Page last updated: 2024-11-06

betamethasone sodium phosphate

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Description

Betamethasone sodium phosphate is a synthetic corticosteroid used in various medical applications, including the treatment of inflammatory conditions like rheumatoid arthritis, eczema, and asthma. It is a potent anti-inflammatory agent that works by suppressing the immune response. Its synthesis involves multiple steps starting from the steroid hormone cortisone, employing various chemical reactions to achieve the desired structure. Betamethasone sodium phosphate is studied extensively due to its therapeutic potential in treating various diseases. Its effectiveness in reducing inflammation and its diverse applications make it an important drug in modern medicine. It is often used in the form of injections, creams, and inhalers. Research continues to explore its therapeutic potential and optimize its use for various conditions.'
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betamethasone sodium phosphate: phosphate ester of betamethasone; RN given refers to the di-Na salt (11beta,16beta)-isomer; structure in Negwer,5th ed, 4975 [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

betamethasone sodium phosphate : An organic sodium salt that is the disodium salt of betamethasone phosphate. [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]

Cross-References

ID SourceID
PubMed CID65478
CHEMBL ID1200762
CHEBI ID3078
SCHEMBL ID8418
MeSH IDM0092825

Synonyms (72)

Synonym
betamethasone 21-disodium phosphate
betamethazone disodium phosphate
nsc-90616
betamethasone sodium phosphate
disodium betamethasone 21-phosphate
AC-2162
betamethasone 21-phosphate disodium
7bk02scl3w ,
unii-7bk02scl3w
beta-methasone disodium phosphate
betamethasone sodium phosphate [usp:jan]
151-73-5
nsc 90616
beta-methasone, disodium phosphate
betamethason sodium phosphate
beta-methasone sodium phosphate
einecs 205-797-0
bentelan
pregna-1,4-diene-3,20-dione, 9-fluoro-11-beta,17,21-trihydroxy-16-beta-methyl-, 21-(dihydrogen phosphate), disodium salt
beta-methasone phosphate
pregna-1,4-diene-3,20-dione, 9-fluoro-11,17-dihydroxy-16-methyl-21-(phosphonooxy)-, disodium salt, (11beta,16beta)-
celestone phosphate injection
pregna-1,4-diene-3,20-dione, 9-fluoro-11beta,17,21-trihydroxy-16beta-methyl-, 21-(dihydrogen phosphate), disodium salt
9-fluoro-11beta,17,21-trihydroxy-16beta-methylpregna-1,4-diene-3,20-dione 21-(disodium phosphate)
CHEBI:3078 ,
disodium 9-fluoro-11beta,17-dihydroxy-16beta-methyl-3,20-dioxopregna-1,4-dien-21-yl phosphate
betamethasone 21-phosphate disodium, >=97%
betamethasone sodium phosphate (jp17/usp)
D00972
betamethasone 21-phosphate disodium salt
CHEMBL1200762
cas-151-73-5
tox21_302467
dtxsid8047137 ,
dtxcid6027137
NCGC00256717-01
vista-methasone
betamethasone 21-phosphate sodium salt
betamethasone sodium phosphate [usp monograph]
betamethasone sodium phosphate [who-dd]
betamethasone sodium phosphate [orange book]
betamethasone sodium phosphate [green book]
betamethasone sodium phosphate [mart.]
celestone soluspan component betamethasone sodium phosphate
betamethasone sodium phosphate [usp-rs]
betamethasone sodium phosphate [jan]
pregna-1,4-diene-3,20-dione, 9-fluoro-11,17-dihydroxy-16-methyl-21-(phosphonooxy)-, disodium salt, (11.beta.,16.beta.)-
betamethasone sodium phosphate component of celestone soluspan
betamethasone sodium phosphate [vandf]
betamethasone sodium phosphate [ep monograph]
betamethasone sodium phosphate [ep impurity]
AKOS015896371
SCHEMBL8418
B4110
mfcd00200361
betamethasone sodium phosphate, european pharmacopoeia (ep) reference standard
betamethasone sodium phosphate, united states pharmacopeia (usp) reference standard
AS-62442
betamethasone sodium phosphate, usp
J-008838
sodium 2-((8s,9r,10s,11s,13s,14s,16s,17r)-9-fluoro-11,17-dihydroxy-10,13,16-trimethyl-3-oxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3h-cyclopenta[a]phenanthren-17-yl)-2-oxoethyl phosphate
disodium;[2-[(8s,9r,10s,11s,13s,14s,16s,17r)-9-fluoro-11,17-dihydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] phosphate
PLCQGRYPOISRTQ-LWCNAHDDSA-L
betamethasonesodiumphosphate
Q27105936
betamethasone sodium phosphate (usp:jan)
betamethasone sodium phosphate (ep monograph)
betamethasone sodium phosphate (ep impurity)
betamethasone sodium phosphate (mart.)
betamethasone sodium phosphate (usp-rs)
9-fluoro-11beta,17,21-trihydroxy-16beta-methylpregna-1,4-diene-3,20-dione 21-(disodium phosphate)
betamethasone sodium phosphate (usp monograph)

Research Excerpts

Toxicity

ExcerptReferenceRelevance
" Thus, toxic effects can be caused by preservatives or inadequate osmolarity of the vehicles alone."( Experimental and clinical observations of the intraocular toxicity of commercial corticosteroid preparations.
Arena, JE; Chandler, D; Hida, T; Machemer, R, 1986
)
0.27
"To study the pharmacokinetics of different betamethasone doses and preparations used to enhance fetal lung maturation in the maternal and fetal circulation of sheep and the adverse effects on fetal blood pressure."( Kinetics of betamethasone and fetal cardiovascular adverse effects in pregnant sheep after different doses.
Coksaygan, T; Jusko, WJ; Nathanielsz, PW; Samtani, MN; Schwab, M, 2006
)
0.33
" Risk-benefit studies are needed to find the effective steroid dose with the least adverse effects."( Kinetics of betamethasone and fetal cardiovascular adverse effects in pregnant sheep after different doses.
Coksaygan, T; Jusko, WJ; Nathanielsz, PW; Samtani, MN; Schwab, M, 2006
)
0.33

Pharmacokinetics

ExcerptReferenceRelevance
" Pharmacokinetic evaluation of the data, obtained according to the one-compartment open model, indicated that there were no significant differences between the extent of absorption, and the first-order elimination rate constants."( Pharmacokinetic evaluation of betamethasone and its water soluble phosphate ester in humans.
Brien, R; Jordan, N; Loo, JC; McGilveray, IJ,
)
0.13
" We therefore designed a study to capture the true pharmacokinetic profiles of betamethasone from these fast acting and dual-release formulations."( Betamethasone pharmacokinetics after two prodrug formulations in sheep: implications for antenatal corticosteroid use.
Grant, A; Jusko, WJ; Lohle, M; Nathanielsz, PW; Samtani, MN, 2005
)
0.33
" The main objectives of the current study were to evaluate the pharmacokinetic and pharmacodynamic features of DFBA when used as an ophthalmic agent, and to compare these features with those of other common ophthalmic agents, to determine which has the highest activity."( Pharmacokinetic features of difluprednate ophthalmic emulsion in rabbits as determined by glucocorticoid receptor-binding bioassay.
Kida, T; Sakaki, H; Tajika, T; Tsuzuki, M; Waki, M, 2011
)
0.37
" However, the pharmacokinetic properties of betamethasone in plasma after intramuscular injection of betamethasone sodium phosphate and betamethasone acetate dual-acting suspension need further investigation."( Pharmacokinetics of betamethasone after single-dose intramuscular administration of betamethasone phosphate and betamethasone acetate to healthy subjects.
Najib, NM; Salem, II, 2012
)
0.59
"The main aim of this study was to determine the pharmacokinetic parameters of betamethasone, betamethasone acetate, and betamethasone phosphate after the administration of a single intramuscular dose of the dual-acting suspension to healthy human volunteers."( Pharmacokinetics of betamethasone after single-dose intramuscular administration of betamethasone phosphate and betamethasone acetate to healthy subjects.
Najib, NM; Salem, II, 2012
)
0.38
" The plasma samples obtained in the second study were stabilized to enable pharmacokinetic profiling of betamethasone esters."( Pharmacokinetics of betamethasone after single-dose intramuscular administration of betamethasone phosphate and betamethasone acetate to healthy subjects.
Najib, NM; Salem, II, 2012
)
0.38
"The observed pharmacokinetic parameters suggested that the acetate ester, and not the phosphate ester, of betamethasone acts as a prodrug or reservoir for betamethasone, conferring on it sustained- and extended-release characteristics."( Pharmacokinetics of betamethasone after single-dose intramuscular administration of betamethasone phosphate and betamethasone acetate to healthy subjects.
Najib, NM; Salem, II, 2012
)
0.38
" Plasma data were analyzed using compartmental pharmacokinetic modeling."( Pharmacokinetics of betamethasone in plasma, urine, and synovial fluid following intra-articular administration to exercised thoroughbred horses.
Harrison, LM; Knych, HK; Mckemie, DS; Stanley, SD, 2017
)
0.46

Compound-Compound Interactions

ExcerptReferenceRelevance
" Building on earlier findings, we hypothesized that when administered in combination with slow-release betamethasone acetate, betamethasone phosphate and the high maternal-fetal betamethasone concentrations it generates are redundant for fetal lung maturation."( Betamethasone phosphate reduces the efficacy of antenatal steroid therapy and is associated with lower birthweights when administered to pregnant sheep in combination with betamethasone acetate.
Carter, S; Fee, EL; Furfaro, L; Jobe, AH; Kemp, MW; Newnham, JP; Saito, M; Schmidt, AF; Takahashi, T; Takahashi, Y; Usuda, H; Yaegashi, N, 2022
)
0.72

Bioavailability

ExcerptReferenceRelevance
" Bioavailability of betamethasone from the phosphate ester was as high as after intravenous injection."( Disposition of betamethasone in parturient women after intramuscular administration.
Ashley, JJ; McBride, WG; Nation, RL; Petersen, MC, 1984
)
0.27
"The main aim of the present work was to formulate and evaluate hydrogel-based drug delivery containing combination of neomycin sulphate and betamethasone sodium phosphate in order to provide prolonged release and also better bioavailability of drugs for the treatment of eye infections."( Novel hydrogel-based ocular drug delivery system for the treatment of conjunctivitis.
Deepthi, S; Jose, J, 2019
)
0.72
"Oral Dex-P had lower bioavailability than Beta-P, giving a lower maximum maternal and fetal concentration."( Oral antenatal corticosteroids evaluated in fetal sheep.
Bridges, JP; Clarke, M; Fee, EL; Jobe, AH; Kannan, PS; Kemp, MW; Kumagai, Y; Newnham, JP; Saito, M; Schmidt, AF; Usuda, H, 2019
)
0.51

Dosage Studied

ExcerptRelevanceReference
" Quantitation is described for betamethasone sodium phosphate in dosage forms in the presence of polar excipients."( Analysis of steroid phosphates by high-pressure liquid chromatography: betamethasone sodium phosphate.
Sancilio, FD; Townley, ER; Upton, LM, 1978
)
0.78
"An intravenous bolus of betamethasone, at an approximate dosage of 3 mg/kg, was administered to 20 patients with septic shock."( Betamethasone sodium phosphate injection: high-dose regimen in septic shock.
Lederer, V, 1984
)
1.71
" It was evaluated in a group of 18 normal subjects to determine whether it exerted any systemic glucocorticoid activity after single oral or intrarectal doses and after short-term dosing by the intranasal route."( Tixocortol pivalate, a corticosteroid with no systemic glucocorticoid effect after oral, intrarectal, and intranasal application.
Bolte, E; Du Souich, P; Goyer, R; Larochelle, P; Lelorier, J, 1983
)
0.27
" Plasma concentrations of betamethasone reached a peak 5-37 min after dosing with betamethasone phosphate, then declined biexponentially with a mean terminal half-life of 262 min."( Disposition of betamethasone in parturient women after intravenous administration.
Ashley, JJ; Collier, CB; McBride, WG; Nation, RL; Petersen, MC, 1983
)
0.27
" The dosage was 50 microg two dose unit sprays and BSP 500 microg, each 4 times daily."( Fluticasone propionate spray and betamethasone sodium phosphate mouthrinse: a randomized crossover study for the treatment of symptomatic oral lichen planus.
Hegarty, AM; Hodgson, TA; Lewsey, JD; Porter, SR, 2002
)
0.6
"Antenatal corticotherapy is responsible for two different phases of fetal heart rate modifications that do not vary according to the corticosteroid or the dosage regimen."( Immediate and delayed effects of antenatal corticosteroids on fetal heart rate: a randomized trial that compares betamethasone acetate and phosphate, betamethasone phosphate, and dexamethasone.
Devos, P; Leclerc, G; Puech, F; Subtil, D; Therby, D; Tiberghien, P; Vaast, P, 2003
)
0.32
" In light of this newly identified long terminal half-life for the betamethasone dual formulation, dosing practices for betamethasone in pregnancy need to be reassessed."( Betamethasone pharmacokinetics after two prodrug formulations in sheep: implications for antenatal corticosteroid use.
Grant, A; Jusko, WJ; Lohle, M; Nathanielsz, PW; Samtani, MN, 2005
)
0.33
"Beta-PO4 alone is ineffective with the dosing schedule used; Beta-Ac can induce lung maturation."( Betamethasone for lung maturation: testing dose and formulation in fetal sheep.
Ikegami, M; Jobe, AH; Kallapur, SG; Moss, TJ; Newnham, JP; Nitsos, I, 2007
)
0.34
" Using this information, we calculated dose-response curves, IC(50) values, and K(d) values to evaluate each drug's K(i) value."( Pharmacokinetic features of difluprednate ophthalmic emulsion in rabbits as determined by glucocorticoid receptor-binding bioassay.
Kida, T; Sakaki, H; Tajika, T; Tsuzuki, M; Waki, M, 2011
)
0.37
"Antenatal steroids are standard of care for women who are at risk of preterm delivery; however, antenatal steroid dosing and formulation have not been evaluated adequately."( Low-dose betamethasone-acetate for fetal lung maturation in preterm sheep.
Furfaro, L; Jobe, AH; Kallapur, SG; Kannan, PS; Kemp, MW; Kramer, BW; Newnham, JP; Rittenschober-Böhm, J; Saito, M; Schmidt, AF; Stock, S; Usuda, H; Watanabe, S, 2018
)
0.48
" Antenatal corticosteroid dosing regimens remain unoptimized and without maternal weight-adjusted dosing."( The efficacy of antenatal steroid therapy is dependent on the duration of low-concentration fetal exposure: evidence from a sheep model of pregnancy.
Clarke, M; Eddershaw, PJ; Furfaro, L; Hanita, T; Ireland, D; Jobe, AH; Kemp, MW; Kumagai, Y; Molloy, TJ; Musk, GC; Newnham, JP; Payne, MS; Saito, M; Sato, S; Schmidt, A; Usuda, H; Watanabe, S, 2018
)
0.48
" These findings underscore the need to develop an optimized steroid dosing regimen that may improve both the efficacy and safety of antenatal corticosteroids therapy."( The efficacy of antenatal steroid therapy is dependent on the duration of low-concentration fetal exposure: evidence from a sheep model of pregnancy.
Clarke, M; Eddershaw, PJ; Furfaro, L; Hanita, T; Ireland, D; Jobe, AH; Kemp, MW; Kumagai, Y; Molloy, TJ; Musk, GC; Newnham, JP; Payne, MS; Saito, M; Sato, S; Schmidt, A; Usuda, H; Watanabe, S, 2018
)
0.48
"Conventional dosage form like eye drops showed poor therapeutic response and also require frequent dosing."( Novel hydrogel-based ocular drug delivery system for the treatment of conjunctivitis.
Deepthi, S; Jose, J, 2019
)
0.51
" We report the pharmacokinetics and pharmacodynamics of oral dosing of ACS using a preterm sheep model."( Oral antenatal corticosteroids evaluated in fetal sheep.
Bridges, JP; Clarke, M; Fee, EL; Jobe, AH; Kannan, PS; Kemp, MW; Kumagai, Y; Newnham, JP; Saito, M; Schmidt, AF; Usuda, H, 2019
)
0.51
"Using a sheep model, we demonstrate the use of pharmacokinetics to develop oral dosing strategies for ACS."( Oral antenatal corticosteroids evaluated in fetal sheep.
Bridges, JP; Clarke, M; Fee, EL; Jobe, AH; Kannan, PS; Kemp, MW; Kumagai, Y; Newnham, JP; Saito, M; Schmidt, AF; Usuda, H, 2019
)
0.51
" Antenatal corticosteroid dosing remains nonoptimized, and there is little understanding of how different treatment-to-delivery intervals may affect treatment efficacy."( The duration of fetal antenatal steroid exposure determines the durability of preterm ovine lung maturation.
Bridges, J; Eddershaw, PJ; Fee, EL; Furfaro, L; Hanita, T; Jobe, AH; Kemp, MW; Kumagai, Y; Musk, GC; Newnham, JP; Payne, MS; Saito, M; Sato, S; Schmidt, AF; Smallwood, K; Stinson, L; Takahashi, T; Usuda, H; Watanabe, S, 2020
)
0.56
" First, we performed pharmacokinetic studies in non-pregnant monkeys to compare blood levels of the steroids using oral dosing with Beta-P, Dex-P and an effective maternal intramuscular dose of the beta-acetate component of the clinical treatment."( Oral dosing for antenatal corticosteroids in the Rhesus macaque.
Bridges, JP; Clarke, MW; Jobe, AH; Kannan, PS; Kemp, MW; Milad, M; Miller, LA; Schmidt, AF, 2019
)
0.51
" Trying to take into account both efficacy and safety, we simulated different dosing schemes in order to maintain a maximum of fetuses above 1 ng/mL without exceeding the total standard dose."( Maternal Betamethasone for Prevention of Respiratory Distress Syndrome in Neonates: Population Pharmacokinetic and Pharmacodynamic Approach.
Benaboud, S; Bouazza, N; Foissac, F; Goffinet, F; Hirt, D; Jarreau, PH; Kayem, G; Lui, G; Mandelbrot, L; Rozenberg, P; Tréluyer, JM; Ville, Y; Zheng, Y, 2020
)
0.56
" There is a marked variation in antenatal steroid dosing strategy, selection for treatment criteria, and agent choice worldwide."( Variability in the efficacy of a standardized antenatal steroid treatment was independent of maternal or fetal plasma drug levels: evidence from a sheep model of pregnancy.
Carter, S; Clarke, M; Fee, EL; Hanita, T; Ikeda, H; Jobe, AH; Kemp, MW; Koshinami, S; Kumagai, Y; Newnham, JP; Saito, M; Sato, S; Schmidt, AF; Takahashi, T; Takahashi, Y; Usuda, H; Watanabe, S; Yaegashi, N, 2020
)
0.56
" However, the optimal (maximum benefit and minimal risk of side effects) antenatal corticosteroid dosing strategy remains unclear."( Betamethasone phosphate reduces the efficacy of antenatal steroid therapy and is associated with lower birthweights when administered to pregnant sheep in combination with betamethasone acetate.
Carter, S; Fee, EL; Furfaro, L; Jobe, AH; Kemp, MW; Newnham, JP; Saito, M; Schmidt, AF; Takahashi, T; Takahashi, Y; Usuda, H; Yaegashi, N, 2022
)
0.72
"Using an established sheep model of prematurity and postnatal ventilation of the preterm lamb, we aimed to compare the pharmacodynamic effects of low-dosage treatment with betamethasone acetate only against a standard dosage of betamethasone phosphate and betamethasone acetate as recommended by the American College of Obstetricians and Gynecologists for women at risk of imminent preterm delivery between 24 0/7 and 35 6/7 weeks' gestation."( Betamethasone phosphate reduces the efficacy of antenatal steroid therapy and is associated with lower birthweights when administered to pregnant sheep in combination with betamethasone acetate.
Carter, S; Fee, EL; Furfaro, L; Jobe, AH; Kemp, MW; Newnham, JP; Saito, M; Schmidt, AF; Takahashi, T; Takahashi, Y; Usuda, H; Yaegashi, N, 2022
)
0.72
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Drug Classes (2)

ClassDescription
organic sodium salt
tertiary alpha-hydroxy ketoneAn alpha-hydroxy ketone in which the carbonyl group and the hydroxy group are linked by a carbon bearing two organyl groups.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (12)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
GLI family zinc finger 3Homo sapiens (human)Potency0.00350.000714.592883.7951AID1259369; AID1259392
AR proteinHomo sapiens (human)Potency0.00780.000221.22318,912.5098AID1259243; AID1259247; AID1259381; AID743036; AID743040; AID743042; AID743053; AID743054
glucocorticoid receptor [Homo sapiens]Homo sapiens (human)Potency0.02370.000214.376460.0339AID720691; AID720692; AID720719
estrogen-related nuclear receptor alphaHomo sapiens (human)Potency48.93630.001530.607315,848.9004AID1224848; AID1224849; AID1259401; AID1259403
pregnane X nuclear receptorHomo sapiens (human)Potency44.19670.005428.02631,258.9301AID1346982
estrogen nuclear receptor alphaHomo sapiens (human)Potency0.44260.000229.305416,493.5996AID1259244; AID1259248; AID743069; AID743078; AID743080; AID743091
peroxisome proliferator activated receptor gammaHomo sapiens (human)Potency50.03810.001019.414170.9645AID743191
aryl hydrocarbon receptorHomo sapiens (human)Potency62.42950.000723.06741,258.9301AID743122
cytochrome P450, family 19, subfamily A, polypeptide 1, isoform CRA_aHomo sapiens (human)Potency0.24850.001723.839378.1014AID743083
thyroid hormone receptor beta isoform 2Rattus norvegicus (Norway rat)Potency24.85360.000323.4451159.6830AID743065
Voltage-dependent calcium channel gamma-2 subunitMus musculus (house mouse)Potency0.88180.001557.789015,848.9004AID1259244
Glutamate receptor 2Rattus norvegicus (Norway rat)Potency0.88180.001551.739315,848.9004AID1259244
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Ceullar Components (1)

Processvia Protein(s)Taxonomy
plasma membraneGlutamate receptor 2Rattus norvegicus (Norway rat)
[Information is prepared from geneontology information from the June-17-2024 release]

Research

Studies (164)

TimeframeStudies, This Drug (%)All Drugs %
pre-199038 (23.17)18.7374
1990's20 (12.20)18.2507
2000's57 (34.76)29.6817
2010's37 (22.56)24.3611
2020's12 (7.32)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 62.00

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

MetricThis Compound (vs All)
Research Demand Index62.00 (24.57)
Research Supply Index5.38 (2.92)
Research Growth Index4.66 (4.65)
Search Engine Demand Index103.94 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (62.00)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials33 (17.93%)5.53%
Reviews5 (2.72%)6.00%
Case Studies34 (18.48%)4.05%
Observational0 (0.00%)0.25%
Other112 (60.87%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (110)

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
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
A Phase Ib, Multi-Center, Randomized, Vehicle- and Comparator-Controlled Trial, Double-Blind for the Investigational Medicinal Products, Observer-Blind for the Comparators to Evaluate the Safety and Antipsoriatic Efficacy of BOS-475 in a Psoriasis Plaque [NCT04221906]Phase 115 participants (Actual)Interventional2020-01-06Completed
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 Phase I, Randomized, Observer-blind, Single-center, Vehicle- And Comparator-controlled, Initial Dose-ranging Study To Assess The Antipsoriatic Efficacy Of Different Concentrations Of An2728 Ointment In A Psoriasis Plaque Test [NCT00762658]Phase 112 participants (Actual)Interventional2007-11-30Completed
A Phase I, Randomized, Observer-blind, Single-center, Vehicle- And Comparator-controlled, Initial Dose-ranging Study To Assess The Antipsoriatic Efficacy Of Different Concentrations Of An2728 Cream In A Psoriasis Plaque Test [NCT00763204]Phase 112 participants (Actual)Interventional2008-02-29Completed
A Double-Blind, Vehicle-Controlled, Rising Dose, Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy Study of Ruxolitinib Phosphate Cream When Applied to Patients With Plaque Psoriasis [NCT00820950]Phase 229 participants (Actual)Interventional2007-05-31Completed
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
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
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
Phase 3 Study, Randomized, Double-blind, Parallel to Evaluate Ketoconazole and Betamethasone Dipropionate(Candicort®) Compared to Clotrimazole and Dexamethasone Acetate(Baycuten N®) in Relief of Fungal Infections/Dermatophytosis Symptoms. [NCT02582177]Phase 3125 participants (Actual)Interventional2019-06-11Completed
A 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
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
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
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
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
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
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
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
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
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
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, Double-Blind Study Comparing TOLMAR Calcipotriene and Betamethasone Suspension to Reference Listed Drug in the Treatment of Scalp Psoriasis [NCT03122353]Phase 1699 participants (Actual)Interventional2017-04-11Completed
Efficacy of Excimer Laser Combined With Either Topical Tazarotene or Topical Betamethasone Valerate Versus Excimer Laser Alone in Treatment of Localized Chronic Plaque Psoriasis; Clinical and Dermoscopic Study [NCT05555797]Phase 430 participants (Anticipated)Interventional2022-10-30Not yet recruiting
Calcipotriol /Betamethasone Ointment Versus Fractional CO2 Laser Plus Calcipotriol /Betamethasone Ointment in the Treatment of Plaque Psoriasis: Randomized Comparative Study [NCT06011083]40 participants (Actual)Interventional2022-08-01Completed
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

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

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

Interventionparticipants (Number)
TACLONEX Ointment20

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

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

Interventionparticipants (Number)
TACLONEX Ointment23

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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

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

(NCT00817219)
Timeframe: Baseline and 4 Weeks

Interventionmmol/g (Mean)
TACLONEX Ointment0.717

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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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