioretinal arterial obstruction combined with central retinal venous occlusion is not established."( Central retinal vein occlusion combined with occlusion of a cilioretinal artery. A case report.
Wrigstad, A, 1998
)
0.3
"1, 1, 5 and 10 mg/ml), phenylbutazone (1000 microgram/ml) and acetylsalicylic acid (25, 250, 2500 microgram/ml) alone, and combined with 10 mg/ml of ofloxacin on the respiratory burst."( [Effect of anti-inflammatory drugs, alone and combined with ofloxacin, on the respiratory burst of human polymorphonuclear leukocytes].
Cabrera, E; Cantón, E; Martínez, P; Orero, A; Velert, MM, 2001
)
0.31
"The therapeutic efficacy of the novel immunomodulator FTY720 (Fingolimod), alone and in combination with betamethasone ointment, was examined in the NC/Nga mouse model of spontaneous steroid-resistant dermatitis."( Therapeutic approach to steroid-resistant dermatitis using novel immunomodulator FTY720 (Fingolimod) in combination with betamethasone ointment in NC/Nga mice.
Fujita, T; Inoue, M; Iwatsuki, R; Kohno, T; Tsuji, T; Yoshida, Y, 2012
)
0.38
" We investigated the therapeutic efficacy of the novel immunomodulator FTY720 (Fingolimod), alone and in combination with betamethasone valerate ointment, in the NC/Nga mouse model of mite-induced intractable dermatitis."( [Therapeutic approach to mite-induced intractable dermatitis using novel immunomodulator FTY720 (fingolimod) in combination with betamethasone ointment in NC/Nga mice].
Fujita, T; Kohno, T; Tsuji, T; Yoshida, Y, 2012
)
0.38
" Group A (N = 95) was treated with chemonucleolysis only (the injection of oxygen-ozone combined with collagenase into the lumbar disc and the epidural space); group B (N = 97) was treated with chemonucleolysis and PCB."( CT-guided chemonucleolysis combined with psoas compartment block in lumbar disc herniation: a randomized controlled study.
Du, Y; Huang, YY; Li, B; Li, Y; Meng, J; Xu, XX; Yang, HF; Zhang, Q, 2014
)
0.4
"Computer tomography (CT)-guided chemonucleolysis combined with PCB leads to rapid pain relief, fewer postoperative pain of collagenase injection happen, and should be regarded as a useful treatment for the management of LDH."( CT-guided chemonucleolysis combined with psoas compartment block in lumbar disc herniation: a randomized controlled study.
Du, Y; Huang, YY; Li, B; Li, Y; Meng, J; Xu, XX; Yang, HF; Zhang, Q, 2014
)
0.4
" The present study was designed to investigate drug-drug interaction in a new combination cream which contains both tazarotene (TZRT) and betamethasone dipropionate (BTMSDP) by comparing the pharmacokinetic (PK) behaviors of TZRT, BTMSDP, and their major metabolites, tazarotenic acid (TZRTAC) and betamethasone (BTMS) with those in the commonly prescribed TZRT gel and BTMSDP cream."( Evaluation of change in the skin concentration of tazarotene and betamethasone dipropionate based on drug-drug interaction for transdermal drug delivery in miniature pig.
Chen, D; Ma, P; Yang, J; Yu, B; Yuan, L, 2015
)
0.42
" Also the effect of betamethasone in combination with some classes of antibiotics was evaluated."( Effect of betamethasone in combination with antibiotics on gram positive and gram negative bacteria.
Artini, M; Barbato, G; Cellini, A; Koverech, A; Papa, R; Selan, L; Tilotta, M,
)
0.13
"To investigate the effect of photodynamic therapy combined with compound betamethasone in the treatment of hypertrophic scar."( [Application of photodynamic therapy combined with compound betamethasone in treatment of hypertrophic scar].
Fang, F; Hong, Z; Meiling, L; Yan, Z, 2015
)
0.42
" The patients in treatment group were treated with photodynamic therapy combined with compound betamethasone injection therapy."( [Application of photodynamic therapy combined with compound betamethasone in treatment of hypertrophic scar].
Fang, F; Hong, Z; Meiling, L; Yan, Z, 2015
)
0.42
"047) CONCLUSIONS: Photodynamic therapy combined with compound betamethasone has good effect and safety for the treatment of hypertrophic scar."( [Application of photodynamic therapy combined with compound betamethasone in treatment of hypertrophic scar].
Fang, F; Hong, Z; Meiling, L; Yan, Z, 2015
)
0.42
"From October 2010 to June 2014, 31 infantile hemangioma patients admitted to our hospital, were administered propranolol combined with betamethasone injection treatment of lesions."( Treatment of infantile hemangioma by intralesional injection of propranolol combined with compound betamethasone.
Li, J; Shao, RZ; Zhao, DH, 2016
)
0.43
"Treatment of infantile hemangioma lesions with an injection of propranolol combined with betamethasone showed good efficacy."( Treatment of infantile hemangioma by intralesional injection of propranolol combined with compound betamethasone.
Li, J; Shao, RZ; Zhao, DH, 2016
)
0.43
" Treatment protocol with high energy of 1800 mJ/P of fractional Er:YAG laser followed by topical betamethasone solution and in combination with NB-UVB made 60% patients achieve marked to excellent improvement in white patches."( Fractional Er:YAG laser assisting topical betamethasone solution in combination with NB-UVB for resistant non-segmental vitiligo.
Chen, H; Chen, HD; Gao, XH; Li, YH; Wu, Y; Yan, R; Yuan, J, 2017
)
0.46
"To assess the effect of percutaneous endoscopic lumbar discectomy (PELD) combined with epidural injection for prolapsed lumbar disc herniation(PLDH)."( [Percutaneous endoscopic lumbar discectomy combined with epidural injection for prolapsed lumbar disc herniation].
Pang, QJ; Tang, T; Wang, Y; Wu, HH; Zhang, ZK, 2017
)
0.46
" And combination with epidural injection has the advantages of pain releasing and function improving in the short-term postoperative period, and it can decrease postoperative hospital stay and time of returning to work, and it is a safe and effective method."( [Percutaneous endoscopic lumbar discectomy combined with epidural injection for prolapsed lumbar disc herniation].
Pang, QJ; Tang, T; Wang, Y; Wu, HH; Zhang, ZK, 2017
)
0.46
"To observe and analyze the clinical effect of cervical paravertebral nerve block combined with Mailuoning and Angelica sinensis injection in treatment of nerve-root type cervical spondylosis."( Clinical effect of cervical paravertebral nerve block combined with Mailuoning and Angelica sinensis in treatment of nerve-root type cervical spondylosis.
Han, J; Li, Y; Liu, X; Yu, H; Zhang, J, 2018
)
0.48
"This prospective randomized study compared efficacy and tolerability as well as histological/immunohistochemical effects of liquid nitrogen contact cryosurgery as a single regimen (group A) and combined with intralesional corticosteroids (group B) on young (<2 years old), small (≤10 cm2) keloids in 40 patients (2-sided effect, α-error 1%, power 95%)."( Cryosurgery as a Single Agent and in Combination with Intralesional Corticosteroids Is Effective on Young, Small Keloids and Induces Characteristic Histological and Immunohistological Changes: A Prospective Randomized Trial.
Zouboulis, CC; Zouridaki, E, 2021
)
0.62
"To investigate the clinical efficacy of targeted injection of drugs surrounding the protruded lumbar disc in combination with the ozone in treatment of lumbar disc protrusion."( Clinical efficacy of targeted injection of drugs in combination with ozone in treatment of lumbar disc protrusion.
Guan, K; Li, GB; Li, PQ; Liang, XG; Yang, Y, 2020
)
0.56
" Building on earlier findings, we hypothesized that when administered in combination with slow-release betamethasone acetate, betamethasone phosphate and the high maternal-fetal betamethasone concentrations it generates are redundant for fetal lung maturation."( Betamethasone phosphate reduces the efficacy of antenatal steroid therapy and is associated with lower birthweights when administered to pregnant sheep in combination with betamethasone acetate.
Carter, S; Fee, EL; Furfaro, L; Jobe, AH; Kemp, MW; Newnham, JP; Saito, M; Schmidt, AF; Takahashi, T; Takahashi, Y; Usuda, H; Yaegashi, N, 2022
)
0.72
" This study aimed to retrospectively analyze the effects of halometasone cream combined with Simiao pill on the efficacy and expression of serum leukotriene B4 (LTB4) and thymic stromal lymphopoietin (TSLP) in patients with eczema, and identify the factors influencing its clinical efficacy."( Effect of halometasone cream combined with Simiao pill on the therapeutic effect and expression of serum leukotriene B4 (LTB4) and thymic stromal lymphopoietin (TSLP) in patients with eczema, and the factors influencing its clinical efficacy.
Cao, J; Ding, XJ; Liu, H, 2021
)
0.62
"We retrospectively collected the medical records of 195 patients with chronic eczema treated in the dermatology department from January 2020 to May 2021, and divided them into two groups according to medication: 98 cases were treated with halometasone cream (control group) and 97 cases were treated with halometasone ointment combined with Simiao pill (observation group)."( Effect of halometasone cream combined with Simiao pill on the therapeutic effect and expression of serum leukotriene B4 (LTB4) and thymic stromal lymphopoietin (TSLP) in patients with eczema, and the factors influencing its clinical efficacy.
Cao, J; Ding, XJ; Liu, H, 2021
)
0.62
"Simiao pill combined with halometasone cream can effectively improve chronic eczema and enhance the clinical efficacy of treatment, which may be related to the reduction of serum LTB4 and TSLP levels."( Effect of halometasone cream combined with Simiao pill on the therapeutic effect and expression of serum leukotriene B4 (LTB4) and thymic stromal lymphopoietin (TSLP) in patients with eczema, and the factors influencing its clinical efficacy.
Cao, J; Ding, XJ; Liu, H, 2021
)
0.62
" This pilot study assesses the effect of twice-weekly maintenance doses of Cal/BD foam after 4 weeks of standard once-daily treatment in combination with apremilast."( The Maintenance Effect of Calcipotriene 0.05% and Betamethasone Dipropionate 0.064% (Cal/BD) Aerosol Foam in Combination With Apremilast.
Kircik, L; Ozyurekoglu, E, 2022
)
0.72
" The purpose of this study was to evaluate whether ACB combined with a LIA cocktail of ropivacaine, morphine, and betamethasone has superior analgesic effect than LIA for TKA."( Adductor canal block combined with local infiltration analgesia with morphine and betamethasone show superior analgesic effect than local infiltration analgesia alone for total knee arthroplasty: a prospective randomized controlled trial.
Chen, X; Luo, ZY; Wang, HY; Xiao, Q; Yu, QP; Zeng, WN; Zhou, Z, 2022
)
0.72
" ACB combined with LIA had significantly lower resting and active VAS pain scores, better ROM, better sleeping quality and higher satisfaction rates than LIA alone within 72 h postoperatively (P < 0."( Adductor canal block combined with local infiltration analgesia with morphine and betamethasone show superior analgesic effect than local infiltration analgesia alone for total knee arthroplasty: a prospective randomized controlled trial.
Chen, X; Luo, ZY; Wang, HY; Xiao, Q; Yu, QP; Zeng, WN; Zhou, Z, 2022
)
0.72
"Adductor canal block combined with Local infiltration analgesia provide better early pain control."( Adductor canal block combined with local infiltration analgesia with morphine and betamethasone show superior analgesic effect than local infiltration analgesia alone for total knee arthroplasty: a prospective randomized controlled trial.
Chen, X; Luo, ZY; Wang, HY; Xiao, Q; Yu, QP; Zeng, WN; Zhou, Z, 2022
)
0.72
"Here, we treated a 3-year-old child with severe AA with microneedling combined with compound betamethasone."( Microneedling combined with compound betamethasone in treatment of severe alopecia areata: A case report.
Chen, L; Pei, D; Yao, Y; Zeng, L; Zhang, G, 2022
)
0.72
"To investigate the clinical efficacy and safety of microplasma radiofrequency technology combined with glucocorticoid injection in the treatment of hypertrophic scarring after early deep burns and scalding."( Clinical Observation of Microplasma Radiofrequency Technology Combined With Glucocorticoid Injection in the Treatment of Hundreds of Cases of Hypertrophic Scar After Early Deep Burn and Scald.
Hu, J; Li, Z; Liu, Y; Qu, C; Su, X; Wang, L; Zhan, S,
)
0.13
" The patients were treated with compound betamethasone injection (Group A), microplasma radiofrequency technique (Group B), and compound betamethasone injection combined with microplasma radiofrequency technology (Group C)."( Clinical Observation of Microplasma Radiofrequency Technology Combined With Glucocorticoid Injection in the Treatment of Hundreds of Cases of Hypertrophic Scar After Early Deep Burn and Scald.
Hu, J; Li, Z; Liu, Y; Qu, C; Su, X; Wang, L; Zhan, S,
)
0.13
"Microplasma radiofrequency combined with glucocorticoid injection in the treatment of hypertrophic scarring after early deep burns is effective, safe, and has a low incidence of adverse reactions, and it merits clinical promotion."( Clinical Observation of Microplasma Radiofrequency Technology Combined With Glucocorticoid Injection in the Treatment of Hundreds of Cases of Hypertrophic Scar After Early Deep Burn and Scald.
Hu, J; Li, Z; Liu, Y; Qu, C; Su, X; Wang, L; Zhan, S,
)
0.13

Bioavailability

The occluded vasoconstrictor assay was used to assess the effect of penetration enhancers on the topical bioavailability of a representative steroid, betamethasone 17-benzoate, with dimethylisosorbide (DMI) as a reference solvent. Bioavailability of betametasone from the phosphate ester was as high as after intravenous injection.

ExcerptReferenceRelevance
"Experiments were conducted to: (a) compare the bioavailability of betamethasone benzoate in a quick-break aerosol foam and semisolid dosage forms, (b) compare the activity of betamethasone benzoate, betamethasone valerate, clobetasol propionate, triamcinolone acetonide, desonide, flumethasoid reservoir formation in skin, and (d) assess the effect of a natural moisturizer."( Bioavailability and activity of topical corticosteroids from a novel drug delivery system, the aerosol quick-break foam.
Barry, BW; Woodford, R, 1977
)
0.26
"This paper review our modification of the vasoconstrictor (blanching) assay for topical corticosteroids using human volunteers, which we have improved and extended so that it may be used as a useful screening test for clinical efficacy besides being employed to determine the bioavailability of steroids from topical bases."( Bioavailability of topical steroids.
Barry, BW, 1976
)
0.26
"An ideal method for measuring the bioavailability of topical corticosteroids should be simple, accurate, and adaptable to a variety of settings and should not require extensive special training to perform."( New approaches to assess topical corticosteroid bioequivalence: pharmacokinetic evaluation.
Pershing, LK, 1992
)
0.28
" Bioavailability of drug from commercial cream and ointment formulations was assessed by quantification of drug content in tape-stripped stratum corneum and skin blanching in the treated skin site under occluded conditions."( Feasibility of measuring the bioavailability of topical betamethasone dipropionate in commercial formulations using drug content in skin and a skin blanching bioassay.
Krueger, GG; Pershing, LK; Shah, VP; Silver, BS; Skelley, JP, 1992
)
0.28
"The non-occluded vasoconstrictor test under thermodynamic control assessed the effect of penetration enhancers on the topical bioavailability of a model steroid betamethasone 17-benzoate, using aqueous dimethylisosorbide (DMI) as a standard solvent."( Optimization of bioavailability of topical steroids: non-occluded penetration enhancers under thermodynamic control.
Barry, BW; Bennett, SL; Woodford, R, 1985
)
0.27
" The molecular structure of diflorasone-17,21-diacetate and the specific pharmaceutical properties of the ointment and cream evidently guarantee a good bioavailability of the glucocorticosteroid in the skin."( [Topical treatment of glucocorticoid-sensitive dermatoses with diflorasone diacetate].
Rozman, TA, 1986
)
0.27
" Bioavailability of betamethasone from the phosphate ester was as high as after intravenous injection."( Disposition of betamethasone in parturient women after intramuscular administration.
Ashley, JJ; McBride, WG; Nation, RL; Petersen, MC, 1984
)
0.27
" If betamethasone was administered for 10 days and then stopped 4-13 days before these parameters were measured, a compensatory increase was found in 1-hydroxylase activity while the Ca absorption rate attained control values in all but the 4 day group in which it was still significantly depressed."( The effect of betamethasone on duodenal calcium absorption and 1,25-dihydroxy vitamin D3 production in the chick.
Blahos, J; Care, AD; Sommerville, BA, 1983
)
0.27
"The occluded vasoconstrictor assay was used to assess the effect of penetration enhancers on the topical bioavailability of a representative steroid, betamethasone 17-benzoate, with dimethylisosorbide (DMI) as a reference solvent."( Optimization of bioavailability of topical steroids: penetration enhancers under occlusion.
Barry, BW; Southwell, D; Woodford, R, 1984
)
0.27
" The absorption rate constant (j) increased with decreasing particle size."( Studies on the absorption of practically water-insoluble drugs following injection VI: Subcutaneous absorption from aqueous suspensions in rats.
Hirano, K; Yamada, H, 1982
)
0.26
"The quantitative structure-bioavailability relationship of 232 structurally diverse drugs was studied to evaluate the feasibility of constructing a predictive model for the human oral bioavailability of prospective new medicinal agents."( QSAR model for drug human oral bioavailability.
Topliss, JG; Yoshida, F, 2000
)
0.31
" Higher efficiency of garasone can be attributed to the advantages of its components: wide-spectrum gentamicin and its high bioavailability for the eyeball tissues and an effective steroid betamethasone."( [Experience of garasone use in surgical practice].
Karlova, IZ; Neroev, VV; Zaĭtseva, OV,
)
0.13
" Such a formulation may provide convenience and enhanced activity compared with separate applications, but it is essential that the biological activity and bioavailability of either active agent is not adversely affected by the other component."( Bioavailability of betamethasone dipropionate when combined with calcipotriol.
Traulsen, J, 2004
)
0.32
"His study was designed to determine whether the bioavailability of the corticosteroid component of Daivobet was equivalent to that in a corticosteroid-only formulation (Diprosone, Schering-Plough Laboratories, France)."( Bioavailability of betamethasone dipropionate when combined with calcipotriol.
Traulsen, J, 2004
)
0.32
" We hypothesized that betamethasone treatment and chorioamnionitis would alter the bioavailability of placental glucocorticoids through the regulation of the 11beta hydroxysteroid dehydrogenase (11beta HSD) isozymes and the glucocorticoid receptor (GR)."( The effects of chorioamnionitis and betamethasone on 11beta hydroxysteroid dehydrogenase types 1 and 2 and the glucocorticoid receptor in preterm human placenta.
Bocking, AD; Challis, JR; Johnstone, JF; Unlugedik, E, 2005
)
0.33
"Labetalol had no clinically relevant influence on the bioavailability (AUC) of atosiban."( Pharmacokinetic interaction studies of atosiban with labetalol or betamethasone in healthy female volunteers.
Larsen, LS; Rasmussen, BB; Senderovitz, T, 2005
)
0.33
"The co-administration of atosiban with betamethasone or labetalol had no clinically relevant influence on their bioavailability or tolerability."( Pharmacokinetic interaction studies of atosiban with labetalol or betamethasone in healthy female volunteers.
Larsen, LS; Rasmussen, BB; Senderovitz, T, 2005
)
0.33
" The purpose of the study was to investigate the topical bioavailability of different topical corticosteroid formulations in healthy human beings focussing on desoximetasone (DM)."( Activity of different desoximetasone preparations compared to other topical corticosteroids in the vasoconstriction assay.
Borelli, C; Fluhr, JW; Gassmueller, J; Korting, HC; Nietsch, KH; Schinzel, S, 2008
)
0.35
" Good topical bioavailability of both DM formulations was detected by chromametric measurement and clinical assessment."( Activity of different desoximetasone preparations compared to other topical corticosteroids in the vasoconstriction assay.
Borelli, C; Fluhr, JW; Gassmueller, J; Korting, HC; Nietsch, KH; Schinzel, S, 2008
)
0.35
" Moreover, the alcohol-free aerosol foam formulation allows a higher penetration of the active ingredients into the skin, resulting in enhanced bioavailability and, consequently, in better clinical outcomes than other products with the same components."( Back to the future: a new topical approach for mild-to-moderate psoriasis.
Calzavara Pinton, P; Cicchetti, A; Cristaudo, A; Girolomoni, G, 2018
)
0.48
"The main aim of the present work was to formulate and evaluate hydrogel-based drug delivery containing combination of neomycin sulphate and betamethasone sodium phosphate in order to provide prolonged release and also better bioavailability of drugs for the treatment of eye infections."( Novel hydrogel-based ocular drug delivery system for the treatment of conjunctivitis.
Deepthi, S; Jose, J, 2019
)
0.51
" This enhanced penetration improves local bioavailability and, consequently, Cal/BD aerosol foam therapy is associated with improved clinical outcomes if compared with other products with the same components."( Calcipotriene plus betamethasone dipropionate in aerosol foam formulation: will this effective treatment for mild-to-moderate psoriasis change clinical practice?
Giacomelli, L; Giovene, GL, 2018
)
0.48
" RO-2 as one of the potent and orally bioavailable compounds was evaluated in various models of autoimmune disorder."( Discovery and pharmacological evaluation of indole derivatives as potent and selective RORγt inverse agonist for multiple autoimmune conditions.
Bala, M; Bhuniya, D; Gavhane, R; Iyer, JP; Jamdar, V; Joshi, S; Kandikere, V; Kulkarni, B; Lohote, M; Meru, A; Mookhtiar, KA; Mukhopadhyay, PP; Munot, YS; Nagaraj, R; Petla, R; Raje, AA; Reddy, S; Rouduri, S; Shaikh, NS; Sherkar, P; Umrani, D, 2019
)
0.51
"Oral Dex-P had lower bioavailability than Beta-P, giving a lower maximum maternal and fetal concentration."( Oral antenatal corticosteroids evaluated in fetal sheep.
Bridges, JP; Clarke, M; Fee, EL; Jobe, AH; Kannan, PS; Kemp, MW; Kumagai, Y; Newnham, JP; Saito, M; Schmidt, AF; Usuda, H, 2019
)
0.51
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51
" For this purpose, cutaneous bioavailability was investigated with the Franz chamber test using a tritium-labeled drug depending on the previous application of a keratolytic agent."( Influence of keratolytics on cutaneous pharmacokinetics of glucocorticoids.
Wohlrab, J, 2021
)
0.62
"The targeted selection of a keratolytic can optimize the therapeutic effect and influence the bioavailability of sequentially applied topicals."( Influence of keratolytics on cutaneous pharmacokinetics of glucocorticoids.
Wohlrab, J, 2021
)
0.62
" When applied, Cal/BD foam forms a supersaturated solution on the skin, increasing the penetration and bioavailability of Cal and BD."( Early efficacy and safety data with fixed-dose combination calcipotriol/betamethasone dipropionate foam attributed to mechanism of absorption and steroid potency.
Iversen, L; Koo, J; Tada, Y, 2021
)
0.62
" Additionally, an ∼85% correlation was obtained between PAMPA pH 5 permeability and in vivo oral bioavailability in mice and rats."( Using in vitro ADME data for lead compound selection: An emphasis on PAMPA pH 5 permeability and oral bioavailability.
Itkin, M; Kabir, M; Mathé, EA; Nguyễn, ÐT; Padilha, EC; Shah, P; Shinn, P; Siramshetty, V; Wang, AQ; Williams, J; Xu, X; Yu, KR; Zhao, T, 2022
)
0.72

Dosage Studied

An intravenous bolus of betamethasone, at an approximate dosage of 3 mg/kg, was administered to 20 patients with septic shock. Sixty gravid CD-1 mice were randomly assigned to receive one of six treatment regimens (n = 10) that consisted of a single or a double SC dosing.

ExcerptRelevanceReference
"5 months of synthetic ACTH-Z medication at either of these dosage levels, the response of urinary 17-KGS was found to have decreased to about 1/2 of its level at the beginning of medication."( [A clinical study on the effect of extrinsic corticotropin on the pituitary-adrenocortical function (author's transl)].
Mori, M, 1978
)
0.26
"Experiments were conducted to: (a) compare the bioavailability of betamethasone benzoate in a quick-break aerosol foam and semisolid dosage forms, (b) compare the activity of betamethasone benzoate, betamethasone valerate, clobetasol propionate, triamcinolone acetonide, desonide, flumethasoid reservoir formation in skin, and (d) assess the effect of a natural moisturizer."( Bioavailability and activity of topical corticosteroids from a novel drug delivery system, the aerosol quick-break foam.
Barry, BW; Woodford, R, 1977
)
0.26
" Emphases of the description are general principles of treatment, indications and dosage in systemic and local treatment, side effects, problems of long-term treatment, application of ACTH, the cortisonoid withdrawal syndrome, prophylaxis of therapy complications and references to the reduction of the dose or to the withdrawal of the treatment with cortisonoids."( [Cortisonoids in the therapy of rheumatic diseases].
Reinicke, C, 1977
)
0.26
" In venous and arterial strips, dose-response curves to epinephrine, norepinephrine, serotonin, or histamine were established in the absence and in the presence of corticosteroid."( Corticosteroid-potentiated vascular responses of the equine digit: a possible pharmacologic basis for laminitis.
Elmes, PJ; Eyre, P; Strickland, S, 1979
)
0.26
" Quantitation is described for betamethasone sodium phosphate in dosage forms in the presence of polar excipients."( Analysis of steroid phosphates by high-pressure liquid chromatography: betamethasone sodium phosphate.
Sancilio, FD; Townley, ER; Upton, LM, 1978
)
0.26
" Steroid was also effective but reduction of the dosage resulted in worsening of symptoms."( [A steroid-effective case with "prolonged" cerebellar ataxia].
Aso, K; Haga, Y; Kito, M; Maeda, N; Negoro, T; Okumura, A; Watanabe, K, 1992
)
0.28
" A skin biopsy was taken at 24 h after each dosing with UVB."( Synergistic effects of oral nonsteroidal drugs and topical corticosteroids in the therapy of sunburn in humans.
Bohan, DF; Caruana, C; Francom, SF; Holland, M; Hughes, GS; Means, LK, 1992
)
0.28
" Antirheumatic therapy therefore requires strict adherence to the prescribed indications and careful selection of the specific drug type and dosage regimen."( [Glucocorticoids].
Hayashi, T, 1992
)
0.28
"An open clinical trial was carried out in order to establish to what extent the application of topical corticosteroids with the UVB therapy influences the complete dosage of the UVB radiation required for the clearing of psoriasis and the duration of remission."( [Evaluation of the effect of local corticosteroids in the phototherapy of psoriasis].
Basta-Juzbasić, A; Dobrić, I; Mustac-Gotovac, M; Paljan, D; Pasić, A, 1991
)
0.28
"9 years (min 33, max 93) were given intranasal sCT at the dosage regimen of 200 IU/day/6 months."( [Use of salmon calcitonin nasal spray in the prevention of corticosteroid-induced osteoporosis in bullous diseases].
Cappio, F; Caputo, R; Colombo, MD, 1990
)
0.28
"The dose-response effect of thyrotropin-releasing hormone in enhancing pulmonary maturation was investigated with six dosing regimens."( Dose response of thyrotropin-releasing hormone on pulmonary maturation in corticosteroid-treated preterm rabbits.
Ikegami, M; Jobe, AH; Oetomo, SB; Tabor, BL; Yamada, T, 1990
)
0.28
" The animals were sacrificed 20 hrs after the last drug dosage and the lung membrane homogenates were prepared for 3H-dihydroalprenolol (3H-DHA) binding in vitro."( Concomitant glucocorticoid treatment prevents the development of beta-adrenoceptor desensitization in the guinea pig lung.
Salonen, RO, 1985
)
0.27
" RU 28 362 was more potent than either hydrocortisone or betamethasone, but all three glucocorticoids had a parallel dose-response curve in suppression of the increase in cell volume that occurs with activation during the first day in culture."( Suppression of growth of PHA-stimulated human lymphocytes by a novel steroid (RU 28 362) lacking the 21-OH group.
Beck, JS; Brown, RA; Deraedt, R; Potts, RC, 1987
)
0.27
" An oral 50 gm, 1-hour glucose challenge test was done 48 hours after terbutaline dosing began."( Carbohydrate intolerance in patients receiving oral tocolytics.
Angel, JL; Knuppel, RA; Morales, WJ; O'Brien, WF; Sims, CJ, 1988
)
0.27
" The naproxen dosage was 250 mg per day for two weeks."( Randomized trial of oral naproxen or local injection of betamethasone in lateral epicondylitis of the humerus.
Eriksson, E; Saartok, T, 1986
)
0.27
" Of 59 patients originally enrolled in the study, 38 assessable patients achieved clearing of at least 85% improvement from baseline with traditional betamethasone in OV twice a day for two to three weeks before intermittent pulse dosing was attempted."( Betamethasone dipropionate in optimized vehicle. Intermittent pulse dosing for extended maintenance treatment of psoriasis.
Grivna, EM; Hien, NT; Katz, HI; Prawer, SE; Scott, JC, 1987
)
0.27
" However, spontaneous premature labor is associated with accelerated lung maturation, and accordingly the present results do not contradict the use of a low dosage of betasympathomimetic drug to delay preterm delivery."( Effects of betamethasone and ritodrine on the fetal secretion of lung surfactant.
Hallman, M; Raivio, K; Sipinen, S; Teramo, K, 1985
)
0.27
" At a dosage of 400 to 800 mug/day for three months there was no evidence of suppression of hypothalamic-pituitary-adrenal function, as assessed by tetracosactrin and insulin stress tests."( Steroid aerosols in asthma: an assessment of betamethasone valerate and a 12-month study of patients on maintenance treatment.
Kochanowski, SJ; McAllen, MK; Shaw, KM, 1974
)
0.25
" Five glucocorticoids, when administered daily to rats for 5-7 days at a dosage of 5mg/kg, were in the following order of effectiveness with respect to their ability to decrease the weight gain of whole animals and the vastus lateralis, vastus medialis and gluteus medius muscles: corticosterone( Relative changes in the function of muscle ribosomes and mitochondria during the early phase of steroid-induced catabolism.
Bullock, GR; Carter, EE; Elliott, P; Peters, RF; Simpson, P; White, AM, 1972
)
0.25
" These results show that a low intravenous dosage of betamethason and collection of blood samples for E3 assays in intervals of 12 hours can be used as a functional test of the fetoplacental unit."( [The betamethasone test in the diagnosis of placental insufficiency].
Bernaschek, G; Bieglmayer, C; Friedrich, F, 1983
)
0.27
"5-1 mg/kg) at a dosage which increased both surfactant synthesis and release did not alter pulmonary receptor concentration."( Glucocorticoids increase pulmonary beta-adrenergic receptors in fetal rabbit.
Ballard, PL; Cheng, JB; Goldfien, A; Roberts, JM, 1980
)
0.26
"An intravenous bolus of betamethasone, at an approximate dosage of 3 mg/kg, was administered to 20 patients with septic shock."( Betamethasone sodium phosphate injection: high-dose regimen in septic shock.
Lederer, V, 1984
)
0.27
" It was evaluated in a group of 18 normal subjects to determine whether it exerted any systemic glucocorticoid activity after single oral or intrarectal doses and after short-term dosing by the intranasal route."( Tixocortol pivalate, a corticosteroid with no systemic glucocorticoid effect after oral, intrarectal, and intranasal application.
Bolte, E; Du Souich, P; Goyer, R; Larochelle, P; Lelorier, J, 1983
)
0.27
" Dose-response data for dilutions of clobetasol propionate and betamethasone 17-valerate showed progressive diminution of both local and systemic effects with decreasing concentrations."( The effect on epidermal DNA synthesis of a combination of topical steroid with either dithranol or tar as used for psoriasis.
Clement, M; du Vivier, A; Hehir, M; Phillips, H, 1983
)
0.27
" Plasma concentrations of betamethasone reached a peak 5-37 min after dosing with betamethasone phosphate, then declined biexponentially with a mean terminal half-life of 262 min."( Disposition of betamethasone in parturient women after intravenous administration.
Ashley, JJ; Collier, CB; McBride, WG; Nation, RL; Petersen, MC, 1983
)
0.27
" It is suggested that high dosage corticosteroids may damage the posterior blood-ocular barrier."( Central serous chorioretinopathy complicating systemic corticosteroid treatment.
Ishikawa, S; Wakakura, M, 1984
)
0.27
" Definite dose-response relations were found for rT3."( Dose related effects of betamethasone on iodothyronines and thyroid hormone-binding proteins in serum.
Gamstedt, A; Järnerot, G; Kågedal, B, 1981
)
0.26
" It is proposed that clinically the most advantageous dosage regimen is a once daily application with no loading dose."( Possible dosage regimens for topical steroids, assessed by vasoconstrictor assays using multiple applications.
Barry, BW; Haigh, JM; Woodford, R, 1983
)
0.27
" It is suggested that the dosage of corticosteroid should be adjusted according to the severity of uveomeningitis."( Systemic corticosteroid treatment in Vogt-Koyanagi-Harada disease.
Hayasaka, S; Okabe, H; Takahashi, J, 1982
)
0.26
" A dosage schedule of 15 mg/kg intravenously as an initial single dose is proposed, and will provide adequate therapeutic levels for 48 hours in the preterm infant and for 24 hours in the term infant."( Pharmacokinetics and tissue distribution of metronidazole in the new born infant.
Baird-Lambert, J; Buchanan, N; Cvejic, M; Doyle, PE; Jager-Roman, E, 1982
)
0.26
" Two oral corticosteroids, prednisolone (8 mg/day) and betamethasone (1 mg/day) have been compared in terms of efficacy and adrenal suppressive activity when used in chronic oral dosage in rheumatoid arthritis."( A pharmacological and clinical comparison of prednisolone and betamethasone in rheumatoid arthritis.
Al-Shakarchi, H; Bird, HA; Dixon, JS; Lowe, JR; Marwah, RJ; Pickup, ME; Wright, V, 1982
)
0.26
" Betamethasone was administered before 34 weeks of gestation according to dosage schedules which have been shown to alter the incidence of respiratory distress syndrome."( Antenatal betamethasone and renal ammoniagenesis in the newborn.
Goodyer, PR; Lazaro-Lopez, F; Papageorgiou, AN, 1981
)
0.26
"Intra-articular injection of betamethasone suspension at the dosage and delivery rate used had no harmful effects on the TMJs of nondiseased adult female goats."( The effects of intra-articular deposition of betamethasone in the goat temporomandibular joint.
Kwon, PH; Oyen, OJ; Ryan, DE; Sewall, SR, 1995
)
0.29
" At variance with the biphasic dose-response curves (positive effects at low-medium doses, negative at high doses) previously obtained with cortisol in a similar model, only negative effects on every variable studied were observed in this experiment."( Monophasic dose-response curves of betamethasone on geometric and mechanical properties of femur diaphyses in growing rats.
Capozza, RF; Cointry, GR; Delgado, CJ; Ferretti, JL; Zanchetta, JR, 1995
)
0.29
" We describe four methods for assessing the dose-response relationship of topical betamethasone dipropionate on the ventral forearm of six human subjects: duration, concentration, film thickness, and surface area."( Topical 0.050% betamethasone dipropionate. Pharmacokinetic and pharmacodynamic dose-response studies in humans.
Lambert, L; Pershing, LK; Shah, VP; Williams, RL; Wright, ED, 1994
)
0.29
" The prolonged changes in skin color measured with a single dose applied at 1600 h suggest that a once-a-day dosing regimen in the late afternoon may be sufficient for dermatologic therapy."( Circadian activity of topical 0.05% betamethasone dipropionate in human skin in vivo.
Corlett, JL; Lambert, LD; Pershing, LK; Poncelet, CE, 1994
)
0.29
" The remaining patients (group A, n = 10) were given diclofenac in a dosage of 150 mg per day for three days then 75 mg per day for three days."( Corticosteroid therapy for the treatment of acute attacks of crystal-induced arthritis: an effective alternative to nonsteroidal antiinflammatory drugs.
Gabay, C; Vischer, TL; Werlen, D, 1996
)
0.29
"Although administration of exogenous corticosteroids accelerates the late gestational rise in fetal rat and lamb lung antioxidant enzyme activity, the effect of dosing intervals on these responses remains uncertain."( Higher lung antioxidant enzyme activity persists after single dose of corticosteroids in preterm lambs.
David-Cu, R; Ikegami, M; Jobe, AH; Mehta, EI; Polk, DH; Walther, FJ, 1996
)
0.29
" Potency estimates were made by comparing the dose-response of natural and synthetic glucocorticoids to that of corticosterone, the major glucocorticoid in rats."( Calcium-lowering action of glucocorticoids in adrenalectomized-parathyroidectomized rats. Specificity and relative potency of natural and synthetic glucocorticoids.
Hirsch, PF; Mahgoub, A; Munson, PL, 1997
)
0.3
" The enhanced response with repetitive dosing indicates that the process of glucocorticoid-induced lung maturation is either reversible and/or gestational age dependent."( Glucocorticoid regulation of surfactant components in immature lambs.
Ballard, PL; Ikegami, M; Jobe, AH; Ning, Y; Polk, D, 1997
)
0.3
"The determination of active compounds in samples of dissolution tests of oral solid dosage forms based on the USP 23 methods was performed by capillary electrophoresis after the use of solid-phase extraction disks for the preconcentration of drugs."( Development and validation of capillary electrophoresis methods for pharmaceutical dissolution assays.
Carducci, CN; Fernández Otero, GC; Lucangioli, SE; Rodríguez, VG; Vizioli, NM,
)
0.13
" The effect of five different concentrations of diltiazem was evaluated to obtain dose-response curves."( The effect of topical diltiazem on the intraocular pressure in betamethasone-induced ocular hypertensive rabbits.
Melena, J; Santafé, J; Segarra, J, 1998
)
0.3
"5 mg/kg betamethasone intravenously 24 hours before delivery (single-dose), four CDH lambs of ewes similarly dosed at 48 and 24 hours before delivery (double-dose), five untreated CDH lambs and five control lambs were studied."( Lung physiological and metabolic changes in lambs with congenital diaphragmatic hernia after administration of prenatal maternal corticosteroids.
Glick, PL; Holm, BA; Irish, MS; Kapur, P; Patel, A; Sokolowski, J, 1999
)
0.3
" Further timing and dosage studies are warranted in this model."( Lung physiological and metabolic changes in lambs with congenital diaphragmatic hernia after administration of prenatal maternal corticosteroids.
Glick, PL; Holm, BA; Irish, MS; Kapur, P; Patel, A; Sokolowski, J, 1999
)
0.3
"The complete separation of a composite mixture that consisted of Betamethasone Dipropionate (BMD), Clotrimazole and their derivatives in a pharmaceutical dosage form was achieved within 15 min using sodium dodecyl sulfate (SDS) micellar electrokinetic chromatography (MEKC)."( Comparison between micellar electrokinetic chromatography and HPLC for the determination of Betamethasone Dipropionate, Clotrimazole and their related substances.
Lin, M; Wu, N, 1999
)
0.3
" Although DB/GB and betaxolol equally delayed or prevented the onset of glaucoma in the second eye, a less frequent dosing schedule for DB/GB suggests demecarium bromide in combination with a topical corticosteroid may be preferable to betaxolol in preventing PCAG in dogs."( The efficacy of topical prophylactic antiglaucoma therapy in primary closed angle glaucoma in dogs: a multicenter clinical trial.
Herrmann, MK; Miller, PE; Schmidt, GM; Swanson, JF; Vainisi, SJ,
)
0.13
" Patients were categorized into two groups according to betamethasone exposure: (1) two 12-mg doses in a 24-hour interval on admission (single-course group) and (2) repeated dosing after the initial single course (multiple-course group)."( Neonatal sepsis and death after multiple courses of antenatal betamethasone therapy.
Newman, RB; Soper, DE; Vermillion, ST, 2000
)
0.31
"We sought to compare lung mechanics in infants treated with multiple courses of antenatal corticosteroids with those in matched control infants delivered >7 days from dosing and those of matched untreated infants."( Timing of antenatal corticosteroids and neonatal pulmonary mechanics.
Bowling, S; Collins, J; Maher, J; McEvoy, C; Tolaymat, L; Williamson, K, 2000
)
0.31
"Eighteen infants who received multiple courses of corticosteroids and were delivered within 7 days of dosing were matched with 18 infants who received 1 course of corticosteroids >7 days before delivery (remote) and 18 untreated infants."( Timing of antenatal corticosteroids and neonatal pulmonary mechanics.
Bowling, S; Collins, J; Maher, J; McEvoy, C; Tolaymat, L; Williamson, K, 2000
)
0.31
"Babies delivered after multiple courses of corticosteroids and within 7 days of dosing demonstrated improved respiratory compliance compared with untreated and remotely treated infants."( Timing of antenatal corticosteroids and neonatal pulmonary mechanics.
Bowling, S; Collins, J; Maher, J; McEvoy, C; Tolaymat, L; Williamson, K, 2000
)
0.31
"A multiple unit dosage form for oral delivery based on the microencapsulation of anti-inflammatory drugs using different biodegradable polymers, poly(epsilon-caprolactone), polylactic acid and poly(lactic-co-glycolic acid), prepared either by the water-in-oil-in-water (w/o/w) or the solid-in-oil-in-water (s/o/w) solvent evaporation method was developed."( Biodegradable microparticles as a two-drug controlled release formulation: a potential treatment of inflammatory bowel disease.
Lamprecht, A; Lehr, CM; Rodero Torres, H; Schäfer, U, 2000
)
0.31
"To determine optimal dosage regimens of intranasal metered dose aerosolized surfactant with and without other medications in the treatment of otitis media with effusion (OME)."( Dosage regimens of intranasal aerosolized surfactant on otitis media with effusion in an animal model.
Chandrasekhar, SS; Connelly, PE; Mautone, AJ; Troublefield, YL; Venkatayan, N, 2001
)
0.31
" Resolution with the once-daily dosage was longer for all conditions."( Dosage regimens of intranasal aerosolized surfactant on otitis media with effusion in an animal model.
Chandrasekhar, SS; Connelly, PE; Mautone, AJ; Troublefield, YL; Venkatayan, N, 2001
)
0.31
" Twice-daily dosing was statistically superior."( Dosage regimens of intranasal aerosolized surfactant on otitis media with effusion in an animal model.
Chandrasekhar, SS; Connelly, PE; Mautone, AJ; Troublefield, YL; Venkatayan, N, 2001
)
0.31
"This study reiterates the effectiveness of OME treatment with an aerosolized synthetic surfactant with and without steroids and establishes a superior twice-daily dosage schedule."( Dosage regimens of intranasal aerosolized surfactant on otitis media with effusion in an animal model.
Chandrasekhar, SS; Connelly, PE; Mautone, AJ; Troublefield, YL; Venkatayan, N, 2001
)
0.31
" Multiple logistic regression was performed to examine the effect of each steroid dosing regimen on respiratory distress syndrome."( Effectiveness of a rescue dose of antenatal betamethasone after an initial single course.
Bland, ML; Soper, DE; Vermillion, ST, 2001
)
0.31
" The physician-grader was blinded to the treatment regimen, and the subjects were randomly assigned to either once-daily or twice-daily dosing in a 1:1 ratio."( Betamethasone valerate in foam vehicle is effective with both daily and twice a day dosing: a single-blind, open-label study in the treatment of scalp psoriasis.
Bartruff, JK; Del Rosso, J; Feldman, SR; Fleischer, AB; Jones, E; Kaplan, R; Kpea, N; Levin, DL; McMichael, A; Ravis, SM; Shavin, J; Weiss, J,
)
0.13
" The dosage was 50 microg two dose unit sprays and BSP 500 microg, each 4 times daily."( Fluticasone propionate spray and betamethasone sodium phosphate mouthrinse: a randomized crossover study for the treatment of symptomatic oral lichen planus.
Hegarty, AM; Hodgson, TA; Lewsey, JD; Porter, SR, 2002
)
0.31
" Every other week for 8 weeks, one shoulder in each rat was injected with methylprednisolone, betamethasone, or saline in a dosage equivalent to that used in humans."( Effects of methylprednisolone and betamethasone injections on the rotator cuff: an experimental study in rats.
Akpinar, S; Demirors, H; Hersekli, MA; Kayaselcuk, F; Tandogan, RN,
)
0.13
" An increased steroid dosage improved his hypercalcemia and genital lesions."( Sarcoidosis with bilateral epididymal and testicular lesions.
Hamada, K; Handa, T; Hoshino, Y; Ito, I; Izumi, T; Mishima, M; Nagai, S; Shigematsu, M, 2003
)
0.32
"Antenatal corticotherapy is responsible for two different phases of fetal heart rate modifications that do not vary according to the corticosteroid or the dosage regimen."( Immediate and delayed effects of antenatal corticosteroids on fetal heart rate: a randomized trial that compares betamethasone acetate and phosphate, betamethasone phosphate, and dexamethasone.
Devos, P; Leclerc, G; Puech, F; Subtil, D; Therby, D; Tiberghien, P; Vaast, P, 2003
)
0.32
" Should the findings of this study be confirmed in randomized controlled trials, the dosage regimen could be simplified, steroid administration reduced and the interval from delivery reduced in acute clinical conditions."( Efficacy of a single dose of antenatal steroid in surfactant-treated babies under 31 weeks' gestation.
Ferguson, SD; Reghu, A; Sen, S, 2002
)
0.31
"Although antenatal glucocorticoids are standard of care for women at risk of preterm delivery before 32 to 34 weeks' gestation, the choice and dosing of the corticosteroid has not been standardized."( Choice and dose of corticosteroid for antenatal treatments.
Jobe, AH; Soll, RF, 2004
)
0.32
"Dexamethasone and betamethasone achieved similar dose-response patterns of surfactant protein-B expression in vitro."( The effects of dexamethasone and betamethasone on surfactant protein-B messenger RNA expression in human type II pneumocytes and human lung adenocarcinoma cells.
Alcorn, JL; Bishop, KD; Gilstrap, LC; Jenkins, GN; Ramin, SM; Vidaeff, AC, 2004
)
0.32
" Intermittent dosing with potent topical steroids and/or combination therapy with steroid and tacrolimus have been frequently used in the daily management of AD to overcome the problems accompanying the long term use of steroids."( Intermittent topical corticosteroid/tacrolimus sequential therapy improves lichenification and chronic papules more efficiently than intermittent topical corticosteroid/emollient sequential therapy in patients with atopic dermatitis.
Fukagawa, S; Furue, M; Koga, T; Nakahara, T; Uchi, H, 2004
)
0.32
" Fourteen clinically healthy, privately owned, small-breed dogs with normal ears and normal adrenocorticotropin (ACTH) stimulation tests were assigned to one of two treatment groups, receiving one of the medications at the manufacturer's recommended dosage twice daily for 2 weeks."( Evaluation of adrenal function in small-breed dogs receiving otic glucocorticoids.
Ghubash, R; Kunkle, G; Marsella, R, 2004
)
0.32
" In light of this newly identified long terminal half-life for the betamethasone dual formulation, dosing practices for betamethasone in pregnancy need to be reassessed."( Betamethasone pharmacokinetics after two prodrug formulations in sheep: implications for antenatal corticosteroid use.
Grant, A; Jusko, WJ; Lohle, M; Nathanielsz, PW; Samtani, MN, 2005
)
0.33
"To determine any differences in neonatal outcomes when dosing betamethasone every 12 hours vs."( Neonatal outcomes with different betamethasone dosing regimens: a comparison.
Fry, EA; Haas, DM; McCullough, W; McNamara, MF; Olsen, CH; Richard, J; Shiau, DT, 2005
)
0.33
"Outcomes using a 12-hour dosing schedule of betamethasone were similar to those using a 24-hour regimen in this retrospective review."( Neonatal outcomes with different betamethasone dosing regimens: a comparison.
Fry, EA; Haas, DM; McCullough, W; McNamara, MF; Olsen, CH; Richard, J; Shiau, DT, 2005
)
0.33
" Beginning at week 8, if synovitis was present, the methotrexate dosage was increased stepwise up to 20 mg/week, with a subsequent stepwise increase in the cyclosporine or placebo-cyclosporine dosage up to 4 mg/kg."( Combination treatment with methotrexate, cyclosporine, and intraarticular betamethasone compared with methotrexate and intraarticular betamethasone in early active rheumatoid arthritis: an investigator-initiated, multicenter, randomized, double-blind, par
Andersen, LS; de Carvalho, A; Ellingsen, T; Hansen, G; Hansen, I; Hetland, ML; Hørslev-Petersen, K; Junker, P; Lauridsen, UB; Lindegaard, H; Lottenburger, T; Pedersen, JK; Pødenphant, J; Skjødt, H; Stengaard-Pedersen, K; Svendsen, A; Tarp, U; Østergaard, M, 2006
)
0.33
"To compare neonatal outcomes when dosing betamethasone every 12 hours compared to the standard 24-hour dosing regimen when premature deliveries occur within 48 hours of presentation."( The first 48 hours: Comparing 12-hour and 24-hour betamethasone dosing when preterm deliveries occur rapidly.
Haas, DM; McCullough, W; McNamara, MF; Olsen, C, 2006
)
0.33
" Separating the results into delivery from 0-24 and 24-48 hour groups, there were no significant differences between the 12-hour and 24-hour dosing groups, although small sample size limited conclusions."( The first 48 hours: Comparing 12-hour and 24-hour betamethasone dosing when preterm deliveries occur rapidly.
Haas, DM; McCullough, W; McNamara, MF; Olsen, C, 2006
)
0.33
" After using the same medication with different dosage schemes, a retrospective analysis was carried out to assess the efficacy of topical steroids in the treatment of tight phimosis."( Phimosis and topical steroids: new clinical findings.
Bianchi, S; Camoglio, FS; Corroppolo, M; Zampieri, N; Zuin, V, 2007
)
0.34
"Beta-PO4 alone is ineffective with the dosing schedule used; Beta-Ac can induce lung maturation."( Betamethasone for lung maturation: testing dose and formulation in fetal sheep.
Ikegami, M; Jobe, AH; Kallapur, SG; Moss, TJ; Newnham, JP; Nitsos, I, 2007
)
0.34
" In the first set, the inactiveness and mortality of the mussels in different drugs were studied through two different dosages and in subsequent tests the fixation of dosage was employed."( Differential growth of the freshwater mussel, Lamellidens marginalis in relation to certain drugs.
Mishra, RK; Mishra, S; Nayak, L; Sahu, BK; Senga, Y, 2008
)
0.35
" It has been reported that treatment of the steroid-induced psychiatric symptoms involves dosage reduction or discontinuation of steroid, and concomitant administration of psychotropics."( Can "steroid switching" improve steroid-induced psychosis in a patient with advanced cancer?
Ito, N; Okishiro, N; Tanimukai, H; Tsuneto, S, 2009
)
0.35
"Betamethasone dipropionate is an active pharmaceutical ingredient (API) that is used in various dosage forms of finished products for the treatment of inflammatory disorders."( Rapid structure elucidation of drug degradation products using mechanism-based stress studies in conjunction with LC-MS(n) and NMR spectroscopy: identification of a photodegradation product of betamethasone dipropionate.
Buevich, AV; Li, M; Lin, M; Osterman, R; Rustum, AM, 2009
)
0.35
" Perhaps individualized dosing of antenatal corticosteroids is needed to further improve neonatal outcomes."( Maternal ethnicity influences on neonatal respiratory outcomes after antenatal corticosteroid use for anticipated preterm delivery.
Haas, DM; McCullough, W; Simsiman, AJ; Sischy, AC, 2011
)
0.37
" For example, a new formulation of calcipotriene/betamethasone scalp solution has a rapid onset of action with once daily dosing that improves compliance."( Scalp psoriasis.
Kircik, LH; Kumar, S, 2010
)
0.36
"Individualization of betamethasone dosing by maternal LBW reduces variability in drug exposure."( Betamethasone in pregnancy: influence of maternal body weight and multiple gestation on pharmacokinetics.
Della Torre, M; Fischer, JH; Hibbard, JU; Jeong, H, 2010
)
0.36
"Randomized controlled trials comparing any corticosteroid with placebo, no treatment, or other drug; or comparing one corticosteroid with another corticosteroid or dosage in women with HELLP syndrome."( Corticosteroids for HELLP (hemolysis, elevated liver enzymes, low platelets) syndrome in pregnancy.
Chandra, S; Dowswell, T; Hofmeyr, GJ; Woudstra, DM, 2010
)
0.36
" Aim of this study was to evaluate the minimum therapeutically effective dosage of betamethasone on neurological symptoms of A-T."( Efficacy of very-low-dose betamethasone on neurological symptoms in ataxia-telangiectasia.
Broccoletti, T; Bruscoli, S; Cirillo, E; Del Giudice, E; Giardino, G; Ginocchio, VM; Pignata, C; Riccardi, C; Vigliano, I, 2011
)
0.37
"Our data indicate that betamethasone is effective in A-T at a minimal dosage and that GILZ may be a useful biomarker of the clinical response."( Efficacy of very-low-dose betamethasone on neurological symptoms in ataxia-telangiectasia.
Broccoletti, T; Bruscoli, S; Cirillo, E; Del Giudice, E; Giardino, G; Ginocchio, VM; Pignata, C; Riccardi, C; Vigliano, I, 2011
)
0.37
" We propose the use of CTZ at the dosage of 30 mg/daily."( Therapeutic hotline. Effectiveness of the association of cetirizine and topical steroids in lichen planus pilaris--an open-label clinical trial.
d'Ovidio, R; Di Prima, TM; Rossi, A,
)
0.13
" Using this information, we calculated dose-response curves, IC(50) values, and K(d) values to evaluate each drug's K(i) value."( Pharmacokinetic features of difluprednate ophthalmic emulsion in rabbits as determined by glucocorticoid receptor-binding bioassay.
Kida, T; Sakaki, H; Tajika, T; Tsuzuki, M; Waki, M, 2011
)
0.37
" The subjects were the RA or SpA patients with the knee arthritis without deformity, moderate or severe bone erosion and obvious joint space narrowing in radiography in the target knees, who had taken at least 6-week therapy with routine dosage of disease modifying anti-rheumatic drugs (DMARDs) before the study."( [A randomized, single-blind, parallel, controlled clinical study on single intra-articular injection of etanercept in treatment of inflammatory knee arthritis].
Guo, JH; Huang, F; Liang, DF; Yang, CH; Zhang, H; Zhang, JL; Zhao, Z, 2010
)
0.36
"Etanercept is approved for the treatment of plaque psoriasis at a subcutaneous (SC) dosage of 50 mg twice-weekly for three months, followed by 50 mg SC once-weekly thereafter."( Topical calcipotriene 0.005% and betamethasone dipropionate 0.064% maintains efficacy of etanercept after step-down dose in patients with moderate-to-severe plaque psoriasis: results of an open label trial.
Kircik, LH, 2011
)
0.37
"We sought to determine whether the incidence of neonatal respiratory distress syndrome (RDS) is similar with 12- vs 24-hour dosing interval of betamethasone."( Betamethasone dosing interval: 12 or 24 hours apart? A randomized, noninferiority open trial.
Chang, E; Hansen, C; Hunter, K; Khandelwal, M; Milcarek, B, 2012
)
0.38
" However, increased incidence of necrotizing enterocolitis was seen with 12-hour dosing (6."( Betamethasone dosing interval: 12 or 24 hours apart? A randomized, noninferiority open trial.
Chang, E; Hansen, C; Hunter, K; Khandelwal, M; Milcarek, B, 2012
)
0.38
"The 12-hour dosing interval is equivalent to the 24-hour dosing interval for prevention of RDS in neonates of mothers delivering prematurely."( Betamethasone dosing interval: 12 or 24 hours apart? A randomized, noninferiority open trial.
Chang, E; Hansen, C; Hunter, K; Khandelwal, M; Milcarek, B, 2012
)
0.38
"To estimate the effect of multiple courses of antenatal corticosteroids on neonatal size, controlling for gestational age at birth and other confounders, and to determine whether there was a dose-response relationship between number of courses of antenatal corticosteroids and neonatal size."( Effect of antenatal corticosteroids on fetal growth and gestational age at birth.
Amankwah, K; Armson, BA; Asztalos, E; Delisle, MF; Gafni, A; Guselle, P; Hannah, ME; Kelly, EN; Lee, SK; Matthews, SG; Murphy, KE; Ohlsson, A; Ross, S; Saigal, S; Willan, AR, 2012
)
0.38
" Finally, a dose-response relationship exists between the number of corticosteroid courses and a decrease in fetal growth."( Effect of antenatal corticosteroids on fetal growth and gestational age at birth.
Amankwah, K; Armson, BA; Asztalos, E; Delisle, MF; Gafni, A; Guselle, P; Hannah, ME; Kelly, EN; Lee, SK; Matthews, SG; Murphy, KE; Ohlsson, A; Ross, S; Saigal, S; Willan, AR, 2012
)
0.38
"The objective of this study was to compare the effects of two betamethasone dosage regimens on selected parameters in mothers and on the status of the preterm newborn."( Dosage regimen of antenatal steroids prior to preterm delivery and effects on maternal and neonatal outcomes.
Czajkowski, K; Oleszczuk, L; Romejko-Wolniewicz, E; Zaręba-Szczudlik, J, 2013
)
0.39
" The betamethasone dosage regimen used did not affect the incidence of moderate and severe respiratory disorders, intraventricular hemorrhage (IVH), necrotizing enterocolitis (NEC), retinopathy (ROP), infection, hyperbilirubinemia or anemia in neonates."( Dosage regimen of antenatal steroids prior to preterm delivery and effects on maternal and neonatal outcomes.
Czajkowski, K; Oleszczuk, L; Romejko-Wolniewicz, E; Zaręba-Szczudlik, J, 2013
)
0.39
"Although the 12-h and 24-h dosing intervals are equivalent with respect to prevention of respiratory distress syndrome, the former enables the completion of treatment in 50% more neonates delivered prematurely."( Antenatal steroids: can we optimize the dose?
Czajkowski, K; Romejko-Wolniewicz, E; Teliga-Czajkowska, J, 2014
)
0.4
"The short-term and long-term effects of the dosage regimen on the pregnant mother and foetus remain unclear."( Antenatal steroids: can we optimize the dose?
Czajkowski, K; Romejko-Wolniewicz, E; Teliga-Czajkowska, J, 2014
)
0.4
" A serial dose-response (around 10(-8 )M), in vitro study was used to examine the effect of DEX, BETA and IL-10, on proinflammatory (PI) cytokine release, phagocytosis and respiratory burst."( Anti-inflammatory actions of endogenous and exogenous interleukin-10 versus glucocorticoids on macrophage functions of the newly born.
Davidson, D; Kasat, K; Patel, H; Predtechenska, O; Vancurova, I, 2014
)
0.4
" Fourier transform infrared spectroscopy and thermal analysis confirmed drug entrapment, while cytotoxicity studies performed in vitro on human keratinocytes, Saccharomyces cerevisiae models and Artemia salina, showed a dose-response relationship for nanoparticles and free drug."( Polymeric nanoparticles modified with fatty acids encapsulating betamethasone for anti-inflammatory treatment.
Ascensão, L; Fernandes, AS; Figueiredo, IV; Molpeceres, J; Reis, CP; Rijo, P; Roberto, A; Silva, CO, 2015
)
0.42
" Results in the BET group suggest that investigation into types, dose, and dosage schedule of glucocorticoids may facilitate placental maturation."( Localization of TGF-β and TGF-β receptor in bovine term placentome and expression differences between spontaneous and induced parturition.
Fujii, T; Fukuda, S; Hirayama, H; Kageyama, S; Koyama, K; Naito, A; Sawai, K, 2015
)
0.42
"Five different chemometric methods were developed for the simultaneous determination of betamethasone dipropionate (BMD), clotrimazole (CT) and benzyl alcohol (BA) in their combined dosage form (Lotriderm® cream)."( Full spectrum and selected spectrum based multivariate calibration methods for simultaneous determination of betamethasone dipropionate, clotrimazole and benzyl alcohol: Development, validation and application on commercial dosage form.
Abdelaleem, Ael-B; Darwish, HW; Elzanfaly, ES; Saad, AS, 2016
)
0.43
" Compared to the dexchlorpheniramine plus betamethasone combination, it showed similar clinical action, but with a lower incidence of adverse events and higher dosing convenience."( Association between desloratadine and prednisolone in the treatment of children with acute symptoms of allergic rhinitis: a double-blind, randomized and controlled clinical trial.
Amazonas, RB; Ensina, LF; Miranda, C; Sano, F; Silva, JMD; Solé, D; Wandalsen, GF,
)
0.13
"Antenatal steroids are standard of care for women who are at risk of preterm delivery; however, antenatal steroid dosing and formulation have not been evaluated adequately."( Low-dose betamethasone-acetate for fetal lung maturation in preterm sheep.
Furfaro, L; Jobe, AH; Kallapur, SG; Kannan, PS; Kemp, MW; Kramer, BW; Newnham, JP; Rittenschober-Böhm, J; Saito, M; Schmidt, AF; Stock, S; Usuda, H; Watanabe, S, 2018
)
0.48
" The aim of this multicenter study, performed with a blind evaluation procedure, was to define the minimal effective dosage of oral betamethasone, thus preventing the occurrence of side effects."( Minimum effective betamethasone dosage on the neurological phenotype in patients with ataxia-telangiectasia: a multicenter observer-blind study.
Cappellari, AM; Cirillo, E; Del Giudice, E; Dell'Era, L; Dellepiane, RM; Micheli, R; Pession, A; Pietrogrande, MC; Pignata, C; Plebani, A; Soresina, A; Specchia, F, 2018
)
0.48
" Antenatal corticosteroid dosing regimens remain unoptimized and without maternal weight-adjusted dosing."( The efficacy of antenatal steroid therapy is dependent on the duration of low-concentration fetal exposure: evidence from a sheep model of pregnancy.
Clarke, M; Eddershaw, PJ; Furfaro, L; Hanita, T; Ireland, D; Jobe, AH; Kemp, MW; Kumagai, Y; Molloy, TJ; Musk, GC; Newnham, JP; Payne, MS; Saito, M; Sato, S; Schmidt, A; Usuda, H; Watanabe, S, 2018
)
0.48
" These findings underscore the need to develop an optimized steroid dosing regimen that may improve both the efficacy and safety of antenatal corticosteroids therapy."( The efficacy of antenatal steroid therapy is dependent on the duration of low-concentration fetal exposure: evidence from a sheep model of pregnancy.
Clarke, M; Eddershaw, PJ; Furfaro, L; Hanita, T; Ireland, D; Jobe, AH; Kemp, MW; Kumagai, Y; Molloy, TJ; Musk, GC; Newnham, JP; Payne, MS; Saito, M; Sato, S; Schmidt, A; Usuda, H; Watanabe, S, 2018
)
0.48
" A fast reversed-phase high-performance liquid chromatography method has been developed for the simultaneous determination of three betamethasone esters-containing binary mixtures along with the excipients of their dosage forms using clobetasone butyrate as internal standard."( Simultaneous HPLC Determination of Betamethasone Esters-Containing Mixtures: Analysis of Their Topical Preparations.
Elkady, EF; Hassib, ST; Mahrouse, MA; Sayed, RM, 2018
)
0.48
" Suboptimal administration included any betamethasone dosing that did not meet the optimal criteria."( Analysis of clinical diagnosis for all patients receiving antenatal betamethasone in a community hospital.
Amicone, LA; Hannah, DM; Martinez, FJ; Taboada, CD; Tressler, TB; Wert, Y, 2018
)
0.48
" oral dexamethasone versus oral prednisone), with consideration for dosing and pharmacokinetic properties, to better identify the optimal IM or oral corticosteroid regimens to improve patient outcomes."( Intramuscular versus oral corticosteroids to reduce relapses following discharge from the emergency department for acute asthma.
Campbell, S; Cross, E; Kirkland, SW; Rowe, BH; Villa-Roel, C, 2018
)
0.48
"Conventional dosage form like eye drops showed poor therapeutic response and also require frequent dosing."( Novel hydrogel-based ocular drug delivery system for the treatment of conjunctivitis.
Deepthi, S; Jose, J, 2019
)
0.51
"Two chromatographic methods were developed, optimized and validated for simultaneous determination of calcipotriol monohydrate (CPM) and betamethasone dipropionate (BMD) in the presence of two dosage form additives named; butylated hydroxytoluene (BHT) and alpha-tocopherol (TOCO)."( Validated Chromatographic Methods for Simultaneous Determination of Calcipotriol Monohydrate and Betamethasone Dipropionate in the Presence of Two Dosage Form Additives.
El-Mosallamy, SS; El-Zeany, BA; Hassan, NY; Merey, HA, 2019
)
0.51
" Hence, dosage of topical steroids should be adjusted in its therapeutic range to prevent their ocular and systemic side effects."( Systemic toxicity of topical corticosteroids.
Gupta, PC; Jinagal, J; Pilania, RK; Ram, J, 2019
)
0.51
" Although betamethasone, predominantly used in developed countries, has been shown to be an effective and safe intervention for reducing neonatal mortality, the choice of ACS and optimal dosing in low and middle income countries (LMICs) remains unclear."( Evaluation of Maternal Drug Exposure Following the Administration of Antenatal Corticosteroids During Late Pregnancy Using Physiologically-Based Pharmacokinetic Modeling.
Ke, AB; Milad, MA, 2019
)
0.51
" This chapter explores some contemporary controversies with ACS, including the choice of corticosteroid, use in threatened preterm birth less than 24 weeks' gestation, use in late preterm birth, use at term before cesarean delivery, and issues surrounding repeated and rescue dosing of antenatal corticosteroids."( Controversies in antenatal corticosteroids.
Grasch, JL; Haas, DM; Quinney, SK; Shanks, AL, 2019
)
0.51
" We report the pharmacokinetics and pharmacodynamics of oral dosing of ACS using a preterm sheep model."( Oral antenatal corticosteroids evaluated in fetal sheep.
Bridges, JP; Clarke, M; Fee, EL; Jobe, AH; Kannan, PS; Kemp, MW; Kumagai, Y; Newnham, JP; Saito, M; Schmidt, AF; Usuda, H, 2019
)
0.51
"Using a sheep model, we demonstrate the use of pharmacokinetics to develop oral dosing strategies for ACS."( Oral antenatal corticosteroids evaluated in fetal sheep.
Bridges, JP; Clarke, M; Fee, EL; Jobe, AH; Kannan, PS; Kemp, MW; Kumagai, Y; Newnham, JP; Saito, M; Schmidt, AF; Usuda, H, 2019
)
0.51
" Antenatal corticosteroid dosing remains nonoptimized, and there is little understanding of how different treatment-to-delivery intervals may affect treatment efficacy."( The duration of fetal antenatal steroid exposure determines the durability of preterm ovine lung maturation.
Bridges, J; Eddershaw, PJ; Fee, EL; Furfaro, L; Hanita, T; Jobe, AH; Kemp, MW; Kumagai, Y; Musk, GC; Newnham, JP; Payne, MS; Saito, M; Sato, S; Schmidt, AF; Smallwood, K; Stinson, L; Takahashi, T; Usuda, H; Watanabe, S, 2020
)
0.56
" First, we performed pharmacokinetic studies in non-pregnant monkeys to compare blood levels of the steroids using oral dosing with Beta-P, Dex-P and an effective maternal intramuscular dose of the beta-acetate component of the clinical treatment."( Oral dosing for antenatal corticosteroids in the Rhesus macaque.
Bridges, JP; Clarke, MW; Jobe, AH; Kannan, PS; Kemp, MW; Milad, M; Miller, LA; Schmidt, AF, 2019
)
0.51
" Trying to take into account both efficacy and safety, we simulated different dosing schemes in order to maintain a maximum of fetuses above 1 ng/mL without exceeding the total standard dose."( Maternal Betamethasone for Prevention of Respiratory Distress Syndrome in Neonates: Population Pharmacokinetic and Pharmacodynamic Approach.
Benaboud, S; Bouazza, N; Foissac, F; Goffinet, F; Hirt, D; Jarreau, PH; Kayem, G; Lui, G; Mandelbrot, L; Rozenberg, P; Tréluyer, JM; Ville, Y; Zheng, Y, 2020
)
0.56
" There is a marked variation in antenatal steroid dosing strategy, selection for treatment criteria, and agent choice worldwide."( Variability in the efficacy of a standardized antenatal steroid treatment was independent of maternal or fetal plasma drug levels: evidence from a sheep model of pregnancy.
Carter, S; Clarke, M; Fee, EL; Hanita, T; Ikeda, H; Jobe, AH; Kemp, MW; Koshinami, S; Kumagai, Y; Newnham, JP; Saito, M; Sato, S; Schmidt, AF; Takahashi, T; Takahashi, Y; Usuda, H; Watanabe, S; Yaegashi, N, 2020
)
0.56
" Given concerns regarding current antenatal corticosteroids dosing patterns, there is an urgent need for randomized controlled trials examining lower versus standard double doses of antenatal corticosteroids."( Neonatal and Maternal Outcomes of Lower Versus Standard Doses of Antenatal Corticosteroids for Women at Risk of Preterm Delivery: A Systematic Review of Randomized Controlled Trials.
Beyene, J; McDonald, SD; Morfaw, F; Murphy, KE; Ninan, K, 2021
)
0.62
" The size and number of the aggregates was determined for undiluted commercial steroid preparations in the usual amount for a single and double dosage used for ESI."( Microscopic Study of Injectable Steroids: Effects of Postmixing Time on Particle Aggregation.
Alvarez-Escudero, J; Cedeno, DL; Martinez, MF; Nebreda-Clavo, C; Orduna-Valls, JM; Ruiz-Sauri, A; Tornero-Tornero, C; Valverde-Navarro, AA, 2020
)
0.56
"We firstly showed that high dosage of Pidotimod could be an effective and safe to reduce the PFAPA attacks in children."( Proposal for a new therapeutic high dosage of Pidotimod in children with periodic fever, aphthous stomatitis, pharyngitis, adenitis (PFAPA) syndrome: a randomized controlled study.
Barone, P; Filosco, F; Finocchiaro, GG; Giugno, A; Leonardi, S; Manti, S; Papale, M; Parisi, GF, 2020
)
0.56
" Betamethasone and dexamethasone are the most widely used drugs, with similar effectiveness and a recommended dosage of 24mg in divided doses, over a 24- hour period."( Efficacy and Safety of Corticosteroids' Administration for Pulmonary Immaturity in Anticipated Preterm Delivery.
Athanasiadis, A; Dagklis, T; Papazisis, G; Tsakiridis, I, 2021
)
0.62
"Betamethasone (BMZ) is used to accelerate fetal lung maturation in women with threatened preterm birth, but its efficacy is variable and limited by the lack of patient individualization in its dosing and administration."( Do maternal demographics and prenatal history impact the efficacy of betamethasone therapy for threatened preterm labor?
Haas, DM; Ibrahim, SA; Kinney, MT; Quinney, SK; Silva, LL; Trussell, HK, 2021
)
0.62
" Associations between RDS diagnosis and maternal demographics, prenatal history, and betamethasone dosing were evaluated in a case-control analysis and multivariable regression adjusted for gestational age at delivery."( Do maternal demographics and prenatal history impact the efficacy of betamethasone therapy for threatened preterm labor?
Haas, DM; Ibrahim, SA; Kinney, MT; Quinney, SK; Silva, LL; Trussell, HK, 2021
)
0.62
" However, among 101 deliveries within 14 days of betamethasone dosing and controlling for gestational age at birth, women who experienced preterm premature rupture of membranes (PPROM) had lower RDS rates than those without PPROM (57."( Do maternal demographics and prenatal history impact the efficacy of betamethasone therapy for threatened preterm labor?
Haas, DM; Ibrahim, SA; Kinney, MT; Quinney, SK; Silva, LL; Trussell, HK, 2021
)
0.62
"A 12-hour dosing interval for betamethasone appears to be more appropriate, as it results in a reduction in some neonatal complications and provides a short dose interval."( The Effect of Betamethasone Dosing Interval on Perinatal Outcomes: 12 Hours or 24 Hours Apart.
Aydin, E; Bulut, AN; Ceyhan, V; Cundubey, CR, 2023
)
0.91
" However, the optimal (maximum benefit and minimal risk of side effects) antenatal corticosteroid dosing strategy remains unclear."( Betamethasone phosphate reduces the efficacy of antenatal steroid therapy and is associated with lower birthweights when administered to pregnant sheep in combination with betamethasone acetate.
Carter, S; Fee, EL; Furfaro, L; Jobe, AH; Kemp, MW; Newnham, JP; Saito, M; Schmidt, AF; Takahashi, T; Takahashi, Y; Usuda, H; Yaegashi, N, 2022
)
0.72
"Using an established sheep model of prematurity and postnatal ventilation of the preterm lamb, we aimed to compare the pharmacodynamic effects of low-dosage treatment with betamethasone acetate only against a standard dosage of betamethasone phosphate and betamethasone acetate as recommended by the American College of Obstetricians and Gynecologists for women at risk of imminent preterm delivery between 24 0/7 and 35 6/7 weeks' gestation."( Betamethasone phosphate reduces the efficacy of antenatal steroid therapy and is associated with lower birthweights when administered to pregnant sheep in combination with betamethasone acetate.
Carter, S; Fee, EL; Furfaro, L; Jobe, AH; Kemp, MW; Newnham, JP; Saito, M; Schmidt, AF; Takahashi, T; Takahashi, Y; Usuda, H; Yaegashi, N, 2022
)
0.72
" Improvements in disease severity outcomes were maintained after reducing Cal/BD dosing frequency."( Adjunctive Use of Calcipotriene 0.005%/Betamethasone Dipropionate 0.064% Foam in Patients With Psoriasis Treated With Ixekizumab.
Bagel, J; Nelson, E, 2022
)
0.72
" Twice-weekly maintenance application of topical Cal/BD aerosolized foam has recently been shown to prolong time to remission and is associated with fewer relapses in patients initially treated with standard dosing of the formulation."( The Maintenance Effect of Calcipotriene 0.05% and Betamethasone Dipropionate 0.064% (Cal/BD) Aerosol Foam in Combination With Apremilast.
Kircik, L; Ozyurekoglu, E, 2022
)
0.72
" A monotonic dose-response relation between BM exposure and activity of the ANS and IQ was estimated in post-hoc analyses."( Association between antenatal glucocorticoid exposure and the activity of the stress system, cognition, and behavior in 8- to 9-year-old children: A prospective observational study.
Dreiling, M; Groten, T; Hoyer, D; Hoyer, H; Kozik, V; Ligges, C; Muth, I; Rakers, F; Rupprecht, S; Schiecke, K; Schleußner, E; Schwab, M, 2022
)
0.72
" In insulin-treated women the increase in insulin dosage was of 61."( Glycemic profile assessment during betamethasone administration in women with twin pregnancies after IVF with or without gestational diabetes.
Ilias, I; Kakoulidis, I; Koukkou, E; Linardi, A; Michou, A; Stergiotis, S; Togias, S, 2022
)
0.72
" Among singletons, exposure to the full dosage (i."( Late preterm antenatal corticosteroids in singleton and twin gestations: a retrospective cohort study.
Dolan, SM; Gross, SJ; Kao, YH; Lau, YK; Li, L; Li, S; Schadt, EE; Stone, JL; Tsevdos, DS; Vieira, LA; Wang, Z; Zheutlin, AB, 2022
)
0.72
" Simulations of maternal plasma concentrations for the dosing regimens of BET and DEX recommended by the World Health Organization based on our findings revealed up to 60% lower exposures than found in nonpregnant women and offers a means of devising alternative dosing regimens."( Minimal physiologically-based hybrid model of pharmacokinetics in pregnant women: Application to antenatal corticosteroids.
Jobe, AH; Jusko, WJ; Krzyzanski, W; Milad, MA, 2023
)
0.91
"Despite widespread use, dosing regimens for antenatal corticosteroid (ACS) therapy are poorly unoptimized."( A Reduction in Antenatal Steroid Dose Was Associated with Reduced Cardiac Dysfunction in a Sheep Model of Pregnancy.
Fee, EL; Furfaro, L; Hamada, H; Hanita, T; Ikeda, H; Jobe, AH; Kemp, MW; Kumagai, Y; Newnham, JP; Saito, M; Sato, S; Schmidt, AF; Takahashi, T; Takahashi, Y; Usuda, H; Watanabe, S; Yaegashi, N, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (3)

RoleDescription
anti-inflammatory drugA substance that reduces or suppresses inflammation.
anti-asthmatic agentAny compound that has anti-asthmatic effects.
immunosuppressive agentAn agent that suppresses immune function by one of several mechanisms of action. Classical cytotoxic immunosuppressants act by inhibiting DNA synthesis. Others may act through activation of T-cells or by inhibiting the activation of helper cells. In addition, an immunosuppressive agent is a role played by a compound which is exhibited by a capability to diminish the extent and/or voracity of an immune response.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (9)

ClassDescription
21-hydroxy steroid
glucocorticoidGlucocorticoids are a class of steroid hormones that regulate a variety of physiological processes, in particular control of the concentration of glucose in blood.
20-oxo steroidAn oxo steroid carrying an oxo group at position 20.
21-hydroxy steroid
17alpha-hydroxy steroidThe alpha-stereoisomer of 17-hydroxy steroid.
fluorinated steroidA steroid which is substituted with one or more fluorine atoms in any position.
11beta-hydroxy steroidAny 11-hydroxy steroid in which the hydroxy group at position 11 has beta- configuration.
3-oxo-Delta(1),Delta(4)-steroidA 3-oxo-Delta(1) steroid containing an additional double bond between positions 4 and 5.
primary alpha-hydroxy ketoneAn alpha-hydroxy ketone in which the carbonyl group and the hydroxy group are linked by a -CH2 (methylene) group.
tertiary alpha-hydroxy ketoneAn alpha-hydroxy ketone in which the carbonyl group and the hydroxy group are linked by a carbon bearing two organyl groups.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (32)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
chromobox protein homolog 1Homo sapiens (human)Potency100.00000.006026.168889.1251AID540317
nuclear factor erythroid 2-related factor 2 isoform 2Homo sapiens (human)Potency0.02310.00419.984825.9290AID504444
pregnane X receptorRattus norvegicus (Norway rat)Potency17.78280.025127.9203501.1870AID651751
GLI family zinc finger 3Homo sapiens (human)Potency9.43920.000714.592883.7951AID1259392
AR proteinHomo sapiens (human)Potency0.01510.000221.22318,912.5098AID1259243; AID1259247; AID1259381; AID588515; AID743036; AID743040; AID743042; AID743053; AID743054
progesterone receptorHomo sapiens (human)Potency10.00730.000417.946075.1148AID1346784; AID1346795; AID1347036
cytochrome P450 family 3 subfamily A polypeptide 4Homo sapiens (human)Potency12.58930.01237.983543.2770AID1346984
glucocorticoid receptor [Homo sapiens]Homo sapiens (human)Potency0.02950.000214.376460.0339AID588532; AID720691; AID720692; AID720719
estrogen-related nuclear receptor alphaHomo sapiens (human)Potency64.86010.001530.607315,848.9004AID1224848; AID1224849
farnesoid X nuclear receptorHomo sapiens (human)Potency33.48890.375827.485161.6524AID743220
pregnane X nuclear receptorHomo sapiens (human)Potency43.27710.005428.02631,258.9301AID1346982
estrogen nuclear receptor alphaHomo sapiens (human)Potency0.02310.000229.305416,493.5996AID1259244; AID743069; AID743080; AID743091
vitamin D (1,25- dihydroxyvitamin D3) receptorHomo sapiens (human)Potency1.99530.023723.228263.5986AID588543
IDH1Homo sapiens (human)Potency3.66260.005210.865235.4813AID686970
aryl hydrocarbon receptorHomo sapiens (human)Potency15.59780.000723.06741,258.9301AID743085; AID743122
cytochrome P450, family 19, subfamily A, polypeptide 1, isoform CRA_aHomo sapiens (human)Potency0.01460.001723.839378.1014AID743083
nuclear receptor subfamily 1, group I, member 2Rattus norvegicus (Norway rat)Potency14.12540.10009.191631.6228AID1346983
thyroid hormone receptor beta isoform aHomo sapiens (human)Potency5.01190.010039.53711,122.0200AID588547
nuclear factor erythroid 2-related factor 2 isoform 2Homo sapiens (human)Potency0.01080.00419.984825.9290AID504444; AID720524
nuclear factor erythroid 2-related factor 2 isoform 1Homo sapiens (human)Potency27.30600.000627.21521,122.0200AID651741
Voltage-dependent calcium channel gamma-2 subunitMus musculus (house mouse)Potency0.08410.001557.789015,848.9004AID1259244
Glutamate receptor 2Rattus norvegicus (Norway rat)Potency0.08410.001551.739315,848.9004AID1259244
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
galanin receptor type 3Homo sapiens (human)IC50 (µMol)29.90000.00661.54317.3650AID687013
ATP-binding cassette sub-family C member 3Homo sapiens (human)IC50 (µMol)133.00000.63154.45319.3000AID1473740
Multidrug resistance-associated protein 4Homo sapiens (human)IC50 (µMol)133.00000.20005.677410.0000AID1473741
Bile salt export pumpHomo sapiens (human)IC50 (µMol)134.00000.11007.190310.0000AID1443980; AID1473738
Glucocorticoid receptorHomo sapiens (human)IC50 (µMol)0.00770.00000.495310.0000AID625263
Glucocorticoid receptorHomo sapiens (human)Ki0.00350.00010.38637.0010AID625263
Glycine receptor subunit alpha-1Rattus norvegicus (Norway rat)IC50 (µMol)0.00770.00150.76005.0740AID625263
Glycine receptor subunit alpha-1Rattus norvegicus (Norway rat)Ki0.00350.00070.76537.0010AID625263
Glycine receptor subunit betaRattus norvegicus (Norway rat)IC50 (µMol)0.00770.00150.76005.0740AID625263
Glycine receptor subunit betaRattus norvegicus (Norway rat)Ki0.00350.00070.78467.0010AID625263
Glycine receptor subunit alpha-2Rattus norvegicus (Norway rat)IC50 (µMol)0.00770.00150.80445.0740AID625263
Glycine receptor subunit alpha-2Rattus norvegicus (Norway rat)Ki0.00350.00070.78467.0010AID625263
Glycine receptor subunit alpha-3Rattus norvegicus (Norway rat)IC50 (µMol)0.00770.00150.76005.0740AID625263
Glycine receptor subunit alpha-3Rattus norvegicus (Norway rat)Ki0.00350.00070.78467.0010AID625263
Canalicular multispecific organic anion transporter 1Homo sapiens (human)IC50 (µMol)133.00002.41006.343310.0000AID1473739
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Activation Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
ORF73Human gammaherpesvirus 8EC50 (µMol)75.00000.06008.134632.1400AID435023
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (72)

Processvia Protein(s)Taxonomy
xenobiotic metabolic processATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
bile acid and bile salt transportATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transportATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
leukotriene transportATP-binding cassette sub-family C member 3Homo sapiens (human)
monoatomic anion transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transport across blood-brain barrierATP-binding cassette sub-family C member 3Homo sapiens (human)
prostaglandin secretionMultidrug resistance-associated protein 4Homo sapiens (human)
cilium assemblyMultidrug resistance-associated protein 4Homo sapiens (human)
platelet degranulationMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic metabolic processMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
bile acid and bile salt transportMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transportMultidrug resistance-associated protein 4Homo sapiens (human)
urate transportMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
cAMP transportMultidrug resistance-associated protein 4Homo sapiens (human)
leukotriene transportMultidrug resistance-associated protein 4Homo sapiens (human)
monoatomic anion transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
export across plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
transport across blood-brain barrierMultidrug resistance-associated protein 4Homo sapiens (human)
guanine nucleotide transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
fatty acid metabolic processBile salt export pumpHomo sapiens (human)
bile acid biosynthetic processBile salt export pumpHomo sapiens (human)
xenobiotic metabolic processBile salt export pumpHomo sapiens (human)
xenobiotic transmembrane transportBile salt export pumpHomo sapiens (human)
response to oxidative stressBile salt export pumpHomo sapiens (human)
bile acid metabolic processBile salt export pumpHomo sapiens (human)
response to organic cyclic compoundBile salt export pumpHomo sapiens (human)
bile acid and bile salt transportBile salt export pumpHomo sapiens (human)
canalicular bile acid transportBile salt export pumpHomo sapiens (human)
protein ubiquitinationBile salt export pumpHomo sapiens (human)
regulation of fatty acid beta-oxidationBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transportBile salt export pumpHomo sapiens (human)
bile acid signaling pathwayBile salt export pumpHomo sapiens (human)
cholesterol homeostasisBile salt export pumpHomo sapiens (human)
response to estrogenBile salt export pumpHomo sapiens (human)
response to ethanolBile salt export pumpHomo sapiens (human)
xenobiotic export from cellBile salt export pumpHomo sapiens (human)
lipid homeostasisBile salt export pumpHomo sapiens (human)
phospholipid homeostasisBile salt export pumpHomo sapiens (human)
positive regulation of bile acid secretionBile salt export pumpHomo sapiens (human)
regulation of bile acid metabolic processBile salt export pumpHomo sapiens (human)
transmembrane transportBile salt export pumpHomo sapiens (human)
negative regulation of transcription by RNA polymerase IIGlucocorticoid receptorHomo sapiens (human)
regulation of gluconeogenesisGlucocorticoid receptorHomo sapiens (human)
chromatin organizationGlucocorticoid receptorHomo sapiens (human)
regulation of DNA-templated transcriptionGlucocorticoid receptorHomo sapiens (human)
apoptotic processGlucocorticoid receptorHomo sapiens (human)
chromosome segregationGlucocorticoid receptorHomo sapiens (human)
signal transductionGlucocorticoid receptorHomo sapiens (human)
glucocorticoid metabolic processGlucocorticoid receptorHomo sapiens (human)
gene expressionGlucocorticoid receptorHomo sapiens (human)
microglia differentiationGlucocorticoid receptorHomo sapiens (human)
adrenal gland developmentGlucocorticoid receptorHomo sapiens (human)
regulation of glucocorticoid biosynthetic processGlucocorticoid receptorHomo sapiens (human)
synaptic transmission, glutamatergicGlucocorticoid receptorHomo sapiens (human)
maternal behaviorGlucocorticoid receptorHomo sapiens (human)
intracellular glucocorticoid receptor signaling pathwayGlucocorticoid receptorHomo sapiens (human)
glucocorticoid mediated signaling pathwayGlucocorticoid receptorHomo sapiens (human)
positive regulation of neuron apoptotic processGlucocorticoid receptorHomo sapiens (human)
negative regulation of DNA-templated transcriptionGlucocorticoid receptorHomo sapiens (human)
positive regulation of transcription by RNA polymerase IIGlucocorticoid receptorHomo sapiens (human)
astrocyte differentiationGlucocorticoid receptorHomo sapiens (human)
cell divisionGlucocorticoid receptorHomo sapiens (human)
mammary gland duct morphogenesisGlucocorticoid receptorHomo sapiens (human)
motor behaviorGlucocorticoid receptorHomo sapiens (human)
cellular response to steroid hormone stimulusGlucocorticoid receptorHomo sapiens (human)
cellular response to glucocorticoid stimulusGlucocorticoid receptorHomo sapiens (human)
cellular response to dexamethasone stimulusGlucocorticoid receptorHomo sapiens (human)
cellular response to transforming growth factor beta stimulusGlucocorticoid receptorHomo sapiens (human)
neuroinflammatory responseGlucocorticoid receptorHomo sapiens (human)
positive regulation of miRNA transcriptionGlucocorticoid receptorHomo sapiens (human)
intracellular steroid hormone receptor signaling pathwayGlucocorticoid receptorHomo sapiens (human)
regulation of transcription by RNA polymerase IIGlucocorticoid receptorHomo sapiens (human)
xenobiotic metabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
negative regulation of gene expressionCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bile acid and bile salt transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
heme catabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic export from cellCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transepithelial transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
leukotriene transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
monoatomic anion transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (43)

Processvia Protein(s)Taxonomy
ATP bindingATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type xenobiotic transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type bile acid transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATP hydrolysis activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
icosanoid transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
guanine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ATP bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type xenobiotic transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
urate transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
purine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type bile acid transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
efflux transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
15-hydroxyprostaglandin dehydrogenase (NAD+) activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATP hydrolysis activityMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingBile salt export pumpHomo sapiens (human)
ATP bindingBile salt export pumpHomo sapiens (human)
ABC-type xenobiotic transporter activityBile salt export pumpHomo sapiens (human)
bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
canalicular bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transporter activityBile salt export pumpHomo sapiens (human)
ABC-type bile acid transporter activityBile salt export pumpHomo sapiens (human)
ATP hydrolysis activityBile salt export pumpHomo sapiens (human)
RNA polymerase II transcription regulatory region sequence-specific DNA bindingGlucocorticoid receptorHomo sapiens (human)
RNA polymerase II cis-regulatory region sequence-specific DNA bindingGlucocorticoid receptorHomo sapiens (human)
DNA-binding transcription factor activity, RNA polymerase II-specificGlucocorticoid receptorHomo sapiens (human)
core promoter sequence-specific DNA bindingGlucocorticoid receptorHomo sapiens (human)
DNA-binding transcription repressor activity, RNA polymerase II-specificGlucocorticoid receptorHomo sapiens (human)
DNA-binding transcription activator activity, RNA polymerase II-specificGlucocorticoid receptorHomo sapiens (human)
DNA-binding transcription factor activityGlucocorticoid receptorHomo sapiens (human)
RNA bindingGlucocorticoid receptorHomo sapiens (human)
nuclear receptor activityGlucocorticoid receptorHomo sapiens (human)
nuclear glucocorticoid receptor activityGlucocorticoid receptorHomo sapiens (human)
steroid bindingGlucocorticoid receptorHomo sapiens (human)
protein bindingGlucocorticoid receptorHomo sapiens (human)
zinc ion bindingGlucocorticoid receptorHomo sapiens (human)
TBP-class protein bindingGlucocorticoid receptorHomo sapiens (human)
protein kinase bindingGlucocorticoid receptorHomo sapiens (human)
identical protein bindingGlucocorticoid receptorHomo sapiens (human)
Hsp90 protein bindingGlucocorticoid receptorHomo sapiens (human)
steroid hormone bindingGlucocorticoid receptorHomo sapiens (human)
sequence-specific double-stranded DNA bindingGlucocorticoid receptorHomo sapiens (human)
estrogen response element bindingGlucocorticoid receptorHomo sapiens (human)
protein bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
organic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type xenobiotic transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP hydrolysis activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (28)

Processvia Protein(s)Taxonomy
plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basal plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basolateral plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
nucleolusMultidrug resistance-associated protein 4Homo sapiens (human)
Golgi apparatusMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
platelet dense granule membraneMultidrug resistance-associated protein 4Homo sapiens (human)
external side of apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneBile salt export pumpHomo sapiens (human)
Golgi membraneBile salt export pumpHomo sapiens (human)
endosomeBile salt export pumpHomo sapiens (human)
plasma membraneBile salt export pumpHomo sapiens (human)
cell surfaceBile salt export pumpHomo sapiens (human)
apical plasma membraneBile salt export pumpHomo sapiens (human)
intercellular canaliculusBile salt export pumpHomo sapiens (human)
intracellular canaliculusBile salt export pumpHomo sapiens (human)
recycling endosomeBile salt export pumpHomo sapiens (human)
recycling endosome membraneBile salt export pumpHomo sapiens (human)
extracellular exosomeBile salt export pumpHomo sapiens (human)
membraneBile salt export pumpHomo sapiens (human)
nucleusGlucocorticoid receptorHomo sapiens (human)
nucleusGlucocorticoid receptorHomo sapiens (human)
nucleoplasmGlucocorticoid receptorHomo sapiens (human)
cytoplasmGlucocorticoid receptorHomo sapiens (human)
mitochondrial matrixGlucocorticoid receptorHomo sapiens (human)
centrosomeGlucocorticoid receptorHomo sapiens (human)
spindleGlucocorticoid receptorHomo sapiens (human)
cytosolGlucocorticoid receptorHomo sapiens (human)
membraneGlucocorticoid receptorHomo sapiens (human)
nuclear speckGlucocorticoid receptorHomo sapiens (human)
synapseGlucocorticoid receptorHomo sapiens (human)
chromatinGlucocorticoid receptorHomo sapiens (human)
protein-containing complexGlucocorticoid receptorHomo sapiens (human)
plasma membraneGlutamate receptor 2Rattus norvegicus (Norway rat)
plasma membraneGlycine receptor subunit betaRattus norvegicus (Norway rat)
plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
cell surfaceCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
intercellular canaliculusCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (146)

Assay IDTitleYearJournalArticle
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID504812Inverse Agonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID504810Antagonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID504749qHTS profiling for inhibitors of Plasmodium falciparum proliferation2011Science (New York, N.Y.), Aug-05, Volume: 333, Issue:6043
Chemical genomic profiling for antimalarial therapies, response signatures, and molecular targets.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1473740Inhibition of human MRP3 overexpressed in Sf9 insect cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 10 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1187198Inhibition of concanavalin A-induced cell proliferation of T cells (unknown origin) at 10 uM after 72 hrs by MTT assay2014Journal of medicinal chemistry, Aug-28, Volume: 57, Issue:16
Pyrano-isochromanones as IL-6 inhibitors: synthesis, in vitro and in vivo antiarthritic activity.
AID74376Relative binding affinity to glucocorticoid receptor on cytosol from liver at 4 hr1988Journal of medicinal chemistry, Jun, Volume: 31, Issue:6
Binding of steroids to the progestin and glucocorticoid receptors analyzed by correspondence analysis.
AID1467586Cytotoxicity against primary human endothelial keratinocytes assessed as inhibition of cell viability preincubated for 2 hrs followed by cytokine addition measured after 72 hrs by PrestoBlue staining based fluorescence assay2017Bioorganic & medicinal chemistry letters, 07-15, Volume: 27, Issue:14
The design, synthesis, and anti-inflammatory evaluation of a drug-like library based on the natural product valerenic acid.
AID588210Human drug-induced liver injury (DILI) modelling dataset from Ekins et al2010Drug metabolism and disposition: the biological fate of chemicals, Dec, Volume: 38, Issue:12
A predictive ligand-based Bayesian model for human drug-induced liver injury.
AID1552499Protection against imiquimod-induced skin inflammation in BALB/c mouse psoriasis model assessed as decrease in ear thickness administered topically at 25 mg qd treated for 1 hr before IMQ application measured at day 52019Bioorganic & medicinal chemistry letters, 08-15, Volume: 29, Issue:16
Discovery and pharmacological evaluation of indole derivatives as potent and selective RORγt inverse agonist for multiple autoimmune conditions.
AID497005Antimicrobial activity against Pneumocystis carinii2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID74373Relative binding affinity to glucocorticoid receptor on cytosol from hepatoma tissue cells at 24 hr1988Journal of medicinal chemistry, Jun, Volume: 31, Issue:6
Binding of steroids to the progestin and glucocorticoid receptors analyzed by correspondence analysis.
AID1853449Inhibition of ConA-induced IL-4 secretion in BALB/c mouse splenocyte at 10 uM incubated for 48 hrs by ELISA relative to control2021RSC medicinal chemistry, Nov-17, Volume: 12, Issue:11
Synthesis and biological evaluation of bergenin derivatives as new immunosuppressants.
AID588218FDA HLAED, lactate dehydrogenase (LDH) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID521220Inhibition of neurosphere proliferation of mouse neural precursor cells by MTT assay2007Nature chemical biology, May, Volume: 3, Issue:5
Chemical genetics reveals a complex functional ground state of neural stem cells.
AID1552501Protection against imiquimod-induced skin inflammation in BALB/c mouse psoriasis model assessed as decrease in scaling administered topically at 25 mg qd treated for 1 hr before IMQ application measured at day 52019Bioorganic & medicinal chemistry letters, 08-15, Volume: 29, Issue:16
Discovery and pharmacological evaluation of indole derivatives as potent and selective RORγt inverse agonist for multiple autoimmune conditions.
AID588214FDA HLAED, liver enzyme composite activity2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID496828Antimicrobial activity against Leishmania donovani2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID540210Clearance in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID126435Relative binding affinity for mineralocorticoid receptor of rat kidney at 24 hr1988Journal of medicinal chemistry, Jun, Volume: 31, Issue:6
Binding of steroids to the progestin and glucocorticoid receptors analyzed by correspondence analysis.
AID74374Relative binding affinity to glucocorticoid receptor on cytosol from hepatoma tissue cells at 4 hr1988Journal of medicinal chemistry, Jun, Volume: 31, Issue:6
Binding of steroids to the progestin and glucocorticoid receptors analyzed by correspondence analysis.
AID1467585Antiinflammatory activity in primary human endothelial keratinocytes assessed as inhibition of IL-17A/TNF-alpha induced IL-8 production at 10 uM preincubated for 2 hrs followed by cytokine addition measured after 72 hrs by HTRF assay relative to control2017Bioorganic & medicinal chemistry letters, 07-15, Volume: 27, Issue:14
The design, synthesis, and anti-inflammatory evaluation of a drug-like library based on the natural product valerenic acid.
AID74377Relative binding affinity to glucocorticoid receptor on cytosol from thymus at 24 hr1988Journal of medicinal chemistry, Jun, Volume: 31, Issue:6
Binding of steroids to the progestin and glucocorticoid receptors analyzed by correspondence analysis.
AID26380Dissociation constant (pKa)2004Journal of medicinal chemistry, Feb-26, Volume: 47, Issue:5
Prediction of human volume of distribution values for neutral and basic drugs. 2. Extended data set and leave-class-out statistics.
AID22293Delta logD (logD6.5 - logD7.4)2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID524795Antiplasmodial activity against Plasmodium falciparum HB3 after 72 hrs by SYBR green assay2009Nature chemical biology, Oct, Volume: 5, Issue:10
Genetic mapping of targets mediating differential chemical phenotypes in Plasmodium falciparum.
AID588219FDA HLAED, gamma-glutamyl transferase (GGT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1079949Proposed mechanism(s) of liver damage. [column 'MEC' in source]
AID1187235Antiarthritic activity in DBA/1J mouse collagen-induced arthritis model assessed as reduction in IL-1beta level at 5 mg/kg, po administered once daily for 49 days starting from onset of disease and measured after 3 to 49 days of disease onset by ELISA met2014Journal of medicinal chemistry, Aug-28, Volume: 57, Issue:16
Pyrano-isochromanones as IL-6 inhibitors: synthesis, in vitro and in vivo antiarthritic activity.
AID1079946Presence of at least one case with successful reintroduction. [column 'REINT' in source]
AID1853448Inhibition of ConA-induced IFN-gamma secretion in BALB/c mouse splenocyte at 10 uM incubated for 48 hrs by ELISA relative to control2021RSC medicinal chemistry, Nov-17, Volume: 12, Issue:11
Synthesis and biological evaluation of bergenin derivatives as new immunosuppressants.
AID1079938Chronic liver disease either proven histopathologically, or through a chonic elevation of serum amino-transferase activity after 6 months. Value is number of references indexed. [column 'CHRON' in source]
AID681354TP_TRANSPORTER: transepithelial transport in MDR1-expressing LLC-PK1 cells2003Pharmaceutical research, Nov, Volume: 20, Issue:11
Structural determinants of P-glycoprotein-mediated transport of glucocorticoids.
AID1079931Moderate liver toxicity, defined via clinical-chemistry results: ALT or AST serum activity 6 times the normal upper limit (N) or alkaline phosphatase serum activity of 1.7 N. Value is number of references indexed. [column 'BIOL' in source]
AID1079944Benign tumor, proven histopathologically. Value is number of references indexed. [column 'T.BEN' in source]
AID588213Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in non-rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID1473739Inhibition of human MRP2 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID39320Relative binding affinity for androgen receptor of prostate of rat at 2 hr1988Journal of medicinal chemistry, Jun, Volume: 31, Issue:6
Binding of steroids to the progestin and glucocorticoid receptors analyzed by correspondence analysis.
AID7783Unbound fraction (plasma)2004Journal of medicinal chemistry, Feb-26, Volume: 47, Issue:5
Prediction of human volume of distribution values for neutral and basic drugs. 2. Extended data set and leave-class-out statistics.
AID1187234Antiarthritic activity in DBA/1J mouse collagen-induced arthritis model assessed as reduction in IL6 level at 5 mg/kg, po administered once daily for 49 days starting from onset of disease and measured after 3 to 49 days of disease onset by ELISA method2014Journal of medicinal chemistry, Aug-28, Volume: 57, Issue:16
Pyrano-isochromanones as IL-6 inhibitors: synthesis, in vitro and in vivo antiarthritic activity.
AID188016Anti-inflammatory effect in rat granuloma assay, activity relative to hydrocortisone and hydrocortisone 21-acetate1983Journal of medicinal chemistry, Mar, Volume: 26, Issue:3
Structure-activity relationships in the antiinflammatory steroids: a pattern-recognition approach.
AID588216FDA HLAED, serum glutamic oxaloacetic transaminase (SGOT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1079943Malignant tumor, proven histopathologically. Value is number of references indexed. [column 'T.MAL' in source]
AID425653Renal clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID1853443Inhibition of ConA-induced proliferation of BALB/c mouse splenocyte at 10 uM incubated for 48 hrs by CCK-8 assay relative to control2021RSC medicinal chemistry, Nov-17, Volume: 12, Issue:11
Synthesis and biological evaluation of bergenin derivatives as new immunosuppressants.
AID1187202Inhibition of LPS-induced TNFalpha production in human THP1 cells after 24 hrs2014Journal of medicinal chemistry, Aug-28, Volume: 57, Issue:16
Pyrano-isochromanones as IL-6 inhibitors: synthesis, in vitro and in vivo antiarthritic activity.
AID310933Permeability across PAMPA membrane after 7 hrs2007Journal of medicinal chemistry, Feb-22, Volume: 50, Issue:4
In silico and in vitro filters for the fast estimation of skin permeation and distribution of new chemical entities.
AID8002Observed volume of distribution2004Journal of medicinal chemistry, Feb-26, Volume: 47, Issue:5
Prediction of human volume of distribution values for neutral and basic drugs. 2. Extended data set and leave-class-out statistics.
AID588215FDA HLAED, alkaline phosphatase increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID310931Partition coefficient, log P of the compound2007Journal of medicinal chemistry, Feb-22, Volume: 50, Issue:4
In silico and in vitro filters for the fast estimation of skin permeation and distribution of new chemical entities.
AID1079941Liver damage due to vascular disease: peliosis hepatitis, hepatic veno-occlusive disease, Budd-Chiari syndrome. Value is number of references indexed. [column 'VASC' in source]
AID384955Intrinsic aqueous solubility at pH 10 by shake-flask method2008Journal of medicinal chemistry, May-22, Volume: 51, Issue:10
Molecular characteristics for solid-state limited solubility.
AID496832Antimicrobial activity against Trypanosoma brucei rhodesiense2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID524796Antiplasmodial activity against Plasmodium falciparum W2 after 72 hrs by SYBR green assay2009Nature chemical biology, Oct, Volume: 5, Issue:10
Genetic mapping of targets mediating differential chemical phenotypes in Plasmodium falciparum.
AID1079939Cirrhosis, proven histopathologically. Value is number of references indexed. [column 'CIRRH' in source]
AID1187199Inhibition of LPS-induced cell proliferation of B cells (unknown origin) at 10 uM after 72 hrs by MTT assay2014Journal of medicinal chemistry, Aug-28, Volume: 57, Issue:16
Pyrano-isochromanones as IL-6 inhibitors: synthesis, in vitro and in vivo antiarthritic activity.
AID588217FDA HLAED, serum glutamic pyruvic transaminase (SGPT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1079940Granulomatous liver disease, proven histopathologically. Value is number of references indexed. [column 'GRAN' in source]
AID496818Antimicrobial activity against Trypanosoma brucei brucei2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1473741Inhibition of human MRP4 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1187221Antiarthritic activity in DBA/1J mouse collagen-induced arthritis model assessed as reduction in paw swelling at 5 mg/kg, po administered once daily for 49 days starting from onset of disease2014Journal of medicinal chemistry, Aug-28, Volume: 57, Issue:16
Pyrano-isochromanones as IL-6 inhibitors: synthesis, in vitro and in vivo antiarthritic activity.
AID496829Antimicrobial activity against Leishmania infantum2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1187233Antiarthritic activity in DBA/1J mouse collagen-induced arthritis model assessed as reduction in TNFalpha level at 5 mg/kg, po administered once daily for 49 days starting from onset of disease and measured after 3 to 49 days of disease onset by ELISA met2014Journal of medicinal chemistry, Aug-28, Volume: 57, Issue:16
Pyrano-isochromanones as IL-6 inhibitors: synthesis, in vitro and in vivo antiarthritic activity.
AID588212Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID1079945Animal toxicity known. [column 'TOXIC' in source]
AID1079935Cytolytic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is > 5 (see ACUTE). Value is number of references indexed. [column 'CYTOL' in source]
AID524794Antiplasmodial activity against Plasmodium falciparum GB4 after 72 hrs by SYBR green assay2009Nature chemical biology, Oct, Volume: 5, Issue:10
Genetic mapping of targets mediating differential chemical phenotypes in Plasmodium falciparum.
AID1079948Times to onset, minimal and maximal, observed in the indexed observations. [column 'DELAI' in source]
AID409954Inhibition of mouse brain MAOA2008Journal of medicinal chemistry, Nov-13, Volume: 51, Issue:21
Quantitative structure-activity relationship and complex network approach to monoamine oxidase A and B inhibitors.
AID1079936Choleostatic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is < 2 (see ACUTE). Value is number of references indexed. [column 'CHOLE' in source]
AID489532Antiinflammatory activity against oxazolone-induced atopic dermatitis in nude mouse assessed as decrease in transepidermal water loss at 0.01 % administered topically bid simultaneously with oxazolone qd for 10 days following 5 days post-oxazolone challen2010Bioorganic & medicinal chemistry letters, Jul-15, Volume: 20, Issue:14
A novel organogermanium protected atopic dermatitis induced by oxazolone.
AID346025Binding affinity to beta cyclodextrin2009Bioorganic & medicinal chemistry, Jan-15, Volume: 17, Issue:2
Convenient QSAR model for predicting the complexation of structurally diverse compounds with beta-cyclodextrins.
AID1443980Inhibition of human BSEP expressed in fall armyworm sf9 cell plasma membrane vesicles assessed as reduction in vesicle-associated [3H]-taurocholate transport preincubated for 10 mins prior to ATP addition measured after 15 mins in presence of [3H]-tauroch2010Toxicological sciences : an official journal of the Society of Toxicology, Dec, Volume: 118, Issue:2
Interference with bile salt export pump function is a susceptibility factor for human liver injury in drug development.
AID524791Antiplasmodial activity against Plasmodium falciparum 7G8 after 72 hrs by SYBR green assay2009Nature chemical biology, Oct, Volume: 5, Issue:10
Genetic mapping of targets mediating differential chemical phenotypes in Plasmodium falciparum.
AID213396Glucocorticoid induced Tyrosine Aminotransferase activity relative to Dexamethasone1988Journal of medicinal chemistry, Jun, Volume: 31, Issue:6
Binding of steroids to the progestin and glucocorticoid receptors analyzed by correspondence analysis.
AID496817Antimicrobial activity against Trypanosoma cruzi2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1187201Inhibition of LPS-induced IL6 production in human THP1 cells after 24 hrs2014Journal of medicinal chemistry, Aug-28, Volume: 57, Issue:16
Pyrano-isochromanones as IL-6 inhibitors: synthesis, in vitro and in vivo antiarthritic activity.
AID1187230Antiarthritic activity in DBA/1J mouse collagen-induced arthritis model assessed as reduction in anticollagen antibody IgG2a level at 5 mg/kg, po administered once daily for 49 days starting from onset of disease and measured after 14 days of disease onse2014Journal of medicinal chemistry, Aug-28, Volume: 57, Issue:16
Pyrano-isochromanones as IL-6 inhibitors: synthesis, in vitro and in vivo antiarthritic activity.
AID29811Oral bioavailability in human2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID1473738Inhibition of human BSEP overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-taurocholate in presence of ATP measured after 15 to 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1187229Antiarthritic activity in DBA/1J mouse collagen-induced arthritis model assessed as reduction in anticollagen antibody IgG1 level at 5 mg/kg, po administered once daily for 49 days starting from onset of disease and measured after 14 days of disease onset2014Journal of medicinal chemistry, Aug-28, Volume: 57, Issue:16
Pyrano-isochromanones as IL-6 inhibitors: synthesis, in vitro and in vivo antiarthritic activity.
AID1079937Severe hepatitis, defined as possibly life-threatening liver failure or through clinical observations. Value is number of references indexed. [column 'MASS' in source]
AID540212Mean residence time in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID74375Relative binding affinity to glucocorticoid receptor on cytosol from liver at 24 hr1988Journal of medicinal chemistry, Jun, Volume: 31, Issue:6
Binding of steroids to the progestin and glucocorticoid receptors analyzed by correspondence analysis.
AID1187232Antiarthritic activity in DBA/1J mouse collagen-induced arthritis model assessed as reduction in anticollagen antibody IgG2a level at 5 mg/kg, po administered once daily for 49 days starting from onset of disease and measured after 49 days of disease onse2014Journal of medicinal chemistry, Aug-28, Volume: 57, Issue:16
Pyrano-isochromanones as IL-6 inhibitors: synthesis, in vitro and in vivo antiarthritic activity.
AID540213Half life in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID496819Antimicrobial activity against Plasmodium falciparum2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID588209Literature-mined public compounds from Greene et al multi-species hepatotoxicity modelling dataset2010Chemical research in toxicology, Jul-19, Volume: 23, Issue:7
Developing structure-activity relationships for the prediction of hepatotoxicity.
AID588211Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in humans2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID29360Ionization constant (pKa)2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID1079947Comments (NB not yet translated). [column 'COMMENTAIRES' in source]
AID1187231Antiarthritic activity in DBA/1J mouse collagen-induced arthritis model assessed as reduction in anticollagen antibody IgG1 level at 5 mg/kg, po administered once daily for 49 days starting from onset of disease and measured after 49 days of disease onset2014Journal of medicinal chemistry, Aug-28, Volume: 57, Issue:16
Pyrano-isochromanones as IL-6 inhibitors: synthesis, in vitro and in vivo antiarthritic activity.
AID26304Partition coefficient (logD6.5)2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID496825Antimicrobial activity against Leishmania mexicana2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496830Antimicrobial activity against Leishmania major2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1079942Steatosis, proven histopathologically. Value is number of references indexed. [column 'STEAT' in source]
AID311367Permeability coefficient in human skin2007Bioorganic & medicinal chemistry, Nov-15, Volume: 15, Issue:22
Transdermal penetration behaviour of drugs: CART-clustering, QSPR and selection of model compounds.
AID977602Inhibition of sodium fluorescein uptake in OATP1B3-transfected CHO cells at an equimolar substrate-inhibitor concentration of 10 uM2013Molecular pharmacology, Jun, Volume: 83, Issue:6
Structure-based identification of OATP1B1/3 inhibitors.
AID1079933Acute liver toxicity defined via clinical observations and clear clinical-chemistry results: serum ALT or AST activity > 6 N or serum alkaline phosphatases activity > 1.7 N. This category includes cytolytic, choleostatic and mixed liver toxicity. Value is
AID1079932Highest frequency of moderate liver toxicity observed during clinical trials, expressed as a percentage. [column '% BIOL' in source]
AID74378Relative binding affinity to glucocorticoid receptor on cytosol from thymus at 4 hr1988Journal of medicinal chemistry, Jun, Volume: 31, Issue:6
Binding of steroids to the progestin and glucocorticoid receptors analyzed by correspondence analysis.
AID496824Antimicrobial activity against Toxoplasma gondii2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496823Antimicrobial activity against Trichomonas vaginalis2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID310932Permeability across human Skin2007Journal of medicinal chemistry, Feb-22, Volume: 50, Issue:4
In silico and in vitro filters for the fast estimation of skin permeation and distribution of new chemical entities.
AID977599Inhibition of sodium fluorescein uptake in OATP1B1-transfected CHO cells at an equimolar substrate-inhibitor concentration of 10 uM2013Molecular pharmacology, Jun, Volume: 83, Issue:6
Structure-based identification of OATP1B1/3 inhibitors.
AID1079934Highest frequency of acute liver toxicity observed during clinical trials, expressed as a percentage. [column '% AIGUE' in source]
AID162613Relative binding affinity for progestin receptor of uterus of rabbit at 24 hr1988Journal of medicinal chemistry, Jun, Volume: 31, Issue:6
Binding of steroids to the progestin and glucocorticoid receptors analyzed by correspondence analysis.
AID496831Antimicrobial activity against Cryptosporidium parvum2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496820Antimicrobial activity against Trypanosoma brucei2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID90104Potency relative to fluocinolone 16,17-acetonide in the human vasoconstictor test1983Journal of medicinal chemistry, Mar, Volume: 26, Issue:3
Structure-activity relationships in the antiinflammatory steroids: a pattern-recognition approach.
AID91224Antiinflammatory activity measured by using McKenzie-Stoughton human vasoconstrictor assay1986Journal of medicinal chemistry, Nov, Volume: 29, Issue:11
Computer-aided studies of the structure-activity relationships between the structure of some steroids and their antiinflammatory activity.
AID524790Antiplasmodial activity against Plasmodium falciparum 3D7 after 72 hrs by SYBR green assay2009Nature chemical biology, Oct, Volume: 5, Issue:10
Genetic mapping of targets mediating differential chemical phenotypes in Plasmodium falciparum.
AID425652Total body clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID496821Antimicrobial activity against Leishmania2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID540211Fraction unbound in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID496826Antimicrobial activity against Entamoeba histolytica2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID540209Volume of distribution at steady state in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID496827Antimicrobial activity against Leishmania amazonensis2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID540299A screen for compounds that inhibit the MenB enzyme of Mycobacterium tuberculosis2010Bioorganic & medicinal chemistry letters, Nov-01, Volume: 20, Issue:21
Synthesis and SAR studies of 1,4-benzoxazine MenB inhibitors: novel antibacterial agents against Mycobacterium tuberculosis.
AID588519A screen for compounds that inhibit viral RNA polymerase binding and polymerization activities2011Antiviral research, Sep, Volume: 91, Issue:3
High-throughput screening identification of poliovirus RNA-dependent RNA polymerase inhibitors.
AID1159550Human Phosphogluconate dehydrogenase (6PGD) Inhibitor Screening2015Nature cell biology, Nov, Volume: 17, Issue:11
6-Phosphogluconate dehydrogenase links oxidative PPP, lipogenesis and tumour growth by inhibiting LKB1-AMPK signalling.
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (5,858)

TimeframeStudies, This Drug (%)All Drugs %
pre-19902528 (43.15)18.7374
1990's751 (12.82)18.2507
2000's1070 (18.27)29.6817
2010's1133 (19.34)24.3611
2020's376 (6.42)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 109.85

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index109.85 (24.57)
Research Supply Index1.95 (2.92)
Research Growth Index4.30 (4.65)
Search Engine Demand Index227.97 (26.88)
Search Engine Supply Index2.35 (0.95)

This Compound (109.85)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials0 (0.00%)5.53%
Trials1,205 (18.98%)5.53%
Reviews0 (0.00%)6.00%
Reviews318 (5.01%)6.00%
Case Studies0 (0.00%)4.05%
Case Studies963 (15.17%)4.05%
Observational0 (0.00%)0.25%
Observational39 (0.61%)0.25%
Other6 (100.00%)84.16%
Other3,824 (60.23%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (219)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Platelet Rich Plasma Injection Compared to Corticosteroid Injection for Treatment of Plantar Fasciitis. A Prospective, Randomized Control Trial [NCT01127672]0 participants (Actual)Interventional2010-05-31Withdrawn
A Phase 1, Open-Label, Randomized Study to Compare the Pharmacokinetics and Pharmacodynamics of Single Dose Dexamethasone and Betamethasone Administered Orally and Intramuscularly in Healthy Female Subjects [NCT03668860]Phase 148 participants (Actual)Interventional2018-09-20Completed
Single Dose Antenatal Corticosteroids (SNACS) Pilot Randomized Control Trial for Women at Risk of Preterm Birth [NCT04494529]Phase 330 participants (Actual)Interventional2021-03-01Completed
Autologous Adipose-derived Mesenchymal Stem Cells in the Treatment of Tendon Disease: a Randomized Controlled Trial [NCT03279796]Phase 2200 participants (Anticipated)Interventional2018-10-01Not yet recruiting
A Phase 2a Trial Evaluating the Anti-psoriatic Effect of LP0113 Aerosol Spray Compared With Its Vehicle and With Daivobet® Gel, LEO 90100 Aerosol Foam, Betamethasone Dipropionate Aerosol Spray and Calcipotriol Aerosol Spray in the Treatment of Psoriasis V [NCT02416258]Phase 250 participants (Actual)Interventional2015-04-30Completed
Efficacy of Connective Tissue Allograft Versus Steroid Injections in Treatment of Lateral Epicondylitis [NCT06171555]Phase 254 participants (Anticipated)Interventional2023-01-26Recruiting
A Phase 3, Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled Trial to Evaluate the Efficacy and Safety of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection in Chinese Participants With Acute Gout [NCT06169891]Phase 3500 participants (Anticipated)Interventional2023-12-31Not yet recruiting
An Investigator Initiated Study Evaluating the Efficacy and Tolerability of Enstilar Foam (Calcipotriene and Betamethasone Dipropionate) in Patients With Nail Psoriasis [NCT04227288]Phase 43 participants (Actual)Interventional2021-11-01Completed
Treatment of FUS-Related ALS With Betamethasone - The TRANSLATE Study [NCT03707795]Early Phase 16 participants (Actual)Interventional2017-08-21Completed
Study Role of the Local Treatments on the Microbiome Modulation in the Psoriatic Skin. Study Monocentric, Interventional, Randomized and Single-blind [NCT03584360]Phase 230 participants (Actual)Interventional2018-09-24Completed
The Maintenance Effect of Enstilar Foam in Combination With Otezla [NCT04555707]Phase 430 participants (Anticipated)Interventional2020-06-24Recruiting
A Comparative Study of Betamethasone (Diprospan) and Triamcinolone Acetonide as Single Intra-Articular Injection in Knee Osteoarthritis, A Double-Blinded, Randomized Controlled Trial [NCT05139875]Phase 4120 participants (Anticipated)Interventional2022-01-01Recruiting
Effect of Antenatal Steroids for Women at Risk of Late Preterm Delivery on Neonatal Respiratory Morbidity [NCT01206946]Phase 2700 participants (Anticipated)Interventional2010-09-30Recruiting
Crossover Study to Evaluate the Comparative Bioavailability, Pharmacokinetics, and Safety of GTX-102 Administered as an Oral Spray Compared to Intramuscular Injection and an Oral Solution of Betamethasone in Healthy Subjects [NCT05531890]Phase 148 participants (Actual)Interventional2022-09-13Active, not recruiting
A PHASE 1, RANDOMIZED, DOUBLE-BLIND, VEHICLE AND ACTIVE COMPARATOR-CONTROLLED, PSORIASIS PLAQUE TEST STUDY TO ASSESS SAFETY, TOLERABILITY, AND PSORIATIC SKIN INFILTRATE THICKNESS FOLLOWING REPEATED, TOPICAL DOSES OF PF-06763809 SOLUTION IN SUBJECTS WITH M [NCT03469336]Phase 118 participants (Actual)Interventional2018-04-24Completed
The Efficacy of Pulse Radiofrequency Treatment to Articular Branches of Femoral and Obturator Nerves in Patients With Coxarthrosis [NCT06034418]28 participants (Anticipated)Interventional2022-11-25Recruiting
A Phase 1b, Randomised, Controlled, Observer-blinded Trial to Assess Safety, Tolerability and Pharmacodynamic Effects of LEO 134310 Cutaneous Solution in Descaled Skin of Adults With Chronic Plaque Psoriasis [NCT03669757]Phase 113 participants (Actual)Interventional2018-09-27Completed
Antenatal Betamethasone and the Risk of Neonatal Hypoglycemia: It's All About Timing [NCT03702959]1,000 participants (Anticipated)Observational [Patient Registry]2018-10-01Not yet recruiting
Effect of Antenatal Corticosteroids on Neonatal Morbidity. [NCT03446937]150 participants (Actual)Interventional2017-12-01Completed
Phase II Study of Navigator vs Standard Needle Injection for Hip [NCT02066844]Phase 240 participants (Actual)Interventional2014-02-28Completed
Therapeutic Effect of Botulinum Toxin A for the Treatment of Plantar Fasciitis. [NCT03054610]Phase 160 participants (Actual)Interventional2015-01-31Completed
A Multicentre Study Evaluating the Efficacy of Combining Topical Antibiotic/Steroid/Moisturizer Therapy Compared to Standard of Care in the Treatment of Severe Atopic Dermatitis, a Phase II Randomized, Clinical Trial [NCT03052348]78 participants (Anticipated)Interventional2017-11-01Not yet recruiting
Efficacy and Safety of Fucicort® Lipid Cream Compared to Combination Treatment With Fucidin® Cream Followed by Betamethasone (Lianbang Beisong®) Cream and Fucicort® Lipid Cream Vehicle in Clinically Infected Atopic Dermatitis/Eczema [NCT03395132]Phase 368 participants (Actual)Interventional2018-07-31Terminated(stopped due to Due to business strategic reasons, LEO Pharma has decided to close down the FCF-38 trial.)
Comparison of Effect of Cyclosporine Ophthalmic Emulsion 2% and Betamethasone Eye Drop on Intraocular Pressure, Conjunctival Hyperemia and Subjective Dry Eye Symptoms Following Trabeculectomy in Open Angle Glaucoma Patients [NCT02114073]Phase 240 participants (Anticipated)Interventional2014-04-30Completed
Efficacy of Nd:Yttrium Aluminum Garnet Laser Treatment of Lichen Sclerosus [NCT03525522]40 participants (Anticipated)Interventional2016-01-28Active, not recruiting
Effects of Antenatal Corticosteroid in Twin Neonates With Late Preterm Birth: Study Protocol for a Randomized Controlled Trial [NCT03547791]Phase 2/Phase 3808 participants (Anticipated)Interventional2018-05-05Recruiting
Randomized Controlled Study of Off-Label Use of Ribavirin in Management of Mucocutaneous Extrahepatic Manifestations of HCV Infection [NCT02261662]30 participants (Anticipated)Interventional2014-06-30Recruiting
Ultrasound-guided Injection for DeQuervain's [NCT02038634]Phase 416 participants (Actual)Interventional2014-08-05Terminated(stopped due to not enough patient data)
Managment of Refractory Cases of Chronic Non Bacterial Prostatitis by TRUS Guided Injection of Betamethason [NCT04210739]Early Phase 120 participants (Anticipated)Interventional2020-07-31Not yet recruiting
Treatment Strategies for IgG4-RD Patients With Superficial Organ Involvement [NCT05789030]90 participants (Anticipated)Interventional2022-07-01Recruiting
Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-group Study Comparing Taro Product to RLD and Both Active Treatments to a Placebo Control in the Treatment of Scalp Psoriasis [NCT03880357]Phase 1485 participants (Actual)Interventional2018-10-22Completed
Efficacy and Safety of Enstilar Foam in Combination With Apremilast (Otezla) in Patients With Moderate Plaque Psoriasis [NCT03441789]Phase 428 participants (Actual)Interventional2017-09-18Completed
Validation of a Novel Composite of Skin Biomarkers as a Primary Outcome Measure for Evaluating the Safety of Treatments for Atopic Dermatitis: a Randomized Controlled Trial (Phase 2) Comparing the Effects of Crisaborole 2% Ointment to Betamethasone Valera [NCT04194814]Phase 237 participants (Actual)Interventional2020-11-20Completed
A 28-day, Double-blind, Randomized, Reference-controlled Open Psoriasis Plaque Test for Within Subject Comparison of Efficacy and Safety of Mapracorat 0.1% Ointment and 4 Reference Products in Symptomatic Volunteers With Stable Plaque-type Psoriasis [NCT03399526]Phase 124 participants (Actual)Interventional2013-02-11Completed
A Phase 1b, Randomised, Controlled, Assessor-blinded Proof of Principle Trial to Assess Safety, Tolerability and Pharmacodynamics Effects of Microarray Patches Containing Calcipotriol/Betamethasone Dipropionate in Descaled Skin of Adults With Chronic Plaq [NCT03898583]Phase 115 participants (Actual)Interventional2019-04-15Completed
A Randomized, Multicenter, Sham Controlled, Double-Masked, Phase 2/3 Study Assessing Efficacy and Safety of Betamethasone Microsphere in Patients With Diabetic Macular Edema [NCT01411254]Phase 2/Phase 30 participants InterventionalCompleted
Phototherpy Versus Tap Water Iontophoresis for Management of Atopic Dermatitis in Children, Randomized Clinical Trial. [NCT04444726]60 participants (Actual)Interventional2019-01-20Completed
Comparison of Nigella Sativa Oil With Conventional Management on Clinical Outcomes in Oral Submucous Fibrosis [NCT04476420]Phase 339 participants (Actual)Interventional2021-02-11Completed
A Randomized Controlled Study on the Effectiveness of Local Injection Combined With Topical Steroids vs. Topical Steroids Mono-therapy in the Treatment of Idiopathic Granulomatous Mastitis [NCT03766997]Phase 4100 participants (Anticipated)Interventional2019-02-19Recruiting
Sonography-guided Steroid Injection for Carpal Tunnel Syndrome [NCT02575729]Phase 339 participants (Actual)Interventional2011-08-31Completed
Greater Occipital Nerve Blockade for the Treatment of Chronic Migraine: a Randomized, Double- Blind, Placebo-controlled Study [NCT02686983]Phase 434 participants (Anticipated)Interventional2016-03-31Not yet recruiting
Real-life Evaluation of an Applicator, as a New Mode of Administration of Daivobet® Gel, on Adherence to Treatment and SAtisfaction of Patients With PSOriasis [NCT02856542]1,560 participants (Actual)Observational2016-05-23Completed
An Open-Label, Bilaterally-Controlled Single Center Study to Compare the Efficacy of Taclonex Ointment With Hydrogel Patch Occlusion to Taclonex Ointment Without Occlusion in the Treatment of Plaque-Type Psoriasis [NCT00924950]Phase 435 participants (Actual)Interventional2009-06-30Terminated
Bioequivalence of Two Augmented Betamethasone Dipropionate 0.05% Topical Creams [NCT00800293]116 participants (Actual)Observational2002-12-31Completed
Efficacy and Safety of Dexamethasone Versus Betamethasone Epidural Caudal Administration for Treatment of Lumbosacral Radiculalgia: Randomized Clinical Trial [NCT02833116]Phase 4320 participants (Anticipated)Interventional2016-06-30Recruiting
A Multi-center, Randomized, Vehicle-Controlled Study to Assess the Efficacy and Safety of Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Syst [NCT00574249]Phase 3730 participants (Actual)Interventional2007-11-30Completed
Effects of Corticosteroid Injection Plus Reparel™ Knee Sleeve on Knee Osteoarthritis: A Randomized Clinical Trial [NCT04859764]74 participants (Anticipated)Interventional2022-06-29Recruiting
Efficacy of Compound Betamethasone Injection Combined With Ropivacaine in Ultrasound-guided Thoracic Paravertebral Nerve Block for Chronic Post-thoracotomy Pain [NCT05175001]Phase 4100 participants (Anticipated)Interventional2021-05-01Recruiting
Pragmatic Randomized Prospective Study of Cervical Interlaminar Epidural Injection of Particulate Steroid and Cervical Transforaminal Epidural Injection of Non-particulate Steroid in Patients With Cervical Radicular Pain [NCT03165825]Phase 40 participants (Actual)Interventional2018-01-31Withdrawn(stopped due to funding)
Multi-center,Single Blind, Parallel-Controlled Study of the Efficacy and Safety of Calcipotriol Betamethasone Ointment Plus Calcipotriol Ointment in Sequential Therapy to Psoriasis Vulgaris [NCT02191007]230 participants (Actual)Interventional2013-11-30Completed
Amnion-Based Injections in the Shoulder for Adhesive Capsulitis and Osteoarthritis [NCT03770546]0 participants (Actual)Interventional2021-10-30Withdrawn(stopped due to Failure of institution to reach agreement with company supplying injections)
Autologous Pure Platelet-rich Plasma in the Treatment of Tendon Disease:A Randomized Controlled Trial [NCT03300531]Phase 2540 participants (Anticipated)Interventional2017-12-01Not yet recruiting
A Randomized Placebo-Controlled Trial of Antenatal Corticosteroid Regimens [NCT00015002]Phase 3486 participants (Actual)Interventional2000-03-31Terminated(stopped due to Concerns regarding neonatal data)
Local Betamethasone Versus Triamcinolone Injection in Management of Thyroid-Related Upper Lid Retraction With and Without Proptosis [NCT04976816]Phase 2/Phase 392 participants (Actual)Interventional2021-12-01Completed
A Comparative Effectiveness Randomised Placebo Controlled Pilot Trial of the Management of Acute Lumbar Radicular Pain: Evaluate Route Versus Pharmacology of Intervention, and Feasibility in Public Hospital and Community Practice Settings. [NCT03240783]Phase 260 participants (Anticipated)Interventional2017-07-08Recruiting
A Comparative Clinical and Immunohistochemical Study Between Topical Pimecrolimus and Corticosteroid in Treatment of Oral Lichen Planus [NCT02443311]Phase 424 participants (Actual)Interventional2010-09-30Completed
Effect of Betamethasone Gel and Lidocaine Jelly Applied Over Tracheal Tube Cuff on Post Operative Sore Throat, Cough and Hoarseness of Voice on the Patients [NCT02114021]Phase 399 participants (Actual)Interventional2012-03-31Completed
Efficacy of Compound Betamethasone Injection Combined With Ropivacaine in Ultrasound-guided Slit Intercostals Nerve Block for Chronic Post-thoracotomy Pain:A Single Blind Randomized Control Trial [NCT05556122]100 participants (Anticipated)Interventional2022-07-04Recruiting
Topical Pentoxifylline; Metformin Versus Betamethasone in the Treatment of Alopecia Areata: a Clinical and Dermoscopic Study. [NCT06087796]Phase 160 participants (Anticipated)Interventional2023-10-31Not yet recruiting
Comparative Evaluation of the Efficacy and Tolerability of Prednisolone Acetate 0.5% Cream Versus Betamethasone Valerate 0.1% Cream in the Treatment of Pediatric and Adult Dermatosis [NCT01011621]Phase 3170 participants (Anticipated)Interventional2010-02-28Not yet recruiting
Efficacy of Micro-pulse Steroid Therapy as Induction Therapy in Patients With Polymyalgia Rheumatica [NCT00982332]20 participants (Anticipated)Interventional2010-03-31Recruiting
A Proof of Concept Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Multiple Topical Administrations of BFH772 in Patients With Psoriasis. [NCT00987870]Phase 1/Phase 215 participants (Actual)Interventional2009-09-30Completed
Dose Reduction of Antenatal Betamethasone Given to Prevent the Neonatal Complications Associated With Very Preterm Birth: a Randomized, Multicentre, Double Blind Placebo-controlled Non Inferiority Trial [NCT02897076]Phase 33,250 participants (Actual)Interventional2017-01-31Completed
A Multicenter, Randomized, Double-blinded, Placebo and Positive Controlled Study to Evaluate the Anti-pruritic Effect, Safety and Tolerability, Systemic and Skin Exposure, After 2 Weeks of Treatment With a Microemulsion Formulation of DNK333 in Atopic Der [NCT01033097]Phase 280 participants (Actual)Interventional2009-11-30Completed
A Phase Ib, Multi-Center, Randomized, Vehicle- and Comparator-Controlled Trial, Double-Blind for the Investigational Medicinal Products, Observer-Blind for the Comparators to Evaluate the Safety and Antipsoriatic Efficacy of BOS-475 in a Psoriasis Plaque [NCT04221906]Phase 115 participants (Actual)Interventional2020-01-06Completed
Turmeric Based Therapy in the Treatment of Psoriasis: A Clinical Trial [NCT04071106]Phase 2/Phase 350 participants (Anticipated)Interventional2019-09-01Not yet recruiting
Evaluation of Potential Benefits of Using Steroids in the Postoperative Transient Hypoparathyroidism Total Thyroidectomy [NCT02652884]Phase 4110 participants (Anticipated)Interventional2016-01-31Recruiting
Prophylaxis of Postoperative Nausea and Vomiting After Cardiac Surgery (PONVACS) [NCT02744495]Phase 3502 participants (Actual)Interventional2016-02-29Completed
A Randomised Controlled Trial of Mild Versus Potent Topical Corticosteroids as Primary Treatment for Non-retractile Foreskin in Children. [NCT00933023]Phase 40 participants (Actual)Interventional2009-08-31Withdrawn(stopped due to Patient numbers estimated to be too low to complete the trial in less than 10 years)
Corneal Epithelium Repair and Therapy Using Autologous Limbal Stem Cell Transplantation [NCT02148016]Phase 1/Phase 230 participants (Anticipated)Interventional2012-12-31Recruiting
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Calcipotriene and Betamethasone Dipropionate Topical Foam, 0.005%/0.064% (Glenmark Pharmaceuticals Ltd) to [NCT03731091]Phase 3494 participants (Actual)Interventional2018-10-31Completed
A Phase I, Randomized, Observer-blind, Single-center, Vehicle- And Comparator-controlled, Initial Dose-ranging Study To Assess The Antipsoriatic Efficacy Of Different Concentrations Of An2728 Ointment In A Psoriasis Plaque Test [NCT00762658]Phase 112 participants (Actual)Interventional2007-11-30Completed
A Phase I, Randomized, Observer-blind, Single-center, Vehicle- And Comparator-controlled, Initial Dose-ranging Study To Assess The Antipsoriatic Efficacy Of Different Concentrations Of An2728 Cream In A Psoriasis Plaque Test [NCT00763204]Phase 112 participants (Actual)Interventional2008-02-29Completed
A Double-Blind, Vehicle-Controlled, Rising Dose, Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy Study of Ruxolitinib Phosphate Cream When Applied to Patients With Plaque Psoriasis [NCT00820950]Phase 229 participants (Actual)Interventional2007-05-31Completed
The Effects of Topical Corticosteroid Use on Insulin Sensitivity and Bone Turnover [NCT04114097]Phase 436 participants (Actual)Interventional2019-08-22Completed
Single Dose of Antenatal Corticosteroids (SNACS) Randomized Controlled Trial for Pregnancies at Risk of Preterm Delivery: To Keep Babies and Children Safe [NCT05114096]Phase 43,254 participants (Anticipated)Interventional2023-07-20Recruiting
Corticosteroid Injection as a Predictor of Outcome in Carpal Tunnel Release [NCT00655915]200 participants (Anticipated)Observational2007-12-31Terminated(stopped due to Study was terminated by principal investigator)
Xamiol® Gel in BODY Psoriasis : lonG-term Management of Psoriasis vUlgARis With Xamiol® Gel in Daily Clinical Practice of Russian Dermatologists. A Long-term Observational, Prospective Study [NCT02636101]603 participants (Actual)Observational2016-01-31Completed
[NCT02733874]Phase 4240 participants (Actual)Interventional2015-04-30Completed
Pimecrolimus 1% Cream vs. Betamethasone Valerate 0.1% Cream in the Treatment of Facial Discoid Lupus Erythematosus: a Double-Blind Randomized, Pilot Study. [NCT00608673]10 participants (Actual)Interventional2006-04-30Completed
Phase 3 Study, Randomized, Double-blind, Parallel to Evaluate Ketoconazole and Betamethasone Dipropionate(Candicort®) Compared to Clotrimazole and Dexamethasone Acetate(Baycuten N®) in Relief of Fungal Infections/Dermatophytosis Symptoms. [NCT02582177]Phase 3125 participants (Actual)Interventional2019-06-11Completed
A Randomized Double-Blinded Study Comparing the Impact of One Versus Two Courses of Antenatal Steroids on Neonatal Outcome [NCT00201643]Phase 4437 participants (Actual)Interventional2003-11-30Completed
A Double-blind, Randomized, Controlled, Equivalence Study Comparing Intra-articular Corticosteroid to Intra-articular Ketorolac Knee Injections [NCT02612272]Phase 4448 participants (Anticipated)Interventional2015-11-30Recruiting
Topical Cetirizine Versus Topical Betamethasone in Treatment of Localized Alopecia Areata [NCT05803070]59 participants (Anticipated)Observational2023-09-01Not yet recruiting
[NCT00914836]0 participants (Actual)Interventional2009-06-30Withdrawn(stopped due to difficulties in the department)
Nebulized Adrenalin and Oral Betamethasone in Children With Bronchiolitis Attending Pediatric Emergencies : a Multicentre Randomized Controlled Trial [NCT02586961]Phase 2/Phase 3195 participants (Actual)Interventional2015-10-31Terminated(stopped due to Removal of Adrénaline lots for safety reasons.)
A Multi-Center Phase II Study to Evaluate Tumor Response to Ipilimumab (BMS-734016) Monotherapy in Subjects With Melanoma Brain Metastases [NCT00623766]Phase 299 participants (Actual)Interventional2008-07-31Completed
Efficacy and Safety of Loratadine-Betamethasone Oral Solution (1 mg/0.05 mg/1 mL) for Initial Treatment of Severe Perennial Allergic Rhinitis in School Age Children [NCT00963573]Phase 4100 participants (Actual)Interventional2003-09-30Completed
Acute Unilateral Vestibulopathy and Corticosteroid Treatment [NCT02912182]Phase 478 participants (Actual)Interventional2015-12-31Terminated(stopped due to Placebo medication expired)
One-year Prospective, Observational Study of the Journey of Patients With Plaque Psoriasis Prescribed Calcipotriol/Betamethasone Aerosol Foam or Other Topical Therapy [NCT02935582]1,214 participants (Actual)Observational2017-01-31Completed
A Randomised, Double-Blind, Active-Controlled, Parallel, Multi-Center Study to Investigate the Efficacy and Safety of Daivobet® Ointment in Patients With Psoriasis Vulgaris [NCT00248456]Phase 4320 participants Interventional2005-10-31Completed
Efficacy of Topical Rapamycin in Treatment of Chronic Erosive Oral Lichen Planus. Double Blind Randomised Controlled Trial Rapamycin vs Topical Steroids [NCT01061853]Phase 376 participants (Actual)Interventional2008-02-29Terminated(stopped due to Per protocol intermediate analyses of 76 patients and enrollment difficulties.)
A Randomized, Prospective, Double-Blind Controlled Evaluation of the Effectiveness of Cervical and Thoracic Interlaminar Epidural Injections in Thoracic and Cervical Disc Herniation, Discogenic Pain, and Post-Cervical Laminectomy Syndrome [NCT01071369]Phase 4120 participants (Actual)Interventional2008-02-29Completed
Dupilumab Impact on Skin Resident Memory T Cells [NCT03983460]20 participants (Anticipated)Interventional2020-03-09Recruiting
Evaluation of Efficacy and Safety of Epidural Steroid Injection Using Dexamethasone or Betamethasone in Patients With Spinal Pain: a Prospective, Randomized, Double-blind Study [NCT01885481]600 participants (Actual)Interventional2013-10-31Completed
Role of Biological Therapy in Rotator Cuff Tendinopathy. Effectiveness of Plasma Rich in Growth Factors Regarding Functional Capacity and Pain Compared With the Conventional Treatment Using Steroids [NCT01915979]Phase 384 participants (Actual)Interventional2014-02-28Completed
A Multicenter, Randomized, Double-Masked, Dose-Ranging Study To Compare The Ocular Safety, Tolerability, And Efficacy Of SURF-200 Ophthalmic Solution (0.02% And 0.04% Betamethasone Sodium Phosphate) To Vehicle In Subjects With A Diagnosis Of Dry Eye Disea [NCT04734210]Phase 2139 participants (Actual)Interventional2021-01-07Completed
[NCT01946386]Phase 135 participants (Actual)Interventional2013-09-30Completed
Calcipotriol Plus Betamethasone Dipropionate Gel Compared to Betamethasone Dipropionate in the Gel Vehicle, Calcipotriol in the Gel Vehicle, and the Gel Vehicle Alone in Scalp Psoriasis [NCT00216827]Phase 31,485 participants Interventional2004-11-30Completed
Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids, Hypertrophic Scars) [NCT04593706]40 participants (Anticipated)Interventional2020-11-01Not yet recruiting
Investigator Initiated Study for Optimal Maintenance Treatment With Calcipotriol /Betamethasone Dipropionate Gel in Korean Patients With Psoriasis Vulgaris [NCT02004574]Phase 4201 participants (Actual)Interventional2013-10-31Completed
Investigation of the Effect of Central Sensitization on Steroid Injection Response in Patients With Shoulder Pain Secondary to Rotator Cuff Lesion [NCT05926895]36 participants (Anticipated)Interventional2023-06-02Recruiting
Comparative Effectiveness of Particulate Versus Nonparticulate Corticosteroid Injections for the Treatment of Musculoskeletal Conditions [NCT04278833]Phase 4198 participants (Anticipated)Interventional2020-09-01Recruiting
Comparison Between Subacromial Ultrasound Guided and Systemic Steroid Injection for Frozen Shoulder: a Randomized Double Blind Study [NCT04931511]Phase 420 participants (Actual)Interventional2021-06-01Terminated(stopped due to Since the COVID-19 pendemic, the regular follow-up of participant became very hard. The participant were not willing to go back to the hospital for repeat measurement. So we stop the study and plan to redesign the protocol.)
A 28-day, Double-blind, Randomized, Reference-controlled Psoriasis Plaque Test to Evaluate the Efficacy and Safety of Two Different BAY1003803 Formulation Types in 2 Concentrations Each in Treatment of Symptomatic Volunteers With Plaque-type Psoriasis [NCT02940002]Phase 123 participants (Actual)Interventional2016-10-12Completed
A Phase I, Single-Center, Randomized, Vehicle-Controlled Study, Double-Blind for the Study Preparations and Observer-Blind for the Comparators to Determine the Antipsoriatic Efficacy and Tolerability of Topical Formulations With Ciclosporin in a Psoriasis [NCT00578370]Phase 1/Phase 225 participants (Anticipated)Interventional2007-11-30Completed
A Randomized, Multicenter STudy to Evaluate the Effect of Secukinumab 300 mg s.c. Administered During 52 Weeks to Patients Suffering From New-onset Moderate to Severe Plaque Psoriasis as Early Intervention Compared to Standard Treatment With Narrow-band U [NCT03020199]Phase 4196 participants (Actual)Interventional2017-03-27Completed
A Double-Blind, Within-Subject Randomised, Placebo-Controlled, Proof of Concept, Comparison Study of SHP-141C Topical Cream in Psoriasis, Using the Microplaque Assay. [NCT01646567]Phase 114 participants (Actual)Interventional2012-09-30Completed
A Phase I Trial to Evaluate Safety and Efficacy of Topically Applied GSK2981278 Ointment in a Psoriasis Plaque Test [NCT02548052]Phase 115 participants (Actual)Interventional2015-10-22Completed
Antenatal Corticoid Therapy for Fetal Lung Maturation in Late Preterm Pregnancies: a Randomized Controlled Trial [NCT00675246]320 participants (Anticipated)Interventional2008-05-31Completed
Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial [NCT01222247]Phase 32,831 participants (Actual)Interventional2010-10-31Completed
Evaluation of Topical Rebamipide Versus Topical Betamethasone for Management of Oral Ulcers in Behcet's Disease: A Randomized Clinical Trial [NCT06084624]Phase 1/Phase 240 participants (Anticipated)Interventional2023-12-31Not yet recruiting
ACTH vs Betamethasone for the Treatment of Acute Gout in Hospitalized Patients: A Randomized, Open Label, Comparative Study [NCT04306653]60 participants (Anticipated)Interventional2018-01-05Recruiting
Prospective, Observational, Non-interventional, Multicenter Study on the Efficacy and Tolerability of Calcipotriol/Betamethasone Aerosol Foam (Enstilar®) in Patients With Plaque Psoriasis Under Daily Practice Conditions [NCT02881346]410 participants (Actual)Observational2016-09-30Completed
Nickel Desensitization Using Topical Therapy [NCT01413477]24 participants (Anticipated)Interventional2011-08-31Not yet recruiting
Unicentric Comparing Effectiveness of Polymyxin B Sulphate + Prednisolone + Benzocaine + Clioquinol to Betamethasone + Gentamicin + Tolnaftate + Clioquinol in Acute and Sub-acute Dermatitis Eczematous [NCT01429701]Phase 376 participants (Actual)Interventional2012-05-31Completed
A Multi Centre, Parallel, Randomised Study of the Skin Tolerance of Betamethasone Creams on Atopic Eczema and the Influence of Moisturiser Treatment on the Recurrence of Eczema [NCT00576238]Phase 355 participants (Actual)Interventional2004-01-31Completed
A Randomised Trial of a Moisturising Cream in Preventing Recurrence of Hand Eczema [NCT00576550]Phase 453 participants (Actual)Interventional2007-10-31Completed
Calcipotriol Plus Betamethasone Dipropionate Gel Compared to Betamethasone Dipropionate in the Gel Vehicle and Calcipotriol in the Gel Vehicle in Scalp Psoriasis [NCT00216840]Phase 31,350 participants Interventional2004-12-31Completed
Long-term Treatment of Scalp Psoriasis With Calcipotriol Plus Betamethasone Dipropionate Gel [NCT00216879]Phase 3800 participants Interventional2005-02-28Completed
A Plaque Test Comparing 4 Steroids With Daivobet® Ointment and a Vehicle Control for the Treatment of Psoriasis Vulgaris [NCT00845481]Phase 224 participants (Actual)Interventional2009-01-31Completed
Observational and Prospective Study in Patients With Nail Psoriasis Treated With Calcipotriene and Betamethasone Dipropionate Aerosol Foam to Evaluate the Change in the Severity of Psoriasis and in the Quality of Life [NCT04380597]10 participants (Actual)Observational2019-03-26Completed
An Open-Label, Study Evaluating Enstilar® (Calcipotriene and Betamethasone Dipropionate) Foam, 0.005%/0.064% QD in Psoriasis Patients Being Treated With Biologic Agents [NCT03080545]Phase 425 participants (Actual)Interventional2017-05-01Completed
Betamethasone Dosing Interval - 12 or 24 Hours? [NCT00453141]200 participants (Anticipated)Interventional2006-04-30Completed
A Phase 3 Study Comparing Once Daily Treatment With Calcipotriol 50 mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) Topical Suspension With Betamethasone 0.5 mg/g (as Dipropionate) in the Topical Suspension Vehicle, Calcipotriol 50 mcg/g in the Topica [NCT01188928]Phase 31,152 participants (Actual)Interventional2010-09-30Completed
Does a Repeat Course of Antenatal Corticosteroids in Pregnant Women With Preterm Premature Rupture of Membranes Decrease Neonatal Morbidity? [NCT02939742]Phase 2/Phase 398 participants (Anticipated)Interventional2016-11-30Recruiting
Nonaromatic Naphthalan - Composition Study and Biological Effects on Epithelial Tissues [NCT02920658]Phase 257 participants (Actual)Interventional2010-12-31Completed
OPtimal TIming of COrticosteroids in Early-onset Fetal Growth REstriction: the OPTICORE Study [NCT05606497]1,800 participants (Anticipated)Observational2022-05-11Recruiting
Evaluation of the Efficacy of Diprospan Injection to the Knee on Rehabilitation of Patients With Bilateral Knee Osteoarthritis After TKR of the Contralateral Knee. [NCT00542139]Phase 450 participants (Anticipated)Interventional2007-12-31Completed
Transforaminal Epidural Steroid Injection in Conjunction With Pulsed Radiofrequency Treatment of the Lumbar Dorsal Root Ganglion for the Management of Chronic Lumbosacral Radicular Pain: a Randomized, Double-blind Trial [NCT02930057]Phase 4120 participants (Anticipated)Interventional2016-10-31Not yet recruiting
Randomized, Double Blind Comparison Trial of Prolotherapy (Dextrose) Compared to Corticosteroid Injection for the Treatment of Symptomatic Thumb Carpo-metacarpal Joint Arthritis [NCT00685880]2 participants (Actual)Interventional2008-05-31Terminated(stopped due to Unable to recruit adequate numbers of patients)
A Psoriasis Plaque Test Comparing LEO 29102 Cream and Its Different Combinations to Daivobet® Ointment and a Vehicle Control for the Treatment of Psoriasis Vulgaris [NCT00875277]Phase 224 participants (Actual)Interventional2009-04-30Completed
A Double-blind,Double Dummy, Randomized, Multicenter Parallel-group Study on Efficacy of Desloratadine and Prednisolone Association Compared to Dexchlorpheniramine and Betamethasone Association in Adults With Moderate - Severe Persistent Allergic Rhinitis [NCT01720485]Phase 3234 participants (Anticipated)Interventional2013-10-31Not yet recruiting
Comparison of Ozone and Steroid Injection in Patients With Greater Trochanteric Pain Syndrome [NCT04420572]63 participants (Actual)Interventional2021-03-11Completed
A Phase 1 Randomized, Placebo and Active Comparator-controlled Trial, Double-blind for the IPs, Observer-blind for the Active Comparator, to Assess the Potency of SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment in a Psoriasis Plaque Test [NCT03004339]Phase 113 participants (Actual)Interventional2016-08-31Completed
Interest in Programming Caesarean Section at 38 Weeks of Pregnancy With Antenatal Betamethasone to Prevent Neonatal Respiratory Distress and to Avoid Emergency Caesarean Section Before Planned Date. [NCT00446953]Phase 4200 participants (Actual)Interventional2007-02-28Completed
Randomized Controlled Trial of Antepartum Betamethasone Treatment for Prevention of Respiratory Distress in Infants Born by Elective Cesarean Section [NCT00139256]Phase 2/Phase 367 participants (Actual)Interventional2005-08-31Terminated(stopped due to Slow enrollment and lack of funds.)
The Effect of Maternal Antenatal Steroid Administration on the Blood Flow Through the Pulmonary Artery in the Term Fetus; a Randomized Control Double Blinded Study [NCT02978976]Phase 4126 participants (Anticipated)Interventional2017-01-31Recruiting
Investigation of Prenatal Steroids for Treatment of Prenatally Diagnosed CCAMs [NCT00670956]Phase 1/Phase 21 participants (Actual)Interventional2008-04-30Terminated(stopped due to Recruitment has been poor. Study drug is being offered as part of standard care of women carrying a pregnancy diagnosed with CCAM)
Combination Treatment With Methotrexate and Cyclosporine in Early Rheumatoid Arthritis. [NCT00209859]Phase 4160 participants Interventional1998-10-31Completed
Efficacy and Safety of add-on Topical Timolol in the Management of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor-induced Paronychia: A Prospective Randomized Open-labelled Trial [NCT06140186]Phase 340 participants (Anticipated)Interventional2023-04-01Recruiting
A Randomized, Sham Controlled, Multicenter, Double-Masked, Phase 2/3 Study Assessing Efficacy and Safety of Betamethasone Microsphere in Patients With Macular Edema Following Branch Retinal Vein Occlusion [NCT01512901]Phase 2/Phase 30 participants InterventionalCompleted
A Double-blind, Randomized, Multicenter Parallel-group Study on Efficacy of Desloratadine and Prednisolone Association Compared to Dexchlorpheniramine and Betamethasone Association in Children (2-12 Years) With Moderate - Severe Persistent Allergic Rhinit [NCT01529229]Phase 3210 participants (Actual)Interventional2013-11-30Completed
A Double-blind, Randomized, Multicenter Parallel-group Study on Efficacy of Desloratadine and Prednisolone Association Compared to Dexchlorpheniramine and Betamethasone Association in Children (2-12 Years) With Acute Cutaneous Rash [NCT01529242]Phase 317 participants (Actual)Interventional2014-02-28Terminated(stopped due to By sponsor decision due to difficulty of recruitment)
A Randomized, Evaluator Blinded, Within Subject, Single-Centre Evaluation of the Vasoconstriction Properties of MC2-01 Cream, Compared to 5 Other Corticosteroids in Healthy Subjects [NCT03758365]Phase 136 participants (Actual)Interventional2018-11-05Completed
Different Treatment Regimens of Calcipotriol Cream and Combination (Calcipotriol/Betamethasone Dipropionate) Ointment in Psoriasis Vulgaris [NCT00216892]Phase 41,032 participants Interventional2005-04-30Completed
An Enhanced Transcutaneous Delivery of Topical Betamethasone for the Treatment of Vitiligo Disease [NCT05233735]20 participants (Anticipated)Interventional2021-01-01Recruiting
Prospective Comparative Trial to Assess the Role of Local Long Acting Steroid Injection After Hypospadias Surgery in Decreasing Complications and Preserving Better Cosmesis [NCT04196400]Early Phase 140 participants (Anticipated)Interventional2019-12-01Enrolling by invitation
Double-blind Evaluation of the Safety and Efficacy of Quadriderme® (Betamethasone Diproprionate, Clotrimazole and Gentamicin) Compared With Betamethasone Diproprionate Combined With Gentamicin Sulfate and With Betamethasone Diproprionate in the Treatment [NCT00671528]Phase 43 participants (Actual)Interventional2009-07-31Terminated(stopped due to terminated early due to lack of recruitment [only 3 of 207 subjects were enrolled])
Rescue Antenatal Steroids and Lung Volumes in Preterm Infants [NCT00669383]85 participants (Actual)Interventional2001-06-30Completed
A Phase 3 Study Comparing a Gel Containing Calcipotriol 50 mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) With Tacalcitol Ointment (4 mcg/g) and Gel Vehicle, Used Once Daily in the Treatment of Psoriasis Vulgaris [NCT00670241]Phase 3458 participants (Actual)Interventional2008-04-30Completed
A Phase Ib/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection in Chinese Participants With Acute Gout [NCT05588908]Phase 1/Phase 2120 participants (Anticipated)Interventional2022-06-29Recruiting
The Comparative Study of Safety and Effectiveness of Intra-articular Injection of Tocilizumab and Compound Betamethasone in Rheumatoid Arthritis of the Knee [NCT03215407]Phase 460 participants (Anticipated)Interventional2017-08-01Not yet recruiting
Calcipotriol Plus Betamethasone Dipropionate Gel Compared to Betamethasone Dipropionate in the Gel Vehicle, Calcipotriol in the Gel Vehicle and the Gel Vehicle Alone in Psoriasis Vulgaris [NCT00263718]Phase 2360 participants Interventional2005-12-31Completed
Calcipotriol Plus Betamethasone Dipropionate Gel Compared to DAIVONEX/DOVONEX Scalp Solution in Patients With Scalp Psoriasis [NCT00243464]Phase 3300 participants Interventional2005-09-30Completed
Calcipotriene Plus Betamethasone Dipropionate Gel Compared to the Gel Vehicle in Scalp Psoriasis, in Patients Receiving Calcipotriene Plus Betamethasone Dipropionate Ointment for Psoriasis Vulgaris of Trunk/Limbs [NCT00279162]Phase 3160 participants (Anticipated)Interventional2005-12-31Completed
Randomized Trial on Efficacy and Safety of the Antenatal Rescue Course of Glucocorticoids in Threatened Premature Birth (ACG Trial) [NCT00295464]Phase 4440 participants Interventional2001-05-31Terminated
[NCT00418353]0 participants Interventional2002-08-31Completed
Safety and Efficacy of TACLONEX Ointment in Adolescent Patients (Aged 12 to 17 Years) With Psoriasis Vulgaris [NCT00817219]Phase 233 participants (Actual)Interventional2009-07-31Completed
The Effect Of Antenatal Corticosteroids On Early And Late Perinatal Outcomes In Late Preterm Pregnant Women [NCT06164080]459 participants (Actual)Interventional2021-06-01Completed
[NCT01710384]Phase 2200 participants (Anticipated)Interventional2012-11-30Not yet recruiting
Interest of Intravitreal Corticotherapy as the First-line Treatment for Post-operative Endophthalmitis. [NCT01768078]Phase 3112 participants (Actual)Interventional2008-09-30Completed
Safety & Efficacy of Genakumab in Patients With Frequent Flares [NCT05983445]Phase 3302 participants (Anticipated)Interventional2023-01-15Recruiting
Facet Versus Trigger Point Injection for Management of Chronic Muscular Neck Pain: A Randomized Clinical Trial and Creation of a Clinical Prediction Algorithm [NCT01808586]Phase 243 participants (Anticipated)Interventional2013-05-31Completed
A Phase 2 Study Comparing Treatment With LEO 90100 With Calcipotriol Plus Betamethasone Ointment, LEO 90100 Vehicle and Ointment Vehicle in Subjects With Psoriasis Vulgaris. [NCT01536886]Phase 2376 participants (Actual)Interventional2012-05-31Completed
Efficacy and Safety of LEO 90105 Ointment (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Japanese Subjects With Psoriasis Vulgaris [NCT01422434]Phase 3676 participants (Actual)Interventional2011-07-31Completed
[NCT01536938]Phase 2303 participants (Actual)Interventional2012-05-31Completed
Treatment Results for Patients With Central Centrifugal Cicatricial Alopecia (CCCA): a Multicenter Prospective Study [NCT04207931]Phase 4250 participants (Anticipated)Interventional2018-04-30Recruiting
The Effect of Enstilar Versus Vehicle on Target Lesions in Moderate Plaque Type Psoriasis Patients [NCT03848871]Phase 420 participants (Actual)Interventional2017-12-12Completed
Patient Preference of Taclonex Ointment to Taclonex Scalp Suspension in Adult Subjects With Psoriasis Vulgaris [NCT01707043]Phase 420 participants (Actual)Interventional2012-10-31Completed
A Comparative Study Between Topical Betamethasone Cream or Topical Olive Oil Cream in Prophylaxis Against Acute Radiodermatitis in Breast Cancer Patients. [NCT05285943]Phase 4132 participants (Anticipated)Interventional2021-11-04Recruiting
Betamethason Versus Ketorolac Injection for the Treatment of DeQuervains Tenosynovitis [NCT02604537]Phase 464 participants (Anticipated)Interventional2015-10-15Active, not recruiting
An Open-Label, Multicenter Study of Patient-Reported Satisfaction Following Twice Daily Dosing With Betamethasone Dipropionate Spray, 0.05% in Subjects With Moderate Plaque Psoriasis [NCT02749799]Phase 445 participants (Actual)Interventional2016-02-29Completed
An Open-Label Study Evaluating Enstilar® (Calcipotriene and Betamethasone Dipropionate) Foam, 0.005%/0.064% QD in Psoriasis Patients Being Treated With Etanercept or Adalimumab [NCT03827876]Phase 430 participants (Anticipated)Interventional2019-01-16Recruiting
A Randomized, Parallel Group, Open-Label, Multicenter Study to Assess the Potential for Adrenal Suppression and Systemic Drug Absorption Following Multiple Dosing With DFD-01 (Betamethasone Dipropionate) Spray, 0.05% [NCT02527421]Phase 33 participants (Actual)Interventional2015-08-19Terminated(stopped due to Not able to recruit patients with the current enrollment criteria.)
A Psoriasis Plaque Test Study With LEO 90100 Cutaneous Spray, Ointment, in Psoriasis Vulgaris [NCT01347255]Phase 224 participants (Actual)Interventional2011-05-31Completed
An Evaluation of the Efficacy, Safety, Preference and Duration of Response of Clobex® (Clobetasol Propionate) Spray and Taclonex® (Calcipotriene 0.05%/Betamethasone Dipropionate 0.064%) Ointment in Subjects With Stable Plaque Psoriasis [NCT00437255]Phase 4122 participants (Actual)Interventional2006-08-31Completed
A Phase IIa Exploratory Study Evaluating the Anti-psoriatic Effect of Daivobet® Gel Applied Then Removed After 10 Minutes, Daivobet® Gel Applied Then Removed After 20 Minutes, Daivobet® Gel Applied for 24 Hours and Daivobet® Gel Vehicle Applied for 24 Hou [NCT01607853]Phase 224 participants (Actual)Interventional2012-06-30Completed
Timing of Late Preterm Corticosteroid Administration and Neonatal Hypoglycemia [NCT04869709]Phase 4210 participants (Anticipated)Interventional2021-07-31Not yet recruiting
A Dose-response Study of Markers of Glucocorticoid Effects (DOSCORT): A Double-blinded, Randomized, 2-dose, Cross-over Study [NCT03210545]Phase 430 participants (Anticipated)Interventional2021-03-02Recruiting
A Randomized Double-Blind Clinical Trial to Investigate the Use of Autologous Conditioned Plasma (ACP) for Patients With Plantar Fasciitis [NCT01614223]140 participants (Anticipated)Interventional2010-09-30Recruiting
The Impact of Stress on Fetal Brain Development [NCT03831126]24 participants (Anticipated)Observational2019-02-01Recruiting
Multicenter Randomized Controlled Trial of Epidural Steroid Injections for Spinal Stenosis in Persons 50 and Older [NCT01238536]Phase 4400 participants (Actual)Interventional2011-04-30Completed
Single-site, Double Blinded, Randomized Investigation of Corticosteroid Versus Placebo Injection Under Ultrasound Guidance in Patients With Syndesmotic Ligament Injury or High Ankle Sprain [NCT02892500]Phase 21 participants (Actual)Interventional2016-04-30Terminated(stopped due to Inability to enroll subjects)
[NCT00004778]Phase 31,090 participants Interventional1993-08-31Completed
The Effect of Betamethasone Dipropionate on Patients With Eosinophilic Chronic Rhinosinusitis [NCT05220293]Phase 1/Phase 212 participants (Anticipated)Interventional2022-02-23Recruiting
Effect of Topical Calcipotriene/Betamethasone (Taclonex) in Managing Localized Mild Breakthrough in Moderate to Severe Plaque Psoriasis Patients Receiving Efalizumab ( Raptiva). [NCT00608777]Phase 46 participants (Actual)Interventional2008-01-31Terminated(stopped due to Withdrawal of marketing autorization of efalizumab by the EMEA.)
A Multicenter, Randomized, Double-Masked Study To Evaluate The Safety, Tolerability, And Efficacy Of SURF-100 Ophthalmic Solution (A Mycophenolic Acid/Betamethasone Sodium Phosphate Combination) In Subjects With Dry Eye Disease [NCT04734197]Phase 2351 participants (Actual)Interventional2021-01-11Completed
A Randomized, Prospective, Double-Blind Controlled Evaluation of the Effectiveness of Caudal Epidural Injections in Lumbar Disc Herniations, Spinal Stenosis, Discogenic Pain, and Post-Lumbar Laminectomy Syndrome [NCT00370799]Early Phase 1240 participants (Actual)Interventional2007-01-31Completed
Comparison of the Efficacy Between Transforaminal Steroid Epidural Injection and Epidural Neuroplasty for the Treatment of Herniated Lumbar Disc:A Single Center, Controlled Clinical Trial [NCT03101033]92 participants (Actual)Interventional2015-05-31Completed
Comparison of the Efficacy of Tacrolimus 0.1% Ointment vs Calcipotriol/Betamethasone in Combination With NBUVB in Treatment of Vitiligo [NCT04440371]40 participants (Anticipated)Interventional2020-06-21Active, not recruiting
Can an App Supporting Psoriasis Patients Improve Adherence to Topical Treatment? A Single-blind Randomized Controlled Trial [NCT02858713]Phase 4134 participants (Actual)Interventional2017-01-09Completed
Effects of Antenatal Corticosteroids in Patients With Early (22 - 23w6d) Threatened Preterm Birth [NCT02351310]Phase 30 participants (Actual)Interventional2015-11-30Withdrawn(stopped due to Company decided not to pursue this study.)
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Calcipotriene and Betamethasone Dipropionate Topical Suspension, 0.005%/0.064% (Glenmark Pharmaceuticals Lt [NCT03331523]Phase 3643 participants (Actual)Interventional2017-10-20Completed
Effectiveness and Pharmacoeconomic Study of Using Different Corticosteroids in the Treatment of Interstitial Lung Diseases [NCT04982809]107 participants (Actual)Interventional2018-07-01Completed
The Role of Intra-articular Injection of Autologous Platelet Rich Plasma Versus Corticosteriods in Treatment of Synovitis in Lumbar Facet Joint Disease [NCT04860531]Phase 330 participants (Actual)Interventional2019-09-17Completed
A Single-Center, Randomized, Observer Blind, Vehicle- and Comparator-controlled Trial to Evaluate the Antipsoriatic Efficacy and Safety of Topical Formulations of C-82 in a Psoriasis Plaque Test [NCT02432027]Phase 1/Phase 214 participants (Actual)Interventional2015-06-30Completed
Non-surgical Treatment of Carpal Tunnel Syndrome: Night Splint Versus Local Corticosteroid Infiltration: Clinical Randomized Trial [NCT03196817]Phase 484 participants (Actual)Interventional2016-08-01Active, not recruiting
An Explorative Clinical Trial to Evaluate an Intra Patient Comparison Design of Topical Agents in Adults With Mild to Moderate Atopic Dermatitis [NCT02376049]Phase 130 participants (Actual)Interventional2015-02-28Completed
Effect of ZILRETTA Versus CELESTONE on Quality of Life, Pain, Neuromuscular Function, and Physical Performance [NCT05058209]Phase 420 participants (Actual)Interventional2020-11-30Completed
Investigating Differences in Flare Reaction Incidence and Intensity Following Trigger Finger Injections Using Betamethasone and Methylprednisolone [NCT04900220]Phase 466 participants (Actual)Interventional2021-09-15Completed
The Effect of Intra-sinus Application of Betamethasone Dipropionate Nasal Cream on Patients With Chronic Rhinosinusitis Post Functional Endoscopic Sinus Surgery (FESS) [NCT05882903]Phase 212 participants (Anticipated)Interventional2023-08-17Recruiting
Effect of Single Dose Antenatal Betamethasone on the Incidence of Neonatal Respiratory Morbidity After Elective Cesarean Section at Term: A Prospective Double Blinded Placebo Controlled Trial [NCT04407975]400 participants (Anticipated)Interventional2020-05-29Recruiting
Comparison of Post-Inflammatory Pigment Alteration After Psoriasis Treatment (PIPA - Dermavant) [NCT05981118]40 participants (Anticipated)Interventional2023-12-31Not yet recruiting
Biologics and Blistering - Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation Through Suction Blistering [NCT05535738]Phase 2/Phase 345 participants (Anticipated)Interventional2022-11-15Recruiting
Exploratory Study to Evaluate the Safety and Efficacy of CD10367 in Subjects With Psoriasis [NCT03025282]Phase 224 participants (Actual)Interventional2016-11-03Completed
A Comparative Study on Clinical Efficacy of Clobetasol and Betamethasone in Orabase in Combination With Clotrimazole, in Oral Lichen Planus [NCT03026478]Phase 230 participants (Anticipated)Interventional2016-05-06Recruiting
A Single-Centre, Explorative, Randomised, Investigator-Blinded, Negative-Controlled, Phase I Clinical Trial With Intra-Individual Comparison of Treatments to Assess Steroid Induced Skin Atrophy on Healthy Skin [NCT02355639]Phase 116 participants (Actual)Interventional2015-01-31Completed
A Randomized Comparative Study of Efficacy and Safety of Topical Latanoprost Versus Topical Corticosteroid in the Treatment of Localized Alopecia Areata [NCT02350023]Phase 450 participants (Actual)Interventional2014-09-30Completed
A Randomized Phase III, Three-parallel Arm, Assessor Blind, Multi-centre Study to Evaluate the Efficacy, Safety and Tolerability of AKP02 Cutaneous Spray Versus Enstilar Cutaneous Foam in Subjects With Mild to Moderate Psoriasis. [NCT05249972]Phase 3294 participants (Anticipated)Interventional2022-01-24Recruiting
A Randomized, Double-Blind Study Comparing TOLMAR Calcipotriene and Betamethasone Suspension to Reference Listed Drug in the Treatment of Scalp Psoriasis [NCT03122353]Phase 1699 participants (Actual)Interventional2017-04-11Completed
Efficacy of Excimer Laser Combined With Either Topical Tazarotene or Topical Betamethasone Valerate Versus Excimer Laser Alone in Treatment of Localized Chronic Plaque Psoriasis; Clinical and Dermoscopic Study [NCT05555797]Phase 430 participants (Anticipated)Interventional2022-10-30Not yet recruiting
Calcipotriol /Betamethasone Ointment Versus Fractional CO2 Laser Plus Calcipotriol /Betamethasone Ointment in the Treatment of Plaque Psoriasis: Randomized Comparative Study [NCT06011083]40 participants (Actual)Interventional2022-08-01Completed
Effectiveness of Cortisone Injection and Splinting for Trigger Finger: A Prospective Randomized Controlled Trial [NCT03156829]Phase 4120 participants (Anticipated)Interventional2017-11-27Recruiting
"Evaluation of Pharmacokinetic Parameters of Diprospan" [NCT03119454]40 participants (Actual)Observational [Patient Registry]2016-10-31Completed
A Study to Investigate the Irritation Potential on Healthy Intact Skin and Effect on Psoriatic Skin of Topical Applications of GW786034 [NCT00358384]Phase 110 participants (Actual)Interventional2005-09-26Completed
A Randomized Double-blinded Trial Comparing the Impact of One Versus Two Courses of Antenatal Steroids on Neonatal Outcome in the Patient With Prelabor Premature Rupture of the Membranes [NCT02469519]Phase 2/Phase 3194 participants (Actual)Interventional2016-03-03Completed
Antenatal Corticosteroid Therapy: Which Impact on Birth Parameters? [NCT05640596]363 participants (Actual)Observational2014-01-01Completed
Betamethasone (Betapred®) as Premedication for Reducing Postoperative Vomiting and Pain After Tonsillectomy - a Randomized, Double-blind, Placebo-controlled Trial [NCT03783182]Phase 4100 participants (Anticipated)Interventional2019-09-10Recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00201643 (9) [back to overview]Number of Neonates With Pneumothorax
NCT00201643 (9) [back to overview]Number of Neonates Who Required Surfactant Therapy After Birth.
NCT00201643 (9) [back to overview]Number of Babies Who Required Ventilatory Support Within the First 28 Days of Life.
NCT00201643 (9) [back to overview]Neonatal Head Circumference Taken at Time of Birth.
NCT00201643 (9) [back to overview]Neonatal Birth Weight Reported in Grams
NCT00201643 (9) [back to overview]Maternal Infectious Morbidity.
NCT00201643 (9) [back to overview]Gestational Age at (@) Delivery
NCT00201643 (9) [back to overview]Composite Neonatal Morbidity < 34 Weeks Gestation at Time of Birth.
NCT00201643 (9) [back to overview]Interuterine Growth Restriction (IUGR) or Small for Gestational Age(SGA)in Babies Delivering at < 34 Weeks Gestation.
NCT00574249 (18) [back to overview]Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 2
NCT00574249 (18) [back to overview]Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 4
NCT00574249 (18) [back to overview]Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 8
NCT00574249 (18) [back to overview]Percentage of Participants Achieving a Physicians Global Assessment (PGA) Response of Clear or Minimal at Week 16
NCT00574249 (18) [back to overview]Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0)
NCT00574249 (18) [back to overview]Percentage of Participants With a PASI100 Response at Week 16 Compared With Baseline (Week 0)
NCT00574249 (18) [back to overview]Percentage of Participants With a PASI50 Response at Week 16 Compared With Baseline (Week 0)
NCT00574249 (18) [back to overview]Percentage of Participants With a PASI90 Response at Week 16 Compared With Baseline (Week 0)
NCT00574249 (18) [back to overview]Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 12 Compared With Baseline (Week 0)
NCT00574249 (18) [back to overview]Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16 Compared With Baseline (Week 0)
NCT00574249 (18) [back to overview]Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 4 Compared With Baseline (Week 0)
NCT00574249 (18) [back to overview]Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 8 Compared With Baseline (Week 0)
NCT00574249 (18) [back to overview]Percent Change in Nail Psoriasis Severity Index (NAPSI) at Week 16.
NCT00574249 (18) [back to overview]Percent Change in Psoriasis Scalp Severity Index (PSSI) From Baseline to Week 16.
NCT00574249 (18) [back to overview]Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 16 Compared With Baseline (Week 0)
NCT00574249 (18) [back to overview]Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 8 Compared With Baseline (Week 0)
NCT00574249 (18) [back to overview]Percent Change in the Dermatology Life Quality Index (DLQI) Total Score at Week 2 Compared With Baseline (Week 0)
NCT00574249 (18) [back to overview]Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 12
NCT00623766 (9) [back to overview]Best Overall Response Rate (BORR) by Modified World Health Organization (mWHO) Criteria and by Immune-relate Response Criteria (irRC)
NCT00623766 (9) [back to overview]Disease Control Rate by Immune-related Response Criteria (irRC)
NCT00623766 (9) [back to overview]Duration of Response (DOR) by Modified World Health Organization (mWHO) Criteria and by Immune-related Response Criteria (irRC)
NCT00623766 (9) [back to overview]Number of Participants Surviving at 6, 12, 18, 24, and 36 Months (Overall Survival [OS] Rate)
NCT00623766 (9) [back to overview]Number of Participants Who Died or Had a Treatment-related Adverse Event (AE), Immune-related AE, Immune-related Serious Adverse Event (SAE), Nervous System Disorder, Treatment-related Nervous System Disorder, SAE, and AE Leading to Discontinuation
NCT00623766 (9) [back to overview]Onset of Response by Modified World Health Organization (mWHO) Criteria and Immune-related Response Criteria (irRC)
NCT00623766 (9) [back to overview]Progression-free Survival (PFS) by Modified World Health Organization (mWHO) Criteria and by Immune-related Response Criteria (irRC)
NCT00623766 (9) [back to overview]Disease Control Rate by Modified World Health Organization (mWHO) Tumor Assessment Criteria
NCT00623766 (9) [back to overview]Overall Survival (OS)
NCT00669383 (3) [back to overview]FiO2
NCT00669383 (3) [back to overview]Measurements of Functional Residual Capacity in Preterm Infants.
NCT00669383 (3) [back to overview]Measurements of Respiratory Compliance (Crs) in Preterm Infants.
NCT00670241 (5) [back to overview]"Subjects With Controlled Disease (Clear or Almost Clear Disease) According to Investigator's Global Assessment of Disease Severity at Week 8"
NCT00670241 (5) [back to overview]The Percentage Change in PASI From Baseline to Week 8
NCT00670241 (5) [back to overview]"Subjects With Controlled Disease According to the Investigator's Global Assessment of Disease Severity at Week 4"
NCT00670241 (5) [back to overview]Subjects With Relapse During the Study
NCT00670241 (5) [back to overview]Subjects With Rebound During the Study
NCT00670956 (2) [back to overview]Incidence of Hydrops Fetalis
NCT00670956 (2) [back to overview]Survival at One-month Between Study and Control Groups.
NCT00671528 (1) [back to overview]Number of Days Required to Achieve Total Remission
NCT00817219 (10) [back to overview]Serum Cortisol Concentration of ≤18 mcg/dL at 30 Minutes After ACTH-challenge at End of Treatment
NCT00817219 (10) [back to overview]Serum Cortisol Concentration of ≤18 mcg/dL at 30 and 60 Minutes After ACTH-challenge at End of Treatment
NCT00817219 (10) [back to overview]Percentage Change in PASI From Baseline to Week 4.
NCT00817219 (10) [back to overview]PASI 75 at Week 4.
NCT00817219 (10) [back to overview]PASI 50 at Week 4.
NCT00817219 (10) [back to overview]Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment.
NCT00817219 (10) [back to overview]"Controlled Disease(i.e., Clear or Almost Clear) According to the Investigator's Global Assessment of Disease Severity at Week 4."
NCT00817219 (10) [back to overview]"Controlled Disease(i.e., Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 4."
NCT00817219 (10) [back to overview]Change in Albumin Corrected Serum Calcium From Baseline to End of Treatment
NCT00817219 (10) [back to overview]Adverse Drug Reactions
NCT00820950 (6) [back to overview]Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline
NCT00820950 (6) [back to overview]Pharmacokinetics Parameter : Skin Flux of INCB018424
NCT00820950 (6) [back to overview]Change in Target Lesion Area Compared to Baseline
NCT00820950 (6) [back to overview]Pharmacokinetics Parameter : Bioavailability of INCB018424
NCT00820950 (6) [back to overview]Number of Participants With Treatment Emergent Adverse Events
NCT00820950 (6) [back to overview]Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline
NCT00845481 (6) [back to overview]The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Daivobet Ointment Vehicle
NCT00845481 (6) [back to overview]The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Daivobet® Ointment
NCT00845481 (6) [back to overview]The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Dermovat Ointment
NCT00845481 (6) [back to overview]The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Diprosalic Ointment
NCT00845481 (6) [back to overview]The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Elocon Ointment
NCT00845481 (6) [back to overview]The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Betnovat® Ointment
NCT00875277 (13) [back to overview]Pathology and Histology by Treatment
NCT00875277 (13) [back to overview]Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound
NCT00875277 (13) [back to overview]Biomarkers by Immunochemistry: Epidermal Proliferation
NCT00875277 (13) [back to overview]Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline (Day 1)
NCT00875277 (13) [back to overview]Pathology and Histology by Treatment: Epidermal Thickness
NCT00875277 (13) [back to overview]Pathology and Histology by Treatment: Frequency of Neutrophil Abscesses
NCT00875277 (13) [back to overview]Biomarkers by Immunochemistry
NCT00875277 (13) [back to overview]Biomarkers by Immunochemistry: Epidermal Differentiation
NCT00875277 (13) [back to overview]Change in Erythema Compared to Baseline
NCT00875277 (13) [back to overview]Change in Infiltration Compared to Baseline
NCT00875277 (13) [back to overview]Change in Scaling Compared to Baseline
NCT00875277 (13) [back to overview]Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline
NCT00875277 (13) [back to overview]Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline
NCT00924950 (1) [back to overview]Change in Total Modified PASI Score at Week 4 Compared to Baseline
NCT01188928 (4) [back to overview]Controlled Disease According to the Investigator's Global Assessment of Disease Severity (IGA) at Weeks 4
NCT01188928 (4) [back to overview]Controlled Disease According to the Investigator's Global Assessment of Disease Severity (IGA) at Weeks 8
NCT01188928 (4) [back to overview]Mean Percentage Change in PASI From Baseline to Week 4
NCT01188928 (4) [back to overview]Mean Percentage Change in PASI From Baseline to Week 8
NCT01222247 (29) [back to overview]Time Until First Neonatal Feeding
NCT01222247 (29) [back to overview]Number of Neonates With Transient Tachypnea of the Newborn
NCT01222247 (29) [back to overview]Number of Neonates With Respiratory Distress Syndrome
NCT01222247 (29) [back to overview]Number of Neonates With Necrotizing Enterocolitic (NEC)
NCT01222247 (29) [back to overview]Number of Neonates With Intraventricular Hemorrhage
NCT01222247 (29) [back to overview]Number of Neonates With Hypothermia
NCT01222247 (29) [back to overview]Number of Neonates With Hypoglycemia
NCT01222247 (29) [back to overview]Number of Neonates Needing Surfactant Administration
NCT01222247 (29) [back to overview]Number of Infants withChronic Lung Disease / Bronchopulmonary Dysplasia (BPD) Requiring Supplemental Oxygen
NCT01222247 (29) [back to overview]Number of Infants With Neonatal Sepsis
NCT01222247 (29) [back to overview]Number of Infants With Neonatal Apnea
NCT01222247 (29) [back to overview]Birth Weight
NCT01222247 (29) [back to overview]Birth Weight Less Than 10th Percentile
NCT01222247 (29) [back to overview]Hours From Randomization to Delivery
NCT01222247 (29) [back to overview]Median Length of Hospital Stay
NCT01222247 (29) [back to overview]Median Length of Maternal Hospital Stay
NCT01222247 (29) [back to overview]Neonatal Death After 72 Hours of Delivery
NCT01222247 (29) [back to overview]Neonatal Feeding Difficulty
NCT01222247 (29) [back to overview]Neonatal Hyperbilirubinemia
NCT01222247 (29) [back to overview]Neonatal Morbidity Composite
NCT01222247 (29) [back to overview]Neonatal Outcome Composite
NCT01222247 (29) [back to overview]Neonates Needing Immediate Resuscitation After Birth
NCT01222247 (29) [back to overview]Neonates With Pneumonia
NCT01222247 (29) [back to overview]Number of Neonates With Pulmonary Air Leak
NCT01222247 (29) [back to overview]Number of Neonates With Severe Respiratory Complication,
NCT01222247 (29) [back to overview]Neonatal Composite Outcome
NCT01222247 (29) [back to overview]Maternal Outcomes (Participant-based)
NCT01222247 (29) [back to overview]Length of NICU or Nursery Stay
NCT01222247 (29) [back to overview]Gestational Age at Delivery
NCT01238536 (4) [back to overview]Roland Morris Disability Questionnaire (RDQ)
NCT01238536 (4) [back to overview]Roland Morris
NCT01238536 (4) [back to overview]Leg Pain NRS
NCT01238536 (4) [back to overview]Pain Numeric Rating Scale
NCT01347255 (5) [back to overview]Change in Clinical Sign Scores
NCT01347255 (5) [back to overview]Change From Baseline in Echo-poor Band Thickness at End of Treatment
NCT01347255 (5) [back to overview]Changes in Total Skin Thickness
NCT01347255 (5) [back to overview]Changes in Total Clinical Score (TCS) by Visit
NCT01347255 (5) [back to overview]Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling and Infiltration) at End of Treatment Compared to Baseline
NCT01422434 (4) [back to overview]Change in mPASI From Baseline to Week 1
NCT01422434 (4) [back to overview]Change From Baseline in Target Lesion Assessment
NCT01422434 (4) [back to overview]Change From Baseline in Modified Psoriasis Area and Severity Index (mPASI)
NCT01422434 (4) [back to overview]Physician's Global Assessment of Psoriasis
NCT01536886 (1) [back to overview]Subjects With 'Controlled Disease' ('Clear'/'Almost Clear' for Subjects w. at Least Moderate Disease at Baseline, 'Clear' for Subjects With Mild Disease at Baseline) According to the Investigator's Global Assessment (IGA) on the Trunk and Limbs at Week 4.
NCT01536938 (1) [back to overview]Subjects With 'Controlled Disease' ('Clear'/'Almost Clear' for Subjects w. at Least Moderate Disease at Baseline, 'Clear' for Subjects With Mild Disease at Baseline) According to the Investigator's Global Assessment (IGA) on the Trunk and Limbs at Week 4.
NCT01607853 (26) [back to overview]Change From Baseline in Infiltration at Day 4
NCT01607853 (26) [back to overview]Change From Baseline in Infiltration at Day 8
NCT01607853 (26) [back to overview]Change From Baseline in Scaling at Day 15
NCT01607853 (26) [back to overview]Change From Baseline in Scaling at Day 18
NCT01607853 (26) [back to overview]Change From Baseline in Scaling at Day 22
NCT01607853 (26) [back to overview]Change From Baseline in Scaling at Day 8
NCT01607853 (26) [back to overview]Change in Lesion Thickness Measured by Ultrasound From Baseline to Day 22.
NCT01607853 (26) [back to overview]Change in Skin Thickness - Echo-poor Band - Measured by Ultrasound From Baseline to Day 22
NCT01607853 (26) [back to overview]Change in Total Clinical Score at Day 11 Compared to Baseline
NCT01607853 (26) [back to overview]Change in Total Clinical Score at Day 15 Compared to Baseline
NCT01607853 (26) [back to overview]Change in Total Clinical Score at Day 18 Compared to Baseline
NCT01607853 (26) [back to overview]Change in Total Clinical Score at Day 4 Compared to Baseline
NCT01607853 (26) [back to overview]Change in Total Clinical Score at Day 8 Compared to Baseline
NCT01607853 (26) [back to overview]Change in Total Clinical Score From Baseline to Day 22
NCT01607853 (26) [back to overview]Change From Baseline in Scaling at Day 11
NCT01607853 (26) [back to overview]Change From Baseline in Scaling at Day 4
NCT01607853 (26) [back to overview]Change From Baseline in Erythema at Day 11
NCT01607853 (26) [back to overview]Change From Baseline in Erythema at Day 15
NCT01607853 (26) [back to overview]Change From Baseline in Erythema at Day 18
NCT01607853 (26) [back to overview]Change From Baseline in Erythema at Day 22
NCT01607853 (26) [back to overview]Change From Baseline in Erythema at Day 4.
NCT01607853 (26) [back to overview]Change From Baseline in Erythema at Day 8.
NCT01607853 (26) [back to overview]Change From Baseline in Infiltration at Day 11
NCT01607853 (26) [back to overview]Change From Baseline in Infiltration at Day 15
NCT01607853 (26) [back to overview]Change From Baseline in Infiltration at Day 18
NCT01607853 (26) [back to overview]Change From Baseline in Infiltration at Day 22
NCT01707043 (2) [back to overview]Subjective Subject Preference Survey for the First Treatment Session
NCT01707043 (2) [back to overview]Subjective Subject Preference Survey for the Second Treatment Session
NCT02038634 (1) [back to overview]"DASH - Disabilities of the Arm, Shoulder, and Hand Score At Baseline, and Change From Baseline at 6-8 Weeks, 12-16 Weeks, and at 1 Year"
NCT02527421 (2) [back to overview]Participants With HPA Axis Suppression at Day 29
NCT02527421 (2) [back to overview]Participants With HPA Axis Suppression at End of Treatment (Day 15 or Day 28) With Recovery 29 Days Later
NCT02749799 (3) [back to overview]Change in Percent Body Surface Area (BSA) Involved.
NCT02749799 (3) [back to overview]Change in Dermatology Life Quality Index (DLQI)
NCT02749799 (3) [back to overview]Change in Investigator's Global Assessment Grade
NCT02858713 (3) [back to overview]Percentage of Adherent Participants
NCT02858713 (3) [back to overview]Dermatology Life Quality Index (DLQI)
NCT02858713 (3) [back to overview]Lattice-System Physician's Global Assessment (LS-PGA)
NCT03101033 (8) [back to overview]Functional Status Assessed by Oswestry Disability Index
NCT03101033 (8) [back to overview]Functional Status Assessed by Oswestry Disability Index
NCT03101033 (8) [back to overview]Pain Assessed by Visual Analogue Scale
NCT03101033 (8) [back to overview]Pain Assessed by Visual Analogue Scale
NCT03101033 (8) [back to overview]Functional Status Assessed by Oswestry Disability Index
NCT03101033 (8) [back to overview]Functional Status Assessed by Oswestry Disability Index
NCT03101033 (8) [back to overview]Pain Assessed by Visual Analogue Scale
NCT03101033 (8) [back to overview]Pain Assessed by Visual Analogue Scale
NCT03441789 (6) [back to overview]Percent of Subjects With PASI 90 and 100 at Week 16
NCT03441789 (6) [back to overview]Percent of Subjects With a Psoriasis Assessment and Severity Index (PASI) 75 at Week 16
NCT03441789 (6) [back to overview]Global Improvement in Itch Visual Analogue Scale (VAS) at Week 4,12 and 16
NCT03441789 (6) [back to overview]Global Percent Improvement in Dermatologic Quality of Life Index (DLQI) at Week 4, 12, and 16
NCT03441789 (6) [back to overview]Percent of Subjects With PASI 75 at Week 4 and Week 12
NCT03441789 (6) [back to overview]Per Cent of Patients With at Least 1-grade Improvement in Physicians Global Assessment (PGA) at Week 4 and Week 12 and Week 16
NCT03469336 (8) [back to overview]Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria
NCT03469336 (8) [back to overview]Number of Participants With Treatment-emergent Adverse Events (AEs)
NCT03469336 (8) [back to overview]Area Under the Curve of the Psoriatic Skin Infiltrate Thickness
NCT03469336 (8) [back to overview]Change From Baseline in Psoriatic Skin Infiltrate Thickness
NCT03469336 (8) [back to overview]Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Betamethasone Solution.
NCT03469336 (8) [back to overview]Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Calcipotriene/Calcipotriol Solution.
NCT03469336 (8) [back to overview]Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria
NCT03469336 (8) [back to overview]Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
NCT03758365 (2) [back to overview]Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
NCT03758365 (2) [back to overview]Comparison of the Vasoconstriction Potential (Skin Blanching Effect) of the MC2-01 Cream With Active Comparators and Vehicle
NCT03848871 (6) [back to overview]Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4
NCT03848871 (6) [back to overview]Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema
NCT03848871 (6) [back to overview]Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling
NCT03848871 (6) [back to overview]Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration
NCT03848871 (6) [back to overview]Change in Lesion Size From Baseline to Week 2 and Week 4
NCT03848871 (6) [back to overview]Change in Body Surface Area (BSA) From Baseline to Week 2 and Week 4
NCT04420572 (9) [back to overview]Functionality
NCT04420572 (9) [back to overview]Patient Reported Quality of Life - Notthingham Health Profile
NCT04420572 (9) [back to overview]Functionality
NCT04420572 (9) [back to overview]Functionality
NCT04420572 (9) [back to overview]Patient Reported Quality of Life - Notthingham Health Profile
NCT04420572 (9) [back to overview]Pain Severity
NCT04420572 (9) [back to overview]Pain Severity
NCT04420572 (9) [back to overview]Pain Severity
NCT04420572 (9) [back to overview]Patient Reported Quality of Life - Notthingham Health Profile
NCT04900220 (2) [back to overview]Incidence of Pain
NCT04900220 (2) [back to overview]Intensity of Pain

Number of Neonates With Pneumothorax

Total number of neonates with pneumothorax diagnosed postpartum. (NCT00201643)
Timeframe: birth to 28 days of life

Interventionparticipants (Number)
"Rescue Course of Betamethasone or Dexamethasone"4
Placebo (Normal Saline)4

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Number of Neonates Who Required Surfactant Therapy After Birth.

The Number of neonates who required surfactant therapy within the first 28 days after birth. (NCT00201643)
Timeframe: Birth to 28 days of life

Interventionparticipant (Number)
"Rescue Course of Betamethasone or Dexamethasone"70
Placebo (Normal Saline)99

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Number of Babies Who Required Ventilatory Support Within the First 28 Days of Life.

The number of babies who required ventilatory support within the first 28 days of life. Equal to or great than 12 hours was considered one day. (NCT00201643)
Timeframe: birth to 28 days of life

Interventionparticipants (Number)
"Rescue Course of Betamethasone or Dexamethasone"70
Placebo (Normal Saline)95

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Neonatal Head Circumference Taken at Time of Birth.

Reported as the average of all neonatal head circumferences (HC) taken at time of birth in each group. (NCT00201643)
Timeframe: Birth

Interventioncentemeters (cm) (Mean)
"Rescue Course of Betamethasone or Dexamethasone"30.2
Placebo (Normal Saline)30.0

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Neonatal Birth Weight Reported in Grams

Measured mean Birth weights of Neonates in each arm as reported in grams on the birth record. (NCT00201643)
Timeframe: At time of Birth

Interventiongrams (Mean)
"Rescue Course of Betamethasone or Dexamethasone"1905
Placebo (Normal Saline)1920

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Maternal Infectious Morbidity.

Total number of Mothers having Maternal infectious morbidity (e.g. endometritis & maternal sepsis) noted from birth through 28 days after birth (NCT00201643)
Timeframe: Up to 28 days after giving birth

Interventionparticipants (Number)
"Rescue Course of Betamethasone or Dexamethasone"8
Placebo (Normal Saline)10

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Gestational Age at (@) Delivery

Reported the average/mean Neonatal gestational age (GA) (reported in weeks of pregnancy) at the time of birth for both groups (ACS vs. Placebo). (NCT00201643)
Timeframe: gestational age at delivery in weeks of gestation

InterventionWeeks (Mean)
"Rescue Course of Betamethasone or Dexamethasone"33.1
Placebo (Normal Saline)33.0

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Composite Neonatal Morbidity < 34 Weeks Gestation at Time of Birth.

This outcome measured the total number of neonates with Composite Neonatal morbidity who delivered at < 34 weeks gestation. Composite Morbidity consisted of respiratory distress syndrome, bronchopulmonary dysplasia, severe intraventricular hemorrhage, periventricular leukomalacia, proven sepsis, necrotizing enterocolitis, or perinatal death (NCT00201643)
Timeframe: From birth to 28 days of life

Interventionparticipants (Number)
"Rescue Course of Betamethasone or Dexamethasone"71
Placebo (Normal Saline)105

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Interuterine Growth Restriction (IUGR) or Small for Gestational Age(SGA)in Babies Delivering at < 34 Weeks Gestation.

Noted as the total number of Neonates delivering at < 34 weeks gestation for which their weights fell within the 10th percentile at time of birth. (NCT00201643)
Timeframe: Measured at birth.

Interventionpaticipants (Number)
"Rescue Course of Betamethasone or Dexamethasone"25
Placebo (Normal Saline)20

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Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 2

PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best). (NCT00574249)
Timeframe: Week 2

Interventionpercentage of participants (Number)
Adalimumab + Placebo7.1
Adalimumab + Calcipotriol/Betamethasone13.9

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Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 4

PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best). (NCT00574249)
Timeframe: Week 4

Interventionpercentage of participants (Number)
Adalimumab + Placebo24.5
Adalimumab + Calcipotriol/Betamethasone33.1

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Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 8

PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best). (NCT00574249)
Timeframe: Week 8

Interventionpercentage of participants (Number)
Adalimumab + Placebo46.2
Adalimumab + Calcipotriol/Betamethasone42.9

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Percentage of Participants Achieving a Physicians Global Assessment (PGA) Response of Clear or Minimal at Week 16

PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best). (NCT00574249)
Timeframe: Week 16

Interventionpercentage of participants (Number)
Adalimumab + Placebo64.6
Adalimumab + Calcipotriol/Betamethasone56.6

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Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0)

PASI75 is defined as at least a 75% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement being 100%. The outcome measure is the percentage of participants who had at least a 75% PASI score decrease. (NCT00574249)
Timeframe: Week 0 and Week 16

Interventionpercentage of participants (Number)
Adalimumab + Placebo70.9
Adalimumab + Calcipotriol/Betamethasone64.8

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Percentage of Participants With a PASI100 Response at Week 16 Compared With Baseline (Week 0)

PASI100 is defined as at least a 100% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst) with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement 100%. The outcome measure is the percentage of participants who had at least a 100% PASI score decrease. (NCT00574249)
Timeframe: Week 0 and Week 16

Interventionpercentage of participants (Number)
Adalimumab + Placebo24.2
Adalimumab + Calcipotriol/Betamethasone15.3

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Percentage of Participants With a PASI50 Response at Week 16 Compared With Baseline (Week 0)

PASI50 is defined as at least a 50% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement 100%. The outcome measure is the percentage of participants who had at least a 50% PASI score decrease. (NCT00574249)
Timeframe: Week 0 and Week 16

Interventionpercentage of participants (Number)
Adalimumab + Placebo82.7
Adalimumab + Calcipotriol/Betamethasone80.9

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Percentage of Participants With a PASI90 Response at Week 16 Compared With Baseline (Week 0)

PASI90 is defined as at least a 90% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement 100%. The outcome measure is the percentage of participants who had at least a 90% PASI score decrease. (NCT00574249)
Timeframe: Week 0 and Week 16

Interventionpercentage of participants (Number)
Adalimumab + Placebo50.3
Adalimumab + Calcipotriol/Betamethasone38.8

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Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 12 Compared With Baseline (Week 0)

DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%. (NCT00574249)
Timeframe: Week 0 and Week 12

Interventionpercent change in score (Mean)
Adalimumab + Placebo-69.49
Adalimumab + Calcipotriol/Betamethasone-66.75

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Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16 Compared With Baseline (Week 0)

DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%. (NCT00574249)
Timeframe: Week 0 and Week 16

Interventionpercent change in score (Mean)
Adalimumab + Placebo-71.46
Adalimumab + Calcipotriol/Betamethasone-67.20

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Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 4 Compared With Baseline (Week 0)

DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%. (NCT00574249)
Timeframe: Week 0 and Week 4

Interventionpercent change in score (Mean)
Adalimumab + Placebo-46.64
Adalimumab + Calcipotriol/Betamethasone-60.93

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Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 8 Compared With Baseline (Week 0)

DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%. (NCT00574249)
Timeframe: Week 0 and Week 8

Interventionpercent change in score (Mean)
Adalimumab + Placebo-63.30
Adalimumab + Calcipotriol/Betamethasone-62.30

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Percent Change in Nail Psoriasis Severity Index (NAPSI) at Week 16.

NAPSI is a sum of 2 scores that grade nail matrix psoriasis (based on presence/absence of pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (based on presence/absence of onycholysis splinter hemorrhages, oil drop [salmon patch] discoloration, and nail bed hyperkeratosis). Each fingernail is given a single score based on presence of psoriasis in quadrant of nail: 0 (none) to 4 (present in 4/4 nail quadrants). Score range: 0 (best) to 80 (worst). Negative change and percent change from Baseline indicate improvement. (NCT00574249)
Timeframe: Week 0 and Week 16

Interventionpercent change in score (Median)
Adalimumab + Placebo-40.00
Adalimumab + Calcipotriol/Betamethasone-37.50

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Percent Change in Psoriasis Scalp Severity Index (PSSI) From Baseline to Week 16.

PSSI is a physician assessment of clinical symptoms of scalp psoriasis. Computed as the sum of scores for erythema, induration, and desquamation (1 = absent; 4 = severest possible) multiplied by involved area (0 = 0%; 6 = 90-100%). Total score range: 0 (best) to 72 (worst). Negative change and percent change from Baseline indicate improvement. (NCT00574249)
Timeframe: Week 0 and Week 16

Interventionpercent change in score (Median)
Adalimumab + Placebo-100.00
Adalimumab + Calcipotriol/Betamethasone-100.00

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Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 16 Compared With Baseline (Week 0)

Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) is a participant-reported outcome that employs a questionnaire that asks for the participant's views about their health. Percent change at Week 16 is calculated as (Week 16 SF-36 PCS minus Week 0 SF-36 PCS) divided by Week 0 SF-36 PCS. Positive percent change in score indicates improvement, with best improvement 100%. (NCT00574249)
Timeframe: Week 0 and Week 16

Interventionpercent change in score (Mean)
Adalimumab + Placebo20.53
Adalimumab + Calcipotriol/Betamethasone19.71

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Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 8 Compared With Baseline (Week 0)

Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) is a participant-reported outcome that employs a questionnaire that asks for the participant's views about their health. Percent change at Week 8 is calculated as (Week 8 SF-36 PCS minus Week 0 SF-36 PCS) divided by Week 0 SF-36 PCS. Positive percent change in score indicates improvement, with best improvement 100%. (NCT00574249)
Timeframe: Week 0 and Week 8

Interventionpercent change in score (Mean)
Adalimumab + Placebo19.35
Adalimumab + Calcipotriol/Betamethasone18.22

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Percent Change in the Dermatology Life Quality Index (DLQI) Total Score at Week 2 Compared With Baseline (Week 0)

DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%. (NCT00574249)
Timeframe: Week 0 and Week 2

Interventionpercent change in score (Mean)
Adalimumab + Placebo-32.14
Adalimumab + Calcipotriol/Betamethasone-47.49

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Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 12

PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best). (NCT00574249)
Timeframe: Week 12

Interventionpercentage of participants (Number)
Adalimumab + Placebo64.8
Adalimumab + Calcipotriol/Betamethasone50.0

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Best Overall Response Rate (BORR) by Modified World Health Organization (mWHO) Criteria and by Immune-relate Response Criteria (irRC)

BORR is defined as the number of patients whose global best overall response (BOR) was complete (CR) or partial response (PR), divided by the total number of participants who received treatment. CR=complete disappearance of all index lesions. PR=decrease, relative to baseline, of 50% or greater in the sum of the products of the 2 largest perpendicular diameters of all index lesions. The global BOR is the best overall response (OR) designation over the study as a whole for an individual in the study based on overall tumor burden. Both central nervous system (CNS) (brain lesions) and non-CNS compartments (lesions outside the brain) are considered for the global BOR. For the analysis of global BOR of CR or PR (by both modified WHO criteria and immune-related response criteria [irRC]), the OR assessment must be confirmed by a second (confirmatory) evaluation meeting the criteria for response and must be performed no less than 4 weeks after the criteria for response are first met. (NCT00623766)
Timeframe: From Day 1, first dose until the last tumor assessment, Week 12

,
InterventionPercentage of participants (Number)
Global BORR (mWHO criteria)BORR in brain (mWHO criteria)BORR in non-CNS compartment (mWHO criteria)Global BORR (irRC)BORR in brain (irRC)BORR in non-CNS compartment (irRC criteria )
Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients4.84.84.84.84.84.8
Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients9.815.713.79.815.713.7

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Number of Participants Surviving at 6, 12, 18, 24, and 36 Months (Overall Survival [OS] Rate)

OS is defined as the time from the first dose of study drug until the date of death. Overall survival rate is the percentage of participants known to be alive at a timepoint. For those patients who did not die, OS was censored at the recorded last date of patient contact, and those with a missing recorded last date of contact will be censored at the last date the patient was known to be alive. The survival rate at a specified time-point is the probability that a patient is alive at that time following randomization. The rate is calculated for each treatment group using the Kaplan-Meier product-limit method. A corresponding 2-sided 95% bootstrap confidence interval will be calculated. (NCT00623766)
Timeframe: From first dose to Months 6, 12, 18, 24, and 36 months

,
InterventionProbability of being alive (Number)
At 6 monthsAt 12 monthsAt 18 monthsAt 24 monthsAt 36 months
Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients0.380.190.190.100.10
Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients0.550.310.260.260.26

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Disease Control Rate by Modified World Health Organization (mWHO) Tumor Assessment Criteria

Disease control rate is defined as the number of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) (global, in brain, or outside of brain) based on mWHO criteria divided by the number of patients who received treatment. By mWHO criteria: CR=complete disappearance of all index lesions. PR=decrease, relative to baseline, of 50% or greater in the sum of the 2 largest perpendicular diameters of all index lesions. SD=does not meet criteria for CR or PR, in the absence of progressive disease (PD). Patients with PR or CR not confirmed after at least 4 weeks are scored as SD unless they have new primary lesions. PD=at least 25% increase in the sum of the diameters of all index lesions (taking as reference the smallest sum recorded at or following baseline) and/or the appearance of any new lesions. CNS=central nervous system. (NCT00623766)
Timeframe: From Day 1, first dose to end of Week 12

,
InterventionPercentage of participants (Number)
Global disease control rateDisease control rate in brain
Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients4.89.5
Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients17.623.5

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Overall Survival (OS)

OS is defined as the time from date of first dose of study drug until the date of death. For those patients who did not die, OS was censored at the recorded last date of patient contact, and those missing a recorded last date of contact will be censored at the last date the patient was known to be alive. (NCT00623766)
Timeframe: From first dose to 24 months

InterventionMonths (Median)
Ipilimumab, 10 mg/kg, IV in Corticosteroid-free Patients6.97
Ipilimumab, 10 mg/kg, IV in Corticosteroid-dependent Patients3.75

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FiO2

(NCT00669383)
Timeframe: During initial hospital stay and planned follow-up

,
InterventionParticipants (Count of Participants)
FiO2 greater or equal to 0.30FiO2 greater or equal to 0.40
A (Betamethasone)75
B (Placebo)1613

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Measurements of Functional Residual Capacity in Preterm Infants.

(NCT00669383)
Timeframe: Within first 72 hours after birth

InterventionmL/kg (Mean)
A (Betamethasone)24.8
B (Placebo)22.0

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Measurements of Respiratory Compliance (Crs) in Preterm Infants.

(NCT00669383)
Timeframe: Within first 72 hours after birth

InterventionmL/cm H2O/kg (Mean)
A (Betamethasone)1.21
B (Placebo)1.01

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"Subjects With Controlled Disease (Clear or Almost Clear Disease) According to Investigator's Global Assessment of Disease Severity at Week 8"

(NCT00670241)
Timeframe: Week 8

InterventionParticipants (Number)
Calcipotriol Plus Betamethasone Dipropionate Gel73
Tacalcitol Ointment33
Gel Vehicle5

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The Percentage Change in PASI From Baseline to Week 8

PASI is Psoriasis Area and Severity Index and is based on the investigator's assessment of extent and severity of the disease. It can range from 0 (best) to 64.8 (worst). (NCT00670241)
Timeframe: Baseline, Week 4 and 8

InterventionPercent change in PASI score (Number)
Calcipotriol Plus Betamethasone Dipropionate Gel-57.0
Tacalcitol Ointment-41.9
Gel Vehicle-17.9

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"Subjects With Controlled Disease According to the Investigator's Global Assessment of Disease Severity at Week 4"

(NCT00670241)
Timeframe: Week 4

Interventionparticipants (Number)
Calcipotriol Plus Betamethasone Dipropionate Gel34
Tacalcitol Ointment12
Gel Vehicle1

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Subjects With Relapse During the Study

Among subjects with controlled disease at week 8 relapse was defined as PASI exceeding the baseline PASI value minus 50% of the reduction in PASI obtained from the baseline visit to the last on-treatment visit (NCT00670241)
Timeframe: Week 8-16

Interventionparticipants (Number)
Calcipotriol Plus Betamethasone Dipropionate Gel28
Tacalcitol Ointment7
Gel Vehicle3

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Subjects With Rebound During the Study

(NCT00670241)
Timeframe: Week 8-16

Interventionparticipants (Number)
Calcipotriol Plus Betamethasone Dipropionate Gel0
Tacalcitol Ointment0
Gel Vehicle0

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Incidence of Hydrops Fetalis

(NCT00670956)
Timeframe: Delivery, up to approximately 20 weeks post-enrollment

Interventionparticipants (Number)
Active Study Group0

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Survival at One-month Between Study and Control Groups.

Status of neonate survival 30 days after delivery (NCT00670956)
Timeframe: 30 days after delivery (up to approximately 24 weeks post-enrollment)

Interventionparticipants (Number)
Active Study Group1

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Number of Days Required to Achieve Total Remission

The speed of action, measured as the number of days required to achieve total remission of all signs and symptoms of the disease. (NCT00671528)
Timeframe: Up to 28 days

InterventionDays (Number)
Quadriderme® Cream15
Betamethasone Diproprionate and Gentamicin Sulfate Cream15
Betamethasone Diproprionate Cream8

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Serum Cortisol Concentration of ≤18 mcg/dL at 30 Minutes After ACTH-challenge at End of Treatment

The ACTH(Adrenocorticotropic hormone)-challenge test involves injecting a synthetic subunit of ACTH into the patient,and measuring the cortisol produced by the adrenal glands 30 and 60 minutes after the injection. (NCT00817219)
Timeframe: Week 4

Interventionparticipants (Number)
TACLONEX Ointment0

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Serum Cortisol Concentration of ≤18 mcg/dL at 30 and 60 Minutes After ACTH-challenge at End of Treatment

The ACTH(Adrenocorticotropic hormone)-challenge test involves injecting a synthetic subunit of ACTH into the patient,and measuring the cortisol produced by the adrenal glands 30 and 60 minutes after the injection. (NCT00817219)
Timeframe: Week 4

Interventionparticipants (Number)
TACLONEX Ointment0

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Percentage Change in PASI From Baseline to Week 4.

PASI is Psoriasis Area and Severity Index and is based on the investigator's assessment of extent and severity of the disease. It can range from 0 (best) to 64.8(worst). The PASI used in this trial is modified to exclude assessment of the head, as trial treatment is not used here. (NCT00817219)
Timeframe: Baseline and 4 weeks

Interventionpercentage (Mean)
TACLONEX Ointment-72.5

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PASI 75 at Week 4.

PASI 75 is at least 75% reduction in PASI from baseline. PASI is Psoriasis Area and Severity Index and is based on the investigator's assessment of extent and severity of the disease. It can range from 0 (best) to 64.8(worst). The PASI used in this trial is modified to exclude assessment of the head, as trial treatment is not used here. (NCT00817219)
Timeframe: 4 weeks

Interventionparticipants (Number)
TACLONEX Ointment17

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PASI 50 at Week 4.

PASI 50 is at least 50% reduction in PASI from baseline. PASI is Psoriasis Area and Severity Index and is based on the investigator'sassessment of extent and severity of the disease. It can range from 0 (best) to 64.8(worst). The PASI used in this trial is modified to exclude assessment of the head, as trial treatment is not used here. (NCT00817219)
Timeframe: Week 4

Interventionparticipants (Number)
TACLONEX Ointment28

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Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment.

(NCT00817219)
Timeframe: Baseline and 4 Weeks

Interventionmmol/g (Mean)
TACLONEX Ointment0.717

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"Controlled Disease(i.e., Clear or Almost Clear) According to the Investigator's Global Assessment of Disease Severity at Week 4."

The investigator made an assessment of the disease severity (Plaque thickening, Scaling and Erythema) using a 6-point scale (Clear, Almost clear, Mild, Moderate, Severe, and Very severe). This assessment represented the average lesion severity on the trunk and limbs. (NCT00817219)
Timeframe: Week 4

Interventionparticipants (Number)
TACLONEX Ointment20

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"Controlled Disease(i.e., Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 4."

The patient made an assessment of the disease severity using a 5-point scale (Clear, Very Mild, Mild, Moderate, and Severe). (NCT00817219)
Timeframe: Week 4

Interventionparticipants (Number)
TACLONEX Ointment23

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Change in Albumin Corrected Serum Calcium From Baseline to End of Treatment

(NCT00817219)
Timeframe: Baseline and 4 weeks

Interventionmmol/L (Mean)
TACLONEX Ointment0.005

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Adverse Drug Reactions

"The number of participants experiencing each type of adverse drug reaction. Adverse drug reactions were defined as adverse events for which the investigator had not described the causal relationship to trial medication as not related." (NCT00817219)
Timeframe: Week 4

Interventionparticipants (Number)
TACLONEX Ointment2

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Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline

The total target lesion score was calculated by summing the scores for erythema, scaling, and thickness for that particular target lesion. The investigator assessed the severity of the clinical signs erythema, scaling, and thickness for each test site by using a 5-point scale from 0 (no evidence) to 4.0 (severe). (NCT00820950)
Timeframe: Baseline, Days 8, 15, 22, 28 and 56

,,,,,,,,,
InterventionScore on Scale (Mean)
Day 8Day 15Day 22Day 28Day 56/ET
Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream-1.3-1.3-2.2-1.0-1.3
Part 1 Cohort A: Vehicle-1.3-1.3-1.4-1.2-1.5
Part 1 Cohort B: Ruxolitinib 1.0% Cream vs. Vehicle Cream-1.7-2.0-3.0-3.80.5
Part 1 Cohort B: Vehicle-1.0-1.3-1.8-2.20.5
Part 1 Cohort C: Ruxolitinib 1.5% Cream vs. Vehicle Cream-3.2-3.0-3.5-3.7-2.0
Part 1 Cohort C: Vehicle Cream-1.7-1.7-1.7-2.2-1.8
Part 2 Cohort D: INCB18424-2.4-2.0-3.6-3.4-3.2
Part 2 Cohort D: Ruxolitinib vs. Calcipotriene (Dovonex®)-2.2-2.2-2.6-3.2-3.0
Part 2 Cohort E: INCB18424-2.3-2.4-3.2-3.00.0
Part 2 Cohort E: Ruxolitinib vs. Betamethasone Dipropionate (Diprolene® AF)-2.8-3.0-3.4-4.2-1.4

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Pharmacokinetics Parameter : Skin Flux of INCB018424

The INCB018424 skin flux was estimated from the overall mean steady-state plasma concentrations for each participant. (NCT00820950)
Timeframe: Days 8, 15, 22, and 28

Interventionng/cm^2/h (Mean)
Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream54.2
Part 1 Cohort B: Ruxolitinib 1.0% Cream Versus Vehicle151
Part 1 Cohort C: Ruxolitinib 1.5% Cream vs. Vehicle Cream422
Part 2 Cohort D: Ruxolitinib vs. Calcipotriene (Dovonex®)363
Part 2 Cohort E: Ruxolitinib vs. Betamethasone Dipropionate (Diprolene® AF)383

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Change in Target Lesion Area Compared to Baseline

Lesion area was estimated on Day 1 and Day 28 using a tracings of the lesion on transparency paper and measurement of the area. (NCT00820950)
Timeframe: Day 28

Interventioncm^2 (Mean)
Cohort A: Vehicle0.35
Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream1.53
Cohort B: Vehicle0.45
Cohort B: Ruxolitinib 1.0% Cream Versus Vehicle-3.18
Cohort C: Vehicle-4.03
Part 1 Cohort C: Ruxolitinib 1.5% Cream vs. Vehicle Cream-11.45
Cohort D: INCB18424-5.22
Part 2 Cohort D: Ruxolitinib vs. Calcipotriene (Dovonex®)-2.54
Cohort E: INCB184241.53
Part 2 Cohort E: Ruxolitinib vs. Betamethasone Dipropionate (Diprolene® AF)-0.48

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Pharmacokinetics Parameter : Bioavailability of INCB018424

The INCB018424 bioavailability will be estimated from the overall mean steady-state plasma concentrations for each subject in this study and the estimated systemic clearance of INCB018424 following oral-dose administration in another study. Bioavailability is defined as the proportion of a drug which enters the circulation when introduced into the body and so is able to have an active effect. (NCT00820950)
Timeframe: Days 8, 15, 22, and 28

InterventionPercentage of dosage (Mean)
Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream2.8
Cohort B: Ruxolitinib 1.0% Cream Versus Vehicle3.0
Part 1 Cohort C: Ruxolitinib 1.5% Cream vs. Vehicle Cream3.0
Part 2 Cohort D: Ruxolitinib vs. Calcipotriene (Dovonex®)2.7
Part 2 Cohort E: Ruxolitinib vs. Betamethasone Dipropionate (Diprolene® AF)2.7

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Number of Participants With Treatment Emergent Adverse Events

A TEAE is any AE either reported for first time or worsening of a pre-existing event after first dose of study drug. (NCT00820950)
Timeframe: 3 months

InterventionParticipants (Count of Participants)
Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream6
Cohort B: Ruxolitinib 1.0% Cream Versus Vehicle1
Part 1 Cohort C: Ruxolitinib 1.5% Cream vs. Vehicle Cream5
Part 2 Cohort D: Ruxolitinib vs. Calcipotriene (Dovonex®)4
Part 2 Cohort E: Ruxolitinib vs. Betamethasone Dipropionate (Diprolene® AF)2

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Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline

The investigator assessed the severity of the clinical signs erythema, scaling, and thickness for each test site by using a 5-point scale from 0 (no evidence) to 4.0 (severe). (NCT00820950)
Timeframe: Baseline, Days 8, 15, 22, 28 and 56

,,,,,,,,,
InterventionScores on a scale (Mean)
Day 8 - ErythemaDay 8 - ScalingDay 8 - ThicknessDay 15 - ErythemaDay 15 - ScalingDay 15 - ThicknessDay 22 - ErythemaDay 22 - ScalingDay 22 - ThicknessDay 28 - ErythemaDay 28 - ScalingDay 28 - ThicknessDay 56/ET - ErythemaDay 56/ET - ScalingDay 56/ET - Thickness
Part 1 Cohort A: Ruxolitinib 0.5% Cream-0.5-0.2-0.7-0.7-0.3-0.3-1.0-0.6-0.6-0.4-0.4-0.2-0.3-0.2-0.3
Part 1 Cohort A: Vehicle Cream-0.5-0.2-0.7-0.7-0.3-0.3-0.8-0.4-0.2-0.6-0.2-0.4-0.5-0.2-0.3
Part 1 Cohort B: Ruxolitinib 1.0% Cream-1.0-0.2-0.3-1.0-0.3-0.3-1.5-0.8-0.5-1.7-1.0-1.0-0.20.70.2
Part 1 Cohort B: Vehicle Cream-0.80.0-0.2-0.8-0.2-0.2-1.0-0.5-0.3-1.2-0.7-0.30.00.30.0
Part 1 Cohort C: Ruxolitinib 1.5% Cream-1.2-1.2-0.8-1.2-1.0-0.8-1.2-1.2-1.2-1.0-1.2-1.5-0.5-0.7-0.8
Part 1 Cohort C: Vehicle Cream-0.7-0.7-0.3-0.5-0.7-0.5-0.3-0.5-0.8-0.5-0.5-1.2-0.5-0.7-0.7
Part 2 Cohort D: Calcipotriene (Dovonex®)-0.8-0.6-0.6-0.8-0.4-0.8-1.0-0.6-0.8-1.2-0.8-1.0-1.2-0.7-1.0
Part 2 Cohort D: INCB18424-1.2-0.6-0.4-1.0-0.2-0.6-1.8-0.6-1.0-1.4-0.8-1.0-1.0-0.8-1.2
Part 2 Cohort E: Betamethasone Dipropionate (Diprolene® AF)-1.3-0.8-0.8-1.2-1.2-0.6-1.6-1.0-0.8-1.8-1.2-1.2-0.6-0.4-0.4
Part 2 Cohort E: INCB18424-1.0-0.8-0.5-1.0-0.8-0.6-1.4-0.8-1.0-1.2-0.8-1.00.2-0.20.0

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The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Daivobet Ointment Vehicle

The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst) (NCT00845481)
Timeframe: Baseline and 3 weeks

InterventionScores on a scale (Mean)
Patients Treated With Daivobet® Ointment Vehicle-1.91

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The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Daivobet® Ointment

The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst) (NCT00845481)
Timeframe: Baseline and 3 weeks

InterventionScores on a scale (Mean)
Patients Treated With Daivobet® Ointment-5.15

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The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Dermovat Ointment

The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst) (NCT00845481)
Timeframe: Baseline and 3 weeks

InterventionScores on a scale (Mean)
Patients Treated With Dermovat Ointment-5.71

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The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Diprosalic Ointment

The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst) (NCT00845481)
Timeframe: Baseline and 3 weeks

InterventionScores on a scale (Mean)
Patients Treated With Diprosalic Ointment-4.50

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The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Elocon Ointment

The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst) (NCT00845481)
Timeframe: Baseline and 3 weeks

InterventionScores on a scale (Mean)
Patients Treated With Elocon Ointment-4.50

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The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Betnovat® Ointment

The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst) (NCT00845481)
Timeframe: Baseline and 3 weeks

InterventionScores on a scale (Mean)
Patients Treated With Betnovat® Ointment-3.33

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Pathology and Histology by Treatment

"Skin biopsies were taken on Day 29. The evaluation of immunohistochemical sections were performed on cross sections of the skin tissue. The same pathologist did all evaluations, and samples were masked to ensure a blind fashion study. The extent of the following parameters were measured in scored semi-quantitatively (semi) on blinded haematoxylin and eosin (HE) sections. Semi-quantitative scoring was categorized as No (0), mild (1), moderate (2), marked (3) or severe (4). In evaluating the morphology of epidermis (Stratum corneum and Stratum granulosum) the tissue was classified by the characteristics seen below:~Morphology of epidermis~Stratum corneum (semi (extent of))~Stratum granulosum (semi (extent of))~Parakeratosis (semi (extent of))~Infiltration of inflammatory cells (semi (extent of))" (NCT00875277)
Timeframe: At end of treatment

,,,,,
Interventionscore on a scale (Mean)
Infiltration of inflammatory cellsParakeratosisStratum CorneumStratum Granulosum
Betamethasone Dipropionate Cream0.170.000.330.17
Daivobet® Ointment0.670.170.330.17
LEO 29102 Cream1.521.391.521.04
LEO 29102 Cream Vehicle1.501.671.831.42
LEO 29102 Plus Betamethasone Dipropionate0.500.000.500.00
LEO 29102 Plus Calcipotriol Cream1.531.351.411.00

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Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound

The lesion thickness was measured by ultrasound at baseline, Day 8, Day 15, Day 22 and end of treatment. (NCT00875277)
Timeframe: At Day 8, Day 15, Day 22 and end of treatment

,,,,,
Interventionmm (Mean)
Visit 8 (Day 8)Visit 14 (Day 15)Visit 20 (Day 22)Visit 26 (Day 29)
Betamethasone Dipropionate Cream-0.14-0.45-0.54-0.63
Daivobet® Ointment-0.39-0.68-0.68-0.78
LEO 29102 Cream0.03-0.16-0.15-0.30
LEO 29102 Cream Vehicle0.05-0.05-0.07-0.13
LEO 29102 Plus Betamethasone Dipropionate-0.30-0.51-0.57-0.68
LEO 29102 Plus Calcipotriol Cream0.00-0.25-0.24-0.38

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Biomarkers by Immunochemistry: Epidermal Proliferation

"3 skin biopsies (punch biopsies of 3 mm) per participant were taken on Day 29 after the clinical scoring and ultrasound measurement.~By measurement of the cell-cycle marker, Ki-67 protein, an evaluation of the degree of skin cell proliferation and thereby epidermal proliferation could be obtained. Cells counted per mm^2 were cells that were positive for the indicated biomarker." (NCT00875277)
Timeframe: At end of treatment

Interventioncells/mm^2 (Mean)
LEO 29102 Cream Vehicle554.1
Betamethasone Dipropionate Cream19.45
LEO 29102 Cream443.3
LEO 29102 Plus Calcipotriol Cream354.3
LEO 29102 Plus Betamethasone Dipropionate20.50
Daivobet® Ointment93.49

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Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline (Day 1)

"The (sub)investigator made the following clinical assessments by use of the scale below:~Score; Intensity; Description~Erythema:~0; No evidence; Normal skin color 0.5; Doubtful or very mild 1.0; Mild; Pink light red 1.5; Mild to moderate 2.0; Moderate; Red 2.5; Moderate to severe 3.0; Severe; Intense red~Scaling:~0; No evidence; No scaling 0.5; Doubtful or very mild 1.0; Mild; Slight roughness, mainly fine scales 1.5; Mild to moderate 2.0; Moderate; Coarse scaling 2.5; Moderate to severe 3.0; Severe; Coarse, thick scales~Infiltration:~0; No evidence 0.5; Doubtful or very mild 1.0; Mild Slight definite infiltration 1.5; Mild to moderate 2.0; Moderate; Moderate infiltration 2.5; Moderate to severe 3.0; Severe; Very marked infiltration~The TCS was defined as the sum of erythema plus scaling plus thickness scores. The TCS therefore ranged from 0 (all symptoms absent) to 9 (all symptoms severe)." (NCT00875277)
Timeframe: From baseline (Day 1) to end of treatment (Day 29)

Interventionscore on a scale (Mean)
LEO 29102 Cream Vehicle-1.60
Betamethasone Dipropionate Cream-4.96
LEO 29102 Cream-3.04
LEO 29102 Plus Calcipotriol Cream-3.96
LEO 29102 Plus Betamethasone Dipropionate-5.56
Daivobet® Ointment-6.10

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Pathology and Histology by Treatment: Epidermal Thickness

Skin biopsies were taken on Day 29. The evaluation of immunohistochemical sections were performed on cross sections of the skin tissue. The same pathologist did all evaluations, and samples were masked to ensure a blind fashion study. In evaluating the morphology of epidermis (Stratum corneum and Stratum granulosum), the tissue was classified by the characteristic epidermal thickness. This was measured in the absolute number of µm measured on blinded haematoxylin and eosin (HE) sections.. (NCT00875277)
Timeframe: At end of treatment

Interventionµm (Mean)
LEO 29102 Cream Vehicle254.6
Betamethasone Dipropionate Cream73.81
LEO 29102 Cream187.5
LEO 29102 Plus Calcipotriol Cream176.4
LEO 29102 Plus Betamethasone Dipropionate68.48
Daivobet® Ointment66.90

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Pathology and Histology by Treatment: Frequency of Neutrophil Abscesses

"Skin biopsies were taken on Day 29. The evaluation of immunohistochemical sections were performed on cross sections of the skin tissue. The same pathologist did all evaluations, and samples were masked to ensure a blind fashion study.~In evaluating the morphology of epidermis (Stratum corneum and Stratum granulosum), the tissue was classified by the characteristic of frequency of neutrophil microabscesses (Monroe´s abscess). This was measured in absolute number of cells that were positive for the marker on blinded haematoxylin and eosin (HE) sections." (NCT00875277)
Timeframe: At end of treatment

Interventioncells/mm^2 (Mean)
LEO 29102 Cream Vehicle0.14
Betamethasone Dipropionate Cream0.00
LEO 29102 Cream0.15
LEO 29102 Plus Calcipotriol Cream0.17
LEO 29102 Plus Betamethasone Dipropionate0.00
Daivobet® Ointment0.05

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Biomarkers by Immunochemistry

"3 skin biopsies (punch biopsies of 3 mm) per participant were taken on Day 29 after the clinical scoring and ultrasound measurement.~Cells counted per mm^2 were cells that were positive for the indicated biomarker." (NCT00875277)
Timeframe: At end of treatment

,,,,,
Interventioncells/mm^2 (Mean)
Macrophages: CD163Dendritic cells CD1aT-cell biomarker CD3Angiogenesis: CD31T-cell biomarker: CD4T-cell biomarker: CD45ROMacrophages: CD68T-cell biomarker: CD8
Betamethasone Dipropionate Cream197.442.14124.5216.359.17101.6120.360.05
Daivobet® Ointment172.956.34143.9186.666.95218.2156.865.05
LEO 29102 Cream291.2229.3464.2331.1246.4630.1323.1220.7
LEO 29102 Cream Vehicle313.9233.8593.8430.7284.3752.0370.8280.5
LEO 29102 Plus Betamethasone Dipropionate178.234.31126.1184.255.56121.6142.166.35
LEO 29102 Plus Calcipotriol Cream383.5244.0492.7348.8239.0643.6303.8253.2

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Biomarkers by Immunochemistry: Epidermal Differentiation

3 skin biopsies (punch biopsies of 3 mm) per participant were taken on Day 29 after the clinical scoring and ultrasound measurement. (NCT00875277)
Timeframe: At end of treatment

,,,,,
Intervention%, positive area/total area (Mean)
Epidermal differentiation: CK10Epidermal differentiation: CK16
Betamethasone Dipropionate Cream0.890.00
Daivobet® Ointment0.890.00
LEO 29102 Cream0.770.08
LEO 29102 Cream Vehicle0.760.11
LEO 29102 Plus Betamethasone Dipropionate0.930.01
LEO 29102 Plus Calcipotriol Cream0.750.02

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Change in Erythema Compared to Baseline

"The severity of the symptoms was rated on screening and on study Days 1 (baseline), 4, 8, 11, 15, 18, 22, 25 and 29 (end of treatment) according to the 0-3 with half-point TCS grading scale.~The (sub)investigator made the following clinical assessments by use of the scale below:~Score; Intensity; Description~Erythema:~0; No evidence; Normal skin color 0.5; Doubtful or very mild 1.0; Mild; Pink light red 1.5; Mild to moderate 2.0; Moderate; Red 2.5; Moderate to severe 3.0; Severe; Intense red" (NCT00875277)
Timeframe: At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22 and Day 25

,,,,,
Interventionunits on a scale (Mean)
Visit 5 (Day 4)Visit 8 (Day 8)Visit 11 (Day 11)Visit 14 (Day 15)Visit 17 (Day 18)Visit 20 (Day 22)Visit 23 (Day 25)
Betamethasone Dipropionate Cream-0.21-0.67-0.94-1.23-1.33-1.48-1.54
Daivobet® Ointment-0.38-0.88-1.19-1.40-1.63-1.85-1.94
LEO 29102 Cream-0.02-0.31-0.46-0.60-0.75-0.83-0.85
LEO 29102 Cream Vehicle-0.04-0.08-0.23-0.40-0.44-0.46-0.42
LEO 29102 Plus Betamethasone Dipropionate-0.40-0.92-1.17-1.46-1.71-1.75-1.83
LEO 29102 Plus Calcipotriol Cream-0.08-0.29-0.44-0.77-0.98-1.04-1.08

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Change in Infiltration Compared to Baseline

"The severity of the symptoms was rated on screening and on study Days 1 (baseline), 4, 8, 11, 15, 18, 22, 25 and 29 (end of treatment) according to the 0-3 with half-point TCS grading scale.~The (sub)investigator made the following clinical assessments by use of the scale below:~Score; Intensity; Description~Infiltration:~0; No evidence 0.5; Doubtful or very mild 1.0; Mild Slight definite infiltration 1.5; Mild to moderate 2.0; Moderate; Moderate infiltration 2.5; Moderate to severe 3.0; Severe; Very marked infiltration" (NCT00875277)
Timeframe: At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25

,,,,,
Interventionunits on a scale (Mean)
Visit 5 (Day 4)Visit 8 (Day 8)Visit 11 (Day 11)Visit 14 (Day 15)Visit 17 (Day 18)Visit 20 (Day 22)Visit 23 (Day 25)
Betamethasone Dipropionate Cream-0.10-0.38-0.77-0.98-1.10-1.25-1.35
Daivobet® Ointment-0.29-0.79-1.29-1.79-1.94-1.98-2.02
LEO 29102 Cream-0.04-0.13-0.31-0.42-0.58-0.56-0.73
LEO 29102 Cream Vehicle-0.06-0.06-0.13-0.25-0.33-0.31-0.38
LEO 29102 Plus Betamethasone Dipropionate-0.27-0.73-1.06-1.35-1.50-1.67-1.67
LEO 29102 Plus Calcipotriol Cream0.00-0.29-0.46-0.69-0.75-0.90-1.06

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Change in Scaling Compared to Baseline

"The severity of the symptoms was rated on screening and on study Days 1 (baseline), 4, 8, 11, 15, 18, 22, 25 and 29 (end of treatment) according to the 0-3 with half-point TCS grading scale.~The (sub)investigator made the following clinical assessments by use of the scale below:~Score; Intensity; Description~Scaling:~0; No evidence; No scaling 0.5; Doubtful or very mild 1.0; Mild; Slight roughness, mainly fine scales 1.5; Mild to moderate 2.0; Moderate; Coarse scaling 2.5; Moderate to severe 3.0; Severe; Coarse, thick scales" (NCT00875277)
Timeframe: At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25

,,,,,
Interventionunits on a scale (Mean)
Visit 5 (Day 4)Visit 8 (Day 8)Visit 11 (Day 11)Visit 14 (Day 15)Visit 17 (Day 18)Visit 20 (Day 22)Visit 23 (Day 25)
Betamethasone Dipropionate Cream-0.31-0.88-1.15-1.33-1.56-1.54-1.81
Daivobet® Ointment-0.52-1.19-1.92-2.04-2.13-2.19-2.21
LEO 29102 Cream-0.13-0.44-0.63-0.73-0.90-0.81-1.17
LEO 29102 Cream Vehicle-0.17-0.27-0.40-0.52-0.65-0.54-0.75
LEO 29102 Plus Betamethasone Dipropionate-0.33-1.17-1.48-1.67-1.83-1.75-2.00
LEO 29102 Plus Calcipotriol Cream-0.21-0.63-0.71-1.00-1.15-1.27-1.46

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Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline

"The (sub)investigator made the following clinical assessments by use of the scale below:~Score; Intensity; Description~Erythema:~0; No evidence; Normal skin color 0.5; Doubtful or very mild 1.0; Mild; Pink light red 1.5; Mild to moderate 2.0; Moderate; Red 2.5; Moderate to severe 3.0; Severe; Intense red~Scaling:~0; No evidence; No scaling 0.5; Doubtful or very mild 1.0; Mild; Slight roughness, mainly fine scales 1.5; Mild to moderate 2.0; Moderate; Coarse scaling 2.5; Moderate to severe 3.0; Severe; Coarse, thick scales~Infiltration:~0; No evidence 0.5; Doubtful or very mild 1.0; Mild Slight definite infiltration 1.5; Mild to moderate 2.0; Moderate; Moderate infiltration 2.5; Moderate to severe 3.0; Severe; Very marked infiltration The TCS was defined as the sum of erythema plus scaling plus thickness scores. The TCS therefore ranged from 0 (all symptoms absent) to 9 (all symptoms severe)." (NCT00875277)
Timeframe: From baseline (Day 1) to end of treatment (Day 29)

,,,,,
Interventionscore on a scale (Mean)
ErythemaInfiltrationScaliness
Betamethasone Dipropionate Cream-1.71-1.46-1.79
Daivobet® Ointment-1.88-2.04-2.19
LEO 29102 Cream-0.90-0.85-1.29
LEO 29102 Cream Vehicle-0.42-0.46-0.73
LEO 29102 Plus Betamethasone Dipropionate-1.85-1.75-1.96
LEO 29102 Plus Calcipotriol Cream-1.19-1.17-1.60

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Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline

"The (sub)investigator made the following clinical assessments by use of the scale below:~Score; Intensity; Description~Erythema:~0; No evidence; Normal skin color 0.5; Doubtful or very mild 1.0; Mild; Pink light red 1.5; Mild to moderate 2.0; Moderate; Red 2.5; Moderate to severe 3.0; Severe; Intense red~Scaling:~0; No evidence; No scaling 0.5; Doubtful or very mild 1.0; Mild; Slight roughness, mainly fine scales 1.5; Mild to moderate 2.0; Moderate; Coarse scaling 2.5; Moderate to severe 3.0; Severe; Coarse, thick scales~Infiltration:~0; No evidence 0.5; Doubtful or very mild 1.0; Mild Slight definite infiltration 1.5; Mild to moderate 2.0; Moderate; Moderate infiltration 2.5; Moderate to severe 3.0; Severe; Very marked infiltration~The TCS was defined as the sum of erythema plus scaling plus thickness scores. The TCS therefore ranged from 0 (all symptoms absent) to 9 (all symptoms severe)." (NCT00875277)
Timeframe: At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25

,,,,,
Interventionscore on a scale (Mean)
Visit 5 (Day 4)Visit 8 (Day 8)Visit 11 (Day 11)Visit 14 (Day 15)Visit 17 (Day 18)Visit 20 (Day 22)Visit 23 (Day 25)
Betamethasone Dipropionate Cream-0.63-1.92-2.85-3.54-4.00-4.27-4.71
Daivobet® Ointment-1.19-2.85-4.40-5.23-5.69-6.02-6.17
LEO 29102 Cream-0.19-0.88-1.40-1.75-2.23-2.21-2.75
LEO 29102 Cream Vehicle-0.27-0.42-0.75-1.17-1.42-1.31-1.54
LEO 29102 Plus Betamethasone Dipropionate-1.00-2.81-3.71-4.48-5.04-5.17-5.50
LEO 29102 Plus Calcipotriol Cream-0.29-1.21-1.60-2.46-2.88-3.21-3.60

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Change in Total Modified PASI Score at Week 4 Compared to Baseline

Modified psoriasis severity index measures erythema, induration, and scaling each measured from 0-4, with a maximum summed score of 12. A higher score means greater psoriasis severity and a lower score means lower psoriasis severity. (NCT00924950)
Timeframe: 4 weeks

InterventionUnits on a scale (Mean)
Taclonex Ointment Occluded With Hydrogel Patch0.86
Taclonex Alone2.2

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Controlled Disease According to the Investigator's Global Assessment of Disease Severity (IGA) at Weeks 4

The IGA was chosen as the primary efficacy assessment. The primary endpoint is subjects with 'Controlled disease' according to the IGA. 'Controlled disease' is defined as clear or almost clear for subjects with moderate disease at baseline and clear for subjects with mild disease at baseline. (NCT01188928)
Timeframe: 4 weeks

Interventionparticipants (Number)
LEO 8018564
Betamethasone60
Calcipotriol5
Topical Suspension Vehicle2

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Controlled Disease According to the Investigator's Global Assessment of Disease Severity (IGA) at Weeks 8

The IGA was chosen as the primary efficacy assessment. The primary endpoint is subjects with 'Controlled disease' according to the IGA. 'Controlled disease' is defined as clear or almost clear for subjects with moderate disease at baseline and clear for subjects with mild disease at baseline. (NCT01188928)
Timeframe: week 8

Interventionparticipants (Number)
LEO 80185140
Betamethasone103
Calcipotriol14
Topical Suspension Vehicle6

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Mean Percentage Change in PASI From Baseline to Week 4

At all treatment phase visits the (sub)investigator made an assessment of the extent and severity of clinical signs of the subject's psoriasis using a modified PASI score (Psoriasis Area and Severity Index) To make up the score, the three features of a psoriatic plaque redness, scaling and thickness are each assigned a number from 0 to 4 with 4 being worst. The extent of involvement of each region of the body is scored from 0 to 6. Adding up the scores give a range of 0 to 72. (NCT01188928)
Timeframe: Baseline and 4 weeks

Interventionpercentage of change in PASI (Mean)
LEO 80185-46.4
Betamethasone-42.7
Calcipotriol-32.2
Topical Suspension Vehicle-17.4

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Mean Percentage Change in PASI From Baseline to Week 8

At all treatment phase visits the (sub)investigator made an assessment of the extent and severity of clinical signs of the subject's psoriasis using a modified PASI score (Psoriasis Area and Severity Index) To make up the score, the three features of a psoriatic plaque redness, scaling and thickness are each assigned a number from 0 to 4 with 4 being worst. The extent of involvement of each region of the body is scored from 0 to 6. Adding up the scores give a range of 0 to 72. (NCT01188928)
Timeframe: Baseline and 8 weeks

Interventionpercentage of change in PASI (Mean)
LEO 80185-55.8
Betamethasone-48.6
Calcipotriol-43.6
Topical Suspension Vehicle-20.9

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Time Until First Neonatal Feeding

Median length of time from delivery until the first neonatal feeding (NCT01222247)
Timeframe: Delivery to 36 hours post delivery

Interventionhours (Median)
Betamethasone5.5
Placebo9.9

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Number of Neonates With Transient Tachypnea of the Newborn

TTN is defined as signs of respiratory distress, specifically tachypnea, that are resolved by 72 hours of age. TTN may be diagnosed in the absence of a chest X-ray or with a chest X-ray that is normal or shows signs of increased perihilar interstitial markings (NCT01222247)
Timeframe: by 72 hours after delivery

InterventionParticipants (Count of Participants)
Betamethasone95
Placebo138

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Number of Neonates With Respiratory Distress Syndrome

Respiratory distress defined as the presence of clinical signs of respiratory distress (tachypnea, retractions, flaring, grunting, or cyanosis) with an oxygen requirement and a chest x-ray that shows hypoaeration and reticulogranular infiltrates (NCT01222247)
Timeframe: Delivery

InterventionParticipants (Count of Participants)
Betamethasone79
Placebo89

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Number of Neonates With Necrotizing Enterocolitic (NEC)

Defined as modified Bell Stage 2 or 3. Stage 2: Clinical signs and symptoms with pneumatosis intestinalis on radiographs. Stage 3: Advanced clinical signs and symptoms, pneumatosis, impending or proven intestinal perforation. (NCT01222247)
Timeframe: Delivery

InterventionParticipants (Count of Participants)
Betamethasone0
Placebo1

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Number of Neonates With Intraventricular Hemorrhage

Grade 3 or 4 Intraventricular Hemorrhage (NCT01222247)
Timeframe: Delivery

InterventionParticipants (Count of Participants)
Betamethasone2
Placebo0

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Number of Neonates With Hypothermia

Rectal temperature < 36 C at any time (NCT01222247)
Timeframe: Delivery through discharge up to 3 weeks

InterventionParticipants (Count of Participants)
Betamethasone132
Placebo112

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Number of Neonates With Hypoglycemia

Glucose < 40 mg per deciliter (2.2 mmol per liter) at any time (NCT01222247)
Timeframe: Delivery through hospital discharge up to 3 weeks

InterventionParticipants (Count of Participants)
Betamethasone343
Placebo210

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Number of Neonates Needing Surfactant Administration

Administration of surfactant for neonatal respiratory treatment (NCT01222247)
Timeframe: Delivery

InterventionParticipants (Count of Participants)
Betamethasone26
Placebo43

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Number of Infants withChronic Lung Disease / Bronchopulmonary Dysplasia (BPD) Requiring Supplemental Oxygen

Infants requiring supplemental oxygen of more than 0.21 for the first 28 days of life (NCT01222247)
Timeframe: 28 days of life

InterventionParticipants (Count of Participants)
Betamethasone2
Placebo9

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Number of Infants With Neonatal Sepsis

Clinical suspicion of systemic infection with a positive blood, cerebral spinal fluid, or catheterized/suprapubic urine culture; or, in the absence of positive cultures, clinical evience of cardiovascular collapse or an X-ray confirming infection. (NCT01222247)
Timeframe: Delivery

InterventionParticipants (Count of Participants)
Betamethasone9
Placebo11

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Number of Infants With Neonatal Apnea

Neonatal apnea with respiratory pauses of more than 20 seconds duration resulting in bradycardia or oxygen desaturation below baseline. (NCT01222247)
Timeframe: 72 hours of life

InterventionParticipants (Count of Participants)
Betamethasone33
Placebo37

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Birth Weight

Weight in grams at delivery (NCT01222247)
Timeframe: Delivery

Interventiongrams (Mean)
Betamethasone2637
Placebo2654

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Birth Weight Less Than 10th Percentile

Neonates whose birth weight is less than the 10th percentile at delivery (NCT01222247)
Timeframe: Delivery

InterventionParticipants (Count of Participants)
Betamethasone255
Placebo220

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Hours From Randomization to Delivery

Median interval of hours from randomization to delivery (NCT01222247)
Timeframe: Randomization through delivery

InterventionHours (Median)
Betamethasone33.0
Placebo30.6

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Median Length of Hospital Stay

Median length of maternal hospital stay following delivery (NCT01222247)
Timeframe: Duration of hospital stay following delivery up to 2 weeks

Interventiondays (Median)
Betamethasone7
Placebo8

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Median Length of Maternal Hospital Stay

Median length of maternal hospital stay in days (NCT01222247)
Timeframe: Delivery through hospital discharge

Interventiondays (Median)
Betamethasone3
Placebo3

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Neonatal Death After 72 Hours of Delivery

Neonatal death after 72 hours of life but before hospital discharge. (NCT01222247)
Timeframe: 72 hours after delivery through hospital discharge up to 3 weeks

InterventionParticipants (Count of Participants)
Betamethasone2
Placebo0

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Neonatal Feeding Difficulty

Inability of the neonate to take all feeds (po), i.e. requiring gavage feeds or IV supplementation. (NCT01222247)
Timeframe: Delivery to 36 hours post delivery

InterventionParticipants (Count of Participants)
Betamethasone211
Placebo223

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Neonatal Hyperbilirubinemia

Peak total bilirubin of at least 15 mg% or the use of phototherapy. (NCT01222247)
Timeframe: Delivery

InterventionParticipants (Count of Participants)
Betamethasone167
Placebo140

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Neonatal Morbidity Composite

A composite endpoint of morbidities known to be affected by steroid administration will also be evaluated. Specifically, this composite will include RDS, intraventricular hemorrhage (IVH), and NEC (NCT01222247)
Timeframe: Delivery

InterventionParticipants (Count of Participants)
Betamethasone81
Placebo90

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Neonatal Outcome Composite

Transient tachypnea of the newborn (TTN), respiratory distress syndrome (RDS), and apnea (NCT01222247)
Timeframe: 72 hours of life

InterventionParticipants (Count of Participants)
Betamethasone198
Placebo249

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Neonates Needing Immediate Resuscitation After Birth

Need for resuscitation after birth: any intervention in the first 30 minutes other than blow-by oxygen (NCT01222247)
Timeframe: Within the first 30 minutes of birth

InterventionParticipants (Count of Participants)
Betamethasone206
Placebo260

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Neonates With Pneumonia

Neonatal pneumonia (NCT01222247)
Timeframe: by 72 hours of life

InterventionParticipants (Count of Participants)
Betamethasone6
Placebo13

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Number of Neonates With Pulmonary Air Leak

Neonatal pulmonary air leak syndrome (NCT01222247)
Timeframe: 72 hours post delivery

InterventionParticipants (Count of Participants)
Betamethasone5
Placebo6

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Number of Neonates With Severe Respiratory Complication,

A severe respiratory complication was defined as any of the following occurrences within 72 hours after birth: CPAP or high-flow nasal cannula for at least 12 hours, supplemental oxygen with a fraction of inspired oxygen of 0.30 or more for at least 24 hours, mechanical ventilation, stillbirth or neonatal death, or the need for ECMO. Except for the duration of CPAP or high-flow nasal cannula and the duration of a fraction of inspired oxygen of 0.30 or more, the criteria for a severe respiratory complication overlap with those of the primary outcome. (NCT01222247)
Timeframe: 72 hours of life

,
InterventionParticipants (Count of Participants)
Severe Respiratory Complication CompositeCPAP or high-flow cannula ≥12 continuous hrsFraction of inspired 02 of ≥0.30 for ≥24 cont hrs
Betamethasone1149320
Placebo16914734

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Neonatal Composite Outcome

Need for respiratory support: Continuous positive airway pressure (CPAP) or humidified high-flow nasal cannula (HHFNC) for greater than or equal to 2 hours or more in the first 72 hours, or fraction of inspired oxygen (FiO2) greater than or equal to 0.30 for 4 hours or more in the first 72 hours, or mechanical ventilation in the first 72 hours, or Extracorporeal membrane oxygenation (ECMO) Stillbirth, or neonatal death less than 72 hours of age (NCT01222247)
Timeframe: 72 hours of life

,
InterventionParticipants (Count of Participants)
Primary Outcome CompositeCPAP or high-flow cannula ≥2 continuous hrsFraction of inspired O2 of ≥0.30 for ≥4 cont hrsMechanical ventilationExtracorporeal membrane oxygenation (ECMO)Stillbirth or neonatal death ≤72 hr after birth
Betamethasone165145483400
Placebo202184614300

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Maternal Outcomes (Participant-based)

Chorioamnionitis: clinical diagnosis and a body temperature of at least 100.4 degrees F., Endometritis: persistent postpartum temperature greater than 100.4 degrees F with uterine tenderness, cesarean delivery (NCT01222247)
Timeframe: Labor and delivery through 72 hours post partum

,
InterventionParticipants (Count of Participants)
ChorioamnionitisPostpartum EndometritisCesarean Delivery
Betamethasone2016454
Placebo3216431

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Length of NICU or Nursery Stay

Includes need for NICU or intermediate care admission and length of stay if admitted. For analysis purposes, death before discharge is assigned maximum rank (NCT01222247)
Timeframe: Delivery through hospital discharge up to 3 weeks

,
InterventionParticipants (Count of Participants)
NICU stay of any durationNICU stay of ≥3 days
Betamethasone596470
Placebo629518

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Gestational Age at Delivery

Number of neonates delivered at ≤ 34 weeks 6 days, between 35 weeks 0 days and 35 weeks 6 days, between 36 weeks 0 days and 36 weeks 6 days, between 37 weeks 0 days and 38 weeks 6 days, or on or after 39 weeks 0 days (NCT01222247)
Timeframe: Delivery

,
InterventionParticipants (Count of Participants)
≤34 weeks 6 days35 weeks 0 days to 35 weeks 6 days36 weeks 0 days to 36 weeks 6 days37 weeks 0 days to 38 weeks 6 days≥39 weeks 0 days
Betamethasone19339460920229
Placebo21338656818548

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Roland Morris Disability Questionnaire (RDQ)

The RDQ is a back pain specific functional status questionnaire adapted from the Sickness Impact Profile (SIP). The RDQ consists of 24 yes/no items, which represent common dysfunctions in daily activities experienced by subjects with low back pain. A single unweighted score is derived by summing the 24 items, with higher scores indicating worse function with 0 (no disability) to 24 (maximum disability). Our primary analysis will be a simple 2-group comparison of the mean Roland score as an evaluation of the short-term efficacy of epidural steroid injection. (NCT01238536)
Timeframe: 12 months

Interventionunits on a scale (Mean)
Epidural Steroid Injection12.0
Epidural Local Anesthetic Injection11.5

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Roland Morris

The primary outcome measure will be back specific functional status, measured by the Roland Scale at 6 weeks. The RDQ is a back pain specific functional status questionnaire adapted from the Sickness Impact Profile (SIP). The RDQ consists of 24 yes/no items, which represent common dysfunctions in daily activities experienced by subjects with low back pain. A single unweighted score is derived by summing the 24 items, with higher scores indicating worse function with 0 (no disability) to 24 (maximum disability). Our primary analysis will be a simple 2-group comparison of the mean Roland score as an evaluation of the short-term efficacy of epidural steroid injection. (NCT01238536)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Epidural Steroid Injection11.8
Epidural Local Anesthetic Injection12.5

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Leg Pain NRS

Leg Pain NRS 0-10 scale (NCT01238536)
Timeframe: 12 months

Interventionunits on a scale (Mean)
Epidural Steroid Injection4.7
Epidural Local Anesthetic Injection4.3

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Pain Numeric Rating Scale

Leg Pain NRS is a second primary outcome at 6 weeks We measured leg pain using a 0-10 pain NRS (0=no pain and 10=worst pain imaginable) assessing average pain over the past week. (NCT01238536)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Epidural Steroid Injection4.4
Epidural Local Anesthetic Injection4.6

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Change in Clinical Sign Scores

"Absolute change in score of each clinical sign (erythema, scaling, infiltration) at end of treatment (Day 29) and at individual visits (Days 4, 8, 11, 15, 18, 22, and 25) compared to Baseline.~The investigator assessed the severity of the clinical signs erythema, scaling, and infiltration for each test site by using a 7-point scale (range 0 (no evidence) to 3 (severe)).~Negative changes in mean score represent improvement." (NCT01347255)
Timeframe: Baseline and Days 4, 8, 11, 15, 18, 22, 25, and 29 (End of Treatment)

,,,
Interventionunits on a scale (Mean)
Erythema (Day 29)Scaling (Day 29)Infiltration (Day 29)Erythema (Day 4)Scaling (Day 4)Infiltration (Day 4)Erythema (Day 8)Scaling (Day 8)Infiltration (Day 8)Erythema (Day 11)Scaling (Day 11)Infiltration (Day 11)Erythema (Day 15)Scaling (Day 15)Infiltration (Day 15)Erythema (Day 18)Scaling (Day 18)Infiltration (Day 18)Erythema (Day 22)Scaling (Day 22)Infiltration (Day 22)Erythema (Day 25)Scaling (Day 25)Infiltration (Day 25)
Daivobet® Ointment-1.50-2.02-1.73-0.33-0.23-0.17-0.67-0.73-0.56-0.83-1.23-0.90-1.04-1.40-1.06-1.35-1.74-1.43-1.44-1.81-1.50-1.56-1.98-1.67
LEO 90100 Cutaneous Spray, Ointment-1.75-2.13-2.13-0.33-0.17-0.13-0.73-0.75-0.60-1.08-1.29-1.00-1.29-1.65-1.31-1.37-1.87-1.61-1.79-2.06-1.85-1.79-2.15-2.10
LEO 90100 Cutaneous Spray, Ointment, Vehicle-0.56-0.90-0.42-0.19-0.19-0.08-0.13-0.21-0.08-0.29-0.46-0.23-0.33-0.46-0.23-0.35-0.67-0.30-0.52-0.67-0.38-0.56-0.85-0.44
LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone-1.44-2.02-1.50-0.33-0.31-0.13-0.60-0.81-0.42-0.75-1.06-0.58-1.06-1.40-0.85-1.20-1.52-1.11-1.29-1.73-1.35-1.44-1.98-1.52

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Change From Baseline in Echo-poor Band Thickness at End of Treatment

Change in echo-poor band thickness from baseline to end of treatment, measured by ultrasound (NCT01347255)
Timeframe: Baseline and Day 29

Interventionmillimetres (Mean)
LEO 90100 Cutaneous Spray, Ointment-0.57
LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone-0.45
LEO 90100 Cutaneous Spray, Ointment, Vehicle-0.12
Daivobet® Ointment-0.46

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Changes in Total Skin Thickness

Change in total skin thickness measured by ultrasound at end of treatment (Day 29) and individual visits (Days 8, 15, and 22) compared to baseline (NCT01347255)
Timeframe: Baseline and Days 8, 15, 22, and 29.

,,,
Interventionmillimetres (Mean)
Day 29Day 8Day 15Day 22
Daivobet® Ointment-0.62-0.33-0.49-0.59
LEO 90100 Cutaneous Spray, Ointment-0.81-0.37-0.57-0.68
LEO 90100 Cutaneous Spray, Ointment, Vehicle-0.23-0.07-0.12-0.18
LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone-0.66-0.28-0.40-0.59

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Changes in Total Clinical Score (TCS) by Visit

Change in Total Clinical Score (TCS; range from 0 (all signs absent) to 9 (all signs severe)) at individual visits (Days 4, 8, 11, 15, 22, and 25) compared to baseline. (NCT01347255)
Timeframe: Baseline and Days 4, 8, 11, 15, 18, 22, 25

,,,
InterventionScores on a scale (Mean)
Day 4Day 8Day 11Day 15Day 18Day 22Day 25
Daivobet® Ointment-0.73-1.96-2.96-3.50-4.52-4.75-5.21
LEO 90100 Cutaneous Spray, Ointment-0.63-2.08-3.38-4.25-4.85-5.71-6.04
LEO 90100 Cutaneous Spray, Ointment, Vehicle-0.46-0.42-0.98-1.02-1.33-1.56-1.85
LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone-0.77-1.83-2.40-3.31-3.83-4.38-4.94

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Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling and Infiltration) at End of Treatment Compared to Baseline

TCS range from 0 (all signs absent) to 9 (all signs severe). (NCT01347255)
Timeframe: Day 1 (Baseline)/Day 29

InterventionScores on a scale (Mean)
LEO 90100 Cutaneous Spray, Ointment-6.00
LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone-4.96
LEO 90100 Cutaneous Spray, Ointment, Vehicle-1.88
Daivobet® Ointment-5.25

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Change in mPASI From Baseline to Week 1

The extent of and severity of redness, thickness and scaliness of psoriasis were recorded for each of three regions (arms, trunk and legs) and these were used to calculate mPASI. The m-PASI could range from 0 to 64.8. The least severe outcome is 0 and the most severe outcome is 64.8 (NCT01422434)
Timeframe: Baseline to Week 1

Interventionpercentage of change (Mean)
Dovonex® Ointment-23.7
LEO 90105 Ointment-39.1
Rinderon® - DP Ointment-29.5

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Change From Baseline in Target Lesion Assessment

"Percentage change in composite severity score of the target lesion from baseline to Week 4.~At Visit 1, the investigator selected a target lesion. Location was recorded as trunk, limb excluding elbow and/or knee.~At Visits 1-4, the investigator assessed the severity of the target lesion for each sign (redness, thickness and scaliness) on a scale from 0 to 8 where 0 is no signs of redness, thickness or scaliness and 8 is the most severe signs of redness, thickeness or scaliniess.~The individual scores for redness, thickness and scaliness were added together to give a single composite score for severity of the target lesion which could range from 0 to 24. The percentage change in the composite severity score from baseline to each visit was also calcutated." (NCT01422434)
Timeframe: Baseline to Week 4

Interventionpercentage of change (Mean)
Dovonex® Ointment-57.1
LEO 90105 Ointment-70.5
Rinderon® - DP Ointment-58.6

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Change From Baseline in Modified Psoriasis Area and Severity Index (mPASI)

"The primary response criterion was the percentage change in m-PASI from baseline to Week 4.~The extent of and severity of redness, thickness and scaliness of psoriasis were recorded for each of three regions (arms, trunk and legs) and these were used to calculate mPASI using the following formula:~Arms: 0.2(R+T+S)E = X Trunk: 0.2(R+T+S)E = Y Legs: 0.2(R+T+S)E = Z where R = score for redness (using a scale from 0 to 4, where o is non signs and 4 is the most severe signs) T = score for thickness (using a scale from 0 to 4, where o is non signs and 4 is the most severe signs) S = score for scaliness (using a scale from 0 to 4, where o is non signs and 4 is the most severe signs) E = score for extent (using a scale from 0 to 6, where 0 is no involvement and 6 is 90-100% involvemnet) The sum of X + Y + Z gave the total m-PASI, which could range from 0 to 64.8." (NCT01422434)
Timeframe: Baseline to Week 4

Interventionpercentage of change (Mean)
Dovonex® Ointment-50.5
LEO 90105 Ointment-64.3
Rinderon® - DP Ointment-53.6

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Physician's Global Assessment of Psoriasis

"Subjects with 'clear' or 'almost clear' disease by physician's global assessment on the following 6 point scale: clear, almost clear, mild, moderate, severe, very severe.~The assessment represents the average lesion severity on the trunk and limbs. The assessment was based on the condition of the disease at the time of evaluation, and not in relation to the condition at a previous visit." (NCT01422434)
Timeframe: Week 4

Interventionparticipants (Number)
Dovonex® Ointment52
LEO 90105 Ointment89
Rinderon® - DP Ointment43

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Subjects With 'Controlled Disease' ('Clear'/'Almost Clear' for Subjects w. at Least Moderate Disease at Baseline, 'Clear' for Subjects With Mild Disease at Baseline) According to the Investigator's Global Assessment (IGA) on the Trunk and Limbs at Week 4.

Assessment of disease severity (Plaque thickening, Scaling and Erythema) using a 5-point scale (Clear, Almost clear, Mild, Moderate, Severe), based on the condition of the disease at the time of evaluation. (NCT01536886)
Timeframe: 4 weeks

Interventionparticipants (Number)
LEO 9010077
Calcipotriol Plus BDP Ointment58
LEO 90100 Vehicle3
Ointment Vehicle4

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Subjects With 'Controlled Disease' ('Clear'/'Almost Clear' for Subjects w. at Least Moderate Disease at Baseline, 'Clear' for Subjects With Mild Disease at Baseline) According to the Investigator's Global Assessment (IGA) on the Trunk and Limbs at Week 4.

Assessment of disease severity (Plaque thickening, Scaling and Erythema) using a 5-point scale (Clear, Almost clear, Mild, Moderate, Severe), based on the condition of the disease at the time of evaluation. (NCT01536938)
Timeframe: 4 weeks

Interventionparticipants (Number)
LEO 9010045
Betamethasone Dipropionate31
Calcipotriol Aerosol Foam15

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Change From Baseline in Infiltration at Day 4

Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent). (NCT01607853)
Timeframe: Baseline to day 4

Interventionunits on a scale (Mean)
Daivobet® Gel Applied Then Removed After 10 Minutes-0.10
Daivobet® Gel Applied Then Removed After 20 Minutes-0.08
Daivobet® Gel Applied for 24 Hours-0.10
Daivobet® Gel Vehicle Applied for 24 Hours0.02

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Change From Baseline in Infiltration at Day 8

Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent). (NCT01607853)
Timeframe: Baseline to day 8

Interventionunits on a scale (Mean)
Daivobet® Gel Applied Then Removed After 10 Minutes-0.33
Daivobet® Gel Applied Then Removed After 20 Minutes-0.33
Daivobet® Gel Applied for 24 Hours-0.38
Daivobet® Gel Vehicle Applied for 24 Hours0.00

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Change From Baseline in Scaling at Day 15

Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent). (NCT01607853)
Timeframe: Baseline to day 15

Interventionunits on a scale (Mean)
Daivobet® Gel Applied Then Removed After 10 Minutes-1.15
Daivobet® Gel Applied Then Removed After 20 Minutes-1.04
Daivobet® Gel Applied for 24 Hours-1.40
Daivobet® Gel Vehicle Applied for 24 Hours-0.42

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Change From Baseline in Scaling at Day 18

Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent). (NCT01607853)
Timeframe: Baseline to day 18

Interventionunits on a scale (Mean)
Daivobet® Gel Applied Then Removed After 10 Minutes-1.35
Daivobet® Gel Applied Then Removed After 20 Minutes-1.27
Daivobet® Gel Applied for 24 Hours-1.50
Daivobet® Gel Vehicle Applied for 24 Hours-0.48

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Change From Baseline in Scaling at Day 22

Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent). (NCT01607853)
Timeframe: Baseline to day 22

Interventionunits on a scale (Mean)
Daivobet® Gel Applied Then Removed After 10 Minutes-1.31
Daivobet® Gel Applied Then Removed After 20 Minutes-1.31
Daivobet® Gel Applied for 24 Hours-1.71
Daivobet® Gel Vehicle Applied for 24 Hours-0.54

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Change From Baseline in Scaling at Day 8

Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent). (NCT01607853)
Timeframe: Baseline to day 8

Interventionunits on a scale (Mean)
Daivobet® Gel Applied Then Removed After 10 Minutes-0.60
Daivobet® Gel Applied Then Removed After 20 Minutes-0.46
Daivobet® Gel Applied for 24 Hours-0.56
Daivobet® Gel Vehicle Applied for 24 Hours-0.06

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Change in Lesion Thickness Measured by Ultrasound From Baseline to Day 22.

(NCT01607853)
Timeframe: Baseline to day 22

Interventionmillimeters (Mean)
Daivobet® Gel Applied Then Removed After 10 Minutes-0.61
Daivobet® Gel Applied Then Removed After 20 Minutes-0.80
Daivobet® Gel Applied for 24 Hours-0.90
Daivobet® Gel Vehicle Applied for 24 Hours-0.11

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Change in Skin Thickness - Echo-poor Band - Measured by Ultrasound From Baseline to Day 22

(NCT01607853)
Timeframe: Baseline to day 22

Interventionmillimeters (Mean)
Daivobet® Gel Applied Then Removed After 10 Minutes-0.57
Daivobet® Gel Applied Then Removed After 20 Minutes-0.54
Daivobet® Gel Applied for 24 Hours-0.62
Daivobet® Gel Vehicle Applied for 24 Hours-0.06

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Change in Total Clinical Score at Day 11 Compared to Baseline

Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score. (NCT01607853)
Timeframe: Baseline to day 11

Interventionunits on a scale (Mean)
Daivobet® Gel Applied Then Removed After 10 Minutes-2.3
Daivobet® Gel Applied Then Removed After 20 Minutes-2.3
Daivobet® Gel Applied for 24 Hours-3.0
Daivobet® Gel Vehicle Applied for 24 Hours-0.7

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Change in Total Clinical Score at Day 15 Compared to Baseline

Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinial Score. (NCT01607853)
Timeframe: Baseline to day 15

Interventionunits on a scale (Mean)
Daivobet® Gel Applied Then Removed After 10 Minutes-3.0
Daivobet® Gel Applied Then Removed After 20 Minutes-2.8
Daivobet® Gel Applied for 24 Hours-3.9
Daivobet® Gel Vehicle Applied for 24 Hours-0.9

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Change in Total Clinical Score at Day 18 Compared to Baseline

Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score. (NCT01607853)
Timeframe: Baseline to day 18

Interventionunits on a scale (Mean)
Daivobet® Gel Applied Then Removed After 10 Minutes-3.4
Daivobet® Gel Applied Then Removed After 20 Minutes-3.4
Daivobet® Gel Applied for 24 Hours-4.3
Daivobet® Gel Vehicle Applied for 24 Hours-1.1

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Change in Total Clinical Score at Day 4 Compared to Baseline

Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score. (NCT01607853)
Timeframe: Baseline to day 4

Interventionunits on a scale (Mean)
Daivobet® Gel Applied Then Removed After 10 Minutes-0.5
Daivobet® Gel Applied Then Removed After 20 Minutes-0.5
Daivobet® Gel Applied for 24 Hours-0.4
Daivobet® Gel Vehicle Applied for 24 Hours-0.1

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Change in Total Clinical Score at Day 8 Compared to Baseline

Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score. (NCT01607853)
Timeframe: Baseline to day 8

Interventionunits on a scale (Mean)
Daivobet® Gel Applied Then Removed After 10 Minutes-1.5
Daivobet® Gel Applied Then Removed After 20 Minutes-1.4
Daivobet® Gel Applied for 24 Hours-1.6
Daivobet® Gel Vehicle Applied for 24 Hours-0.2

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Change in Total Clinical Score From Baseline to Day 22

Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clincal Score (NCT01607853)
Timeframe: baseline to day 22

Interventionunits on a scale (Mean)
Daivobet® Gel Applied Then Removed After 10 Minutes-3.6
Daivobet® Gel Applied Then Removed After 20 Minutes-3.7
Daivobet® Gel Applied for 24 Hours-4.9
Daivobet® Gel Vehicle Applied for 24 Hours-1.3

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Change From Baseline in Scaling at Day 11

Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent). (NCT01607853)
Timeframe: Baseline to day 11

Interventionunits on a scale (Mean)
Daivobet® Gel Applied Then Removed After 10 Minutes-0.90
Daivobet® Gel Applied Then Removed After 20 Minutes-0.88
Daivobet® Gel Applied for 24 Hours-1.08
Daivobet® Gel Vehicle Applied for 24 Hours-0.35

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Change From Baseline in Scaling at Day 4

Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent). (NCT01607853)
Timeframe: Baseline to day 4

Interventionunits on a scale (Mean)
Daivobet® Gel Applied Then Removed After 10 Minutes-0.19
Daivobet® Gel Applied Then Removed After 20 Minutes-0.19
Daivobet® Gel Applied for 24 Hours-0.10
Daivobet® Gel Vehicle Applied for 24 Hours-0.08

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Change From Baseline in Erythema at Day 11

Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent). (NCT01607853)
Timeframe: Baseline to day 11

Interventionunits on a scale (Mean)
Daivobet® Gel Applied Then Removed After 10 Minutes-0.79
Daivobet® Gel Applied Then Removed After 20 Minutes-0.85
Daivobet® Gel Applied for 24 Hours-1.06
Daivobet® Gel Vehicle Applied for 24 Hours-0.27

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Change From Baseline in Erythema at Day 15

Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent). (NCT01607853)
Timeframe: Baseline to day 15

Interventionunits on a scale (Mean)
Daivobet® Gel Applied Then Removed After 10 Minutes-1.00
Daivobet® Gel Applied Then Removed After 20 Minutes-1.04
Daivobet® Gel Applied for 24 Hours-1.29
Daivobet® Gel Vehicle Applied for 24 Hours-0.31

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Change From Baseline in Erythema at Day 18

Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent). (NCT01607853)
Timeframe: Baseline to day 18

Interventionunits on a scale (Mean)
Daivobet® Gel Applied Then Removed After 10 Minutes-1.04
Daivobet® Gel Applied Then Removed After 20 Minutes-1.19
Daivobet® Gel Applied for 24 Hours-1.42
Daivobet® Gel Vehicle Applied for 24 Hours-0.46

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Change From Baseline in Erythema at Day 22

Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent). (NCT01607853)
Timeframe: Baseline to day 22

Interventionunits on a scale (Mean)
Daivobet® Gel Applied Then Removed After 10 Minutes-1.17
Daivobet® Gel Applied Then Removed After 20 Minutes-1.31
Daivobet® Gel Applied for 24 Hours-1.56
Daivobet® Gel Vehicle Applied for 24 Hours-0.42

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Change From Baseline in Erythema at Day 4.

Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent). (NCT01607853)
Timeframe: Baseline to day 4

Interventionunits on a scale (Mean)
Daivobet® Gel Applied Then Removed After 10 Minutes-0.17
Daivobet® Gel Applied Then Removed After 20 Minutes-0.23
Daivobet® Gel Applied for 24 Hours-0.23
Daivobet® Gel Vehicle Applied for 24 Hours-0.06

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Change From Baseline in Erythema at Day 8.

Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent). (NCT01607853)
Timeframe: Baseline to day 8

Interventionunits on a scale (Mean)
Daivobet® Gel Applied Then Removed After 10 Minutes-0.54
Daivobet® Gel Applied Then Removed After 20 Minutes-0.56
Daivobet® Gel Applied for 24 Hours-0.67
Daivobet® Gel Vehicle Applied for 24 Hours-0.15

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Change From Baseline in Infiltration at Day 11

Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent). (NCT01607853)
Timeframe: Baseline to day 11

Interventionunits on a scale (Mean)
Daivobet® Gel Applied Then Removed After 10 Minutes-0.63
Daivobet® Gel Applied Then Removed After 20 Minutes-0.60
Daivobet® Gel Applied for 24 Hours-0.81
Daivobet® Gel Vehicle Applied for 24 Hours-0.08

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Change From Baseline in Infiltration at Day 15

Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent). (NCT01607853)
Timeframe: Baseline to day 15

Interventionunits on a scale (Mean)
Daivobet® Gel Applied Then Removed After 10 Minutes-0.81
Daivobet® Gel Applied Then Removed After 20 Minutes-0.73
Daivobet® Gel Applied for 24 Hours-1.19
Daivobet® Gel Vehicle Applied for 24 Hours-0.15

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Change From Baseline in Infiltration at Day 18

Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent). (NCT01607853)
Timeframe: Baseline to day 18

Interventionunits on a scale (Mean)
Daivobet® Gel Applied Then Removed After 10 Minutes-1.00
Daivobet® Gel Applied Then Removed After 20 Minutes-0.98
Daivobet® Gel Applied for 24 Hours-1.42
Daivobet® Gel Vehicle Applied for 24 Hours-0.17

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Change From Baseline in Infiltration at Day 22

Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent). (NCT01607853)
Timeframe: Baseline to day 22

Interventionunits on a scale (Mean)
Daivobet® Gel Applied Then Removed After 10 Minutes-1.08
Daivobet® Gel Applied Then Removed After 20 Minutes-1.06
Daivobet® Gel Applied for 24 Hours-1.60
Daivobet® Gel Vehicle Applied for 24 Hours-0.31

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Subjective Subject Preference Survey for the First Treatment Session

Subjective Subject Preference Survey The Subjective Subject Preference Survey consist of 15 questions relating to patients preference of study drug. The survey includes questions such as how the medication feels to touch, how greasy it is, and time it takes to apply. The final question asks patients to rate the overall appeal of the vehicle. Questions are scored on a 7-point scale, where a score of 1 is extremely unpleasant, 4 is neutral, and a score of 7 is extremely appealing. Total preference score based on the Subjective Subject Preference Survey could range from 15-105. (NCT01707043)
Timeframe: 3 days

Interventionunits on a scale (Mean)
Taclonex Scalp Suspension First Then Taclonex Ointment81.1
Taclonex Ointment First, Then Taclonex Scalp Suspension77.6

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Subjective Subject Preference Survey for the Second Treatment Session

Subjective Subject Preference Survey The Subjective Subject Preference Survey consist of 15 questions relating to patients preference of study drug. The survey includes questions such as how the medication feels to touch, how greasy it is, and time it takes to apply. The final question asks patients to rate the overall appeal of the vehicle. Questions are scored on a 7-point scale, where a score of 1 is extremely unpleasant, 4 is neutral, and a score of 7 is extremely appealing. Total preference score based on the Subjective Subject Preference Survey could range from 15-105. (NCT01707043)
Timeframe: 3 days

Interventionunits on a scale (Mean)
Taclonex Scalp Suspension First Then Taclonex Ointment78.9
Taclonex Ointment First, Then Taclonex Scalp Suspension69.4

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"DASH - Disabilities of the Arm, Shoulder, and Hand Score At Baseline, and Change From Baseline at 6-8 Weeks, 12-16 Weeks, and at 1 Year"

"Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire. Questions 1-30, the scale is a 1-5 scale (1=no difficulty; 2=mild difficulty; 3=moderate difficulty; 4=severe difficulty; 5=unable) DASH Disability/Symptom Score = [(sum of n responses)/n) -1] x 25. A lower score is a better outcome. The Dash is based on a scale of 0-100. Our scores were averaged and the Mean scores are what we reported. Total scores are listed below.~US Guided Group - Dash #1 (Min=25, Mean=58, Max=90) n=12; Dash #2 (Min=3, Mean=38, Max=91) n=12; Dash #3 (Min=6, Mean=42, Max=71) n=10; 1 Year Dash (Min=0, Mean =29, Max=91) n=12.~Non-US Guided Group - Dash #1 (Min=23, Mean=39, Max=61) n=3; Dash #2 (Min=0, Mean=11, Max=22) n=3; Dash #3 (Min=7, Mean=30, Max=49) n=3; 1 Year Dash (Min=0, Mean=9, Max=25) n=3." (NCT02038634)
Timeframe: Prior to injection (Dash #1), 6-8 weeks (Dash #2), 12-16 weeks (Dash #3), and 1 year (Dash #4) post-injection

,
Interventionscore on a scale (Mean)
Dash #1 Pre-InjectionDash #2 6-8 WeeksDash #3 12-16 WeeksDash #4 - 1 Year
Ultrasound-guided Injections58384229
Unguided Injections3911309

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Participants With HPA Axis Suppression at Day 29

Number of participants with HPA axis suppression at Day 29, by measuring the level of cortisol in the blood after ACTH stimulation test (NCT02527421)
Timeframe: Day 29

InterventionParticipants (Count of Participants)
DFD01 Spray Group 10
DFD01 Spray Group 21

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Participants With HPA Axis Suppression at End of Treatment (Day 15 or Day 28) With Recovery 29 Days Later

Number of participants with HPA axis suppression at End of Treatment (day 15 or day 28) with recovery 29 days later, by measuring the level of cortisol in the blood after ACTH stimulation test (NCT02527421)
Timeframe: End of Treatment (day 15 or day 28) with recovery 29 days later

InterventionParticipants (Count of Participants)
DFD01 Spray Group 10
DFD01 Spray Group 21

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Change in Percent Body Surface Area (BSA) Involved.

Change in the BSA of involvement with psoriasis from baseline to Day 14 was assessed. BSA was assessed at Baseline, Days 8, 14 and 29. (NCT02749799)
Timeframe: Change from Baseline to Day 14.

Interventionpercentage of BSA (Mean)
DFD-01 (Betamethasone Dipropionate) Spray, 0.05%-1.3

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Change in Dermatology Life Quality Index (DLQI)

"DLQI is a simple, compact, and practical questionnaire to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. The participant responds on a four-point scale, ranging from Very Much (score 3) to Not at All or Not relevant (score 0). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best. A lower score (i.e., negative change score) indicates improvement in the Quality of Life." (NCT02749799)
Timeframe: Change from Baseline to Day 14.

Interventionunits on a scale (Mean)
DFD-01 (Betamethasone Dipropionate) Spray, 0.05%-6.6

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Change in Investigator's Global Assessment Grade

The mean change in the IGA score from baseline to Day 14 was assessed. IGA score is a static assessment of disease severity and is based on overall severity of signs at each visit. It's a 4-point scale where '0' is absent disease and '4' is 'Severe/Very Severe' disease. A lower score at the end of the study compared to baseline (negative change), indicates an improvement in the disease condition. (NCT02749799)
Timeframe: Change from Baseline to Day 14.

Interventionunits on a scale (Mean)
DFD-01 (Betamethasone Dipropionate) Spray, 0.05%-0.8

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Percentage of Adherent Participants

Rate of adherent patients, defined as dichotomized adherence rates obtained by number of days with applied medication with a selected cut-off of 80%, with adherence rates above 80% considered adherent (NCT02858713)
Timeframe: Week 4

Interventionpercentage of participants (Number)
App as Intervention + Enstilar©65
Conventional Instructions + Enstilar©38

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Dermatology Life Quality Index (DLQI)

"Change from baseline to week 4~Description of Dermatology Life Quality Index (DLQI): A score from 0-30 [0, patients' quality of life not affected; 30, patients' quality of life severely affected by the skin disease]. The DLQI-scale is a summary of 10 questions on subscales, where patients' report how severely their quality of life has been affected for the last week (patient reported outcome measurements (PROM), each subscale have a score from 0 (not affected by skin disease) to 3 (severely affected by skin disease).~The minimum score is 0 and the highest score is 30, a high score means worse outcome." (NCT02858713)
Timeframe: Baseline, week 4, 8 and 26

,
Interventionunits on a scale (Mean)
Change from baseline to week 4Change from baseline to week 8Change from baseline to week 26
App as Intervention + Enstilar©4.124.594.23
Conventional Instructions + Enstilar©4.545.175.00

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Lattice-System Physician's Global Assessment (LS-PGA)

"Change from baseline to week 4, 8 and 26~Lattice System Physican's Gloabal Assessment (LS-PGA) is a measure from 0-8 (0, patients skin clear; 8, patients' skin severely affected by psoriasis). The scale is a summary of three subscales: 1). thickness of psoriasis, 2). extent of scaling and 3). body surface ares (BSA) affected. The minimum score is 0 and the maximum score is 8, a high score represents a worse outcome." (NCT02858713)
Timeframe: Week 4, 8 and 26

,
Interventionunits on a scale (Mean)
Change from baseline to week 4Change from baseline to week 8Change from baseline to week 26
App + Enstilar©1.862.251.98
Conventional Instructions + Enstilar©1.462.161.80

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Functional Status Assessed by Oswestry Disability Index

ODI (Oswestry disability index) consists of 10 subscales, which evaluates pain intensity, and functional satus of personal care, lifting, walking, sitting, standing, sleeping, sex, social life, traveling. Each subscales range from 0 to 5, with the higher score indicating more severe functional damage. the ODI score ranges from 0 to 100. it equals the sum of all the subscales and divided by 50. If the patients answers 9 subscale questions, then the total sum should be divided by 45, and by this analogy. (NCT03101033)
Timeframe: at six-month post-treatment

Interventionunits on a scale (Mean)
Epidural Neuroplasty Group30.52
Transforaminal Steroid Injection Group46.39

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Functional Status Assessed by Oswestry Disability Index

ODI (Oswestry disability index) consists of 10 subscales, which evaluates pain intensity, and functional satus of personal care, lifting, walking, sitting, standing, sleeping, sex, social life, traveling. Each subscales range from 0 to 5, with the higher score indicating more severe functional damage. the ODI score ranges from 0 to 100. it equals the sum of all the subscales and divided by 50. If the patients answers 9 subscale questions, then the total sum should be divided by 45, and by this analogy. (NCT03101033)
Timeframe: at one-month post-treatment

Interventionunits on a scale (Mean)
Epidural Neuroplasty Group29.11
Transforaminal Steroid Injection Group35.02

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Pain Assessed by Visual Analogue Scale

VAS (Visual analogue scale), with the highest score of 10, representing the most severe pain one could experience, and the lowest score of 0, representing no pain at all. The higher score means more severe pain. (NCT03101033)
Timeframe: at three-month post-treatment

Interventionunits on a scale (Mean)
Epidural Neuroplasty Group2.19
Transforaminal Steroid Injection Group3.25

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Pain Assessed by Visual Analogue Scale

VAS (Visual analogue scale), with the highest score of 10, representing the most severe pain one could experience, and the lowest score of 0, representing no pain at all. The higher score means more severe pain. (NCT03101033)
Timeframe: at one-month post-treatment

Interventionunits on a scale (Mean)
Epidural Neuroplasty Group2.37
Transforaminal Steroid Injection Group2.35

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Functional Status Assessed by Oswestry Disability Index

ODI (Oswestry disability index) consists of 10 subscales, which evaluates pain intensity, and functional satus of personal care, lifting, walking, sitting, standing, sleeping, sex, social life, traveling. Each subscales range from 0 to 5, with the higher score indicating more severe functional damage. the ODI score ranges from 0 to 100. it equals the sum of all the subscales and divided by 50. If the patients answers 9 subscale questions, then the total sum should be divided by 45, and by this analogy. (NCT03101033)
Timeframe: before treatment

Interventionunits on a scale (Mean)
Epidural Neuroplasty Group53.85
Transforaminal Steroid Injection Group57.84

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Functional Status Assessed by Oswestry Disability Index

ODI (Oswestry disability index) consists of 10 subscales, which evaluates pain intensity, and functional satus of personal care, lifting, walking, sitting, standing, sleeping, sex, social life, traveling. Each subscales range from 0 to 5, with the higher score indicating more severe functional damage. the ODI score ranges from 0 to 100. it equals the sum of all the subscales and divided by 50. If the patients answers 9 subscale questions, then the total sum should be divided by 45, and by this analogy. (NCT03101033)
Timeframe: at three-month post-treatment

Interventionunits on a scale (Mean)
Epidural Neuroplasty Group28.93
Transforaminal Steroid Injection Group39.82

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Pain Assessed by Visual Analogue Scale

VAS (Visual analogue scale), with the highest score of 10, representing the most severe pain one could experience, and the lowest score of 0, representing no pain at all. The higher score means more severe pain. (NCT03101033)
Timeframe: at six-month post-treatment

Interventionunits on a scale (Mean)
Epidural Neuroplasty Group2.81
Transforaminal Steroid Injection Group4.06

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Pain Assessed by Visual Analogue Scale

VAS (Visual analogue scale), with the highest score of 10, representing the most severe pain one could experience, and the lowest score of 0, representing no pain at all. The higher score means more severe pain. (NCT03101033)
Timeframe: before treatment

Interventionunits on a scale (Mean)
Epidural Neuroplasty Group5.63
Transforaminal Steroid Injection Group5.92

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Percent of Subjects With PASI 90 and 100 at Week 16

Psoriasis Area & Severity Index (PASI) is a tool used to measure the severity of psoriasis. It combines the assessment of the severity of lesions and the area affected into a single score ranging from 0(no disease) to 72(maximal disease.) (NCT03441789)
Timeframe: 16 weeks

,
InterventionParticipants (Count of Participants)
PASI 90PASI 100
Otezla Plus Enstilar Foam41
Otezla Plus Vehicle Foam20

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Percent of Subjects With a Psoriasis Assessment and Severity Index (PASI) 75 at Week 16

PASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0(no disease) to 72(maximal disease.) The body is divided into 4 sections: head (10% of total body surface area,) arms (20%,) trunk(30%,) and legs (40%.) Each of these is scored by itself and the 4 scores then combined to obtain thePASI. For each body area, the percent of skin area involved is estimated and graded based on this value (0=0% of area involved, 1=<10%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89%, 6=90-100%.) Within each area, the severity of disease is based on 3 clinical signs: erythema or redness, induration or thickness, and desquamation or scaliness. Each is graded on a scale from 0(none) to 4(maximum.) The sum of all 3 parameters is calculated for each body section, multiplied by the area score for that section and then multiplied by the weight of that section (.1for head, .2 arms, .3 trunk and .4 legs) (NCT03441789)
Timeframe: 16 weeks

InterventionParticipants (Count of Participants)
Otezla Plus Enstilar Foam7
Otezla Plus Vehicle Foam2

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Global Improvement in Itch Visual Analogue Scale (VAS) at Week 4,12 and 16

The Itch VAS (Visual Analog Scale) is completed by subjects wherein they are asked to rate the severity of their itching over the last 48 hours on a scale from 0 (no itching) to 10 (unbearable itching); low scores indicate a better outcome. (NCT03441789)
Timeframe: 4 weeks, 12 weeks, 16 weeks

,
Interventionscale unit (Mean)
week 4week 12week 16
Otezla Plus Enstilar Foam243
Otezla Plus Vehicle Foam544

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Global Percent Improvement in Dermatologic Quality of Life Index (DLQI) at Week 4, 12, and 16

The DLQI is a 10-question tool completed by subjects to ascertain the severity of disease based on the extent to which disease interferes with daily life. Each question is scored according to the response wherein Very Much =3, A lot=2, A little=1 and Not at all=0. The sum of all responses is then recorded on a scale from 0 to 30, lower scores indicating better quality of life. (NCT03441789)
Timeframe: 4 weeks, 12, weeks, 16 weeks

,
Interventionscore on a scale (Mean)
week 4week 12week 16
Otezla Plus Enstilar Foam253
Otezla Plus Vehicle Foam556

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Percent of Subjects With PASI 75 at Week 4 and Week 12

Psoriasis Area & Severity Index (PASI) is a tool used to measure the severity of psoriasis. It combines the assessment of the severity of lesions and the area affected into a single score ranging from 0(no disease) to 72(maximal disease.) (NCT03441789)
Timeframe: 4 weeks, 12 weeks

,
InterventionParticipants (Count of Participants)
week 4week 12
Otezla Plus Enstilar Foam74
Otezla Plus Vehicle Foam12

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Per Cent of Patients With at Least 1-grade Improvement in Physicians Global Assessment (PGA) at Week 4 and Week 12 and Week 16

The Investigator will rate the severity of of disease based on the assessment of 3 clinical signs (erythema, induration, desquamation) wherein 0=no signs of psoriasis, 1=almost clear, 2=mild, 3=moderate, 4=severe (NCT03441789)
Timeframe: 4 weeks, 12 weeks, 16 weeks

InterventionParticipants (Count of Participants)
week 472517757week 472517758week 1272517758week 1272517757week 1672517758week 1672517757
severeclearalmost clearmildmoderate
Otezla Plus Enstilar Foam5
Otezla Plus Enstilar Foam7
Otezla Plus Vehicle Foam0
Otezla Plus Vehicle Foam3
Otezla Plus Vehicle Foam4
Otezla Plus Enstilar Foam6
Otezla Plus Vehicle Foam7
Otezla Plus Enstilar Foam1
Otezla Plus Vehicle Foam1
Otezla Plus Enstilar Foam8
Otezla Plus Enstilar Foam4
Otezla Plus Enstilar Foam0
Otezla Plus Vehicle Foam9

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Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria

Baseline was defined to be the measurement on Day 1. Vital Signs including diastolic blood pressure (DBP), pulse rate, and systolic blood pressure (SBP) were measured. (NCT03469336)
Timeframe: Day 1 to Day 49

InterventionParticipants (Count of Participants)
DBP Value <50 mmHgDBP Chg >= 20 mmHg increaseDBP Chg >= 20 mmHg decreasePulse Rate Value <40 beats per minute (bpm)Pulse Rate Value >120 bpmSBP Value <90 mmHgSBP Chg >= 30 mmHg increaseSBP Chg >= 30 mmHg decrease
PF-06763809+Vehicle+Calcipotriene+Betamethasone00000000

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Number of Participants With Treatment-emergent Adverse Events (AEs)

Baseline was defined to be the measurement on Day 1. An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of investigational product. (NCT03469336)
Timeframe: Day 1 to Day 49

InterventionParticipants (Count of Participants)
PF-06763809+Vehicle+Calcipotriene+Betamethasone6

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Area Under the Curve of the Psoriatic Skin Infiltrate Thickness

Baseline was defined to be the measurement on Day 1. To evaluate the Area Under the Curve (AUC) of psoriatic skin infiltrate thickness/EPB for PF 06763809 compared to vehicle by mixed model analysis. The AUC of the psoriatic skin infiltrate thickness/EPB from Day 1 to Day 19 was determined using the linear trapezoidal rule. The log AUC was performed by the natural logarithm of the AUC of the psoriatic skin infiltrate thickness/EPB. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories. (NCT03469336)
Timeframe: Day 1 to Day 19

Interventionnanograms*hour per milliliter (ng*h/mL) (Geometric Mean)
A: PF-06763809 2.3% Solution6191.52
B: PF-06763809 0.8% Solution5996.26
C: PF-06763809 0.23% Solution6921.58
D: PF-06763809 Vehicle6204.82

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Change From Baseline in Psoriatic Skin Infiltrate Thickness

Baseline was defined to be the measurement on Day 1. MMRM analysis of changes in psoriatic skin in psoriatic skin infiltrate thickness/echo poor band (EPB) in response to PF-06763809 2.3%, 0.8% and 0.23% applied topically for 18 consecutive days as compared to the vehicle control. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories. (NCT03469336)
Timeframe: Baseline, Days 7, 13 and 19

,,,
Interventionmicrometer (μm) (Geometric Mean)
Day 7Day 13Day 19
A: PF-06763809 2.3% Solution0.890.740.71
B: PF-06763809 0.8% Solution0.920.760.70
C: PF-06763809 0.23% Solution0.970.870.80
D: PF-06763809 Vehicle0.930.800.70

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Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Betamethasone Solution.

The effect of PF-06763809 compared to betamethasone solution in the change of psoriatic skin infiltrate thickness/EPB both within and following 18 days of treatment. Baseline was defined to be the measurement on Day 1. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories. (NCT03469336)
Timeframe: Baseline, Days 7, 13 and 19

,,,
Interventionμm (Geometric Mean)
Day 7Day 13Day 19
A: PF-06763809 2.3% Solution0.890.740.71
B: PF-06763809 0.8% Solution0.920.760.70
C: PF-06763809 0.23% Solution0.970.870.80
F: Betamethasone Solution.0.430.030.01

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Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Calcipotriene/Calcipotriol Solution.

The effect of PF-06763809 compared to calcipotriene/calcipotriol solution in the change of psoriatic skin infiltrate thickness/EPB both within and following 18 days of treatment. Baseline was defined to be the measurement on Day 1. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories. (NCT03469336)
Timeframe: Baseline, Days 7, 13 and 19

,,,
Interventionμm (Geometric Mean)
Day 7Day 13Day 19
A: PF-06763809 2.3% Solution0.890.740.71
B: PF-06763809 0.8% Solution0.920.760.70
C: PF-06763809 0.23% Solution0.970.870.80
E: Calcipotriene/Calcipotriol Solution0.770.860.90

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Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria

Baseline was defined to be the measurement on Day 1. ECG categorical summarization criteria: 1) PR interval (Value>=300 milliseconds [msec], %Change [Chg]>=25/50%); 2) QRS interval (Value>=140 msec, >=50% change from baseline; 2) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): >=300 msec, >=25% change when baseline is > 200 msec or >=50% change when baseline is less than or equal to (<=) 200 msec; 3) QT interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole): absolute value of >=500 msec; 4) QTc interval (QT corrected for heart rate): absolute value of 450 to <480 msec, 480 to <500 msec, >=500 msec; a change from baseline of 30 to <60 msec or >=60 msec. The corrected QT interval by Fredericia=QTcF Interval. (NCT03469336)
Timeframe: Day 1 to Day 49

InterventionParticipants (Count of Participants)
Value>=300 msec (PR Interval)%Change (Chg)>=25/50% (PR Interval)Value>=140 msec (QRS Interval)%Chg>=50% (QRS Interval)Value>=500 msec (QT Interval)450<=Value<480 msec (QTc Interval)480<=Value<500 msec (QTc Interval)Value>=500 msec (QTc Interval)30<=Chg<60 msec (QTc Interval)Chg>=60 msec (QTc Interval)450<=Value<480 msec (QTcF Interval)480<=Value<500 msec (QTcF Interval)Value>=500 msec (QTcF Interval)30<=Chg<60 msec (QTcF Interval)Chg>=60 msec (QTcF Interval)
PF-06763809+Vehicle+Calcipotriene+Betamethasone000002002100000

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Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)

Baseline was defined to be the measurement on Day 1. The safety laboratory tests including Hematology, Clinical Chemistry and Urinalysis were performed. Hematology evaluation included: hemoglobin (HGB) (gram per decilitre=g/dL), hematocrit, erythrocytes (Ery.), Ery. Mean Corpuscular Volume, Ery. Mean Corpuscular Hemoglobin, Ery. Mean Corpuscular HGB Concentration (picograms per cell=pg/cell), platelets, leukocytes, lymphocytes, and neutrophils. Clinical chemistry evaluation included: bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, urea nitrogen, urea, creatinine, urate, sodium, potassium, chloride, calcium, bicarbonate, creatine kinase, and glucose. Urinalysis evaluation included: pH, urine glucose, ketones, urine protein, urine hemoglobin, urobilinogen, urine bilirubin, nitrite, and leukocyte esterase. LLN=lower limit of normal, ULN=upper limit of normal. (NCT03469336)
Timeframe: Day 1 to Day 49

InterventionParticipants (Count of Participants)
Hemoglobin (HGB) (g/dL) <0.8xLLNHematocrit (%) <0.8xLLNErythrocytes (10^6/mm^3) <0.8xLLNEry. Mean Corpuscular Volume (μm^3) <0.9xLLNEry. Mean Corpuscular Volume (μm^3) >1.1xULNEry. Mean Corpuscular HGB (pg/cell) <0.9xLLNEry. Mean Corpuscular HGB (pg/cell) >1.1xULNEry. Mean Corpuscular HGB Conc. (g/dL) <0.9xLLNEry. Mean Corpuscular HGB Conc. (g/dL) >1.1xULNPlatelets (10^3/mm^3) <0.5xLLNPlatelets (10^3/mm^3) >1.75xULNLeukocytes (10^3/mm^3) <0.6xLLNLeukocytes (10^3/mm^3) >1.5xULNLymphocytes (10^3/mm^3) <0.8xLLNLymphocytes (10^3/mm^3) >1.2xULNNeutrophils (10^3/mm^3) <0.8xLLNNeutrophils (10^3/mm^3) >1.2xULNBasophils (10^3/mm^3) >1.2xULNEosinophils (10^3/mm^3) >1.2xULNMonocytes (10^3/mm^3) >1.2xULNBilirubin (mg/dL) >1.5xULNAspartate Aminotransferase (U/L) >3.0xULNAlanine Aminotransferase (U/L) >3.0xULNAlkaline Phosphatase (U/L) >3.0xULNProtein (g/dL) <0.8xLLNProtein (g/dL) >1.2xULNAlbumin (g/dL) <0.8x LLNAlbumin (g/dL) >1.2xULNUrea Nitrogen (mg/dL) >1.3xULNUrea (mmol/L) >1.3xULNCreatinine (mg/dL) >1.3xULNUrate (mg/dL) >1.2xULNSodium (mEq/L) <0.95xLLNSodium (mEq/L) >1.05xULNPotassium (mEq/L) <0.9x LLNPotassium (mEq/L) >1.1xULNChloride (mEq/L) <0.9xLLNChloride (mEq/L) >1.1xULNCalcium (mg/dL) <0.9x LLNCalcium (mg/dL) >1.1xULNBicarbonate (mEq/L) <0.9x LLNBicarbonate (mEq/L) >1.1xULNGlucose (mg/dL) <0.6xLLNGlucose (mg/dL) >1.5xULNpH (Scalar) <4.5pH (Scalar) >8URINE Glucose (Scalar) >=1Ketones (Scalar) >=1URINE Protein (Scalar) >=1URINE Hemoglobin (Scalar) >=1Urobilinogen (Scalar) >=1URINE Bilirubin (Scalar) >=1Nitrite (Scalar) >=1Leukocyte Esterase (Scalar) >=1
PF-06763809+Vehicle+Calcipotriene+Betamethasone000010010000020000010000000000000000000000000000000000

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Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle

The local tolerability of the creams will be assesed using a predefined scale: 0 = No reaction; 0.5 = Only slight erythema; 1 = Only erythema; 2 = Erythema with papules or oedema; 3 = Erythema, oedema with papules, oedema with vesicle; 4 = Blisters (NCT03758365)
Timeframe: Day 2

InterventionParticipants (Count of Participants)
MC2-01 Cream72211385Clobetasol Propionate 0.05% Lotion72211385Betamethasone Dipropionate 0.05% Cream72211385Triamcinolone Acetonide 0.1% Cream72211385Hydrocortisone Butyrate 0.1% Cream72211385Desonide 0.05% Cream72211385Vehicle Cream72211385
Erythema with papules or oedemaNo reactionOnly Slight reactionOnly erythemaErythema, oedema with papules, oedema with vesicleBlisters
MC2-01 Cream + Comparators0
MC2-01 Cream + Comparators36

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Comparison of the Vasoconstriction Potential (Skin Blanching Effect) of the MC2-01 Cream With Active Comparators and Vehicle

Blanching of the skin will be assessed individually by two trained observers blinded to treatment. The observers will score the blanching of the skin from 0-4 (0 = No change in color skin; 1 = Slight (barely visible) blanching; 3 = Obvious blanching; 4 = Blanching judged to be maximal). The results is presented as Mean ± SD. (NCT03758365)
Timeframe: Day 2

Interventionscore on a scale (Mean)
MC2-01 CreamClobetasol Propionate 0.05% LotionBetamethasone Dipropionate 0.05% CreamTriamcinolone Acetonide 0.1% CreamHydrocortisone Butyrate 0.1% CreamDesonide 0.05% CreamVehicle Cream
MC2-01 Cream + Comparators1.663.052.451.922.062.110.14

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Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4

Physician assessment of disease severity. 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate (NCT03848871)
Timeframe: screening/baseline, week 2, week 4

InterventionParticipants (Count of Participants)
Baseline72169599Week 272169599Week 472169599
Almost ClearClearModerateMild
Enstilar Foam20
Enstilar Foam0
Enstilar Foam1
Enstilar Foam13
Enstilar Foam4
Enstilar Foam9
Enstilar Foam6

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Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema

A combined score of disease severity of target lesion which includes assessment of erythema (0=none, 1= slightly pink, 2=pink, 4=red, 6=very red, 8=extremely red), induration (0=no evidence of plaque above normal skin level, 2=slight definite elevation above normal skin level, 4=moderate elevation with rounded or sloped edges to plaque, 6=marked elevation with hard sharp edges to plaque), and scaling (0=no evidence of scaling on lesion, 2= mild mainly fine scales with some of lesion at least partially covered, 4=moderate somewhat coarser scale and most of lesion at least partially covered, 6= severe coarse thick scales and rough surface covering virtually all of lesion, 8=very severe coarse very thick scales and rough surface covering entire lesion (NCT03848871)
Timeframe: screening/baseline, week 2, week 4

InterventionParticipants (Count of Participants)
Baseline72169599Week 272169599Week 472169599
0 None8 Extremely Red6 Very Red4 Red2 Pink1 Slightly Pink
Enstilar Foam5
Enstilar Foam13
Enstilar Foam2
Enstilar Foam0
Enstilar Foam4
Enstilar Foam14
Enstilar Foam1
Enstilar Foam7
Enstilar Foam8

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Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling

A combined score of disease severity of target lesion which includes assessment of erythema (0=none, 2=pink, 4=red, 6=very red, 8=extremely red), induration (0=no evidence of plaque above normal skin level, 2=slight definite elevation above normal skin level, 4=moderate elevation with rounded or sloped edges to plaque, 6=marked elevation with hard sharp edges to plaque, 8=very marked elevation with very hard sharp edges to plaque), and scaling (0=no evidence of scaling on lesion, 2= mild mainly fine scales with some of lesion at least partially covered, 4=moderate somewhat coarser scale and most of lesion at least partially covered, 6= severe coarse thick scales and rough surface covering virtually all of lesion, 8=very severe coarse very thick scales and rough surface covering entire lesion) (NCT03848871)
Timeframe: screening/baseline, week 2, week 4

InterventionParticipants (Count of Participants)
Baseline72169599Week 272169599Week 472169599
8 Very Severe4 Moderate6 Severe2 Mild0 None
Enstilar Foam7
Enstilar Foam12
Enstilar Foam0
Enstilar Foam1
Enstilar Foam10
Enstilar Foam9
Enstilar Foam4
Enstilar Foam15

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Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration

A combined score of disease severity of target lesion which includes assessment of erythema (0=none, 2=pink, 4=red, 6=very red, 8=extremely red), induration (0=no evidence of plaque above normal skin level, 1=very slight, 2=slight definite elevation above normal skin level, 3=mild, 4=moderate elevation with rounded or sloped edges to plaque, 6=marked elevation with hard sharp edges to plaque), and scaling (0=no evidence of scaling on lesion, 2= mild mainly fine scales with some of lesion at least partially covered, 4=moderate somewhat coarser scale and most of lesion at least partially covered, 6= severe coarse thick scales and rough surface covering virtually all of lesion, 8=very severe coarse very thick scales and rough surface covering entire lesion (NCT03848871)
Timeframe: screening/baseline, week 2, week 4

InterventionParticipants (Count of Participants)
Baseline72169599Week 272169599Week 472169599
1 Very Slight0 None6 Marked3 Mild2 Slight4 Moderate
Enstilar Foam5
Enstilar Foam13
Enstilar Foam2
Enstilar Foam3
Enstilar Foam1
Enstilar Foam9
Enstilar Foam6
Enstilar Foam0
Enstilar Foam8
Enstilar Foam11

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Change in Lesion Size From Baseline to Week 2 and Week 4

Size of target lesion recorded as height in cm x length in cm (NCT03848871)
Timeframe: screening/baseline, week 2, week 4

Interventioncm^2 (Mean)
BaselineWeek 2Week 4
Enstilar Foam191610

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Change in Body Surface Area (BSA) From Baseline to Week 2 and Week 4

Percent of total body surface affected by psoriasis, calculated by multiplying the percent of a specified body area affected by psoriasis x the percent of total body surface area represented by the specified area (where head = 10% of total body surface, trunk = 30%, upper limbs = 20%, lower limbs = 40%) (NCT03848871)
Timeframe: screening/baseline, week 2, week 4

Interventionpercentage of body covered by psoriasis (Mean)
BaselineWeek 2Week 4
Enstilar Foam9.89.26.9

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Functionality

harris hip score: gives information about the functionality of patients. harris hip score minimum score: 0 maximum score: 100. High scores reflect better functionality (NCT04420572)
Timeframe: day 0 (before intervention)

Interventionscore on a scale (Mean)
Ozone Injection Group53.03
Steroid Injection Group53.03

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Patient Reported Quality of Life - Notthingham Health Profile

"Notthingham Health Profile: general patient reported outcome measure which measures subjective health status.~38 questions in 6 subareas, with each question assigned a weighted value; the sum of all weighted valuesin a given subarea adds up to 100. Overall score is calculated by summing up 6 subdomian scores.~Overall minimum: 0 maximum: 600 (6X100) Higher scores reflect worse health status" (NCT04420572)
Timeframe: 1 month after intervention

Interventionscore on a scale (Mean)
Ozone Injection Group210.28
Steroid Injection Group188.62

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Functionality

harris hip score: gives information about the functionality of patients. harris hip score minimum score: 0 maximum score: 100. High scores reflect better functionality (NCT04420572)
Timeframe: 1 week after intervention

Interventionscore on a scale (Mean)
Ozone Injection Group72.85
Steroid Injection Group75.00

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Functionality

harris hip score: gives information about the functionality of patients. harris hip score minimum score: 0 maximum score: 100. High scores reflect better functionality (NCT04420572)
Timeframe: 1 month after intervention

Interventionscore on a scale (Mean)
Ozone Injection Group72.79
Steroid Injection Group74.97

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Patient Reported Quality of Life - Notthingham Health Profile

"Notthingham Health Profile: general patient reported outcome measure which measures subjective health status.~38 questions in 6 subareas, with each question assigned a weighted value; the sum of all weighted valuesin a given subarea adds up to 100. Overall score is calculated by summing up 6 subdomian scores.~Overall minimum: 0 maximum: 600 (6X100) Higher scores reflect worse health status" (NCT04420572)
Timeframe: day 0 (before intervention)

Interventionscore on a scale (Mean)
Ozone Injection Group261.72
Steroid Injection Group255.51

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Pain Severity

visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain (NCT04420572)
Timeframe: 1 month after intervention

Interventionscore on a scale (Mean)
Ozone Injection Group3.30
Steroid Injection Group3.00

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Pain Severity

visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain (NCT04420572)
Timeframe: day 0 (before intervention)

Interventionscore on a scale (Mean)
Ozone Injection Group8.36
Steroid Injection Group8.17

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Pain Severity

visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain (NCT04420572)
Timeframe: 1 week after intervention

Interventionscore on a scale (Mean)
Ozone Injection Group3.64
Steroid Injection Group2.93

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Patient Reported Quality of Life - Notthingham Health Profile

"Notthingham Health Profile: general patient reported outcome measure which measures subjective health status.~38 questions in 6 subareas, with each question assigned a weighted value; the sum of all weighted valuesin a given subarea adds up to 100. Overall score is calculated by summing up 6 subdomian scores.~Overall minimum: 0 maximum: 600 (6X100) Higher scores reflect worse health status" (NCT04420572)
Timeframe: 1 week after intervention

Interventionscore on a scale (Mean)
Ozone Injection Group215.40
Steroid Injection Group193.04

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Incidence of Pain

Recorded when subject reports pain. Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever (NCT04900220)
Timeframe: Up to 7 days

InterventionParticipants (Count of Participants)
Betamethasone6
Methylprednisolone11

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Intensity of Pain

Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever (NCT04900220)
Timeframe: Up to 7 days

,
Interventionscore on a scale (Mean)
BaselineFive MinutesDay 1Day 2Day 3Day 4Day 5Day 6Day 7
Betamethasone2.80.31.41.31.00.70.60.60.5
Methylprednisolone2.10.82.92.11.51.00.80.70.6

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