Page last updated: 2024-12-06

betamethasone-17,21-dipropionate

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Description

Betamethasone-17,21-dipropionate is a potent synthetic corticosteroid with anti-inflammatory and immunosuppressive properties. It is a prodrug that is converted to betamethasone upon hydrolysis in the body. Betamethasone-17,21-dipropionate is used topically to treat a variety of skin conditions, including eczema, psoriasis, and dermatitis. It is also available as an inhaler for the treatment of asthma. The synthesis of betamethasone-17,21-dipropionate involves a multi-step process that starts with the steroid hormone cortisone. Cortisone is first converted to prednisolone, which is then reacted with dipropionic anhydride to form betamethasone-17,21-dipropionate. Betamethasone-17,21-dipropionate is a potent anti-inflammatory agent that works by suppressing the production of inflammatory mediators, such as prostaglandins and leukotrienes. It is also an immunosuppressant, which means that it can suppress the immune system. This property makes it useful for treating conditions such as autoimmune disorders and organ transplantation. Betamethasone-17,21-dipropionate is studied because of its effectiveness in treating a variety of conditions. However, it is also important to understand the potential side effects of this drug, such as thinning of the skin, acne, and adrenal suppression. Betamethasone-17,21-dipropionate is a widely used and effective medication for a variety of conditions. However, it is important to use it as directed and to be aware of the potential side effects.'

betamethasone-17,21-dipropionate: may also contain chlorocresol (UD 25:22R) [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID146364
SCHEMBL ID4566
MeSH IDM0057280
PubMed CID21800
CHEMBL ID1200384
CHEBI ID31276
SCHEMBL ID7519
MeSH IDM0057280

Synonyms (114)

Synonym
betamethasone-17,21-dipropionate
HMS2090K11
[2-[(8s,10s,11s,13s,14s,16s,17r)-9-fluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-17-propanoyloxy-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] propanoate
SCHEMBL4566
AB01275498-01
AKOS025312304
(8s,10s,11s,13s,14s,16s,17r)-9-fluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-17-(2-(propionyloxy)acetyl)-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3h-cyclopenta[a]phenanthren-17-yl propionate
betamethasone-17,21-dipropionate 100 microg/ml in acetonitrile
betamethasone dipropionate for peak identification
betamethasone dipropionate for system suitability a
diproderm
(11beta,16beta)-9-fluoro-11-hydroxy-16-methyl-3,20-dioxopregna-1,4-diene-17,21-diyl dipropanoate
rinderon dp
psorion
diprolene
s-3440 ,
pregna-1,4-diene-3,20-dione, 9-fluoro-11-beta,17,21-trihydroxy-16-beta-methyl-, 17,21-dipropionate
beta-methasone 17,21-dipropionate
9-fluoro-11beta,17,21-trihydroxy-16beta-methylpregna-1,4-diene-3,20-dione 17,21-di(propionate)
diprosone
alphatrex
diprosis
einecs 227-005-2
maxivate
pregna-1,4-diene-3,20-dione, 9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxopropoxy)-, (11beta,16beta)
s 3440
sch 11460
9-fluoro-11beta,17,21-trihydroxy-16beta-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate
diprolene af
brn 3638108
9-fluoro-11beta-hydroxy-16beta-methyl-3,20-dioxopregna-1,4-diene-17,21-diyl dipropanoate
9-fluoro-11beta,17,21-trihydroxy-16beta-methylpregna-1,4-diene-3,20-dione-17,21-dipropionate
CHEBI:31276 ,
(11-beta,16-beta)-9-chloro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione
rinderon-dp (tn)
diprolene (tn)
D01637
betamethasone dipropionate (jp17/usp)
sernivo (tn)
9alpha-fluoro-11beta,17alpha,21-trihydroxy-16beta-methyl-1,4-pregnadiene-3,20-dione 17,21-dipropionate
B3166
CHEMBL1200384
nsc-758415
diprospan
betamethasone (as dipropionate)
sch-11460
[2-[(8s,9r,10s,11s,13s,14s,16s,17r)-9-fluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-17-propanoyloxy-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] propanoate
dtxsid2022672 ,
dtxcid302672
tox21_113343
cas-5593-20-4
AKOS015969733
2-((2s,10s,11s,13s,15s,17s,1r,14r)-1-fluoro-17-hydroxy-2,13,15-trimethyl-5-oxo -14-propanoyloxytetracyclo[8.7.0.0<2,7>.0<11,15>]heptadeca-3,6-dien-14-yl)-2-o xoethyl propanoate
sernivo
betamethasone dipropionate [usan:usp:jan]
826y60901u ,
unii-826y60901u
nsc 758415
S1688
bdbm50421892
betamethasone dipropionate [usan]
betamethasone dipropionate [green book]
betamethasone dipropionate [vandf]
betamethasone dipropionate component of wynzora
betamethasone dipropionate component of leo-90100
betamethasone dipropionate [jan]
lotrisone component betamethasone dipropionate
leo-90100 component betamethasone dipropionate
betamethasone dipropionate [usp-rs]
betamethasone 17.alpha.,21-dipropionate
betamethasone dipropionate, augmented
taclonex component betamethasone dipropionate
wynzora component betamethasone dipropionate
betamethasone dipropionate [usp monograph]
betamethasone dipropionate component of lotrisone
enstilar component betamethasone dipropionate
betamethasone dipropionate [ep monograph]
betamethasone dipropionate [who-dd]
pregna-1,4-diene-3,20-dione, 9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxopropoxy)-, (11.beta.,16.beta.)
betamethasone dipropionate component of taclonex
betamethasone dipropionate [mart.]
betamethasone dipropionate component of enstilar
betamethasone dipropionate [orange book]
betamethasone 17,21-dipropionate [mi]
SCHEMBL7519
KS-5303
AB01274713-01
9-fluoro-11.beta.,17,21-trihydroxy-16.beta.-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate
9-fluoro-11.beta.-hydroxy-16.beta.-methyl-3,20-dioxo-17-(propionyloxy)pregna-1,4-dien-21-yl propionate #
pregna-1,4-diene-3,20-dione, 9-fluoro-11-.beta.,17,21-trihydroxy-16-.beta.-methyl-,17,21-dipropionate
rinderon-dp
component of alphatrex (salt/mix)
component of betasone (salt/mix)
(11.beta.,16.beta.)-9-fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate
CS-7549
AB01274713_02
NCGC00159443-01
HY-13571
Q4897349
betamethasone diprop
AMY22130
BRD-K58148589-001-03-6
betamethasone-dipropionate
CCG-269732
NCGC00159443-05
9alpha-fluoro-11beta,17alpha,21-trihydroxy-16beta-methyl-3,20-dioxopregna-1,4-diene- 17,21-diyl dipropionate
pregna-1,4-diene-3,20-dione,9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxopropoxy)-, (11b,16b)-
betamethasone dipropionate (ep monograph)
betamethasone dipropionate (usp monograph)
betamethasone dipropionate (mart.)
betamethasone dipropionateaugmented
betamethasone dipropionate (usp-rs)
betamethasone dipropionate (usan:usp:jan)
betamethasone dipropionate usp, 0.05%

Research Excerpts

Toxicity

ExcerptReferenceRelevance
" 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
" 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
"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
"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
"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
" 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
" 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
" 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
" 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
" 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
" 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
" 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
" 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
" 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
"  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
"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

Pharmacokinetics

ExcerptReferenceRelevance
"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

Compound-Compound Interactions

ExcerptReferenceRelevance
"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
" 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
" 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

Bioavailability

ExcerptReferenceRelevance
" 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
" 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
" 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
"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

Dosage Studied

ExcerptRelevanceReference
" 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
"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
" 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
" 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 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
" 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
"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
"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
"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
" 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
"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
" 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
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (1)

RoleDescription
antipsoriaticA drug used to treat psoriasis.
[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 (6)

ClassDescription
steroid ester
11beta-hydroxy steroidAny 11-hydroxy steroid in which the hydroxy group at position 11 has beta- configuration.
20-oxo steroidAn oxo steroid carrying an oxo group at position 20.
fluorinated steroidA steroid which is substituted with one or more fluorine atoms in any position.
propanoate esterAny carboxylic ester where the carboxylic acid component is propionic acid.
3-oxo-Delta(1),Delta(4)-steroidA 3-oxo-Delta(1) steroid containing an additional double bond between positions 4 and 5.
[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 (12)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Chain A, MAJOR APURINIC/APYRIMIDINIC ENDONUCLEASEHomo sapiens (human)Potency39.81070.003245.467312,589.2998AID2517
Chain A, Ferritin light chainEquus caballus (horse)Potency25.11895.623417.292931.6228AID485281
Chain A, CruzipainTrypanosoma cruziPotency39.81070.002014.677939.8107AID1476
TDP1 proteinHomo sapiens (human)Potency24.23070.000811.382244.6684AID686978; AID686979
AR proteinHomo sapiens (human)Potency6.84720.000221.22318,912.5098AID743035; AID743036; AID743040; AID743042; AID743053; AID743054; AID743063
glucocorticoid receptor [Homo sapiens]Homo sapiens (human)Potency0.00710.000214.376460.0339AID720691; AID720692; AID720719
estrogen nuclear receptor alphaHomo sapiens (human)Potency4.60220.000229.305416,493.5996AID743069; AID743075; AID743077; AID743078; AID743080; AID743091
cytochrome P450, family 19, subfamily A, polypeptide 1, isoform CRA_aHomo sapiens (human)Potency3.75780.001723.839378.1014AID743083
thyroid hormone receptor beta isoform 2Rattus norvegicus (Norway rat)Potency32.55480.000323.4451159.6830AID743065; AID743067
DNA polymerase kappa isoform 1Homo sapiens (human)Potency25.11890.031622.3146100.0000AID588579
Cellular tumor antigen p53Homo sapiens (human)Potency21.13170.002319.595674.0614AID651631
[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)
Glucocorticoid receptorRattus norvegicus (Norway rat)IC50 (µMol)0.00520.00010.39756.0000AID74248
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (124)

Processvia Protein(s)Taxonomy
negative regulation of cell population proliferationCellular tumor antigen p53Homo sapiens (human)
regulation of cell cycleCellular tumor antigen p53Homo sapiens (human)
regulation of cell cycle G2/M phase transitionCellular tumor antigen p53Homo sapiens (human)
DNA damage responseCellular tumor antigen p53Homo sapiens (human)
ER overload responseCellular tumor antigen p53Homo sapiens (human)
cellular response to glucose starvationCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to DNA damage by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
regulation of apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
positive regulation of miRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
negative regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
mitophagyCellular tumor antigen p53Homo sapiens (human)
in utero embryonic developmentCellular tumor antigen p53Homo sapiens (human)
somitogenesisCellular tumor antigen p53Homo sapiens (human)
release of cytochrome c from mitochondriaCellular tumor antigen p53Homo sapiens (human)
hematopoietic progenitor cell differentiationCellular tumor antigen p53Homo sapiens (human)
T cell proliferation involved in immune responseCellular tumor antigen p53Homo sapiens (human)
B cell lineage commitmentCellular tumor antigen p53Homo sapiens (human)
T cell lineage commitmentCellular tumor antigen p53Homo sapiens (human)
response to ischemiaCellular tumor antigen p53Homo sapiens (human)
nucleotide-excision repairCellular tumor antigen p53Homo sapiens (human)
double-strand break repairCellular tumor antigen p53Homo sapiens (human)
regulation of DNA-templated transcriptionCellular tumor antigen p53Homo sapiens (human)
regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
protein import into nucleusCellular tumor antigen p53Homo sapiens (human)
autophagyCellular tumor antigen p53Homo sapiens (human)
DNA damage responseCellular tumor antigen p53Homo sapiens (human)
DNA damage response, signal transduction by p53 class mediator resulting in cell cycle arrestCellular tumor antigen p53Homo sapiens (human)
DNA damage response, signal transduction by p53 class mediator resulting in transcription of p21 class mediatorCellular tumor antigen p53Homo sapiens (human)
transforming growth factor beta receptor signaling pathwayCellular tumor antigen p53Homo sapiens (human)
Ras protein signal transductionCellular tumor antigen p53Homo sapiens (human)
gastrulationCellular tumor antigen p53Homo sapiens (human)
neuroblast proliferationCellular tumor antigen p53Homo sapiens (human)
negative regulation of neuroblast proliferationCellular tumor antigen p53Homo sapiens (human)
protein localizationCellular tumor antigen p53Homo sapiens (human)
negative regulation of DNA replicationCellular tumor antigen p53Homo sapiens (human)
negative regulation of cell population proliferationCellular tumor antigen p53Homo sapiens (human)
determination of adult lifespanCellular tumor antigen p53Homo sapiens (human)
mRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
rRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
response to salt stressCellular tumor antigen p53Homo sapiens (human)
response to inorganic substanceCellular tumor antigen p53Homo sapiens (human)
response to X-rayCellular tumor antigen p53Homo sapiens (human)
response to gamma radiationCellular tumor antigen p53Homo sapiens (human)
positive regulation of gene expressionCellular tumor antigen p53Homo sapiens (human)
cardiac muscle cell apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of cardiac muscle cell apoptotic processCellular tumor antigen p53Homo sapiens (human)
glial cell proliferationCellular tumor antigen p53Homo sapiens (human)
viral processCellular tumor antigen p53Homo sapiens (human)
glucose catabolic process to lactate via pyruvateCellular tumor antigen p53Homo sapiens (human)
cerebellum developmentCellular tumor antigen p53Homo sapiens (human)
negative regulation of cell growthCellular tumor antigen p53Homo sapiens (human)
DNA damage response, signal transduction by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
negative regulation of transforming growth factor beta receptor signaling pathwayCellular tumor antigen p53Homo sapiens (human)
mitotic G1 DNA damage checkpoint signalingCellular tumor antigen p53Homo sapiens (human)
negative regulation of telomere maintenance via telomeraseCellular tumor antigen p53Homo sapiens (human)
T cell differentiation in thymusCellular tumor antigen p53Homo sapiens (human)
tumor necrosis factor-mediated signaling pathwayCellular tumor antigen p53Homo sapiens (human)
regulation of tissue remodelingCellular tumor antigen p53Homo sapiens (human)
cellular response to UVCellular tumor antigen p53Homo sapiens (human)
multicellular organism growthCellular tumor antigen p53Homo sapiens (human)
positive regulation of mitochondrial membrane permeabilityCellular tumor antigen p53Homo sapiens (human)
cellular response to glucose starvationCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to DNA damage by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
positive regulation of apoptotic processCellular tumor antigen p53Homo sapiens (human)
negative regulation of apoptotic processCellular tumor antigen p53Homo sapiens (human)
entrainment of circadian clock by photoperiodCellular tumor antigen p53Homo sapiens (human)
mitochondrial DNA repairCellular tumor antigen p53Homo sapiens (human)
regulation of DNA damage response, signal transduction by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
positive regulation of neuron apoptotic processCellular tumor antigen p53Homo sapiens (human)
transcription initiation-coupled chromatin remodelingCellular tumor antigen p53Homo sapiens (human)
negative regulation of proteolysisCellular tumor antigen p53Homo sapiens (human)
negative regulation of DNA-templated transcriptionCellular tumor antigen p53Homo sapiens (human)
positive regulation of DNA-templated transcriptionCellular tumor antigen p53Homo sapiens (human)
positive regulation of RNA polymerase II transcription preinitiation complex assemblyCellular tumor antigen p53Homo sapiens (human)
positive regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
response to antibioticCellular tumor antigen p53Homo sapiens (human)
fibroblast proliferationCellular tumor antigen p53Homo sapiens (human)
negative regulation of fibroblast proliferationCellular tumor antigen p53Homo sapiens (human)
circadian behaviorCellular tumor antigen p53Homo sapiens (human)
bone marrow developmentCellular tumor antigen p53Homo sapiens (human)
embryonic organ developmentCellular tumor antigen p53Homo sapiens (human)
positive regulation of peptidyl-tyrosine phosphorylationCellular tumor antigen p53Homo sapiens (human)
protein stabilizationCellular tumor antigen p53Homo sapiens (human)
negative regulation of helicase activityCellular tumor antigen p53Homo sapiens (human)
protein tetramerizationCellular tumor antigen p53Homo sapiens (human)
chromosome organizationCellular tumor antigen p53Homo sapiens (human)
neuron apoptotic processCellular tumor antigen p53Homo sapiens (human)
regulation of cell cycleCellular tumor antigen p53Homo sapiens (human)
hematopoietic stem cell differentiationCellular tumor antigen p53Homo sapiens (human)
negative regulation of glial cell proliferationCellular tumor antigen p53Homo sapiens (human)
type II interferon-mediated signaling pathwayCellular tumor antigen p53Homo sapiens (human)
cardiac septum morphogenesisCellular tumor antigen p53Homo sapiens (human)
positive regulation of programmed necrotic cell deathCellular tumor antigen p53Homo sapiens (human)
protein-containing complex assemblyCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to endoplasmic reticulum stressCellular tumor antigen p53Homo sapiens (human)
thymocyte apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of thymocyte apoptotic processCellular tumor antigen p53Homo sapiens (human)
necroptotic processCellular tumor antigen p53Homo sapiens (human)
cellular response to hypoxiaCellular tumor antigen p53Homo sapiens (human)
cellular response to xenobiotic stimulusCellular tumor antigen p53Homo sapiens (human)
cellular response to ionizing radiationCellular tumor antigen p53Homo sapiens (human)
cellular response to gamma radiationCellular tumor antigen p53Homo sapiens (human)
cellular response to UV-CCellular tumor antigen p53Homo sapiens (human)
stem cell proliferationCellular tumor antigen p53Homo sapiens (human)
signal transduction by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
reactive oxygen species metabolic processCellular tumor antigen p53Homo sapiens (human)
cellular response to actinomycin DCellular tumor antigen p53Homo sapiens (human)
positive regulation of release of cytochrome c from mitochondriaCellular tumor antigen p53Homo sapiens (human)
cellular senescenceCellular tumor antigen p53Homo sapiens (human)
replicative senescenceCellular tumor antigen p53Homo sapiens (human)
oxidative stress-induced premature senescenceCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathwayCellular tumor antigen p53Homo sapiens (human)
oligodendrocyte apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of execution phase of apoptosisCellular tumor antigen p53Homo sapiens (human)
negative regulation of mitophagyCellular tumor antigen p53Homo sapiens (human)
regulation of mitochondrial membrane permeability involved in apoptotic processCellular tumor antigen p53Homo sapiens (human)
regulation of intrinsic apoptotic signaling pathway by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
positive regulation of miRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
negative regulation of G1 to G0 transitionCellular tumor antigen p53Homo sapiens (human)
negative regulation of miRNA processingCellular tumor antigen p53Homo sapiens (human)
negative regulation of glucose catabolic process to lactate via pyruvateCellular tumor antigen p53Homo sapiens (human)
negative regulation of pentose-phosphate shuntCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to hypoxiaCellular tumor antigen p53Homo sapiens (human)
regulation of fibroblast apoptotic processCellular tumor antigen p53Homo sapiens (human)
negative regulation of reactive oxygen species metabolic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of reactive oxygen species metabolic processCellular tumor antigen p53Homo sapiens (human)
negative regulation of stem cell proliferationCellular tumor antigen p53Homo sapiens (human)
positive regulation of cellular senescenceCellular tumor antigen p53Homo sapiens (human)
positive regulation of intrinsic apoptotic signaling pathwayCellular tumor antigen p53Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (34)

Processvia Protein(s)Taxonomy
transcription cis-regulatory region bindingCellular tumor antigen p53Homo sapiens (human)
RNA polymerase II cis-regulatory region sequence-specific DNA bindingCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription factor activity, RNA polymerase II-specificCellular tumor antigen p53Homo sapiens (human)
cis-regulatory region sequence-specific DNA bindingCellular tumor antigen p53Homo sapiens (human)
core promoter sequence-specific DNA bindingCellular tumor antigen p53Homo sapiens (human)
TFIID-class transcription factor complex bindingCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription repressor activity, RNA polymerase II-specificCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription activator activity, RNA polymerase II-specificCellular tumor antigen p53Homo sapiens (human)
protease bindingCellular tumor antigen p53Homo sapiens (human)
p53 bindingCellular tumor antigen p53Homo sapiens (human)
DNA bindingCellular tumor antigen p53Homo sapiens (human)
chromatin bindingCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription factor activityCellular tumor antigen p53Homo sapiens (human)
mRNA 3'-UTR bindingCellular tumor antigen p53Homo sapiens (human)
copper ion bindingCellular tumor antigen p53Homo sapiens (human)
protein bindingCellular tumor antigen p53Homo sapiens (human)
zinc ion bindingCellular tumor antigen p53Homo sapiens (human)
enzyme bindingCellular tumor antigen p53Homo sapiens (human)
receptor tyrosine kinase bindingCellular tumor antigen p53Homo sapiens (human)
ubiquitin protein ligase bindingCellular tumor antigen p53Homo sapiens (human)
histone deacetylase regulator activityCellular tumor antigen p53Homo sapiens (human)
ATP-dependent DNA/DNA annealing activityCellular tumor antigen p53Homo sapiens (human)
identical protein bindingCellular tumor antigen p53Homo sapiens (human)
histone deacetylase bindingCellular tumor antigen p53Homo sapiens (human)
protein heterodimerization activityCellular tumor antigen p53Homo sapiens (human)
protein-folding chaperone bindingCellular tumor antigen p53Homo sapiens (human)
protein phosphatase 2A bindingCellular tumor antigen p53Homo sapiens (human)
RNA polymerase II-specific DNA-binding transcription factor bindingCellular tumor antigen p53Homo sapiens (human)
14-3-3 protein bindingCellular tumor antigen p53Homo sapiens (human)
MDM2/MDM4 family protein bindingCellular tumor antigen p53Homo sapiens (human)
disordered domain specific bindingCellular tumor antigen p53Homo sapiens (human)
general transcription initiation factor bindingCellular tumor antigen p53Homo sapiens (human)
molecular function activator activityCellular tumor antigen p53Homo sapiens (human)
promoter-specific chromatin bindingCellular tumor antigen p53Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (19)

Processvia Protein(s)Taxonomy
nuclear bodyCellular tumor antigen p53Homo sapiens (human)
nucleusCellular tumor antigen p53Homo sapiens (human)
nucleoplasmCellular tumor antigen p53Homo sapiens (human)
replication forkCellular tumor antigen p53Homo sapiens (human)
nucleolusCellular tumor antigen p53Homo sapiens (human)
cytoplasmCellular tumor antigen p53Homo sapiens (human)
mitochondrionCellular tumor antigen p53Homo sapiens (human)
mitochondrial matrixCellular tumor antigen p53Homo sapiens (human)
endoplasmic reticulumCellular tumor antigen p53Homo sapiens (human)
centrosomeCellular tumor antigen p53Homo sapiens (human)
cytosolCellular tumor antigen p53Homo sapiens (human)
nuclear matrixCellular tumor antigen p53Homo sapiens (human)
PML bodyCellular tumor antigen p53Homo sapiens (human)
transcription repressor complexCellular tumor antigen p53Homo sapiens (human)
site of double-strand breakCellular tumor antigen p53Homo sapiens (human)
germ cell nucleusCellular tumor antigen p53Homo sapiens (human)
chromatinCellular tumor antigen p53Homo sapiens (human)
transcription regulator complexCellular tumor antigen p53Homo sapiens (human)
protein-containing complexCellular tumor antigen p53Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (34)

Assay IDTitleYearJournalArticle
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.
AID137616Skin thickness of mouse was measured at 75 ug/mouse.1990Journal of medicinal chemistry, Jul, Volume: 33, Issue:7
Synthesis and antiinflammatory activity of novel 12 beta-substituted analogues of betamethasone.
AID136384Percentage systemic effect to assess the degree of absorption was measured at 75 ug/mouse1990Journal of medicinal chemistry, Jul, Volume: 33, Issue:7
Synthesis and antiinflammatory activity of novel 12 beta-substituted analogues of betamethasone.
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.
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.
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.
AID136379Percentage systemic effect to assess the degree of absorption was measured at 25 ug/mouse1990Journal of medicinal chemistry, Jul, Volume: 33, Issue:7
Synthesis and antiinflammatory activity of novel 12 beta-substituted analogues of betamethasone.
AID135529Topical Antiinflammatory activity was measured in the TPA induced mouse ear edema assay at 25 ug/mouse.1990Journal of medicinal chemistry, Jul, Volume: 33, Issue:7
Synthesis and antiinflammatory activity of novel 12 beta-substituted analogues of betamethasone.
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.
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.
AID136377Percentage systemic effect to assess the degree of absorption was measured at 2.5 ug/mouse1990Journal of medicinal chemistry, Jul, Volume: 33, Issue:7
Synthesis and antiinflammatory activity of novel 12 beta-substituted analogues of betamethasone.
AID115719Anti-inflammatory activity in mouse croton oil ear assay relative to clobetasol propionate1991Journal of medicinal chemistry, Aug, Volume: 34, Issue:8
Synthesis and evaluation of antiinflammatory activities of a series of corticosteroid 17 alpha-esters containing a functional group.
AID1064650Antiinflammatory activity in Balb/C chronic mouse ear edema model assessed as reduction in TPA-induced myeloperoxidase accumulation at 0.9 umol/ear administered topically, bid from day 7 to day 10 measured every day during compound administration relative2014Journal of natural products, Jan-24, Volume: 77, Issue:1
Polyandric acid A, a clerodane diterpenoid from the Australian medicinal plant Dodonaea polyandra, attenuates pro-inflammatory cytokine secretion in vitro and in vivo.
AID135516Systemic Antiinflammatory activity was measured in the TPA induced mouse ear edema assay at 2.5 ug/mouse1990Journal of medicinal chemistry, Jul, Volume: 33, Issue:7
Synthesis and antiinflammatory activity of novel 12 beta-substituted analogues of betamethasone.
AID595604Antiinflammatory activity against TPA-induced ear edema in mouse assessed as ear thickness at 0.90 umol/ear, sc administered 30 mins after TPA challenge measured after 2 to 48 hrs2011Journal of natural products, Apr-25, Volume: 74, Issue:4
In vivo activity of benzoyl ester clerodane diterpenoid derivatives from Dodonaea polyandra.
AID118293Relative topical anti inflammatory activity was measured in mice by comparing with cumulative potency of betamethasone valerate by using croton oil ear assay1980Journal of medicinal chemistry, Apr, Volume: 23, Issue:4
Synthesis and structure-activity studies of a series of 7 alpha-halogeno corticosteroids.
AID190476The thymolytic activity was measured relative to clobetasol propionate (CP=1) in rat granuloma pouch assay system1991Journal of medicinal chemistry, Aug, Volume: 34, Issue:8
Synthesis and evaluation of antiinflammatory activities of a series of corticosteroid 17 alpha-esters containing a functional group.
AID230431It is the ratio of topical(edema inhibition) to systemic (thymolysis) activities.1991Journal of medicinal chemistry, Aug, Volume: 34, Issue:8
Synthesis and evaluation of antiinflammatory activities of a series of corticosteroid 17 alpha-esters containing a functional group.
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.
AID1064654Antiinflammatory activity in Balb/C chronic mouse ear edema model assessed as reduction in TPA-induced edema at 0.9 umol/ear administered topically, bid from day 7 to day 10 measured every day during compound administration relative to control2014Journal of natural products, Jan-24, Volume: 77, Issue:1
Polyandric acid A, a clerodane diterpenoid from the Australian medicinal plant Dodonaea polyandra, attenuates pro-inflammatory cytokine secretion in vitro and in vivo.
AID135518Systemic Antiinflammatory activity was measured in the TPA induced mouse ear edema assay at 25 ug/mouse1990Journal of medicinal chemistry, Jul, Volume: 33, Issue:7
Synthesis and antiinflammatory activity of novel 12 beta-substituted analogues of betamethasone.
AID1421375Protection against DNFB-induced atopic dermatitis in mouse assessed as reduction in ear thickness administered topically measured up to 4 days post DNFB treatment2018European journal of medicinal chemistry, Oct-05, Volume: 158Piperidinyl-embeded chalcones possessing anti PI3Kδ inhibitory properties exhibit anti-atopic properties in preclinical models.
AID74248Competitive displacement of [3H]dexamethasone from glucocorticoid receptor of rat liver cytosol1991Journal of medicinal chemistry, Aug, Volume: 34, Issue:8
Synthesis and evaluation of antiinflammatory activities of a series of corticosteroid 17 alpha-esters containing a functional group.
AID135512Atrophogenicity potency was observed in mouse at at 75 ug/mouse.1990Journal of medicinal chemistry, Jul, Volume: 33, Issue:7
Synthesis and antiinflammatory activity of novel 12 beta-substituted analogues of betamethasone.
AID91225Antiinflammatory activity measured by using McKenzie-Stoughton human vasoconstrictor assay; Potent1986Journal 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.
AID127966ED100 of was measured in the TPA induced mouse ear edema assay.1990Journal of medicinal chemistry, Jul, Volume: 33, Issue:7
Synthesis and antiinflammatory activity of novel 12 beta-substituted analogues of betamethasone.
AID135533Topical Antiinflammatory activity was measured in the TPA induced mouse ear edema assay at 75 ug/mouse.1990Journal of medicinal chemistry, Jul, Volume: 33, Issue:7
Synthesis and antiinflammatory activity of novel 12 beta-substituted analogues of betamethasone.
AID135527Topical Antiinflammatory activity was measured in the TPA induced mouse ear edema assay at 2.5 ug/mouse.1990Journal of medicinal chemistry, Jul, Volume: 33, Issue:7
Synthesis and antiinflammatory activity of novel 12 beta-substituted analogues of betamethasone.
AID135523Systemic Antiinflammatory activity was measured in the TPA induced mouse ear edema assay at 75 ug/mouse1990Journal of medicinal chemistry, Jul, Volume: 33, Issue:7
Synthesis and antiinflammatory activity of novel 12 beta-substituted analogues of betamethasone.
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.
AID1347160Primary screen NINDS Rhodamine qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347159Primary screen GU Rhodamine qHTS for Zika virus inhibitors: Unlinked NS2B-NS3 protease assay2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
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.
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.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (484)

TimeframeStudies, This Drug (%)All Drugs %
pre-199082 (16.94)18.7374
1990's68 (14.05)18.2507
2000's98 (20.25)29.6817
2010's152 (31.40)24.3611
2020's84 (17.36)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 17.88

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 moderate demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index17.88 (24.57)
Research Supply Index2.56 (2.92)
Research Growth Index5.26 (4.65)
Search Engine Demand Index10.37 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (17.88)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials188 (36.15%)5.53%
Trials0 (0.00%)5.53%
Reviews44 (8.46%)6.00%
Reviews0 (0.00%)6.00%
Case Studies99 (19.04%)4.05%
Case Studies0 (0.00%)4.05%
Observational10 (1.92%)0.25%
Observational0 (0.00%)0.25%
Other179 (34.42%)84.16%
Other12 (100.00%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (113)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
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
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
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
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
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 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
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 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
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
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
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
Bioequivalence of Two Augmented Betamethasone Dipropionate 0.05% Topical Creams [NCT00800293]116 participants (Actual)Observational2002-12-31Completed
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
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 Clinical and Immunohistochemical Study Between Topical Pimecrolimus and Corticosteroid in Treatment of Oral Lichen Planus [NCT02443311]Phase 424 participants (Actual)Interventional2010-09-30Completed
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
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
Phase II Multicentric Study About Preventive Treatment of Folliculitis Induced by the EGF-R Inhibitors in Patients With Metastatic Colorectal Cancer and Treated by Cetuximab or With Non-small-cell Lung Carcinoma Treated by Erlotinib [NCT00910676]Phase 230 participants (Actual)Interventional2007-10-31Completed
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
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
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
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
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
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
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.)
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 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
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
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
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.)
The Maintenance Effect of Enstilar Foam in Combination With Otezla [NCT04555707]Phase 430 participants (Anticipated)Interventional2020-06-24Recruiting
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
The Effects of Topical Corticosteroid Use on Insulin Sensitivity and Bone Turnover [NCT04114097]Phase 436 participants (Actual)Interventional2019-08-22Completed
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
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
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
Nickel Desensitization Using Topical Therapy [NCT01413477]24 participants (Anticipated)Interventional2011-08-31Not yet recruiting
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
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
Nonaromatic Naphthalan - Composition Study and Biological Effects on Epithelial Tissues [NCT02920658]Phase 257 participants (Actual)Interventional2010-12-31Completed
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
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 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
A Phase I Exploratory Study Evaluating 3 Formulations of LEO 29102 Plus Calcipotriol, Ointment, LEO 29102 Ointment, Calcipotriol Ointment, Daivonex® Ointment and Diprosone® Ointment in the Treatment of Psoriasis [NCT01466478]Phase 124 participants (Actual)Interventional2011-11-30Completed
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])
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
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
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
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
[NCT00418353]0 participants Interventional2002-08-31Completed
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
The Effect of Enstilar Versus Vehicle on Target Lesions in Moderate Plaque Type Psoriasis Patients [NCT03848871]Phase 420 participants (Actual)Interventional2017-12-12Completed
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
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
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
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
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
Timing of Late Preterm Corticosteroid Administration and Neonatal Hypoglycemia [NCT04869709]Phase 4210 participants (Anticipated)Interventional2021-07-31Not yet recruiting
The Impact of Stress on Fetal Brain Development [NCT03831126]24 participants (Anticipated)Observational2019-02-01Recruiting
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
The Effect of Betamethasone Dipropionate on Patients With Eosinophilic Chronic Rhinosinusitis [NCT05220293]Phase 1/Phase 212 participants (Anticipated)Interventional2022-02-23Recruiting
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
Vasoconstriction Trial Comparing LEO 90100 With Dermovate Cream, Diprosone Ointment, Elocon Cream, Locoid Ointment and LEO 90100 Vehicle [NCT02973776]Phase 136 participants (Actual)Interventional2016-12-31Completed
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
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)
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
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
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
Comparison of Post-Inflammatory Pigment Alteration After Psoriasis Treatment (PIPA - Dermavant) [NCT05981118]40 participants (Anticipated)Interventional2023-12-31Not yet recruiting
Treatment Results for Patients With Central Centrifugal Cicatricial Alopecia (CCCA): a Multicenter Prospective Study [NCT04207931]Phase 4250 participants (Anticipated)Interventional2018-04-30Recruiting
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
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
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
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
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
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
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
NCT00671528 (1) [back to overview]Number of Days Required to Achieve Total Remission
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]Adverse Drug Reactions
NCT00817219 (10) [back to overview]Change in Albumin Corrected Serum Calcium From Baseline to End of Treatment
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]Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment.
NCT00817219 (10) [back to overview]PASI 50 at Week 4.
NCT00817219 (10) [back to overview]PASI 75 at Week 4.
NCT00817219 (10) [back to overview]Percentage Change in PASI From Baseline to Week 4.
NCT00817219 (10) [back to overview]Serum Cortisol Concentration of ≤18 mcg/dL at 30 and 60 Minutes After ACTH-challenge at End of Treatment
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]Number of Participants With Treatment Emergent Adverse Events
NCT00820950 (6) [back to overview]Pharmacokinetics Parameter : Bioavailability of INCB018424
NCT00820950 (6) [back to overview]Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline
NCT00820950 (6) [back to overview]Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) 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
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
NCT01188928 (4) [back to overview]Mean Percentage Change in PASI From Baseline to Week 8
NCT01188928 (4) [back to overview]Mean Percentage Change in PASI From Baseline to Week 4
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
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]Change in Clinical Sign Scores
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 Modified Psoriasis Area and Severity Index (mPASI)
NCT01422434 (4) [back to overview]Change From Baseline in Target Lesion Assessment
NCT01422434 (4) [back to overview]Physician's Global Assessment of Psoriasis
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.
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
NCT02749799 (3) [back to overview]Change in Investigator's Global Assessment Grade
NCT02749799 (3) [back to overview]Change in Dermatology Life Quality Index (DLQI)
NCT02749799 (3) [back to overview]Change in Percent Body Surface Area (BSA) Involved.
NCT02858713 (3) [back to overview]Lattice-System Physician's Global Assessment (LS-PGA)
NCT02858713 (3) [back to overview]Dermatology Life Quality Index (DLQI)
NCT02858713 (3) [back to overview]Percentage of Adherent Participants
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]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]Pain Assessed by Visual Analogue Scale
NCT03101033 (8) [back to overview]Pain Assessed by Visual Analogue Scale
NCT03441789 (6) [back to overview]Global Improvement in Itch Visual Analogue Scale (VAS) at Week 4,12 and 16
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
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 PASI 75 at Week 4 and Week 12
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 a Psoriasis Assessment and Severity Index (PASI) 75 at Week 16
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 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 Erythema
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 Lesion Size 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 Induration
NCT03848871 (6) [back to overview]Change in Body Surface Area (BSA) From Baseline to Week 2 and Week 4

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

[back to top]

"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

[back to top]

"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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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 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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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

[back to top]

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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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 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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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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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. (NCT01536938)
Timeframe: 4 weeks

Interventionparticipants (Number)
LEO 9010045
Betamethasone Dipropionate31
Calcipotriol Aerosol Foam15

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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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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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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 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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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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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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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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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 one-month post-treatment

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

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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 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: 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: before treatment

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

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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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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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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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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 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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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 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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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 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 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 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 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 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 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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