Page last updated: 2024-11-10

clobetasol

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

Description

Clobetasol: A derivative of PREDNISOLONE with high glucocorticoid activity and low mineralocorticoid activity. Absorbed through the skin faster than FLUOCINONIDE, it is used topically in treatment of PSORIASIS but may cause marked adrenocortical suppression. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

clobetasol : A 3-oxo-Delta(1),Delta(4)-steroid that is 16beta-methylpregna-1,4-diene-3,20-dione bearing hydroxy groups at the 11beta and 17alpha positions, fluorine at position 9, and a chlorine substituent at position 21. It is used as its 17alpha-propionate ester to treat various skin disorders, including exzema and psoriasis. [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 CID5311051
CHEMBL ID1201362
CHEBI ID205919
SCHEMBL ID3996
MeSH IDM0004578

Synonyms (50)

Synonym
AC-1775
clobecort amex (tn)
25122-41-2
D07715
clobetasol (inn)
clobetasol
einecs 246-633-8
clobetasolum [inn-latin]
clofenazon
clobetasol [inn:ban]
pregna-1,4-diene-3,20-dione, 21-chloro-9-fluoro-11,17-dihydroxy-16-methyl-, (11beta,16beta)-
CHEMBL1201362
(8s,9r,10s,11s,13s,14s,16s,17r)-17-(2-chloroacetyl)-9-fluoro-11,17-dihydroxy-10,13,16-trimethyl-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-3-one
clobecort amex
dovate
21-chloro-9-fluoro-11beta,17-dihydroxy-16beta-methylpregna-1,4-diene-3,20-dione
clobetasolum
(11beta,16beta)-21-chloro-9-fluoro-11,17-dihydroxy-16-methylpregna-1,4-diene-3,20-dione
chebi:205919 ,
cas-25122-41-2
dtxsid2048955 ,
dtxcid9028881
tox21_113384
adn79d536h ,
unii-adn79d536h
hsdb 7994
clobetasol impurity g (pheur)
clobetasol [mi]
betamethasone impurity b [ep impurity]
clobetasol [vandf]
clobetasol [who-dd]
pregna-1,4-diene-3,20-dione, 21-chloro-9-fluoro-11,17-dihydroxy-16-methyl-, (11.beta.,16.beta.)-
clobetasol [inn]
clobetasol propionate impurity g [ep impurity]
SCHEMBL3996
AKOS025401451
(1r,2s,10s,11s,13s,14r,15s,17s)-14-(2-chloroacetyl)-1-fluoro-14,17-dihydroxy-2,13,15-trimethyltetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadeca-3,6-dien-5-one
clobetasol, >=95.0% (hplc), pharmaceutical impurity standard
21-chloro-9-fluoro-11beta,17-dihydroxy-16beta-methylpregna-1,4-diene-3,20-dione (clobetasol)
J-015820
DB11750
Q4224007
furfurylacrylate
CS-0450071
(1r,2s,3as,3bs,9as,9br,10s,11as)-1-(2-chloroacetyl)-9b-fluoro-1,10-dihydroxy-2,9a,11a-trimethyl-1h,2h,3h,3ah,3bh,4h,5h,7h,9ah,9bh,10h,11h,11ah-cyclopenta[a]phenanthren-7-one
EN300-19844878
clobetasolum (inn-latin)
clobetasolo
d07ad01
betamethasone impurity b (ep impurity)

Research Excerpts

Overview

Clobetasol propionate is a super-high potent class 1 topical corticosteroid. It is available in several formulations, including a spray formulation that is approved for use up to 4 weeks in patients aged 18 years and older with moderate to severe plaque psoriasis.

ExcerptReferenceRelevance
"Clobetasol is an effective treatment for abutment skin/scar overgrowth. "( Bone-anchored hearing aid abutment skin overgrowth reduction with clobetasol.
Falcone, MT; Haynes, DS; Kaylie, DM; Labadie, RF, 2008
)
2.03
"Clobetasol propionate is a super-high potent class 1 topical corticosteroid available in several formulations, including a spray formulation that is approved for use up to 4 weeks in patients aged 18 years and older with moderate to severe plaque psoriasis. "( Clobetasol propionate spray 0.05% for the treatment of moderate to severe plaque psoriasis.
Menter, A, 2012
)
3.26
"Clobetasol propionate is a super-highpotent class I topical corticosteroid."( Impact of clobetasol propionate 0.05% spray on health-related quality of life in patients with plaque psoriasis.
Caveney, SW; Gottschalk, RW; Menter, MA, 2012
)
1.5
"Clobetasol propionate is a very effective treatment for psoriasis. "( Clobetasol propionate for psoriasis: are ointments really more potent?
Balkrishnan, R; Feldman, SR; Warino, L, 2006
)
3.22
"Clobetasol mouthwash is a safe and efficacious option for the treatment of severe oral erosive lesions."( Treatment of severe chronic oral erosive lesions with clobetasol propionate in aqueous solution.
Gonzalez-Moles, MA; Gonzalez-Moles, S; Isabel, IR; Morales, P; Rodriguez-Archilla, A, 2002
)
2.01

Effects

ExcerptReferenceRelevance
"Clobetasol has significantly higher efficacy and tacrolimus may be an alternative treatment."( A comparative study in efficacy and safety of 0.1% tacrolimus and 0.05% clobetasol propionate ointment in discoid lupus erythematosus by modified cutaneous lupus erythematosus disease area and severity index.
Janjumratsang, P; Pothinamthong, P, 2012
)
1.33

Actions

ExcerptReferenceRelevance
"Clobetasol proved to inhibit UVB-induced proliferation of epidermal cells, tenascin induction, keratin 16 induction and the accumulation of T lymphocytes and CD1a-positive cells."( Effects of calcipotriol and clobetasol-17-propionate on UVB-irradiated human skin: an immunohistochemical study.
de Jong, EM; Snijders, CG; van de Kerkhof, PC; van der Vleuten, CJ, 1996
)
1.31

Treatment

Clobetasol treatment ranked as the best treatment for disease remission. Treatment of U937 cells induced an up- and down-regulation of SLPI expression in a dose-dependent manner. Treatment was successful without necessitating discontinuation of immunotherapy.

ExcerptReferenceRelevance
"Clobetasol treatment ranked as the best treatment for disease remission after evaluating rank probabilities (40% chance of ranking first compared with tacrolimus [38%])."( An arm-based network meta-analysis on treatments for vulvar lichen sclerosus and a call for development of core outcome sets.
Bellos, I; Biliou, EC; Doumouchtsis, SK; Mitsopoulou, D; Pergialiotis, V; Varnava, P, 2020
)
1.28
"Clobetasol treatment exhibited an equivalent pharmacological effect."( Clobetasol Modulates Adult Neural Stem Cell Growth via Canonical Hedgehog Pathway Activation.
Bernstock, JD; Giallongo, C; Giunta, MAS; Gulino, R; Gulisano, M; Leanza, G; Li Volti, G; Parenti, R; Spitale, FM; Tibullo, D; Vicario, N, 2019
)
2.68
"Clobetasol treatment of U937 cells induced an up- and down-regulation of SLPI expression in a dose-dependent manner."( Clobetasol down-regulates SLPI expression in U937 monocytoid cells.
Kitagishi, Y; Matsuda, S; Nishimura, Y; Okumura, N; Yoshida, H, 2012
)
2.54
"Treatment with clobetasol ointment was successful without necessitating discontinuation of immunotherapy."( PD1 inhibitor induced inverse lichenoid eruption: a case series.
Garg, V; Lee, JB; Sethi, M; Yang, S, 2020
)
0.9
"Treatment with clobetasol propionate 0.05% spray for up to four weeks is effective and well tolerated for moderate-to-severe plaque psoriasis of the scalp."( Clobetasol propionate 0.05% spray for the management of moderate-to-severe plaque psoriasis of the scalp: results from a randomized controlled trial.
Caveney, SW; Colón, LE; Cook-Bolden, FE; Gottschalk, RW; Hudson, CP; Preston, N; Sofen, H, 2011
)
2.16
"Treatment with clobetasol cream 0.05% led to resolution of his lichen planus lesions."( Imiquimod reactivation of lichen planus.
Chaney, KC; Domingues, E; Scharf, MJ; Wiss, K, 2012
)
0.72
"Pretreatment with clobetasol-17-propionate, applied three times a day for 4 days, did not affect the activity of galactosylhydroxylysyl glucosyltransferase (GGT) in fresh blisters but post-blistering treatment for 3 days with the steroid markedly inhibited the increase of this enzyme activity during the initial phases of re-epithelialization."( A local potent glucocorticosteroid decreases the induction of galactosylhydroxylysyl glucosyltransferase in suction blisters but has no effect on basement membrane structures.
Foidart, JM; Hintikka, J; Kiistala, U; Oikarinen, A; Peltonen, L, 1983
)
0.59
"Treatment with clobetasol kept patients free from relapses during the entire observation period in 70%, with flupredniden in 30%."( Intermittent maintenance therapy in chronic hand eczema with clobetasol propionate and flupredniden acetate.
Dahl, G; Möller, H; Svartholm, H, 1983
)
0.85
"Treatment with clobetasol propionate 0.05% cream is effective against lichen sclerosus et atrophicus (LSA) of the vulva."( Penile lichen sclerosus et atrophicus treated with clobetasol dipropionate 0.05% cream: a retrospective clinical and histopathological study.
Dahlman-Ghozlan, K; Hedblad, MA; von Krogh, G, 1999
)
0.91
"Pretreatment with clobetasole-17-propionate cream on the skin for 1 week prior to prick tests did not affect the blood flow response elicited by histamine or allergen, in either the initial part (up to 1 h) or the protracted 24 h determinations."( Blood flow in histamine- and allergen-induced weal and flare responses, effects of an H1 antagonist, alpha-adrenoceptor agonist and a topical glucocorticoid.
Hammarlund, A; Olsson, P; Pipkorn, U, 1990
)
0.6

Toxicity

Clobetasol propionate lotion was safe and well tolerated. Adverse events were more common in the calcipotriol group. Oral NAC and PTX added to the therapeutic efficacy of topical clobet asol.

ExcerptReferenceRelevance
" No other adverse cutaneous effects were observed."( The safety of halobetasol 0.05% ointment in the treatment of psoriasis.
Freer, JP; Kalb, RE; Krochmal, L; Siskin, SB; Watson, WA, 1990
)
0.28
" From the above evidence, it was concluded that HBP ointment was less toxic than the other topical corticosteroids."( Comparative toxicity study of hydrocortisone 17-butyrate 21-propionate (HBP) ointment and other topical corticosteroids in rats.
Kimura, M; Nakane, S; Otomo, S; Tarumoto, Y, 1986
)
0.27
"3 mg/kg/day, however, some dose-dependent symptoms such as suppression of body weight gain, emaciation, regressive changes in adrenals, lymphatic and hematopoietic tissues, decrease in circulating white blood cell and lymphocyte counts, which have been known as toxic effects of synthetic corticosteroids, were induced."( [Studies on toxicity of clobetasone-17-butyrate (II)--chronic toxicity in rats (author's transl)].
Aoishi, M; Bando, T; Ezaki, H; Hashimoto, K; Matsumoto, M; Moriwaki, T; Nagasawa, R; Okamura, C; Sato, N; Sutoh, M; Tamura, J; Tatami, A, 1980
)
0.26
" Adverse events were reported by 34."( Efficacy and safety of twice-daily augmented betamethasone dipropionate lotion versus clobetasol propionate solution in patients with moderate-to-severe scalp psoriasis.
Bressinck, R; Cornell, R; Katz, HI; Lindholm, JS; Morman, M; Pariser, DM; Pariser, RJ; Shavin, JS; Weiss, JS; Weng, W,
)
0.35
" Despite earlier fears, widespread availability and use of these creams is not associated with clinically significant adverse effects."( Eumovate (clobetasone butyrate 0.05%) cream: a review of clinical efficacy and safety.
Cork, MJ; Goustas, P; Higson, D, 2003
)
0.32
" Adverse events were more common in the calcipotriol group than in the clobetasol propionate shampoo group."( Clobetasol propionate shampoo 0.05% and calcipotriol solution 0.005%: a randomized comparison of efficacy and safety in subjects with scalp psoriasis.
Acebes, LO; Arsonnaud, S; Caputo, R; de Waard-van der Spek, FB; Decroix, J; Figueiredo, A; Mrowietz, U; Poncet, M; Reygagne, P, 2005
)
2
" Clobetasol propionate lotion was safe and well tolerated."( Clobetasol propionate lotion, an efficient and safe alternative to clobetasol propionate emollient cream in subjects with moderate to severe plaque-type psoriasis.
Feldman, SR; Foley, V; Lin, YL; Lowe, N; Shavin, JS; Sherer, D; Soto, P; Weiss, J, 2005
)
2.68
"The present study demonstrates that clobetasol propionate lotion is an efficacious, safe and well-tolerated alternative to the currently available emollient cream formulation, while showing a better remission profile after 4 weeks of treatment-free follow-up period."( Clobetasol propionate lotion, an efficient and safe alternative to clobetasol propionate emollient cream in subjects with moderate to severe plaque-type psoriasis.
Feldman, SR; Foley, V; Lin, YL; Lowe, N; Shavin, JS; Sherer, D; Soto, P; Weiss, J, 2005
)
2.05
" No adverse events were recorded during the trial in either treatment group."( Clobetasol propionate 0.05% in a novel foam formulation is safe and effective in the short-term treatment of patients with delayed pressure urticaria: a randomized, double-blind, placebo-controlled trial.
Cassano, N; D'Argento, V; Milani, M; Vena, GA, 2006
)
1.78
"5 million adverse drug reaction (ADR) reports for 8620 drugs/biologics that are listed for 1191 Coding Symbols for Thesaurus of Adverse Reaction (COSTAR) terms of adverse effects."( Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
Benz, RD; Contrera, JF; Kruhlak, NL; Matthews, EJ; Weaver, JL, 2004
)
0.32
" Adverse events were reported throughout the study."( An intra-individual randomized safety and efficacy comparison of clobetasol propionate 0.05% spray and its vehicle in the treatment of plaque psoriasis.
Beutner, K; Chakrabarty, A; Lemke, S; Yu, K, 2006
)
0.57
" No serious adverse event occurred during the course of the study."( An intra-individual randomized safety and efficacy comparison of clobetasol propionate 0.05% spray and its vehicle in the treatment of plaque psoriasis.
Beutner, K; Chakrabarty, A; Lemke, S; Yu, K, 2006
)
0.57
"05% spray was effective and safe in reducing overall plaque severity, scaling, erythema, and plaque elevation from the first week of treatment continuing throughout the trial."( An intra-individual randomized safety and efficacy comparison of clobetasol propionate 0.05% spray and its vehicle in the treatment of plaque psoriasis.
Beutner, K; Chakrabarty, A; Lemke, S; Yu, K, 2006
)
0.57
" Both treatments were safe and well-tolerated."( A randomized, investigator-masked clinical evaluation of the efficacy and safety of clobetasol propionate 0.05% shampoo and tar blend 1% shampoo in the treatment of moderate to severe scalp psoriasis.
Arsonnaud, S; Barker, JN; Finlay, AY; Fleming, CJ; Griffiths, CE; Mizzi, F, 2006
)
0.56
"This new formulation of clobetasol propionate foam is an effective, safe and well-tolerated topical treatment for AA."( Efficacy and safety of a new clobetasol propionate 0.05% foam in alopecia areata: a randomized, double-blind placebo-controlled trial.
Botta, GL; Iorizzo, M; Milani, M; Tosti, A, 2006
)
0.93
" No treatment-related serious adverse events occurred during the course of the study."( Evaluation of the efficacy and safety of clobetasol propionate spray in the treatment of plaque-type psoriasis.
Brodell, RT; Clark, SD; Jarratt, MT; Safley, CF; Savin, RC; Swinyer, LJ; Yu, K, 2006
)
0.6
"While glucocorticoids (GC) exert beneficial effects (anti-inflammatory), they also have adverse effects on the epidermis including decreased epidermal differentiation, decreased keratinocyte proliferation, and decreased cutaneous permeability barrier homeostasis."( Activators of PPARs and LXR decrease the adverse effects of exogenous glucocorticoids on the epidermis.
Chang, S; Choi, EH; Demerjian, M; Elias, PM; Feingold, KR; Man, MQ, 2009
)
0.35
" CP shampoo was also safe during the 7-month study period, without leading to more cases of skin atrophy, telangiectasia, hypothalamic-pituitary-adrenal (HPA) axis suppression or adverse events compared to vehicle."( Clobetasol propionate shampoo 0.05% is efficacious and safe for long-term control of moderate scalp psoriasis.
Barber, K; Bissonnette, R; Kerrouche, N; Papp, K; Poulin, Y; Villemagne, H, 2010
)
1.8
"05% is an efficacious and safe treatment for scalp psoriasis."( Clobetasol propionate shampoo 0.05% is efficacious and safe for long-term control of scalp psoriasis.
Bissonnette, R; Guenther, L; Kerrouche, N; Lynde, C; Papp, K; Poulin, Y; Tan, J; Villemagne, H, 2010
)
1.8
" Topical vitamin D, which is used to treat mild-to-moderate psoriasis, has been shown to be safe when used daily for up to 52 weeks."( A multi-center, open-label study to evaluate the safety and efficacy of a sequential treatment regimen of clobetasol propionate 0.05% spray followed by Calcitriol 3 mg/g ointment in the management of plaque psoriasis.
Brodell, RT; Bruce, S; Colón, LE; Gottschalk, RW; Hudson, CP; Johnson, LA; Weiss, JS, 2011
)
0.58
" The sequential treatment regimen was well tolerated with no unexpected adverse events."( A multi-center, open-label study to evaluate the safety and efficacy of a sequential treatment regimen of clobetasol propionate 0.05% spray followed by Calcitriol 3 mg/g ointment in the management of plaque psoriasis.
Brodell, RT; Bruce, S; Colón, LE; Gottschalk, RW; Hudson, CP; Johnson, LA; Weiss, JS, 2011
)
0.58
"05% spray treatment for four weeks immediately followed by an eight-week treatment phase with calcitriol 3 μg/g ointment is efficacious and safe for the management of moderate-to-severe plaque psoriasis."( A multi-center, open-label study to evaluate the safety and efficacy of a sequential treatment regimen of clobetasol propionate 0.05% spray followed by Calcitriol 3 mg/g ointment in the management of plaque psoriasis.
Brodell, RT; Bruce, S; Colón, LE; Gottschalk, RW; Hudson, CP; Johnson, LA; Weiss, JS, 2011
)
0.58
" The short-contact clobetasol propionate 0·05% shampoo (CP) is an efficacious and safe once-daily treatment for scalp psoriasis."( Efficacious and safe management of moderate to severe scalp seborrhoeic dermatitis using clobetasol propionate shampoo 0·05% combined with ketoconazole shampoo 2%: a randomized, controlled study.
Faergemann, J; Kerrouche, N; Lee, JH; Nikkels, AF; Ortonne, JP; Ponce Olivera, RM; Reich, K; Sidou, F, 2011
)
0.92
" Similarly low incidences of telangiectasia, burning and adverse events were observed among the four groups."( Efficacious and safe management of moderate to severe scalp seborrhoeic dermatitis using clobetasol propionate shampoo 0·05% combined with ketoconazole shampoo 2%: a randomized, controlled study.
Faergemann, J; Kerrouche, N; Lee, JH; Nikkels, AF; Ortonne, JP; Ponce Olivera, RM; Reich, K; Sidou, F, 2011
)
0.59
" Dermatologists seek alternative treatments of patients with plaque psoriasis that provide both efficacy and safety while minimizing exposure to high-potency steroids that can have adverse effects following long-term use."( An open-label, multicenter study of the efficacy and safety of an AM/PM treatment regimen with clobetasol propionate spray 0.05% and calcitriol ointment 3 microg/g in the management of plaque psoriasis.
Colón, LE; Gottschalk, R; Hudson, CP; Johnson, LA; Kempers, S; Menter, A; Papp, K; Smith, S; Sofen, H, 2011
)
0.59
" Although highly effective, long-term use of topical steroids can cause adverse side effects."( An open-label, multicenter study of the efficacy and safety of a weekday/weekend treatment regimen with calcitriol ointment 3 microg/g and clobetasol propionate spray 0.05% in the management of plaque psoriasis.
Colón, LE; Gottschalk, R; Hudson, CP; Johnson, LA; Kempers, S; Menter, A; Papp, K; Smith, S; Sofen, H, 2011
)
0.57
" Clobetasone butyrate, at low dosage, proved to be safe and effective in treating this condition."( Safety and efficacy of 0.1% clobetasone butyrate eyedrops in the treatment of dry eye in Sjögren syndrome.
Aragona, P; Postorino, E; Puzzolo, D; Rania, L; Roszkowska, AM; Sommario, MS; Spinella, R,
)
0.13
" Adverse events (AEs) were reported in 18% of subjects in the clobetasol propionate foam group and 8% of subjects in the vehicle foam group."( A randomized, double-blind phase 4 study of the efficacy and safety of ethanol-free clobetasol propionate foam, 0.05%, vs vehicle foam in the treatment of chronic hand dermatitis.
Eastman, WJ; Gwazdauskas, J; Kircik, LH, 2013
)
0.85
" Comparable numbers of adverse events occurred in each arm."( A randomized study to evaluate the efficacy and safety of adding topical therapy to etanercept in patients with moderate to severe plaque psoriasis.
Callis Duffin, K; Hooper, M; Kircik, L; Koo, J; Kricorian, G; Lebwohl, MG; Pariser, D; Thompson, EH; Wenkert, D; Yang, J, 2013
)
0.39
"Addition of CP to etanercept yielded increased efficacy compared with etanercept alone at week 12 without an increase in treatment-related adverse events."( A randomized study to evaluate the efficacy and safety of adding topical therapy to etanercept in patients with moderate to severe plaque psoriasis.
Callis Duffin, K; Hooper, M; Kircik, L; Koo, J; Kricorian, G; Lebwohl, MG; Pariser, D; Thompson, EH; Wenkert, D; Yang, J, 2013
)
0.39
" For many inflammatory-based scalp diseases, glucocorticoids are an essential part of treatment, even though they are known to cause systemic as well as local adverse effects when applied topically."( Nanocarriers for optimizing the balance between interfollicular permeation and follicular uptake of topically applied clobetasol to minimize adverse effects.
Beck, RCR; Conrad, P; De Rossi, C; Garrigues, TM; Guterres, SS; Hansen, S; Lehr, CM; Mathes, C; Melero, A; Pohlmann, AR; Prado, WA; Rigo, L; Schaefer, UF; Selzer, D; Vogt, T, 2016
)
0.64
" Safety and treatment emergent adverse events (TEAEs) were evaluated throughout."( A Phase 2, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of a Halobetasol/Tazarotene Fixed Combination in the Treatment of Plaque Psoriasis.
Alexander, BJ; Gold, LS; Lebwohl, MG; Pariser, DM; Pillai, R; Sugarman, JL, 2017
)
0.46
" The adverse effects (most commonly hyperpigmentation) were noted more frequently on the excimer-treated sides; however, they were well tolerated."( Comparison of effectiveness and safety of excimer lamp vs topical calcipotriol-clobetasol propionate combination in the treatment of palmoplantar psoriasis.
Bishnoi, A; Dogra, S; Narang, T; Thakur, A, 2018
)
0.71
" Safety and treatment-emergent adverse events were evaluated throughout."( Safety and efficacy of a fixed combination of halobetasol and tazarotene in the treatment of moderate-to-severe plaque psoriasis: Results of 2 phase 3 randomized controlled trials.
Gold, LS; Israel, R; Lebwohl, MG; Lin, T; Martin, G; Pariser, DM; Pillai, R; Ramakrishna, T; Sugarman, JL, 2018
)
0.48
" The most frequently reported treatment-related adverse events were contact dermatitis (6."( Safety and efficacy of a fixed combination of halobetasol and tazarotene in the treatment of moderate-to-severe plaque psoriasis: Results of 2 phase 3 randomized controlled trials.
Gold, LS; Israel, R; Lebwohl, MG; Lin, T; Martin, G; Pariser, DM; Pillai, R; Ramakrishna, T; Sugarman, JL, 2018
)
0.48
" The target Nail Psoriasis Severity Index (NAPSI) score of each finger was evaluated, any adverse effects were recorded, and photographs were taken."( A randomized comparison of efficacy and safety of intralesional triamcinolone injection and clobetasol propionate ointment for psoriatic nails.
Boontaveeyuwat, E; Danchaivijitr, N; Silpa-Archa, N; Wongpraparut, C, 2019
)
0.73
"In spite of its temporary effect, the intralesional triamcinolone injection is an effective and safe treatment for psoriatic nails."( A randomized comparison of efficacy and safety of intralesional triamcinolone injection and clobetasol propionate ointment for psoriatic nails.
Boontaveeyuwat, E; Danchaivijitr, N; Silpa-Archa, N; Wongpraparut, C, 2019
)
0.73
" Compared with conventional chemotherapy, immunotherapy is associated with a unique set of immune reactions known collectively as immune-related adverse events (irAEs)."( A Case of Nivolumab-Induced Bullous Pemphigoid: Review of Dermatologic Toxicity Associated with Programmed Cell Death Protein-1/Programmed Death Ligand-1 Inhibitors and Recommendations for Diagnosis and Management.
Geskin, L; Lopez, AT, 2018
)
0.48
"PD-1/PD-L1 inhibitor-induced bullous pemphigoid (BP) is a rare but potentially serious dermatologic toxicity associated with checkpoint inhibitorsIn patients with pruritus or rash that is refractory to topical steroids, physicians should have a greater index of suspicion for higher-grade cutaneous immune-related adverse events."( A Case of Nivolumab-Induced Bullous Pemphigoid: Review of Dermatologic Toxicity Associated with Programmed Cell Death Protein-1/Programmed Death Ligand-1 Inhibitors and Recommendations for Diagnosis and Management.
Geskin, L; Lopez, AT, 2018
)
0.48
" Safety and treatment emergent adverse events (AEs) evaluated throughout."( Safety and Efficacy of a Once-Daily Halobetasol Propionate 0.01% Lotion in the Treatment of Moderate-to-Severe Plaque Psoriasis: Results of Two Phase 3 Randomized Controlled Trials.
Bagel, J; Cook-Bolden, FE; Green, LJ; Israel, R; Kerdel, FA; Lin, T; Martin, G; Pillai, R; Ramakrishna, T, 2018
)
0.48
" Safety and treatment-emergent adverse events (AEs) were evaluated throughout."( Safety and efficacy of halobetasol propionate lotion 0.01% in the treatment of moderate to severe plaque psoriasis: a pooled analysis of 2 phase 3 studies.
Harris, S; Lin, T; Martin, G; Pillai, R; Soung, J; Sugarman, JL; Tanghetti, EA; Weiss, JS; Yamauchi, PS, 2019
)
0.51
"This study aimed to evaluate the potential adverse effects of the dermal administration of Dillenia indica Linnaeus (D."( Study of the potential adverse effects caused by the dermal application of Dillenia indica L. fruit extract standardized to betulinic acid in rodents.
Carvalho, AC; da Silva, GS; Fernandes, FS; Hilel, AS; Kanis, LA; Kviecinski, MR; Martins, DF; Remor, KVT; Schlindwein, AD, 2019
)
0.51
" Safety and treatment emergent adverse events (TEAEs) were evaluated throughout."( Efficacy, Safety, and Tolerability of a Halobetasol 0.01% /Tazarotene 0.045% Fixed Combination in the Treatment of Severe Localized Plaque Psoriasis: Post Hoc Analysis of Two Phase III Randomized Controlled Trials
Israel, R; Lebwohl, MG; Lin, T; Stein Gold, L; Sugarman, JL, 2019
)
0.51
" Because MF is a chronic disease, prolonged treatment is needed, raising the concern of CS-induced cutaneous adverse effects (AEs)."( Topical clobetasol propionate treatment and cutaneous adverse effects in patients with early-stage mycosis fungoides: an observational study.
Geller, S; Myskowski, PL, 2020
)
0.99
" The most common treatment-related adverse events were application site reactions of dermatitis, pruritus, pain and irritation."( Long-term safety and efficacy of a fixed-combination halobetasol propionate 0.01%/tazarotene 0.045% lotion in moderate-to-severe plaque psoriasis: phase 3 open-label study.
Han, G; Harris, S; Jacobson, A; Lebwohl, MG; Lin, T; Papp, K; Pariser, DM; Stein Gold, L, 2021
)
0.62
" To assess what impact can be expected from this regulatory action, we analyzed reports of adverse drug events due to topical corticosteroids at a hospital-based pharmacovigilance center between January 2017 and August 2018."( Topical steroid containing combinations: Burden of adverse effects and why the recent regulatory action may not be enough.
Asati, DP; Chaudhary, D; Jhaj, R; Sadasivam, B,
)
0.13
"45%) were the corticosteroids most frequently associated with adverse events."( Topical steroid containing combinations: Burden of adverse effects and why the recent regulatory action may not be enough.
Asati, DP; Chaudhary, D; Jhaj, R; Sadasivam, B,
)
0.13
"Nearly half of the cutaneous adverse effects were due to topical steroid combinations which are still widely available over the counter."( Topical steroid containing combinations: Burden of adverse effects and why the recent regulatory action may not be enough.
Asati, DP; Chaudhary, D; Jhaj, R; Sadasivam, B,
)
0.13
" The use of oral NAC and PTX added to the therapeutic efficacy of topical clobetasol in the treatment of LPP, suggesting that they might be beneficial and safe adjuvant therapies and add to the efficacy of topical treatment without any noticeable impact on the adverse effects experienced by patients."( Efficacy, safety, tolerability, and satisfaction of N-acetylcysteine and pentoxifylline in lichen planopilaris patients under treatment with topical clobetasol: A triple arm blinded randomized controlled trial.
Ahmadi Kahjoogh, H; Behrangi, E; Goodarzi, A; Hejazi, P; Roohaninasab, M; Yazdanian, N, 2022
)
1.15
" Patients were visited every 2 months to assess the lichen planopilaris activity index (LPPAI) and record probable adverse events."( Efficacy and safety of oral pioglitazone in the management of lichen planopilaris in comparison with clobetasol: A randomized clinical trial.
Azar, PM; Balighi, K; Daneshpazhooh, M; Dasdar, S; Ghiasi, M; Kianfar, N; Lajevardi, V; Peymanfar, AA, 2022
)
0.94
" Secondary endpoints included maximum daily and median cumulative doses, reduction in pruritus and occurrence of adverse events."( Safety and efficacy of high-dose clobetasol propionate 0.05% in cutaneous lichen planus.
Bergqvist, C; Bouchereau, S; Condamina, M; Giraud-Kerleroux, L; Guelimi, R; Hirsch, G; Hua, C; Le Cleach, L; Melin, A; Skayem, C; Wolkenstein, P, 2023
)
1.19

Compound-Compound Interactions

Isotretinoin combined with topical treatments is more effective than monotherapy with clobetasol and tacrolimus for FFA. In this 12-week study, patients with moderate to severe psoriasis received twice weekly treatments with a 308-nm excimer laser.

ExcerptReferenceRelevance
" It is concluded that steroids in combination with UVB should be used only during the initial period in order to achieve a more rapid alleviation of symptoms and to avoid the side effects."( The effect on psoriasis of clobetasol propionate used alone or in combination with UVB.
Larkö, O; Svartholm, H; Swanbeck, G, 1984
)
0.56
"To evaluate the efficacy and safety of CP alone and combined with ketoconazole shampoo 2% (KC) in the treatment of moderate to severe scalp seborrhoeic dermatitis."( Efficacious and safe management of moderate to severe scalp seborrhoeic dermatitis using clobetasol propionate shampoo 0·05% combined with ketoconazole shampoo 2%: a randomized, controlled study.
Faergemann, J; Kerrouche, N; Lee, JH; Nikkels, AF; Ortonne, JP; Ponce Olivera, RM; Reich, K; Sidou, F, 2011
)
0.59
"In this 12-week study, patients with moderate to severe psoriasis received twice weekly treatment with XTRAC® Velocity 308-nm excimer laser combined with clobetasol propionate twice daily followed by calitriol ointment twice daily."( Supraerythemogenic excimer laser in combination with clobetasol spray and calcitriol ointment for the treatment of generalized plaque psoriasis: Interim results of an open label pilot study.
Brown, G; Butler, D; Debbaneh, M; Gupta, R; Huynh, M; Koo, JY; Leon, A; Levin, E; Malakouti, M; Wang, E, 2015
)
0.86
"Excimer laser therapy combined with an optimized topical regimen that includes clobetasol spray followed by calictriol ointment appears to be an effective treatment for moderate to severe generalized psoriasis that avoids the risk of serious internal side effects associated with many systemic agents."( Supraerythemogenic excimer laser in combination with clobetasol spray and calcitriol ointment for the treatment of generalized plaque psoriasis: Interim results of an open label pilot study.
Brown, G; Butler, D; Debbaneh, M; Gupta, R; Huynh, M; Koo, JY; Leon, A; Levin, E; Malakouti, M; Wang, E, 2015
)
0.89
" In this 12-week study, patients with moderate to severe psoriasis received twice weekly treatments with a 308-nm excimer laser combined with clobetasol proprionate twice daily for a month followed by calcitriol ointment twice daily for the next month."( An open label pilot study of supraerythemogenic excimer laser in combination with clobetasol spray and calcitriol ointment for the treatment of generalized plaque psoriasis.
Beroukhim, K; Danesh, MJ; Koo, J; Leon, A; Levin, E; Nguyen, CM, 2016
)
0.86
"To assess the therapeutic effect of fractional CO2 laser resurfacing in combination with potent topical corticosteroids on hypertrophic burn scars in pediatric age group."( Fractional Carbon Dioxide Laser Resurfacing in Combination With Potent Topical Corticosteroids for Hypertrophic Burn Scars in the Pediatric Age Group: An Open Label Study.
Imran, S; Majid, I, 2018
)
0.48
"Fractional CO2 laser resurfacing in combination with potent topical steroids leads to significant therapeutic benefits in children with postburn hypertrophic scars."( Fractional Carbon Dioxide Laser Resurfacing in Combination With Potent Topical Corticosteroids for Hypertrophic Burn Scars in the Pediatric Age Group: An Open Label Study.
Imran, S; Majid, I, 2018
)
0.48
"Isotretinoin combined with topical treatments is more effective than monotherapy with clobetasol and tacrolimus for FFA."( Oral isotretinoin combined with topical clobetasol 0.05% and tacrolimus 0.1% for the treatment of frontal fibrosing alopecia: a randomized controlled trial.
Abedini, R; Amini, M; Daneshpazhooh, M; Mahmoudi, H; Nili, A; Rostami, A; Salehi Farid, A; Tavakolpour, S; Teimourpour, A, 2022
)
1.21

Bioavailability

Dermal microdialysis was used to assess the bioavailability of a topical corticosteroid, clobetasol propionate, following application onto the skin of human subjects. absorption rate was greater from the foam than from the solution in cadaver skin.

ExcerptReferenceRelevance
"Twelve percent ammonium lactate produced a significant sparing of atrophy in both the epidermis and dermis without any influence on the bioavailability or antiinflammatory properties of the corticosteroid."( Effects of topical ammonium lactate on cutaneous atrophy from a potent topical corticosteroid.
Kaidbey, K; Lavker, RM; Leyden, JJ, 1992
)
0.28
"This study describes the bioavailability of Clobetasone, which is topically applied as an anti-inflammatory drug."( Distribution of clobetasone in rabbit eye tissues after topical application.
Connors, B; Hockwin, O; Rink, H; Umlauf, A; Wegener, A, 1989
)
0.28
"In order to quantify the intensity of skin blanching and thus predict the bioavailability of topical corticoids, a physical device allowing the measurement of light reflected from skin without any contact between the probe and the skin was used (Leveque et al."( Objective determination of the bioavailability of dermocorticoids--influence of the formulation.
Le Gall, F; Leveque, JL; Poelman, MC, 1984
)
0.27
" Their potency and bioavailability are tested with different methods."( Evaluation of the vasoconstrictive effects of topical steroids by laser-Doppler-perfusion-imaging.
Kessels, A; Neumann, M; Sommer, A; Veraart, J, 1998
)
0.3
"The concentration of clobetasol propionate in the stratum corneum after application of three different formulations was determined, quantifying the influence of the formulations on the bioavailability of the drug."( Bioavailability of clobetasol propionate-quantification of drug concentrations in the stratum corneum by dermatopharmacokinetics using tape stripping.
Hagemeister, T; Lademann, J; Lindscheid, M; Molzahn, R; Schaefer, H; Schaefer, M; Shah, VP; Sterry, W; v Pelchrzim, R; Weigmann, H,
)
0.78
" It was reported that the absorption rate of clobetasol was greater from the foam than from the solution in cadaver skin."( Clobetasol propionate foam, 0.05%.
Jarvis, B; Melian, EB; Spencer, CM, 2001
)
2.01
" Differences in corticosteroid bioavailability could account for differences in efficacy."( Bioavailability of clobetasol propionate in different vehicles.
Feldman, SR; Franz, TJ; Lehman, PA; Spellman, MC,
)
0.46
" The purpose of the study was to investigate the topical bioavailability of different topical corticosteroid formulations in healthy human beings focussing on desoximetasone (DM)."( Activity of different desoximetasone preparations compared to other topical corticosteroids in the vasoconstriction assay.
Borelli, C; Fluhr, JW; Gassmueller, J; Korting, HC; Nietsch, KH; Schinzel, S, 2008
)
0.35
" Good topical bioavailability of both DM formulations was detected by chromametric measurement and clinical assessment."( Activity of different desoximetasone preparations compared to other topical corticosteroids in the vasoconstriction assay.
Borelli, C; Fluhr, JW; Gassmueller, J; Korting, HC; Nietsch, KH; Schinzel, S, 2008
)
0.35
"Dermal microdialysis was used to assess the bioavailability of a topical corticosteroid, clobetasol propionate, following application onto the skin of human subjects."( Application of dermal microdialysis for the determination of bioavailability of clobetasol propionate applied to the skin of human subjects.
Au, WL; Benfeldt, E; Kanfer, I; Skinner, MF; Verbeeck, RK, 2012
)
0.83
" However, despite being effective, its low and variable bioavailability prompt for development of novel carrier that could effectively target CP to site of action without producing undesirable side-effects."( Topical delivery of clobetasol propionate loaded microemulsion based gel for effective treatment of vitiligo--part II: rheological characterization and in vivo assessment through dermatopharmacokinetic and pilot clinical studies.
Barot, BS; Parejiya, PB; Patel, HK; Shelat, PK; Shukla, A, 2014
)
0.73
"To compare the sensitivity of a pharmacokinetic assay, the in vitro permeation test (IVPT), with that of a pharmacodynamic assay, the human skin blanching or vasoconstrictor (VC) assay, in assessing the relative bioavailability of topical clobetasol propionate products."( Assessing topical bioavailability and bioequivalence: a comparison of the in vitro permeation test and the vasoconstrictor assay.
Franz, TJ; Lehman, PA, 2014
)
0.58
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51

Dosage Studied

Using the visual score, we found dose-response blanching at all concentrations of clobetasol propionate. Dose-response data for dilutions of betamethasone 17-valerate showed progressive diminution of both local and systemic effects with decreasing concentrations.

ExcerptRelevanceReference
"The inflammatory dose-response to anthralin was measured in human skin 24 h after pretreatment with topical corticosteroids and anthralin, and 48 h after removal of the stratum corneum with adhesive tape."( Mechanism of anthralin inflammation. 2. Effect of pretreatment with glucocorticoids, anthralin and removal of stratum corneum.
Lawrence, CM; Shuster, S, 1985
)
0.27
" Dose-response data for dilutions of clobetasol propionate and betamethasone 17-valerate showed progressive diminution of both local and systemic effects with decreasing concentrations."( The effect on epidermal DNA synthesis of a combination of topical steroid with either dithranol or tar as used for psoriasis.
Clement, M; du Vivier, A; Hehir, M; Phillips, H, 1983
)
0.54
" Initially, the dose-response relationship was established for each agent by applying a series of five doses (0."( Fluorescence spectroscopy: a rapid, noninvasive method for measurement of skin surface thickness of topical agents.
Diffey, BL; Rhodes, LE, 1997
)
0.3
" Even when steroids are for external use, their dosage and administration should be monitored, and the risk of ONF should also be considered."( Osteonecrosis of the femoral head that developed after long-term topical steroid application.
Hirasawa, Y; Kojima, A; Kubo, T; Ueshima, K; Yamamoto, T; Yamazoe, S, 2001
)
0.31
" Laser Doppler perfusion imaging (LDPI) data can be combined with dosimetry data to produce objective dose-response plots in addition to the MED."( Phototesting with a divergent UVB beam in the investigation of anti-inflammatory effects of topically applied substances.
Anderson, C; Falk, M; Ilias, MA; Wårdell, K, 2003
)
0.32
" The reaction diameter, the mean perfusion, and the average dose-response plots for each group and treatment were extracted from the LDPI data."( Phototesting with a divergent UVB beam in the investigation of anti-inflammatory effects of topically applied substances.
Anderson, C; Falk, M; Ilias, MA; Wårdell, K, 2003
)
0.32
" Analysis of the dose-response data at doses higher than the MED showed a linear relationship (0."( Phototesting with a divergent UVB beam in the investigation of anti-inflammatory effects of topically applied substances.
Anderson, C; Falk, M; Ilias, MA; Wårdell, K, 2003
)
0.32
"The divergent beam protocol can be used to demonstrate and quantify the effects of topical agents on the UVB reaction, in terms of reaction diameter, mean perfusion and changes in dose-response characteristics."( Phototesting with a divergent UVB beam in the investigation of anti-inflammatory effects of topically applied substances.
Anderson, C; Falk, M; Ilias, MA; Wårdell, K, 2003
)
0.32
"2) with the same dosage regimen."( A new delivery system of clobetasol-17-propionate (lipid-loaded microspheres 0.025%) compared with a conventional formulation (lipophilic ointment in a hydrophilic phase 0.025%) in topical treatment of atrophic/erosive oral lichen planus. A Phase IV, rand
Aricò, P; Campisi, G; De Caro, V; Di Liberto, C; Giandalia, G; Giannola, LI, 2004
)
0.63
"Using the visual score, we found dose-response blanching at all concentrations of clobetasol propionate."( Evaluation of the effects of topical clobetasol propionate by visual score, electrical impedance and laser Doppler flowmetry.
Emtestam, L; Kuzmina, N; Talme, T, 2007
)
0.84
" Seven different dosage forms are available to deliver the drug to the living cells of the skin."( Clobetasol propionate--where, when, why?
Lademann, J; Pels, R; Sterry, W, 2008
)
1.79
" For example, a new formulation of calcipotriene/betamethasone scalp solution has a rapid onset of action with once daily dosing that improves compliance."( Scalp psoriasis.
Kircik, LH; Kumar, S, 2010
)
0.36
" Conventional dosage forms like creams and ointments are commonly prefered for the therapy."( Microparticulate based topical delivery system of clobetasol propionate.
Badıllı, U; Sen, T; Tarımcı, N, 2011
)
0.62
"A 28-year-old man with decreased libido received ashwagandha in the usual daily dosage of 5 g for 10 days."( Fixed-drug eruption caused by ashwagandha (Withania somnifera): a widely used Ayurvedic drug.
Bhattacharya, SN; Sehgal, VN; Verma, P,
)
0.13
"A novel, sensitive, stability-indicating, gradient, reverse-phase high-performance liquid chromatographic method has been developed for quantitative determination of halobetasol propionate and its impurities in topical dosage forms."( Quantification of halobetasol propionate and its impurities present in topical dosage forms by stability-indicating LC method.
Kulkarni, D; Nalwade, S; Reddy, VR; Todamal, S, 2015
)
0.42
"To study the reservoir effect of topical steroids in a steroid-responsive condition which may enable a decrease in the dosing frequency of topical steroids."( The reservoir effect of topical steroids in vitiliginous skin: A cross-sectional study.
Nasir, F; Singh, SK,
)
0.13
" Self-medication and poor adherence to dosage recommendations were noted in the patient's medical history."( [Oral hairy leukoplakia induced by topical steroids].
Boulanger, M; Fricain, JC; Projetti, F; Sibaud, V; Vigarios, E, 2015
)
0.42
"Attempts to use topical cyclosporine in treatment of psoriasis have failed because of unfavorable physicochemical properties and inappropriate formulation design of the conventional dosage forms."( Efficacy of Novel Topical Liposomal Formulation of Cyclosporine in Mild to Moderate Stable Plaque Psoriasis: A Randomized Clinical Trial.
Amarji, B; Dogra, S; Katare, OP; Kumar, R; Kumar, S; Mahajan, R; Singh, B; Vinay, K, 2016
)
0.43
"The aim of this research was the development and characterization of three gel dosage forms of Halobetasol propionate loaded lipid nanoparticles (HB-NLC) for the treatment of inflammatory skin diseases."( Nanostructured lipid carriers loaded with Halobetasol propionate for topical treatment of inflammation: Development, characterization, biopharmaceutical behavior and therapeutic efficacy of gel dosage forms.
Araya, C; Calpena, AC; Carvajal-Vidal, P; Espina, M; García, ML; Gómez de Aranda, I; González-Pizarro, R; Halbaut, L, 2020
)
0.56
" The DPE 3D printing of these dosage forms can allow the reduction of frequency regimen, the therapy personalization, and reduction of oral cavity administration discomfort."( 3D printed mucoadhesive orodispersible films manufactured by direct powder extrusion for personalized clobetasol propionate based paediatric therapies.
Arduino, I; Cilurzo, F; Denora, N; Lopalco, A; Lopedota, A; Meazzini, C; Musazzi, UM; Pistone, M; Racaniello, GF; Rizzi, R, 2023
)
1.13
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (2)

RoleDescription
anti-inflammatory drugA substance that reduces or suppresses inflammation.
SMO receptor agonistAn agonist that enhances the action of smoothened (SMO) receptor.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (8)

ClassDescription
11beta-hydroxy steroidAny 11-hydroxy steroid in which the hydroxy group at position 11 has beta- configuration.
17alpha-hydroxy steroidThe alpha-stereoisomer of 17-hydroxy steroid.
20-oxo steroidAn oxo steroid carrying an oxo group at position 20.
glucocorticoidGlucocorticoids are a class of steroid hormones that regulate a variety of physiological processes, in particular control of the concentration of glucose in blood.
fluorinated steroidA steroid which is substituted with one or more fluorine atoms in any position.
3-oxo-Delta(1),Delta(4)-steroidA 3-oxo-Delta(1) steroid containing an additional double bond between positions 4 and 5.
chlorinated steroidA steroid which is substituted with one or more chlorine atoms in any position.
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 (6)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
TDP1 proteinHomo sapiens (human)Potency0.05310.000811.382244.6684AID686978
AR proteinHomo sapiens (human)Potency4.00810.000221.22318,912.5098AID743035; AID743036; AID743040; AID743053; AID743054; AID743063
glucocorticoid receptor [Homo sapiens]Homo sapiens (human)Potency0.00160.000214.376460.0339AID720691; AID720692; AID720719
estrogen nuclear receptor alphaHomo sapiens (human)Potency0.37860.000229.305416,493.5996AID743069; AID743078
peroxisome proliferator activated receptor gammaHomo sapiens (human)Potency21.31380.001019.414170.9645AID743140
aryl hydrocarbon receptorHomo sapiens (human)Potency10.00780.000723.06741,258.9301AID743085; AID743122
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Bioassays (41)

Assay IDTitleYearJournalArticle
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1664332Inhibition of LPS-induced TNFalpha release in human PBMC cells relative to control2020Bioorganic & medicinal chemistry letters, 08-15, Volume: 30, Issue:16
Discovery of the potent non-steroidal glucocorticoid receptor modulator BAY 1003803 as clinical candidate.
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID588216FDA HLAED, serum glutamic oxaloacetic transaminase (SGOT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID588214FDA HLAED, liver enzyme composite activity2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1664339Inhibition of PHA-induced IL4 release in human PBMC cells2020Bioorganic & medicinal chemistry letters, 08-15, Volume: 30, Issue:16
Discovery of the potent non-steroidal glucocorticoid receptor modulator BAY 1003803 as clinical candidate.
AID1664331Inhibition of LPS-induced TNFalpha release in human PBMC cells2020Bioorganic & medicinal chemistry letters, 08-15, Volume: 30, Issue:16
Discovery of the potent non-steroidal glucocorticoid receptor modulator BAY 1003803 as clinical candidate.
AID588215FDA HLAED, alkaline phosphatase increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID588218FDA HLAED, lactate dehydrogenase (LDH) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID588219FDA HLAED, gamma-glutamyl transferase (GGT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID588217FDA HLAED, serum glutamic pyruvic transaminase (SGPT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1664334Inhibition of LPS-induced IL12p40 release in human PBMC cells relative to control2020Bioorganic & medicinal chemistry letters, 08-15, Volume: 30, Issue:16
Discovery of the potent non-steroidal glucocorticoid receptor modulator BAY 1003803 as clinical candidate.
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1664335Inhibition of PHA-induced IL2 release in human PBMC cells2020Bioorganic & medicinal chemistry letters, 08-15, Volume: 30, Issue:16
Discovery of the potent non-steroidal glucocorticoid receptor modulator BAY 1003803 as clinical candidate.
AID729901Antiinflammatory activity in human PBMCs assessed as inhibition of LPS-induced TNFalpha release incubated for 15 mins prior to LPS challenge measured after 24 hrs by HTRF assay2013Bioorganic & medicinal chemistry letters, Mar-15, Volume: 23, Issue:6
Structure-activity relationships of 6-(aminomethylphenoxy)-benzoxaborole derivatives as anti-inflammatory agent.
AID1664340Inhibition of PHA-induced IL4 release in human PBMC cells relative to control2020Bioorganic & medicinal chemistry letters, 08-15, Volume: 30, Issue:16
Discovery of the potent non-steroidal glucocorticoid receptor modulator BAY 1003803 as clinical candidate.
AID729897Antiinflammatory activity in human PBMCs assessed as inhibition of LPS-induced IL1-beta release at 100 uM incubated for 15 mins prior to LPS challenge measured after 24 hrs by HTRF assay relative to control2013Bioorganic & medicinal chemistry letters, Mar-15, Volume: 23, Issue:6
Structure-activity relationships of 6-(aminomethylphenoxy)-benzoxaborole derivatives as anti-inflammatory agent.
AID729899Antiinflammatory activity in human PBMCs assessed as inhibition of LPS-induced IL6 release incubated for 15 mins prior to LPS challenge measured after 24 hrs by HTRF assay2013Bioorganic & medicinal chemistry letters, Mar-15, Volume: 23, Issue:6
Structure-activity relationships of 6-(aminomethylphenoxy)-benzoxaborole derivatives as anti-inflammatory agent.
AID729900Antiinflammatory activity in human PBMCs assessed as inhibition of LPS-induced IL1-beta release incubated for 15 mins prior to LPS challenge measured after 24 hrs by HTRF assay2013Bioorganic & medicinal chemistry letters, Mar-15, Volume: 23, Issue:6
Structure-activity relationships of 6-(aminomethylphenoxy)-benzoxaborole derivatives as anti-inflammatory agent.
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1702763Antiinflammatory activity against imiquimod-induced psoriasis BALB/c mouse model assessed as body weight loss at 0.02 % applied topically once daily for 12 days2020European journal of medicinal chemistry, Feb-01, Volume: 187Discovery of novel N-sulfonamide-tetrahydroquinolines as potent retinoic acid receptor-related orphan receptor γt inverse agonists for the treatment of autoimmune diseases.
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1664338Inhibition of PHA-induced IFNgamma release in human PBMC cells relative to control2020Bioorganic & medicinal chemistry letters, 08-15, Volume: 30, Issue:16
Discovery of the potent non-steroidal glucocorticoid receptor modulator BAY 1003803 as clinical candidate.
AID1664337Inhibition of PHA-induced IFNgamma release in human PBMC cells2020Bioorganic & medicinal chemistry letters, 08-15, Volume: 30, Issue:16
Discovery of the potent non-steroidal glucocorticoid receptor modulator BAY 1003803 as clinical candidate.
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1664336Inhibition of PHA-induced IL2 release in human PBMC cells relative to control2020Bioorganic & medicinal chemistry letters, 08-15, Volume: 30, Issue:16
Discovery of the potent non-steroidal glucocorticoid receptor modulator BAY 1003803 as clinical candidate.
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID729896Antiinflammatory activity in human PBMCs assessed as inhibition of LPS-induced IL6 release at 100 uM incubated for 15 mins prior to LPS challenge measured after 24 hrs by HTRF assay relative to control2013Bioorganic & medicinal chemistry letters, Mar-15, Volume: 23, Issue:6
Structure-activity relationships of 6-(aminomethylphenoxy)-benzoxaborole derivatives as anti-inflammatory agent.
AID1664333Inhibition of LPS-induced IL12p40 release in human PBMC cells2020Bioorganic & medicinal chemistry letters, 08-15, Volume: 30, Issue:16
Discovery of the potent non-steroidal glucocorticoid receptor modulator BAY 1003803 as clinical candidate.
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID729898Antiinflammatory activity in human PBMCs assessed as inhibition of LPS-induced TNFalpha release at 100 uM incubated for 15 mins prior to LPS challenge measured after 24 hrs by HTRF assay relative to control2013Bioorganic & medicinal chemistry letters, Mar-15, Volume: 23, Issue:6
Structure-activity relationships of 6-(aminomethylphenoxy)-benzoxaborole derivatives as anti-inflammatory agent.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (1,421)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990211 (14.85)18.7374
1990's220 (15.48)18.2507
2000's344 (24.21)29.6817
2010's502 (35.33)24.3611
2020's144 (10.13)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 117.16

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 Index117.16 (24.57)
Research Supply Index7.56 (2.92)
Research Growth Index4.74 (4.65)
Search Engine Demand Index239.93 (26.88)
Search Engine Supply Index2.19 (0.95)

This Compound (117.16)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials389 (25.39%)5.53%
Reviews118 (7.70%)6.00%
Case Studies520 (33.94%)4.05%
Observational4 (0.26%)0.25%
Other501 (32.70%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (109)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Combined Topical 5% Minoxidil and Potent Topical Corticosteroid Versus Intralesional Corticosteroid in the Treatment of Alopecia Areata A Randomized Controlled Trial [NCT03535233]Phase 440 participants (Actual)Interventional2016-03-31Completed
Investigating Anti-inflammatory Effects of Topical Antibiotics in an LPS Skin Challenge Model [NCT03779360]32 participants (Actual)Interventional2018-10-12Completed
Spray® and Vectical Ointment® in the Treatment of Plaque Psoriasis [NCT01205880]Phase 412 participants (Actual)Interventional2009-12-31Completed
A Randomized, Open-Label, Controlled Trial of Topical AC-203 in Subjects With Bullous Pemphigoid [NCT03286582]Phase 210 participants (Actual)Interventional2017-09-05Terminated(stopped due to Terminated with partial enrollment completed)
Comparison of Monotherapy With Protracted Superpotent Topical Steroids to Superpotent Topical Steroids Associated With Methotrexate in Bullous Pemphigoid [NCT02313870]Phase 3322 participants (Actual)Interventional2008-01-22Completed
Screening for Adrenal Insufficiency During Dermocorticoid Reduction in Bullous Pemphigoid [NCT06148090]50 participants (Anticipated)Interventional2023-11-22Not yet recruiting
A Randomised, Double-blind (for GW870086), Placebo-controlled Study of Topical GW870086 Formulation to Explore the Potential for Skin Thinning in Healthy Adult Volunteers [NCT01381445]Phase 120 participants (Actual)Interventional2011-04-14Completed
Treatment of Hypertrophic Scars Using Fractional Laser and Fractional Laser-assisted Topical Corticosteroid Delivery [NCT02487212]Phase 424 participants (Actual)Interventional2014-04-30Completed
A Study of Topical Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) and a Phase III Comparative Treatment Study of HAL PDT in Female Genital Erosive Lichen Planus (GELP) [NCT01282515]Phase 2/Phase 340 participants (Actual)Interventional2011-08-31Completed
A Prospective, Randomised, Investigator-Blinded, Vehicle-Controlled, Phase I Clinical Trial With Intra-Individual Comparison of Treatments to Assess the Potential of LEO 130852A Gel to Reduce Steroid Induced Skin Atrophy on Healthy Skin [NCT02392130]Phase 140 participants (Actual)Interventional2015-03-31Completed
Effect of the Probiotic Bifidobacterium Animalis Subsp. Lactis HN019 on Clinical, Histopathological and Immunophenotypic Features of Oral Lichen Planus [NCT03386643]Phase 222 participants (Actual)Interventional2017-11-06Completed
A Phase 3, Multicenter, Randomized, Evaluator-blinded Clinical Trial to Assess the Safety and Efficacy of Clobetasol Propionate Ophthalmic Nanoemulsion, 0.05% Compared to Prednisolone Acetate, 1% in the Treatment of Inflammation After Cataract Surgery in [NCT05724446]Phase 360 participants (Anticipated)Interventional2022-12-12Recruiting
Comparative Efficacy of Tacrolimus 0.1% and Clobetasol Propionate 0.05% in the Treatment of Alopecia Areata [NCT05885269]Phase 170 participants (Actual)Interventional2022-11-01Completed
A Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Parallel Group Study of the Efficacy and Safety of DFD-06 Cream in the Treatment of Moderate to Severe Plaque Psoriasis for 14 Days [NCT02635204]Phase 3267 participants (Actual)Interventional2015-12-31Completed
A Randomized, Unblinded Trial of Topical Steroids Plus CO2 Laser Compared to Steroids Alone in the Treatment of Vulvovaginal Lichen Sclerosus [NCT05243563]Phase 2/Phase 352 participants (Anticipated)Interventional2022-04-13Recruiting
A Phase 1b Open Label, Randomized Study Evaluating the Absorption and Systemic Pharmacokinetics and HPA Axis Suppression Potential of Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects With Moderate to Severe Plaque Psoriasis [NCT03058744]Phase 194 participants (Actual)Interventional2015-04-30Completed
Safety and Efficacy of Clobetasol Propionate 0.05% E Foam in the Treatment of Central Centrifugal Cicatricial Alopecia [NCT01111981]Phase 430 participants (Anticipated)Interventional2009-10-31Recruiting
Influence of Dermocorticoids on Bone Mineral Density in Patients With Bullous Pemphigoid [NCT03926377]Phase 450 participants (Anticipated)Interventional2019-04-01Recruiting
A Randomized Placebo Controlled Split-body Double-blind Phase II Clinical Trial to Investigate the Safety and Efficacy of Clobetasol 0.05% Ointment for the Treatment of Toxic Epidermal Necrolysis (TEN) [NCT02319616]Phase 1/Phase 20 participants (Actual)Interventional2016-11-30Withdrawn(stopped due to Lack of enrollment)
An Open Label Study to Evaluate Safety, Efficacy and Tolerability of Clobetasol Propionate for the Condition of Chronic Hand Dermatitis [NCT00828464]Phase 430 participants (Actual)Interventional2008-10-31Completed
Apremilast in Combination With Clobetasol Spray for the Treatment of Plaque Psoriasis [NCT03453190]Phase 420 participants (Anticipated)Interventional2018-02-25Recruiting
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 Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Halobetasol Propionate and Tazarotene Topical Lotion 0.01%/0.045% (Taro Pharmaceuticals U.S.A., Inc.) to Duobrii® Lotion (Halobetasol Propionate and Tazarotene L [NCT05282771]Early Phase 1402 participants (Actual)Interventional2021-04-16Completed
Clinical Trial of Effectiveness and Safety of Topical Halobetasol Propionate in the Treatment of Patients With Psoriasis Plate, and as Comparator the Product Psorex (Clobetasol Propionate). [NCT00715975]Phase 2/Phase 3140 participants (Anticipated)Interventional2008-07-31Completed
A Comparison Between Clobetasol Propionate (Clobex®) Spray and Clobetasol Propionate Ointment With Regard to Efficacy, Safety, Subject Satisfaction and Duration of Response in Moderate to Severe Plaque Psoriasis [NCT00733954]Phase 4250 participants (Actual)Interventional2007-08-31Completed
An Open-label, Multi-center, Randomized, Evaluator-Blinded Study to Evaluate the Safety and Efficacy of Two Treatment Regimens Involving Vectical™ (Calcitriol) Ointment 3 µg/g and Clobex® (Clobetasol Propionate) Spray, 0.05% in the Treatment of Moderate P [NCT00988637]Phase 4138 participants (Actual)Interventional2009-10-31Completed
Effect of Topical Corticosteroids on the Incidence of Postinflammatory Hyperpigmentation Following Q-switched Nd:YAG 532 nm Laser for Treatment of Facial Lentigines - A Pilot Study [NCT02492373]21 participants (Actual)Interventional2015-02-28Completed
An Open-label Safety Study to Assess the Multiple-dose Pharmacokinetics and Potential for Adrenal Suppression Following Topical Treatment With Halobetasol Propionate 0.05% Topical Spray Applied Twice Daily for 28 Days in Patients With Moderate to Severe P [NCT03298581]Phase 20 participants (Actual)Interventional2017-01-01Withdrawn(stopped due to Sponsor decision)
Platelet Rich-plasma in Management of Chronic Multiple Oral Ulcers [NCT03878771]Phase 1804 participants (Actual)Interventional2019-03-13Completed
A Multicenter Randomized Double-blind Placebo-controlled Parallel Group Phase II Study Evaluating the Clinical Efficacy and Safety of GN-037 Cream Used in the Treatment of Mild to Moderate Plaque Psoriasis [NCT05706870]Phase 2190 participants (Actual)Interventional2022-12-07Active, not recruiting
Monocentric, Prospective, Randomised, Single Blinded, Active-controlled Trial to Prove That the Treatment With Monalisa Glide is Equal to Topic Clobetasol Propionate Maintenance Therapy in Vulvar Lichen Sclerosus [NCT06135402]120 participants (Anticipated)Interventional2023-11-10Recruiting
A Demonstration of the Anti-Inflammatory Effects of 0.045% Tazarotene/0.01% Halobetasol Lotion as Compared to 0.05% Clobetasol Propionate Cream in the Treatment of Psoriasis [NCT06042647]Phase 410 participants (Actual)Interventional2023-07-13Completed
A Psoriasis Plaque Study Comparing Clobetasol Propionate Plus Calcipotriol Ointment With Clobetasol Propionate Ointment Alone, Calcipotriol Ointment Alone and a Vehicle Control for the Treatment of Psoriasis Vulgaris [NCT01043224]Phase 124 participants (Actual)Interventional2010-01-31Completed
Pilot Study of Vulvar Lichen Sclerosus (VLS) Treatment Using Adipose Tissue Associated With Autologous Platelet-rich Plasma (PRP). [NCT03961126]Phase 220 participants (Actual)Interventional2017-09-06Completed
A Randomized Controlled Trial of Vulvar Fractionated CO2-Laser Therapy With and Without Concomitant Topical Clobetasol Propionate 0.05% Ointment for Treatment of Vulvar Lichen Sclerosus [NCT04951206]Phase 4184 participants (Anticipated)Interventional2022-03-01Recruiting
Comparison of Tacrolimus 0.1% and Clobetasol 0.05% in the Management of Symptomatic Oral Lichen Planus- A Double-blinded Randomized Clinical Trial in Sri Lanka [NCT02744378]Phase 268 participants (Actual)Interventional2014-06-30Completed
A Phase 3, Multicenter, Randomized, Double-Masked Clinical Trial to Assess the Efficacy and Safety of Clobetasol Propionate Ophthalmic Nanoemulsion 0.05% Compared to Placebo in the Treatment of Inflammation and Pain Associated With Cataract Surgery [NCT04249076]Phase 3215 participants (Actual)Interventional2020-06-04Completed
Comparison of Skin Thickness Under Treatment With Pimecrolimus 1% Cream (Elidel® 1% Cream), Hydrocortisonacetat 1% Cream (Hydrogalen® Cream), Betamethasonvalerat 0,1% Cream (Betagalen® Cream) and Clobetasol-17-propionat 0,05% Cream (Clobegalen® Cream) Ass [NCT00655512]Phase 140 participants (Actual)Interventional2008-01-31Completed
A Multi-Center, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Clobetasol Propionate Spray Versus Vehicle for the Management of Moderate to Severe Plaque Psoriasis of the Scalp [NCT00881868]Phase 481 participants (Actual)Interventional2009-04-30Completed
[NCT01946386]Phase 135 participants (Actual)Interventional2013-09-30Completed
A Steroid-Sparing Effect of Supplemental LCD Treatment in Patients With Moderate-to-Severe Localized Psoriasis Lesions: a Pilot Study. [NCT00769184]15 participants (Actual)Interventional2008-10-31Completed
Pilot Open-Label Clinical Trial to Test Efficacy and Safety of Combination of Clobex® Spray With Excimer Laser Therapy [Photomedex XTRAC ® Velocity] in the Treatment of Generalized Plaque Psoriasis Followed by Maintenance With Topical Vectical® Ointment [NCT01012713]Phase 430 participants (Actual)Interventional2010-06-30Completed
A Phase 3, Multicenter, Randomized, Double-Masked Clinical Trial to Assess the Efficacy and Safety of Clobetasol Propionate Ophthalmic Nanoemulsion 0.05% Compared to Placebo in the Treatment of Inflammation and Pain Associated With Cataract Surgery [NCT04246801]Phase 3250 participants (Actual)Interventional2020-06-10Completed
Comparative Effectiveness Trial of Topical Calcipotriene, Clobetasol, and Tacrolimus in the Treatment of Pediatric Plaque Morphea [NCT02680717]Phase 10 participants (Actual)Interventional2016-03-31Withdrawn(stopped due to Unable to obtain IRB approval at all sites)
[NCT01166646]Phase 243 participants (Actual)Interventional2010-07-31Completed
Bioequivalence of Two Clobetasol Propionate 0.05% Topical Foams [NCT00803439]80 participants (Actual)Observational2005-04-30Completed
[NCT02733874]Phase 4240 participants (Actual)Interventional2015-04-30Completed
A Single-blind, Single Exposure Study, to Evaluate the Vasoconstriction Activity of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects: Pivotal Bioequivalence Study [NCT00865605]Phase 171 participants (Actual)Interventional2003-12-31Completed
Interest of Topical Spironolactone's Administration to Prevent Corticoid-induced Epidermal Atrophy [NCT01407471]Phase 226 participants (Actual)Interventional2011-09-30Completed
Bioequivalence of Two Clobetasol Propionate 0.05% Topical Lotions [NCT00864500]Phase 1224 participants (Actual)Interventional2005-11-30Completed
Efficacy and Safety of Clobetasol Propionate Shampoo 0.05% Used in Association With an Antifungal Shampoo in the Treatment of Moderate to Severe Scalp Seborrheic Dermatitis [NCT00862654]Phase 3326 participants (Actual)Interventional2009-03-31Completed
A Double Blind Phase II Study Comparing Safety and Efficacy of Tacrolimus Versus Topical Clobetasol Propionate in the Treatment of Vulvar Lichen Sclerosus. [NCT00757874]Phase 256 participants (Actual)Interventional2006-04-30Completed
A Multi-Center, Open-Label Study to Evaluate the Safety and Efficacy of a Consecutive Treatment Regimen of Clobetasol Propionate 0.05% Spray, Followed by Calcitriol Ointment 3µg/g, in the Management of Moderate to Severe Plaque Psoriasis [NCT00658788]Phase 3305 participants (Actual)Interventional2008-03-31Completed
Bioequivalence of Three Halobetasol Propionate 0.05% Topical Creams [NCT00803166]60 participants (Actual)Observational2004-01-31Completed
Comparison of Efficacy of Glycerol, Two Topical Steroids, and a Topical Immune Modulator Against Experimentally Induced Skin Irritation [NCT00779792]Phase 436 participants (Actual)Interventional2008-09-30Active, not recruiting
Dose Response of Clobex 0.05% Lotion [NCT00864240]Phase 115 participants (Actual)Interventional2005-10-31Completed
Dupilumab Impact on Skin Resident Memory T Cells [NCT03983460]20 participants (Anticipated)Interventional2020-03-09Recruiting
DRESS - Setting of Corticosteroid Treatment. [NCT01987076]112 participants (Anticipated)Interventional2013-10-31Recruiting
Efficacy of Topical Treatment With Clobetasol in Symptomatic Oral Lichen Planus. A Multicenter Placebo-controlled Randomized Clinical Trial. [NCT04364555]Phase 2/Phase 390 participants (Anticipated)Interventional2020-05-18Recruiting
A Randomized Study to Evaluate the Efficacy and Safety of Adding Topical Therapy to Etanercept in Subjects With Moderate to Severe Plaque Psoriasis [NCT01235442]Phase 3592 participants (Actual)Interventional2010-09-30Completed
Evaluation of Topical Rebamipide Versus Topical Clobetasol in Management of Methotrexate-Induced Oral Ulceration in Rheumatoid Arthritis Patients: Randomized-Controlled Clinical Trial [NCT04649697]Phase 339 participants (Anticipated)Interventional2020-12-01Recruiting
A 28-day, Double-blind, Randomized, Reference-controlled Psoriasis Plaque Test to Evaluate the Efficacy and Safety of Two Different BAY1003803 Formulation Types in 2 Concentrations Each in Treatment of Symptomatic Volunteers With Plaque-type Psoriasis [NCT02940002]Phase 123 participants (Actual)Interventional2016-10-12Completed
A Study to Evaluate the Efficacy and Tolerability of Clobetasol Propionate vs. Vehicle in the Treatment of Mild to Moderate Plaque-Type Psoriasis [NCT00842153]Phase 458 participants (Actual)Interventional2007-11-30Completed
Bioequivalence of Two Halobetasol Propionate 0.05% Topical Ointments [NCT00802958]76 participants (Actual)Observational2003-07-31Completed
A Double-Blind, Parallel-group Trial of Topical Pimecrolimus Cream 1% (Elidel®) Versus Clobetasol 0.05% Cream for the Treatment of Vulvar Lichen Sclerosus [NCT00393263]Phase 238 participants (Actual)Interventional2006-10-31Completed
A Randomized, Dose-Ranging, Double Blind Study to Demonstrate the Safety and Efficacy of a CITI-002 Cream in the Seven Day Twice-Daily Treatment of Grade II or III Hemorrhoids [NCT05348200]Phase 2304 participants (Actual)Interventional2022-04-22Completed
A Clinical Study Comparing the Efficacy of Ultravate Ointment Once Daily vs. Twice Daily in Combination With Lac-Hydrin Lotion in the Treatment of Stable Plaque Psoriasis [NCT00990561]Phase 440 participants (Actual)Interventional2009-07-31Completed
Ethanol-Free Clobetasol Propionate Foam 0.05% (Olux-E Foam) vs Vehicle Foam in the Treatment of Chronic Hand Dermatitis. [NCT01323673]Phase 4125 participants (Actual)Interventional2010-11-15Completed
Escalating Dose Study for Safety, Tolerability and Pharmacokinetics After Single and Multiple Dermal Administration of Two BAY1003803 Formulation Types With Two Concentrations Each in Healthy Male Volunteers, Applying a Double-blind, Vehicle-controlled De [NCT02936492]Phase 132 participants (Actual)Interventional2016-10-24Terminated
Ointment Therapy and Prevention of Cannulation-Induced Superficial Phlebitis [NCT04685031]Phase 1/Phase 2110 participants (Anticipated)Interventional2021-02-01Not yet recruiting
Regorafenib Dose Optimization Study (ReDOS): A Phase II Randomized Study of Lower Dose Regorafenib Compared to Standard Dose Regorafenib in Patients With Refractory Metastatic Colorectal Cancer (mCRC) [NCT02368886]Phase 2123 participants (Actual)Interventional2015-03-27Completed
A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-122 Lotion (0.01% Halobetasol Propionate) to Ultravate® (Halobetasol Propionate) Cream, in the Treatment of Plaque Psoriasis [NCT02785185]Phase 2150 participants (Actual)Interventional2016-06-30Completed
Comparison of the Maintenance Effect of Clobex® Shampoo 0.05% Used Twice Weekly vs. Vehicle on Scalp Psoriasis in Subjects Who Successfully Responded to a 4-week Daily Course of Clobex® Shampoo 0.05% [NCT00400725]Phase 3288 participants (Actual)Interventional2006-09-29Completed
CO2 Non-ablative Laser Versus Topical Clobetasol for Lichen Sclerosus: a Prospective, Open-label, Randomized Trial [NCT05010421]Phase 3198 participants (Anticipated)Interventional2021-11-02Recruiting
A Study to Evaluate Safety and Efficacy of Clobetasol Propionate for Treatment of Plaque-Type Psoriasis in Adult Subjects. [NCT00852761]Phase 434 participants (Actual)Interventional2009-03-31Completed
Valacyclovir+Temovate Gel for the Episodic Treatment of Herpes Labialis: A Patient-Initiated Double-Blind, Placebo-Controlled Study, Randomized Study. [NCT00297011]Phase 2300 participants Interventional2004-09-30Completed
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
Randomized Double-blid Clinical Trial Comparing the Topical Treatment With Clobetasol and Dexamethasone for Oral Lesions of Chronic Graft-versus-host Disease in Allogeneic Hematopoietic Stem Cell Transplant Recipients [NCT01699412]Phase 328 participants (Actual)Interventional2008-08-31Completed
Comparison of Efficacy and Safety of Psoriatic Nails Treatment Between by Intralesional 0.1%Triamcinolone Injection and Topical 0.05%Clobetasol Propionate Ointment [NCT01703325]Phase 416 participants (Actual)Interventional2010-11-30Completed
Mechanistically-based Optimization of UV Radiation Therapy in Psoriasis [NCT00470392]9 participants (Actual)Interventional2007-05-31Terminated(stopped due to Recruiting complete and administrative termination)
Subject Reported Target-lesion Numeric Rating Scale Evaluation by Subjects With Plaque Psoriasis Treated With Clobex® (Clobetasol Propionate) Spray 0.05% [NCT01893567]Phase 428 participants (Actual)Interventional2013-07-31Completed
Treatment Results for Patients With Central Centrifugal Cicatricial Alopecia (CCCA): a Multicenter Prospective Study [NCT04207931]Phase 4250 participants (Anticipated)Interventional2018-04-30Recruiting
Open-Label Study of the Pharmacokinetics and Safety Including HPA Axis Suppression Potential of Clobetasol Topical Oil in Pediatric Subjects With Moderate to Severe Atopic Dermatitis [NCT03847389]Phase 1/Phase 28 participants (Actual)Interventional2019-09-09Terminated(stopped due to Difficulty in enrollment and COVID-19 pandemic.)
Efficacy of a Topic Therapy With Progesterone Compared to the Conventional Therapy With Clobetasol Propionate in Patients With Vulvar Lichen Sclerosus. A Double Blind, Randomized Phase II Pilot Study. [NCT01126255]Phase 237 participants (Actual)Interventional2011-03-31Terminated(stopped due to Recruitment problems)
Phase 4 Open-Label Multicenter Community-based 4-Wk Trial to Assess Efficacy, Tolerance to Tx & Patient Satisfaction w/ CLOBEX® Spray When Used as Mono- or Add-on Therapy to Existing Systemic/Topical Agents for Tx of Plaque Psoriasis [NCT00437216]2,488 participants (Actual)Observational2006-02-28Completed
A Randomized Double-Blind Pilot Study of Topical Clobetasol 0.05% Oral Rinse for Oral Chronic Graft-Versus-Host-Disease [NCT01557517]Phase 240 participants (Actual)Interventional2012-01-26Completed
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
Efficacy and Safety of Duobrii in the Management of Acne Keloidalis Nuchae (AKN) [NCT05608499]Phase 330 participants (Anticipated)Interventional2022-10-26Recruiting
Olux E Foam and Sorilux Foam Combination Therapy for the Maintenance of Treatment Response in Patients With Moderate Plaque Psoriasis [NCT01745133]Phase 463 participants (Actual)Interventional2013-01-31Completed
An Open Label Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of Twice Daily Halobetasol Propionate Lotion, 0.05% in Subjects 12 to 16 Years 11 Months of Age With Plaque Psoriasis Receiving Two Weeks of Treatment [NCT03212963]Phase 416 participants (Actual)Interventional2017-03-21Terminated(stopped due to Sponsor's Decision)
A Randomized Controlled Trial of Clobetasol Propionate 0.05% Cream Versus Hydrocortisone 1% Cream in Children With Alopecia Areata [NCT01453686]Phase 341 participants (Actual)Interventional2002-08-31Completed
Randomized Clinical Trial, Controlled to Conventional Treatment, to Evaluate the Efficacy of Plasma Rich in Growth Factors (PRGF) for the Treatment of Lichen Sclerosus Atrophicus of the Vulva [NCT05364515]Phase 330 participants (Anticipated)Interventional2022-10-31Not yet recruiting
Prospective, Randomized, Active-controlled Investigator Initiated Clinical Trial to Demonstrate That the Nd:YAG/Er:YAG Dual Laser Therapy is Effective to Treat Vulvar Lichen Sclerosus and Similar to Standard Treatment With Steroid Cream [NCT03926299]66 participants (Actual)Interventional2019-07-15Active, not recruiting
Vasoconstriction Trial Comparing LEO 90100 With Dermovate Cream, Diprosone Ointment, Elocon Cream, Locoid Ointment and LEO 90100 Vehicle [NCT02973776]Phase 136 participants (Actual)Interventional2016-12-31Completed
A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-118 Lotion to Ultravate® in the Treatment of Plaque Psoriasis [NCT02785172]Phase 2154 participants (Actual)Interventional2016-04-30Completed
Evaluation of Fluid Retention Due to Superpotent Topical Corticosteroid in Patients With Bullous Pemphigoid [NCT02360202]Phase 435 participants (Anticipated)Interventional2015-04-30Recruiting
A Randomized Trial of Clobetasol Propionate Versus Fractionated CO2 Laser for the Treatment of Lichen Sclerosus (CuRLS) [NCT02573883]Phase 352 participants (Actual)Interventional2015-10-31Completed
Vulvar Lichen Sclerosus: Therapeutic Comparison Between Clobetasol Propionate, Photodynamic Therapy and Low-Intensity Laser [NCT02416531]30 participants (Actual)Interventional2015-01-31Completed
Evaluation of the Efficacy of Supplementary Probiotic Capsules With Topical Clobetasol Propionate 0.05% in the Treatment of Oral Lichen Planus [NCT06119672]Phase 336 participants (Anticipated)Interventional2023-05-01Recruiting
Impact of Topical Clobetasol on Gingival Crevicular Fluid miRNAs in Subjects Affected by Oral Lichen Planus: a Randomized Clinical Trial [NCT05818618]64 participants (Actual)Interventional2020-03-12Completed
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
A Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Parallel Group Study of the Efficacy and Safety of DFD-06 Cream in the Treatment of Moderate to Severe Plaque Psoriasis for 14 Days [NCT02445807]Phase 3265 participants (Actual)Interventional2015-12-31Completed
A Randomized, Double-blind, Placebo-controlled, Parallel Group Clinical Study to Assess the Safety and Efficacy of Three Doses of Clobetasol Propionate When Administered Intra-orally Twice Daily in Patients With Oral Lichen Planus (OLP) Using Rivelin®-CLO [NCT03592342]Phase 2140 participants (Actual)Interventional2018-06-28Completed
A Comparison Between Clobetasol Propionate (Clobex®) Spray and Clobetasol Propionate (Olux®) Foam With Regard to Efficacy, Safety, Preference and Duration of Response in Stable Plaque Psoriasis [NCT00436540]Phase 478 participants (Actual)Interventional2006-03-31Completed
Efficacy of Photobiomodulation for Oral Lichen Planus Treatment [NCT03320460]44 participants (Anticipated)Interventional2018-11-01Recruiting
A Comparative Study on Clinical Efficacy of Clobetasol and Betamethasone in Orabase in Combination With Clotrimazole, in Oral Lichen Planus [NCT03026478]Phase 230 participants (Anticipated)Interventional2016-05-06Recruiting
A Single-Centre, Explorative, Randomised, Investigator-Blinded, Negative-Controlled, Phase I Clinical Trial With Intra-Individual Comparison of Treatments to Assess Steroid Induced Skin Atrophy on Healthy Skin [NCT02355639]Phase 116 participants (Actual)Interventional2015-01-31Completed
A Randomized, Open Label, Study to Assess the Potential for Adrenal Suppression and Systemic Drug Absorption With DFD-06 Cream Versus Clobetasol Propionate Cream, 0.05% in Subjects With Moderate to Severe Plaque Psoriasis [NCT02131324]Phase 250 participants (Actual)Interventional2014-05-08Completed
An Open Label, Multicenter Study to Assess the Potential for Adrenal Suppression and Systemic Drug Absorption Following Multiple Dosing With DFD-06 in Pediatric Subjects With Moderate to Severe Plaque Psoriasis [NCT03179605]Phase 222 participants (Actual)Interventional2017-05-02Terminated(stopped due to Difficulty in enrollment)
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00400725 (8) [back to overview]Maintenance Phase: Time to First Relapse
NCT00400725 (8) [back to overview]Initial Phase: Percentage of Participants With Global Severity Scores
NCT00400725 (8) [back to overview]Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores
NCT00400725 (8) [back to overview]Initial Phase: Percentage of Participants With Pruritus Scores
NCT00400725 (8) [back to overview]Maintenance Phase: Percentage of Participants Who Had First Relapse
NCT00400725 (8) [back to overview]Maintenance Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores at First Time of Relapse
NCT00400725 (8) [back to overview]Maintenance Phase: Percentage of Participants With Number of Relapses Experienced
NCT00400725 (8) [back to overview]Maintenance Phase: Percentage of Participants With Scalp Psoriasis Pruritus Score at First Time of Relapse
NCT00470392 (3) [back to overview]Number of Subjects With Improvement in Lesional Psoriasis Area and Assessment (PASI) Score After Imiquimod and UVB Treatment
NCT00470392 (3) [back to overview]Number of Subjects With Elevated MyxA
NCT00470392 (3) [back to overview]Number of Subjects With a 1.5 Fold Increase in mRNA Expression of GRAMD1A and DMXL2
NCT00658788 (12) [back to overview]Signs of Psoriasis - Plaque Elevation
NCT00658788 (12) [back to overview]Signs of Psoriasis - Erythema
NCT00658788 (12) [back to overview]Overall Disease Severity
NCT00658788 (12) [back to overview]Global Improvement Score
NCT00658788 (12) [back to overview]Percent Change From Baseline in Body Surface Area (% BSA) Affected
NCT00658788 (12) [back to overview]Tolerability Assessment - Telangiectasias
NCT00658788 (12) [back to overview]Tolerability Assessment - Stinging/ Burning
NCT00658788 (12) [back to overview]Overall Disease Severity Success (ODS)
NCT00658788 (12) [back to overview]Tolerability Assessment - Skin Atrophy
NCT00658788 (12) [back to overview]Tolerability Assessment - Pruritus
NCT00658788 (12) [back to overview]Tolerability Assessment - Folliculitis
NCT00658788 (12) [back to overview]Signs of Psoriasis - Scaling
NCT00733954 (19) [back to overview]Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to After Two Weeks of Treatment
NCT00733954 (19) [back to overview]Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to After Two Weeks of Treatment
NCT00733954 (19) [back to overview]Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to End of Treatment
NCT00733954 (19) [back to overview]Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to Two Weeks Post Treatment
NCT00733954 (19) [back to overview]Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to After Two Weeks of Treatment
NCT00733954 (19) [back to overview]Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to End of Treatment
NCT00733954 (19) [back to overview]Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to Two Weeks Post Treatment
NCT00733954 (19) [back to overview]Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to End of Treatment
NCT00733954 (19) [back to overview]Number of Participants Who Are Clear/Almost Clear of Plaque Psoriasis From Baseline to 2 Weeks Post Treatment Based on the Overall Disease Severity (ODS) Scale
NCT00733954 (19) [back to overview]Number of Participants Who Are Clear/Almost Clear of Plaque Psoriasis From Baseline to After Two Weeks of Treatment Based on the Overall Disease Severity (ODS) Scale
NCT00733954 (19) [back to overview]Number of Participants Who Are Clear/Almost Clear of Plaque Psoriasis From Baseline to End of Treatment Based on the Overall Disease Severity (ODS) Scale
NCT00733954 (19) [back to overview]Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to After Two Weeks of Treatment
NCT00733954 (19) [back to overview]Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to End of Treatment
NCT00733954 (19) [back to overview]Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to Two Weeks Post Treatment
NCT00733954 (19) [back to overview]Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to Two Weeks Post Treatment
NCT00733954 (19) [back to overview]Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to After Two Weeks of Treatment
NCT00733954 (19) [back to overview]Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to End of Treatment
NCT00733954 (19) [back to overview]Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to Two Weeks Post Treatment
NCT00733954 (19) [back to overview]Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Two Weeks Post Treatment
NCT00769184 (2) [back to overview]Mean Percent Improvement in Disease Severity Using PGA and OTLS Scores of Target Lesions
NCT00769184 (2) [back to overview]Percentage of Patients Who Are Clear (PGA Score 0) or Have Minimal Disease (PGA Score 1) on Each Treated Side at Each Visit.
NCT00828464 (14) [back to overview]Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Finger Tips
NCT00828464 (14) [back to overview]Change in Subject's Visual Analogue Assessment Scale
NCT00828464 (14) [back to overview]Change in Subject's Visual Analogue Assessment Scale From Baseline to Day 15
NCT00828464 (14) [back to overview]Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline - Fingers
NCT00828464 (14) [back to overview]Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Back of Hands
NCT00828464 (14) [back to overview]Proportion of Subjects With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Fingers
NCT00828464 (14) [back to overview]Proportion of Subjects at Day 8 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Palm of Hands
NCT00828464 (14) [back to overview]Proportion of Subjects With at Least 1-grade Improvement From Baseline to Day 15 in Investigator's Static Global Assessment Score (ISGA) Score
NCT00828464 (14) [back to overview]Proportion of Subjects Who Achieve at Least a 1-grade Improvement Based on the ISGA at Day 8.
NCT00828464 (14) [back to overview]Proportion of Subjects at Day 8 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Wrists
NCT00828464 (14) [back to overview]Proportion of Subjects at Day 8 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Finger Tips
NCT00828464 (14) [back to overview]Proportion of Subjects at Day 8 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Back of Hands
NCT00828464 (14) [back to overview]Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Wrists
NCT00828464 (14) [back to overview]Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Palm of Hands
NCT00842153 (15) [back to overview]Number of Participants With a Scaling Score of 0 or 1 at Baseline and Week 4
NCT00842153 (15) [back to overview]Number of Participants With a Scaling Score of 0 or 1 at Week 2
NCT00842153 (15) [back to overview]Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Week 2
NCT00842153 (15) [back to overview]Number of Participants With a Plaque Thickness Score of 0 or 1 at Baseline and Week 4
NCT00842153 (15) [back to overview]Number of Participants With a Target Lesion Global Improvement (TLGI) Score of 0, 1, or 2 at Weeks 1, 2, and 4
NCT00842153 (15) [back to overview]Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Baseline and Week 4
NCT00842153 (15) [back to overview]Number of Participants With a Plaque Thickness Score of 0 or 1 at Week 2
NCT00842153 (15) [back to overview]Mean Percent Change From Baseline to Week 4 in Pruritus (Target Lesion)
NCT00842153 (15) [back to overview]Mean Percent Change From Baseline to Week 2 in Pruritus (Target Lesion)
NCT00842153 (15) [back to overview]Number of Participants With an Erythema Score of 0 or 1 at Week 2
NCT00842153 (15) [back to overview]Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Week 2
NCT00842153 (15) [back to overview]Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Baseline and Week 4
NCT00842153 (15) [back to overview]Number of Participants With an Erythema Score of 0 or 1 at Baseline and Week 4
NCT00842153 (15) [back to overview]Number of Participants With a TLGI Score of 0, 1, or 2 at Week 1 and Week 4
NCT00842153 (15) [back to overview]Number of Participants With a TLGI Score of 0, 1, 2, or 3 at Weeks 1, 2, and 4
NCT00852761 (19) [back to overview]At Least 1 Grade Improvement in the Psoriasis Global Assessment
NCT00852761 (19) [back to overview]At Least 1 Grade Improvement in Subject's Global Assessment
NCT00852761 (19) [back to overview]At Least a One Grade Improvement for the Target Psoriasis Lesion on the Elbow or Knee (Psoriasis Grading Scale)
NCT00852761 (19) [back to overview]At Least a 2 Grade Improvement in the Psoriasis Global Assessment
NCT00852761 (19) [back to overview]At Least a 3 Grade Improvement in Subject's Global Assessment
NCT00852761 (19) [back to overview]At Least a 3 Grade Improvement in the Psoriasis Global Assessment
NCT00852761 (19) [back to overview]At Least a 2 Grade Improvement Psoriasis Grading Scale
NCT00852761 (19) [back to overview]Dermatology Life Quality Index (DLQI) Categories
NCT00852761 (19) [back to overview]Dermatology Quality of Life - Daily Activities
NCT00852761 (19) [back to overview]Dermatology Quality of Life - Leisure
NCT00852761 (19) [back to overview]Dermatology Quality of Life - Personal Relationships
NCT00852761 (19) [back to overview]Dermatology Quality of Life - Symptoms and Feelings
NCT00852761 (19) [back to overview]Dermatology Quality of Life - Treatment
NCT00852761 (19) [back to overview]Dermatology Quality of Life - Work and School
NCT00852761 (19) [back to overview]Median Change in Psoriasis Grading Scale
NCT00852761 (19) [back to overview]Total Dermatology Life Quality Index (DLQI) Score
NCT00852761 (19) [back to overview]At Least a 2 Grade Improvement in Subject's Global Assessment
NCT00852761 (19) [back to overview]At Least 1 Grade Improvement Psoriasis Grading Scale
NCT00852761 (19) [back to overview]At Least a 3 Grade Improvement Psoriasis Grading Scale
NCT00862654 (1) [back to overview]Total Severity Score (TSS): Percent Change From Baseline at Week 4
NCT00881868 (4) [back to overview]Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4
NCT00881868 (4) [back to overview]Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4
NCT00881868 (4) [back to overview]Number of Participants in Each Category of Pruritus at Baseline and Week 4
NCT00881868 (4) [back to overview]Number of Participants Who Were a Success or Failure Based on the Global Severity Score (GSS) of Scalp Psoriasis From Baseline to End of Treatment (Week 4 or Week 2 if Clear)
NCT00988637 (13) [back to overview]Median Percent (%) Change From Baseline in % Treatable BSA (Body Surface Area) From Baseline to Week 4
NCT00988637 (13) [back to overview]Number of Participants Who Were a Success (Clear/Almost Clear) of Plaque Psoriasis at Week 2 Based on the Overall Disease Severity (ODS), Dichotomized Scale From Baseline to Week 2
NCT00988637 (13) [back to overview]Number of Participants Who Were a Success (Clear/Almost Clear) of Plaque Psoriasis at Week 4 Based on the Overall Disease Severity (ODS), Full Ordinal Scale From Baseline to Week 4
NCT00988637 (13) [back to overview]Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Week 4
NCT00988637 (13) [back to overview]"Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question I am Satisfied With my Appearance at Week 4"
NCT00988637 (13) [back to overview]"Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question I am Satisfied With the Results of This Treatment Program at Week 4"
NCT00988637 (13) [back to overview]"Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question I Would Use This Treatment Program Again if Recommended by the Dermatologist at Week 4"
NCT00988637 (13) [back to overview]"Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question The Treatment Program Was Easy to Follow at Week 4"
NCT00988637 (13) [back to overview]Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4
NCT00988637 (13) [back to overview]Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) Scores From Baseline to Week 4
NCT00988637 (13) [back to overview]Number of Participants With Decrease in Signs of Psoriasis (Scaling) Scores From Baseline to Week 4
NCT00988637 (13) [back to overview]Number of Participants With a Decrease in Signs of Psoriasis (Erythema) Scores From Baseline to Week 4
NCT00988637 (13) [back to overview]Mean Change From Baseline Scores for the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) From Baseline to Week 4
NCT00990561 (1) [back to overview]Change in Modified Psoriasis Area Severity Index (PASI) Score
NCT01012713 (3) [back to overview]A Tertiary Endpoint Will be the Percentage of Patients Achieving 90% Reduction in Psoriasis Area and Severity Index at Week 12.
NCT01012713 (3) [back to overview]The Secondary Endpoint Will be the Percentage of Patients Achieving a 75% Reduction in Psoriasis Area and Severity Index at Weeks 4 and 8.
NCT01012713 (3) [back to overview]The Primary Endpoint Will be the Percentage of Patients Achieving a 75% Reduction in the Psoriasis Area and Severity Index at Week 12.
NCT01166646 (6) [back to overview]Adrenal Suppression Potential
NCT01166646 (6) [back to overview]"Number of Subjects Whose Signs of Psoriasis Was Designated Success"
NCT01166646 (6) [back to overview]Pharmacokinetic Properties (Tmax)
NCT01166646 (6) [back to overview]Pharmacokinetic Properties (Cmax)
NCT01166646 (6) [back to overview]Pharmacokinetic Properties (AUC)
NCT01166646 (6) [back to overview]Changes in Disease Severity (Success)
NCT01235442 (7) [back to overview]sPGA (0,1) at Week 24
NCT01235442 (7) [back to overview]sPGA (0,1) at Week 12
NCT01235442 (7) [back to overview]Percent PASI Improvement From Baseline at Week 12
NCT01235442 (7) [back to overview]PASI 90 at Week 12
NCT01235442 (7) [back to overview]PASI 75 at Week 24
NCT01235442 (7) [back to overview]PASI 75 at Week 12
NCT01235442 (7) [back to overview]Patient Satisfaction at Week 12
NCT01323673 (8) [back to overview]Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15
NCT01323673 (8) [back to overview]Number of Participants With an ISGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15
NCT01323673 (8) [back to overview]Number of Participants With an Improvement of at Least 1 Grade in the Subject Global Assessment (SGA) (Target Hand) Score From Baseline to Days 3, 8, and 15
NCT01323673 (8) [back to overview]Number of Participants With an Improvement of at Least 1 Grade in the ISGA (Target Hand) Score From Baseline to Day 15
NCT01323673 (8) [back to overview]Number of Participants With an SGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15
NCT01323673 (8) [back to overview]Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) (Target Hand) Score From Baseline to Day 15
NCT01323673 (8) [back to overview]Number of Participants With an Improvement of at Least 1 Grade in the ISGA (Target Hand) Score From Baseline to Day 3 and and to Day 8
NCT01323673 (8) [back to overview]Number of Participants With an Improvement of at Least 2 Grades in the ISGA (Target Hand) Score From Baseline to Day 3 and to Day 8
NCT01557517 (9) [back to overview]Percent Change in Participants' Raw Score of Oral cGVHD Related Sensitivity on a 0-10 Rating Scale
NCT01557517 (9) [back to overview]Time to Maximum Plasma Concentration (Cmax) of Clobetasol
NCT01557517 (9) [back to overview]Percent Change in Participants' Raw Score of Oral cGVHD Related Pain on a 0-10 Rating Scale
NCT01557517 (9) [back to overview]Percentage of Participants With a Response as Assessed by the 273-point Oral Mucositis Rating Scale (OMRS) Who Received Topical Clobetasol 0.05% Oral Rinse for Oral Chronic Graft-versus-host-disease (cGVHD) During a Four-week Treatment Period
NCT01557517 (9) [back to overview]Plasma Concentrations of Clobetasol Mouth Rinse in cGVHD Patients at Baseline (Day 0) and Day 28
NCT01557517 (9) [back to overview]Area Under the Plasma Concentration vs Time Curve for All Time Points
NCT01557517 (9) [back to overview]Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
NCT01557517 (9) [back to overview]Maximum Plasma Concentration (Cmax) of Clobetasol During Pharmacokinetic Testing
NCT01557517 (9) [back to overview]Percent Change in Participants' Raw Score of Oral cGVHD Related Dryness on a 0-10 Rating Scale
NCT01745133 (1) [back to overview]Physician Global Assessement
NCT01893567 (2) [back to overview]Investigator Reported Target Lesion Severity Score
NCT01893567 (2) [back to overview]Subject Reported Target Lesion Severity Score.
NCT02131324 (1) [back to overview]The Percentage of Subjects With HPA Axis Suppression.
NCT02368886 (7) [back to overview]Changes in QOL (According to the Linear Analogue Self-Assessment [LASA] Questionnaire)
NCT02368886 (7) [back to overview]Dose Intensity of Regorafenib Received by Patients in the First Two Cycles as Measured by the Percentage of Planned Dose Received
NCT02368886 (7) [back to overview]Overall Survival (OS)
NCT02368886 (7) [back to overview]Progression Free Survival (PFS)
NCT02368886 (7) [back to overview]Proportion of Patients in Each Arm Who Complete 2 Cycles of Protocol Treatment and Initiate Cycle 3
NCT02368886 (7) [back to overview]Time to Progression (TTP)
NCT02368886 (7) [back to overview]Cumulative (Total) Dose of Regorafenib Received by Patients in the First Two Cycles
NCT02445807 (3) [back to overview]The Percentage of Subjects With Treatment Success at the Day 8 Visit.
NCT02445807 (3) [back to overview]The Percent Change in Body Surface Area of Psoriasis
NCT02445807 (3) [back to overview]Efficacy (Percentage of Subjects With Treatment Success)
NCT02573883 (15) [back to overview]Number of Patients With Adverse Outcomes
NCT02573883 (15) [back to overview]Number of Patients With Adverse Outcomes
NCT02573883 (15) [back to overview]Change Objective Provider VAS Visual Analog Scale
NCT02573883 (15) [back to overview]Change Objective Provider VAS Visual Analog Scale
NCT02573883 (15) [back to overview]Change Vulvar Symptom Visual Analog Scale (VAS) Score
NCT02573883 (15) [back to overview]Change Vulvar Symptom Visual Analog Scale (VAS) Score
NCT02573883 (15) [back to overview]Change in SkinDEX-29 Score
NCT02573883 (15) [back to overview]Change in Subjective Vulvovaginal Symptoms Questionnaire (VSQ)
NCT02573883 (15) [back to overview]Change in Subjective Vulvovaginal Symptoms Questionnaire (VSQ)
NCT02573883 (15) [back to overview]Change SkinDEX-29 Score
NCT02573883 (15) [back to overview]Change Vaginal Health Index (VHI) Score
NCT02573883 (15) [back to overview]Change Vaginal Health Index (VHI) Score
NCT02573883 (15) [back to overview]Number of Participants Considered Satisfied as Assessed by Health Related Quality of Life (HRQOL) Score
NCT02573883 (15) [back to overview]Number of Participants Considered Satisfied as Assessed by Health Related Quality of Life (HRQOL) Score
NCT02573883 (15) [back to overview]Number of Patients With Adverse Outcomes
NCT02635204 (3) [back to overview]Percent Change From Baseline in Body Surface Area at Day 15
NCT02635204 (3) [back to overview]Percent of Subjects With Treatment Success at Day 8 Visit
NCT02635204 (3) [back to overview]Percentage of Subjects With Treatment Success at Day 15
NCT02785172 (1) [back to overview]Percent of Subjects With Treatment Success
NCT02785185 (1) [back to overview]Percentage of Participants With Treatment Success of a 2-Grade IGA Score Improvement From Baseline and an IGA Score of Clear or Almost Clear at Week 2
NCT03179605 (3) [back to overview]Plasma Concentration of Clobetasol Propionate
NCT03179605 (3) [back to overview]Percentage of Subjects With HPA Axis Suppression at Day 15
NCT03179605 (3) [back to overview]Number of Participants With Improvement in IGA Grade From Baseline
NCT03212963 (4) [back to overview]Number of Subjects With Abnormal Hypothalamus-Pituitary-Adrenal Axis Response
NCT03212963 (4) [back to overview]Percent Body Surface Area Treated With Test Article
NCT03212963 (4) [back to overview]Percent BSA Affected With Disease
NCT03212963 (4) [back to overview]Investigator's Global Assessment
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
NCT04246801 (2) [back to overview]Pain Visual Analogue Scale (VAS) Score
NCT04246801 (2) [back to overview]Anterior Chamber Cell Grade
NCT04249076 (2) [back to overview]Pain Visual Analogue Scale (VAS) Score
NCT04249076 (2) [back to overview]Anterior Chamber Cell Grade

Maintenance Phase: Time to First Relapse

Time to first relapse was defined as the duration between baseline of maintenance phase and the visit where the relapse occurred. The first relapse was defined as the first time during the maintenance phase when participant presented with a GSS >2. (NCT00400725)
Timeframe: Baseline up to 24 Weeks

Interventiondays (Mean)
Maintenance Phase: Clobex® Shampoo93.5
Maintenance Phase: Clobex® Vehicle Shampoo56.8

[back to top]

Initial Phase: Percentage of Participants With Global Severity Scores

Global severity score was evaluated on a scale of 0-4 and it was categorized as; Clear (score 0); no clinical signs or symptoms detected (hyperpigmentation or residual red coloration might be present), very mild (score 1); only very slight signs or symptoms detected (e.g., very fine scaling or slight erythema), mild (score 2); slight signs or symptoms detected (e.g., mild erythema and scaling, eventually associated to some barely detectable plaque elevation), moderate (score 3); moderate or clearly detectable signs or symptoms (e.g., definite redness with obvious scaling on a plaque that was elevated above skin level), severe (score 4); severe signs or symptoms detected (e.g., intense redness, profuse shedding, definite plaque thickness was most often present) where 0 indicates best and 4 indicates worst. Percentage of participants with GSS was reported. Missing Clobex® shampoo data were imputed using last observation carried forward (LOCF). (NCT00400725)
Timeframe: Baseline, Weeks 2 and 4 LOCF

Interventionpercentage of participants (Number)
Baseline: Score 0 (Clear)Baseline: Score 1 (Very mild)Baseline: Score 2 (Mild)Baseline: Score 3 (Moderate)Baseline: Score 4 (Severe)Week 2-LOCF: Score 0 (Clear)Week 2-LOCF: Score 1 (Very mild)Week 2-LOCF: Score 2 (Mild)Week 2-LOCF: Score 3 (Moderate)Week 2-LOCF: Score 4 (Severe)Week 4-LOCF: Score 0 (Clear)Week 4-LOCF: Score 1 (Very mild)Week 4-LOCF: Score 2 (Mild)Week 4-LOCF: Score 3 (Moderate)Week 4-LOCF: Score 4 (Severe)
Initial Phase:- Clobex® Shampoo (Clobetasol Propionate 0.05% [W/W])00058.341.72.410.135.443.19.07.625.345.118.43.5

[back to top]

Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores

Individual sign scores of erythema (abnormal redness of skin), scaling (scales attached to the scalp), plaque thickening (a thickening or elevation of a circumscribed lesion or plaque) were evaluated on a scale of 0-4; 0= none , 1= mild , 2=moderate , 3= severe, 4= very severe, where 0 indicates best and 4 indicates worst. Percentage of participants with individual signs (erythema, scaling, and plaque thickening) scores were reported. Missing Clobex® shampoo data were imputed using last observation carried forward (LOCF). (NCT00400725)
Timeframe: Baseline, Weeks 2 and 4 LOCF

Interventionpercentage of participants (Number)
Erythema at Baseline: Score 0 (None)Erythema at Baseline: Score 1 (Mild)Erythema at Baseline: Score 2 (Moderate)Erythema at Baseline: Score 3 (Severe)Erythema at Baseline: Score 4 (Very Severe)Erythema at Week 2 - LOCF: Score 0 (None)Erythema at Week 2 - LOCF: Score 1 (Mild)Erythema at Week 2 - LOCF : 2: ModerateErythema at Week 2 - LOCF: Score 3 (Severe)Erythema at Week 2 - LOCF: Score 4 (Very Severe)Erythema at Week 4 - LOCF: Score 0 (None)Erythema at Week 4 - LOCF: Score 1 (Mild)Erythema at Week 4 - LOCF: Score 2 (Moderate)Erythema at Week 4 - LOCF: Score 3 (Severe)Erythema at Week 4 - LOCF: Score 4 (Very Severe)Scaling at Baseline: Score 0 (None)Scaling at Baseline: Score 1 (Mild)Scaling at Baseline: Score 2 (Moderate)Scaling at Baseline: Score 3 (Severe)Scaling at Baseline: Score 4: (Very Severe)Scaling at Week 2-LOCF: Score 0 (None)Scaling at Week 2-LOCF: Score 1 (Mild)Scaling at Week 2-LOCF: Score 2 (Moderate)Scaling at Week 2-LOCF: Score 3 (Severe)Scaling at Week 2-LOCF: Score 4 (Very Severe)Scaling at Week 4-LOCF: Score 0 (None)Scaling at Week 4-LOCF: Score 1 (Mild)Scaling at Week 4-LOCF: Score 2 (Moderate)Scaling at Week 4-LOCF: Score 3 (Severe)Scaling at Week 4-LOCF: Score 4 (Very Severe)Plaque Thickening at Baseline: Score 0 (None)Plaque Thickening at Baseline: score 1 (Mild)Plaque Thickening at Baseline: Score 2 (Moderate)Plaque Thickening at Baseline: Score 3 (Severe)Plaque Thickening at Baseline: Score 4 (Very Severe)Plaque Thickening at Week 2-LOCF: Score 0 (None)Plaque Thickening at Week 2-LOCF: Score 1 (Mild)Plaque Thickening at Week 2-LOCF: Score 2 (Moderate)Plaque Thickening at Week 2-LOCF: Score 3 (Severe)Plaque Thickening at Week 2- LOCF: Score 4 (Very Severe)Plaque Thickening at Week 4- LOCF: Score 0 (None)Plaque Thickening at Week 4- LOCF: Score 1 (Mild)Plaque Thickening at Week 4-LOCF: Score 2 (Moderate)Plaque Thickening at Week 4- LOCF: Score 3 (Severe)Plaque Thickening at Week 4- LOCF: Score 4 (Very Severe)
Initial Phase:- Clobex® Shampoo01.747.245.55.62.439.644.113.20.412.251.430.94.90.700.742.049.77.65.935.145.510.82.814.250.730.63.51.00.74.954.236.53.810.837.543.46.91.423.649.323.32.81.0

[back to top]

Initial Phase: Percentage of Participants With Pruritus Scores

Pruritus (itching sensation) score of were evaluated on a scale from 0 - 3 (0 = None [no itching], 1 = Mild [slight itching], not really bothersome), 2 = Moderate [definite itching that is somewhat bothersome; without loss of sleep], and 3 = severe [intense itching that has caused pronounced discomfort; night rest interrupted and excoriations of the skin from scratching may be present]) , where 0 indicates best and 3 indicates worst. Percentage of participants with pruritus score was reported. Missing Clobex® shampoo data were imputed using last observation carried forward (LOCF). (NCT00400725)
Timeframe: Baseline, Weeks 2 and 4 LOCF

Interventionpercentage of participants (Number)
Baseline: Score 0 (None)Baseline: Score 1 (Mild)Baseline: Score 2 (Moderate)Baseline: Score 3 (Severe)Week 2- LOCF: Score 0 (None)Week 2- LOCF: Score 1 (Mild)Week 2- LOCF: Score 2 (Moderate)Week 2- LOCF: Score 3 (Severe)Week 4- LOCF: Score 0 (None)Week 4- LOCF: Score 1 (Mild)Week 4- LOCF: Score 2 (Moderate)Week 4- LOCF: Score 3 (Severe)
Initial Phase:- Clobex® Shampoo3.820.851.723.619.853.523.63.135.447.615.61.4

[back to top]

Maintenance Phase: Percentage of Participants Who Had First Relapse

The first relapse was defined as the first time during the maintenance phase when participant presented with a GSS >2. Relapse was categorized into relapse or no relapse. Percentage of participants with relapse were reported. (NCT00400725)
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24

,
Interventionpercentage of participants (Number)
Maintenance Baseline : RelapseWeek 4 : RelapseWeek 8 : RelapseWeek 12 : RelapseWeek 16 : RelapseWeek 20 : RelapseWeek 24 : Relapse
Maintenance Phase: Clobex® Shampoo04152.855.762.966.768.9
Maintenance Phase: Clobex® Vehicle Shampoo064.576.684.589.290.191.9

[back to top]

Maintenance Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores at First Time of Relapse

The first relapse was defined as the first time during the maintenance phase when participant presented with a GSS >2. Individual sign scores of erythema were evaluated on a scale of 0-4 (0= none, 1= mild, 2=moderate, 3= severe, 4= very severe), where 0 indicates best and 4 indicates worst. Percentage of participants with individual signs (erythema, scaling and plaque thickening) scores were reported. There were no participants in scaling category with 0 score. (NCT00400725)
Timeframe: Baseline up to Week 24

,
Interventionpercentage of participants (Number)
Erythema: Score 0 (None)Erythema: Score 1 (Mild)Erythema: Score 2 (Moderate)Erythema: Score 3 (Severe)Erythema: Score 4 (Very Severe)Scaling: Score 1 (Mild)Scaling: Score 2 (Moderate)Scaling: Score 3 (Severe)Scaling: Score 4 (Very Severe)Plaque Thickening: Score 0 (None)Plaque Thickening: Score 1 (Mild)Plaque Thickening: Score 2 (Moderate)Plaque Thickening : Score 3 (Severe)Plaque Thickening: Score 4 (Very Severe)
Maintenance Phase: Clobex® Shampoo1.513.257.425.02.94.457.435.32.91.517.664.716.20
Maintenance Phase: Clobex® Vehicle Shampoo013.454.630.914.164.929.91.02.114.467.014.42.1

[back to top]

Maintenance Phase: Percentage of Participants With Number of Relapses Experienced

"Number of relapses of participants were categorized as 0; zero relapse, 1; one relapse, 2; two relapse, 3; three relapse, 4; two consecutive relapses.~Percentage of participants with total number of relapses experienced during maintenance period was reported." (NCT00400725)
Timeframe: Baseline up to Week 28

,
Interventionpercentage of participants (Number)
0: Zero Relapse1: One Relapse2: Two Relapse3: Three Relapse4: Two Consecutive Relapses
Clobex® Shampoo31.126.49.47.525.5
Clobex® Vehicle Shampoo8.122.525.218.026.1

[back to top]

Maintenance Phase: Percentage of Participants With Scalp Psoriasis Pruritus Score at First Time of Relapse

Pruritus (itching sensation) score of were evaluated on a scale from 0 - 3 (0 = None [no itching], 1 = Mild [slight itching, not really bothersome], 2 = Moderate [definite itching that is somewhat bothersome; without loss of sleep], and 3 = severe [intense itching that has caused pronounced discomfort; night rest interrupted and excoriations of the skin from scratching may be present]) , where 0 indicates best and 3 indicates worst. Percentage of participants with scalp psoriasis pruritus score at first relapse was reported. (NCT00400725)
Timeframe: Baseline up to Week 24

,
Interventionpercentage of participants (Number)
0: None1: Mild2: Moderate3: Severe
Maintenance Phase: Clobex® Shampoo13.229.451.55.9
Maintenance Phase: Clobex® Vehicle Shampoo7.226.852.613.4

[back to top]

Number of Subjects With Improvement in Lesional Psoriasis Area and Assessment (PASI) Score After Imiquimod and UVB Treatment

The PASI is a disease burden measure that integrates area, erythema, thickness and scale of each target lesion. The severity score for each region is calculated by adding the scores for redness, thickness and scale (each of which are graded from 0 to 4). The maximum severity score is 12. The higher the PASI, the worse the disease. Thus, an improvement in PASI score is a lower score than the pre-treatment PASI. (NCT00470392)
Timeframe: 2 weeks after Imiquimod and UVB

Interventionparticipants (Number)
Imiquimod4

[back to top]

Number of Subjects With Elevated MyxA

Lesions were treated with either Imiquimod or Clobetasol cream. Lesions were subsequently treated with UVB and biopsied. From the biopsy samples obtained from the Imiquimod arm, quantitative PCR was performed to measure levels of Myx A, an imiquimod response gene. (NCT00470392)
Timeframe: Biopsy samples for analysis were taken 1 hour post UVB treatment

Interventionparticipants (Number)
Imiquimod1

[back to top]

Number of Subjects With a 1.5 Fold Increase in mRNA Expression of GRAMD1A and DMXL2

Based upon upregulated mRNA expression of MyxA in 1 out of 7 patients treated with Imiquimod, a list of alternative target genes responsive to Imiquimod was generated. The target mRNAs examined included GRAMD1A, IL2RA, TGHD1, DMXL2. The target gene was consider upregulated if there was a 1.5 fold increase in the mRNA expression of the target gene. (NCT00470392)
Timeframe: Biopsy samples for analysis were taken 1 hour post UVB treatment

Interventionparticipants (Number)
Imiquimod1

[back to top]

Signs of Psoriasis - Plaque Elevation

(NCT00658788)
Timeframe: 2, 4, 8 and 12 weeks

,,,
Interventionparticipants (Number)
ClearAlmost ClearMildModerateSevere/Very Severe
Week 12244561391
Week 2226954241
Week 446783691
Week 8355068170

[back to top]

Signs of Psoriasis - Erythema

(NCT00658788)
Timeframe: 2, 4, 8 and 12 weeks

,,,
Interventionparticipants (Number)
ClearAlmost ClearMildModerateSevere/Very Severe
Week 12124160534
Week 204682357
Week 498157230
Week 8135370322

[back to top]

Overall Disease Severity

(NCT00658788)
Timeframe: 2, 4, 8 and 12 weeks

,,,
Interventionparticipants (Number)
ClearAlmost ClearMildModerateSevere/Very Severe
Week 12114570440
Week 205383313
Week 4510053120
Week 896088130

[back to top]

Global Improvement Score

(NCT00658788)
Timeframe: 2, 4, 8 and 12 weeks

,,,
Interventionparticipants (Number)
-1:Symptoms0:No Change1:Minimal Improvement2:Definite Improvement3:Considerable Improvement4:Clearing
Week 1201319495831
Week 2149539311
Week 4024269642
Week 801012437728

[back to top]

Percent Change From Baseline in Body Surface Area (% BSA) Affected

(NCT00658788)
Timeframe: 2, 4, 8 and 12 weeks

InterventionPercent Change from Baseline (Mean)
Week 220.1
Week 443.1
Week 846.6
Week 1246.2

[back to top]

Tolerability Assessment - Telangiectasias

(NCT00658788)
Timeframe: Baseline, 2, 4, 8 and 12 weeks

,,,,
Interventionparticipants (Number)
NoneMildModerateSevere
Baseline303101
Week 12230500
Week 2284400
Week 4283200
Week 8273100

[back to top]

Tolerability Assessment - Stinging/ Burning

(NCT00658788)
Timeframe: Baseline, 2, 4, 8 and 12 weeks

,,,,
Interventionparticipants (Number)
NoneMildModerateSevere
Baseline200443130
Week 122002483
Week 223242131
Week 42453441
Week 823418193

[back to top]

Overall Disease Severity Success (ODS)

Success was defined as a one-grade improvement in ODS from baseline. (NCT00658788)
Timeframe: 8 and 12 weeks

Interventionpercentage of participants (Number)
Week 8Week 12
Sequential Treatment Regimen100.084.1

[back to top]

Tolerability Assessment - Skin Atrophy

(NCT00658788)
Timeframe: Baseline, 2, 4, 8 and 12 weeks

,,,,
Interventionparticipants (Number)
AbsentPresent
Baseline3032
Week 122332
Week 22862
Week 42787
Week 82704

[back to top]

Tolerability Assessment - Pruritus

(NCT00658788)
Timeframe: Baseline, 2, 4, 8 and 12 weeks

,,,,
Interventionparticipants (Number)
NoneMildModerateSevere
Baseline74848463
Week 12128653210
Week 217991135
Week 42205690
Week 817266315

[back to top]

Tolerability Assessment - Folliculitis

(NCT00658788)
Timeframe: Baseline, 2, 4, 8 and 12 weeks

,,,,
Interventionparticipants (Number)
AbsentPresent
Baseline3032
Week 122323
Week 22862
Week 427411
Week 82713

[back to top]

Signs of Psoriasis - Scaling

(NCT00658788)
Timeframe: 2, 4, 8 and 12 weeks

,,,
Interventionparticipants (Number)
ClearAlmost ClearMildModerateSevere/Very Severe
Week 12315654263
Week 2256163194
Week 441833790
Week 836537191

[back to top]

Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to After Two Weeks of Treatment

Success Rate of decrease in Signs of Psoriasis (plaque elevation) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost clear being success and all others being failure from Baseline to after 2 weeks of treatment (NCT00733954)
Timeframe: Baseline and Week 2

InterventionParticipants (Number)
Clobetasol Propionate Spray48
Clobetasol Propionate Ointment52

[back to top]

Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to After Two Weeks of Treatment

Percent decrease in Body Surface Area affected (% BSA affected) from Baseline to after two weeks of treatment (NCT00733954)
Timeframe: Baseline and Week 2

Intervention% BSA (Mean)
Clobetasol Propionate Spray28.6
Clobetasol Propionate Ointment35.9

[back to top]

Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to End of Treatment

Percent decrease in body surface area affected (%BSA affected) from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment) (NCT00733954)
Timeframe: Baseline and Week 2 and Baseline and Week 4

Intervention% BSA (Mean)
Clobetasol Propionate Spray51
Clobetasol Propionate Ointment35.9

[back to top]

Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to Two Weeks Post Treatment

Percent decrease in body surface area affected (%BSA affected) from Baseline two weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment) (NCT00733954)
Timeframe: Baseline and Week 4 and Baseline and Week 6

Intervention% BSA (Mean)
Clobetasol Propionate Spray48
Clobetasol Propionate Ointment37.6

[back to top]

Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to After Two Weeks of Treatment

Percent decrease from baseline in Body Surface Area treated (% BSA treated) from Baseline to after two weeks of treatment (NCT00733954)
Timeframe: Baseline and Week 2

Intervention% BSA (Mean)
Clobetasol Propionate Spray29.1
Clobetasol Propionate Ointment38.4

[back to top]

Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to End of Treatment

Percent decrease from baseline in body surface area treated (%BSA treated) from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment) (NCT00733954)
Timeframe: Baseline and Week 2 and Baseline and Week 4

Intervention% BSA (Mean)
Clobetasol Propionate Spray52
Clobetasol Propionate Ointment38.4

[back to top]

Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to Two Weeks Post Treatment

Percent decrease in body surface area treated (%BSA treated) from Baseline to two weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment) (NCT00733954)
Timeframe: Baseline and Week 4 and Baseline and Week 6

Intervention% BSA (Mean)
Clobetasol Propionate Spray48.6
Clobetasol Propionate Ointment38.3

[back to top]

Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to End of Treatment

Success Rate on decrease in Signs of Psoriasis (plaque elevation) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment) (NCT00733954)
Timeframe: Baseline and Week 2 and Baseline and Week 4

InterventionParticipants (Number)
Clobetasol Propionate Spray72
Clobetasol Propionate Ointment52

[back to top]

Number of Participants Who Are Clear/Almost Clear of Plaque Psoriasis From Baseline to 2 Weeks Post Treatment Based on the Overall Disease Severity (ODS) Scale

Success Rate on Overall Disease Severity scale (Clear/Almost Clear, Moderate, Severe/Very Severe) with Clear/Almost Clear being best and Severe/Very Severe being worst at 2 weeks post treatment (week 6 - clobetasol propionate spray and week 4 - clobetasol propionate ointment) (NCT00733954)
Timeframe: Baseline and Week 4 and Baseline and Week 6

InterventionParticipants (Number)
Clobetasol Propionate Spray50
Clobetasol Propionate Ointment33

[back to top]

Number of Participants Who Are Clear/Almost Clear of Plaque Psoriasis From Baseline to After Two Weeks of Treatment Based on the Overall Disease Severity (ODS) Scale

Success Rate on Overall Disease Severity (ODS) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being best and Severe/Very Severe being worst from Baseline to after 2 weeks of treatment (NCT00733954)
Timeframe: Baseline and Week 2

InterventionParticipants (Number)
Clobetasol Propionate Spray39
Clobetasol Propionate Ointment44

[back to top]

Number of Participants Who Are Clear/Almost Clear of Plaque Psoriasis From Baseline to End of Treatment Based on the Overall Disease Severity (ODS) Scale

Success Rate on Overall Disease Severity (ODS) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe with Clear/Almost Clear being best and Severe/Very Severe being worst) from Baseline to End of Treatment (wk 4 - clobetasol propionate spray; wk 2 - clobetasol propionate ointment) (NCT00733954)
Timeframe: Baseline and Week 2 and Baseline and Week 4

InterventionParticipants (Number)
Clobetasol Propionate Spray62
Clobetasol Propionate Ointment44

[back to top]

Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to After Two Weeks of Treatment

Success Rate of decrease in Signs of Psoriasis (erythema) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost clear being success and all others being failure from Baseline to after 2 weeks of treatment (NCT00733954)
Timeframe: Baseline and Week 2

InterventionParticipants (Number)
Clobetasol Propionate Spray29
Clobetasol Propionate Ointment33

[back to top]

Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to End of Treatment

Success Rate on decrease in Signs of Psoriasis (erythema) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others failure from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment) (NCT00733954)
Timeframe: Baseline and Week 2 and Baseline and Week 4

InterventionParticipants (Number)
Clobetasol Propionate Spray53
Clobetasol Propionate Ointment33

[back to top]

Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to Two Weeks Post Treatment

Success Rate on decrease in Signs of Psoriasis (erythema) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline to 2 weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment) (NCT00733954)
Timeframe: Baseline and Week 4 and Baseline and Week 6

InterventionParticipants (Number)
Clobetasol Propionate Spray48
Clobetasol Propionate Ointment32

[back to top]

Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to Two Weeks Post Treatment

Success Rate on decrease in Signs of Psoriasis (plaque elevation) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline and 2 weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment) (NCT00733954)
Timeframe: Baseline and Week 4 and Baseline and Week 6

InterventionParticipants (Number)
Clobetasol Propionate Spray55
Clobetasol Propionate Ointment35

[back to top]

Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to After Two Weeks of Treatment

Success Rate of decrease in Signs of Psoriasis (scaling) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost clear being success and all others being failure from Baseline to after 2 weeks of treatment (NCT00733954)
Timeframe: Baseline and Week 2

InterventionParticipants (Number)
Clobetasol Propionate Spray53
Clobetasol Propionate Ointment72

[back to top]

Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to End of Treatment

Success Rate on decrease in Signs of Psoriasis (scaling) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment) (NCT00733954)
Timeframe: Baseline and Week 2 and Baseline and Week 4

InterventionParticipants (Number)
Clobetasol Propionate Spray73
Clobetasol Propionate Ointment72

[back to top]

Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to Two Weeks Post Treatment

Success Rate on decrease in Signs of Psoriasis (scaling) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline to 2 weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment) (NCT00733954)
Timeframe: Baseline and Week 4 and Baseline and Week 6

InterventionParticipants (Number)
Clobetasol Propionate Spray56
Clobetasol Propionate Ointment43

[back to top]

Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Two Weeks Post Treatment

Number of Participants with Tolerability assessments (Pruritus, Telangiectasias, Stinging/Burning, Skin atrophy, Folliculitis) resulting in adverse events from Baseline to two weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment) (NCT00733954)
Timeframe: Baseline and Week 4 and Baseline and Week 6

InterventionParticipants (Number)
Clobetasol Propionate Spray1
Clobetasol Propionate Ointment0

[back to top]

Mean Percent Improvement in Disease Severity Using PGA and OTLS Scores of Target Lesions

Mean percent improvement in disease severity using Physician Global Assessment (PGA) [PGA scale: Clear (0) - Very Severe (5)] and overall severity scores of target lesions (OTLS) [OTLS scale None (0) - Very Severe (4)] based on erythema, scaling and induration, at each visit interval. (NCT00769184)
Timeframe: Weeks 2, 6, & 12

,
InterventionMean Percent Improvement (Mean)
Percent improvement of PGA score at Week 2Percent improvement of PGA score at Week 6Percent improvement of PGA score at Week 12Percent improvement of OTLS score at Week 2Percent improvement of OTLS score at Week 6Percent improvement of OTLS score at Week 12
Corticosteroid + LCD394731434629
Corticosteroid + Placebo34251243207

[back to top]

Percentage of Patients Who Are Clear (PGA Score 0) or Have Minimal Disease (PGA Score 1) on Each Treated Side at Each Visit.

Those patients that have reached a PGA score of zero [PGA scale: clear (0) - very severe (5)], and are considered clear of chronic plaque psoriasis, or have reached a PGA score of 1, with minimal disease at each visit, in each condition. Data was collected at weeks 2, 6 and 12. (NCT00769184)
Timeframe: Weeks 2, 6, & 12.

,
Interventionpercentage of participants (Number)
Percentage with PGA scores ≤ 1 at Week 2Percentage with PGA scores ≤ 1 at Week 6Percentage with PGA scores ≤ 1 at Week 12
Corticosteroid + LCD33.346.225.0
Corticosteroid + Placebo6.715.416.7

[back to top]

Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Finger Tips

"Proportion of subjects at day 15 with at least 1-Grade improvement in the Hand Eczema Severity Index Score (HESI) for all symptoms present at baseline - Finger Tips. The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe." (NCT00828464)
Timeframe: Baseline, Day 15

InterventionPercentage of Participants (Number)
Clobetasol Propionate Foam73.3

[back to top]

Change in Subject's Visual Analogue Assessment Scale

Mean change in subject's visual analogue assessment scale from baseline to day 8. At each visit, the subject is requested to rate the changes in their skin on the hands on a 1 to 10 scale with 0 being poor and 10 being excellent. (NCT00828464)
Timeframe: Baseline, Day 8

InterventionUnits on a scale (Mean)
Clobetasol Propionate Foam1.46

[back to top]

Change in Subject's Visual Analogue Assessment Scale From Baseline to Day 15

Mean change in subject's visual analogue assessment scale from baseline to day 15. At each visit, the subject is requested to rate the changes in their skin on the hands on a 1 to 10 scale with 0 being poor and 10 being excellent. (NCT00828464)
Timeframe: Baseline, Day 15

InterventionUnits on a scale (Mean)
Clobetasol Propionate Foam3.40

[back to top]

Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline - Fingers

"Proportion of Subjects at day 15 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Fingers.~The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe." (NCT00828464)
Timeframe: Baseline, Day 15

InterventionPercentage of Participants (Number)
Clobetasol Propionate Foam70

[back to top]

Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Back of Hands

"Proportion of Subjects at Day 15 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Back of Hands.~The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe." (NCT00828464)
Timeframe: Baseline, Day 15

InterventionPercentage of Participants (Number)
Clobetasol Propionate Foam66.7

[back to top]

Proportion of Subjects With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Fingers

"Proportion of Subjects at day 8 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline - Fingers~The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe." (NCT00828464)
Timeframe: Baseline, Day 8

InterventionPercentage of Participants (Number)
Clobetasol Propionate Foam50

[back to top]

Proportion of Subjects at Day 8 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Palm of Hands

"Proportion of Subjects at Day 8 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline - Palm of Hands.~The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe." (NCT00828464)
Timeframe: Baseline, Day 8

InterventionPercentage of Participants (Number)
Clobetasol Propionate Foam56.7

[back to top]

Proportion of Subjects With at Least 1-grade Improvement From Baseline to Day 15 in Investigator's Static Global Assessment Score (ISGA) Score

"Proportion of Subjects with at least a 1-Grade Improvement from Baseline to Day 15 In Investigator's Static Global Assessment Score (ISGA) - Chronic Hand Dermatitis Please note that the proportion of participants is being reported as a percentage of participants.~ISGA grades:~Score = 0 (Clear) Score = 1 (Almost Clear) Score = 2 (Mild) Score = 3 (Moderate) Score = 4 (Severe)" (NCT00828464)
Timeframe: Baseline, Day 15

InterventionPercentage of Participants (Number)
Clobetasol Propionate Foam96.7

[back to top]

Proportion of Subjects Who Achieve at Least a 1-grade Improvement Based on the ISGA at Day 8.

"Please note that the proportion of participants is being reported as a percentage of participants.~Investigator's Static Global Assessment Score (ISGA) At least 1-grade improvement (%) at Day 8~ISGA grades:~Score = 0 (Clear) Score = 1 (Almost Clear) Score = 2 (Mild) Score = 3 (Moderate) Score = 4 (Severe)" (NCT00828464)
Timeframe: Baseline, Day 8

InterventionPercentage of Participants (Number)
Clobetasol Propionate Foam76.7

[back to top]

Proportion of Subjects at Day 8 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Wrists

"Proportion of Subjects at Day 8 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Wrists.~The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe." (NCT00828464)
Timeframe: Baseline, Day 8

InterventionPercentage of Participants (Number)
Clobetasol Propionate Foam40

[back to top]

Proportion of Subjects at Day 8 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Finger Tips

"Proportion of Subjects at day 8 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Finger Tips~The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe." (NCT00828464)
Timeframe: Baseline, Day 8

InterventionPercentage of Participants (Number)
Clobetasol Propionate Foam43.3

[back to top]

Proportion of Subjects at Day 8 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Back of Hands

"Proportion of Subjects at Day 8 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Back of Hands.~The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe." (NCT00828464)
Timeframe: Baseline, Day 8

InterventionPercentage of Participants (Number)
Clobetasol Propionate Foam33.3

[back to top]

Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Wrists

"Proportion of Subjects at Day 15 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI)for All Symptoms Present at Baseline Wrists.~The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe." (NCT00828464)
Timeframe: Baseline, Day 15

InterventionPercentage of Participants (Number)
Clobetasol Propionate Foam40

[back to top]

Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Palm of Hands

"Proportion of Subjects at Day 15 with at least a 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Palm of Hands The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe." (NCT00828464)
Timeframe: Baseline, Day 15

InterventionPercentage of Participants (Number)
Clobetasol Propionate Foam73.3

[back to top]

Number of Participants With a Scaling Score of 0 or 1 at Baseline and Week 4

The investigator individually graded the severity of scaling in participants as: 0=no scaling; 1=no evidence of scaling; 2=minimal, occasional fine scale over less than 5% of the lesion; 3=mild, fine scales predominate; 4=moderate, coarse scales predominate; and 5=marked, thick nontenacious scales predominate. (NCT00842153)
Timeframe: Baseline (Week 0) and Week 4

,
Interventionparticipants (Number)
Baseline (Week 0), n=28, 30Week 4, n=27, 28
Olux-E Foam06
Vehicle Foam04

[back to top]

Number of Participants With a Scaling Score of 0 or 1 at Week 2

The investigator individually graded the severity of scaling in participants as: 0=no scaling; 1=no evidence of scaling; 2=minimal, occasional fine scale over less than 5% of the lesion; 3=mild, fine scales predominate; 4=moderate, coarse scales predominate; and 5=marked, thick nontenacious scales predominate. (NCT00842153)
Timeframe: Week 2

Interventionparticipants (Number)
Olux-E Foam11
Vehicle Foam5

[back to top]

Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Week 2

Participants assessed their level of pruritus (itching) over the previous 24-hour period using the following scale: 0=no itching; 1=minimal, very rarely aware of localized itching, present when relaxing and lasted for very short time; 2=mild, aware of itching at times, present when relaxing, not present when focused on other activities; 3=moderate, often aware of itching, annoying, sometimes disturbed sleep and daytime activities; and 4=severe, constant itching, distressing, frequent sleep disturbance, interfered with activities. (NCT00842153)
Timeframe: Week 2

Interventionparticipants (Number)
Olux-E Foam21
Vehicle Foam17

[back to top]

Number of Participants With a Plaque Thickness Score of 0 or 1 at Baseline and Week 4

The investigator individually graded the severity of plaque thickness in participants as: 0=no elevation over normal skin; 1=possible but difficult to ascertain whether there is a slight elevation above normal skin; 2=slight but definite elevation, typically edges are indistinct or sloped; 3=moderate elevation with rough or sloped edges; 4=marked elevation typically with hard or sharp edges; and 5=very marked elevation typically with hard, sharp edges. (NCT00842153)
Timeframe: Baseline (Week 0) and Week 4

,
Interventionparticipants (Number)
Baseline (Week 0), n=28, 30Week 4, n=27, 28
Olux-E Foam012
Vehicle Foam02

[back to top]

Number of Participants With a Target Lesion Global Improvement (TLGI) Score of 0, 1, or 2 at Weeks 1, 2, and 4

The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease. (NCT00842153)
Timeframe: Weeks 1, 2, and 4

,
Interventionparticipants (Number)
Week 1, n=26, 30Week 2, n=26, 30Week 4, n=27, 28
Olux-E Foam61912
Vehicle Foam232

[back to top]

Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Baseline and Week 4

Participants assessed all treated areas using the Subject Global Assessment scale: 0=skin completely clear, possible residual hyperpigmentation; 1=psoriasis almost clear, patchy remnants of fine scaling present; 2=psoriasis mild, with small amount of psoriasis remaining (i.e., fine to coarse scales in some areas, definite redness, barely visible plaque thickness); 3=psoriasis moderate, between slight and definitely noticeable; 4=psoriasis very noticeable with redness, scaling, plaque thickness; 5=psoriasis severe with severe redness, thick scaling, and plaques. (NCT00842153)
Timeframe: Baseline (Week 0) and Week 4

,
Interventionparticipants (Number)
Baseline (Week 0), n=28, 30Week 4, n=27, 28
Olux-E Foam07
Vehicle Foam01

[back to top]

Number of Participants With a Plaque Thickness Score of 0 or 1 at Week 2

The investigator individually graded the severity of plaque thickness in participants as: 0=no elevation over normal skin; 1=possible but difficult to ascertain whether there is a slight elevation above normal skin; 2=slight but definite elevation, typically edges are indistinct or sloped; 3=moderate elevation with rough or sloped edges; 4=marked elevation typically with hard or sharp edges; and 5=very marked elevation typically with hard, sharp edges. (NCT00842153)
Timeframe: Week 2

Interventionparticipants (Number)
Olux-E Foam16
Vehicle Foam4

[back to top]

Mean Percent Change From Baseline to Week 4 in Pruritus (Target Lesion)

"Participants assessed their level of pruritus (itching) for the target lesion using a 10 centimeter (cm) Visual Analogue Scale (VAS) with the left side anchored with 0=None and the right side anchored with 10=Very Severe. A target lesion (>2 cm squared [cm^2]) was considered to be one on the trunk or extremities (excluding palms/soles, elbows, or knees). Percent change from Baseline was calculated as the value at Week 4 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100." (NCT00842153)
Timeframe: Baseline (Week 0) and Week 4

InterventionPercent change in scores on a scale (Mean)
Olux-E Foam-6.8
Vehicle Foam-40.2

[back to top]

Mean Percent Change From Baseline to Week 2 in Pruritus (Target Lesion)

"Participants assessed their level of pruritus (itching) for the target lesion using a 10 centimeter (cm) Visual Analogue Scale (VAS) with the left side anchored with 0=None and the right side anchored with 10=Very Severe. A target lesion (>2 cm squared [cm^2]) was considered to be one on the trunk or extremities (excluding palms/soles, elbows, or knees). Percent change from Baseline was calculated as the value at Week 2 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100." (NCT00842153)
Timeframe: Baseline (Week 0) and Week 2

InterventionPercent change in scores on a scale (Mean)
Olux-E Foam-30.5
Vehicle Foam40.1

[back to top]

Number of Participants With an Erythema Score of 0 or 1 at Week 2

The investigator individually graded the severity of erythema (redness of skin) in participants as: 0=hyperpigmentation, pigmented macules (flat, distinct, colored area of skin), diffuse faint pink or red coloration; 1=no evidence of erythema, hyperpigmentation present; 2=faint erythema; 3=light red coloration; 4=moderate red coloration; and 5=bright red coloration. (NCT00842153)
Timeframe: Week 2

Interventionparticipants (Number)
Olux-E Foam6
Vehicle Foam1

[back to top]

Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Week 2

Participants assessed all treated areas using the Subject Global Assessment scale: 0=skin completely clear, possible residual hyperpigmentation; 1=psoriasis almost clear, patchy remnants of fine scaling present; 2=psoriasis mild, with small amount of psoriasis remaining (i.e., fine to coarse scales in some areas, definite redness, barely visible plaque thickness); 3=psoriasis moderate, between slight and definitely noticeable; 4=psoriasis very noticeable with redness, scaling, plaque thickness; 5=psoriasis severe with severe redness, thick scaling, and plaques. (NCT00842153)
Timeframe: Week 2

Interventionparticipants (Number)
Olux-E Foam5
Vehicle Foam1

[back to top]

Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Baseline and Week 4

Participants assessed their level of pruritus (itching) over the previous 24-hour period using the following scale: 0=no itching; 1=minimal, very rarely aware of localized itching, present when relaxing and lasted for very short time; 2=mild, aware of itching at times, present when relaxing, not present when focused on other activities; 3=moderate, often aware of itching, annoying, sometimes disturbed sleep and daytime activities; and 4=severe, constant itching, distressing, frequent sleep disturbance, interfered with activities. (NCT00842153)
Timeframe: Baseline (Week 0) and Week 4

,
Interventionparticipants (Number)
Baseline (Week 0), n=28, 30Week 4, n=27, 28
Olux-E Foam819
Vehicle Foam917

[back to top]

Number of Participants With an Erythema Score of 0 or 1 at Baseline and Week 4

The investigator individually graded the severity of erythema (redness of skin) in participants as: 0=hyperpigmentation, pigmented macules (flat, distinct, colored area of skin), diffuse faint pink or red coloration; 1=no evidence of erythema, hyperpigmentation present; 2=faint erythema; 3=light red coloration; 4=moderate red coloration; and 5=bright red coloration. (NCT00842153)
Timeframe: Baseline (Week 0) and Week 4

,
Interventionparticipants (Number)
Baseline (Week 0), n=28, 30Week 4, n=27, 28
Olux-E Foam06
Vehicle Foam01

[back to top]

Number of Participants With a TLGI Score of 0, 1, or 2 at Week 1 and Week 4

The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease. (NCT00842153)
Timeframe: Week 1 and Week 4

,
Interventionparticipants (Number)
Week 1, n=26, 30Week 4, n=27, 28
Olux-E Foam612
Vehicle Foam22

[back to top]

Number of Participants With a TLGI Score of 0, 1, 2, or 3 at Weeks 1, 2, and 4

The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease. (NCT00842153)
Timeframe: Weeks 1, 2, and 4

,
Interventionparticipants (Number)
Week 1, n=26, 30Week 2, n=26, 30Week 4, n=27, 28
Olux-E Foam192115
Vehicle Foam698

[back to top]

At Least 1 Grade Improvement in the Psoriasis Global Assessment

Number of participants who acheive at least a 1 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe. (NCT00852761)
Timeframe: Baseline, days 3, 8, 15

,
Interventionparticipants (Number)
Day 3Day 8Day 15
Clobex Lotion71314
Olux-E Foam61014

[back to top]

At Least 1 Grade Improvement in Subject's Global Assessment

Number of participants who achieve treatment success (minimum one grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques. (NCT00852761)
Timeframe: Baseline, days 3, 8, 15

,
Interventionparticipants (Number)
Day 3Day 8Day 15
Clobex Lotion121617
Olux-E Foam81515

[back to top]

At Least a One Grade Improvement for the Target Psoriasis Lesion on the Elbow or Knee (Psoriasis Grading Scale)

Number of participants who achieved a minimum 1-grade improvement in elbow and/or knee lesion using the Psoriasis Grading Scale for Target Lesion Score: 0 = No evidence of scaling, erythema, or elevation. 1 = Minimal; occasional scale, faint erythema, slight elevation. 2 = Mild; fine scales, light red color, slight elevation. 3 = Moderate; coarse scales, moderate red coloration and elevation . 4 = Marked; thick scale, bright red coloration, marked elevation. 5 = Severe; very thick tenacious scale predominates, dusky to deep red coloration, very marked elevation. (NCT00852761)
Timeframe: Baseline to day 15

Interventionparticipants (Number)
Olux-E Foam15
Clobex Lotion14

[back to top]

At Least a 2 Grade Improvement in the Psoriasis Global Assessment

Number of participants who acheive at least a 2 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe. (NCT00852761)
Timeframe: Baseline, days 3, 8, 15

,
Interventionparticipants (Number)
Day 3Day 8Day 15
Clobex Lotion1710
Olux-E Foam063

[back to top]

At Least a 3 Grade Improvement in Subject's Global Assessment

Number of participants who achieve treatment success (minimum three grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques. (NCT00852761)
Timeframe: Baseline, days 3, 8, 15

,
Interventionparticipants (Number)
Day 3Day 8Day 15
Clobex Lotion0811
Olux-E Foam068

[back to top]

At Least a 3 Grade Improvement in the Psoriasis Global Assessment

Number of participants who acheive at least a 3 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe. (NCT00852761)
Timeframe: Baseline, days 3, 8, 15

,
Interventionparticipants (Number)
Day 3Day 8Day 15
Clobex Lotion003
Olux-E Foam000

[back to top]

At Least a 2 Grade Improvement Psoriasis Grading Scale

"Number of participants who achieve a minimum two grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion.~The scale is the same as used for the primary outcome (0 through 5)." (NCT00852761)
Timeframe: Baseline, days 3, 8, 15

,
Interventionparticipants (Number)
Day 3Day 8Day 15
Clobex Lotion11313
Olux-E Foam255

[back to top]

Dermatology Life Quality Index (DLQI) Categories

Number of participants who indicated one of the following for total DLQI: 0-1 No effect on the patient's life; 2-5 Small effect on the patient's life; 6-10 Moderate effect on the patient's life; 11-20 Very large effect on the patient's life. (NCT00852761)
Timeframe: Days 3, 8, 15

,
Interventionparticipants (Number)
Day 3 Score 0 -1 No effectDay 3 Score 2- 5 Small effectDay 3 Score 6- 10 Moderate effectDay 3 Score 11- 20 Very large effectDay 8 Score 0 -1 No effectDay 8 Score 2- 5 Small effectDay 8 Score 6- 10 Moderate effectDay 8 Score 11- 20 Very large effectDay 15 Score 0 -1 No effectDay 15 Score 2- 5 Small effectDay 15 Score 6- 10 Moderate effectDay 15 Score 11- 20 Very large effect
Clobex Lotion4472763110511
Olux-E Foam5650943111321

[back to top]

Dermatology Quality of Life - Daily Activities

"Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.~Sum of scores for questions 3 and 4. Score range from 0 to 6. A higher score denotes a more impaired quality of life" (NCT00852761)
Timeframe: Baseline, Days 3, 8, 15

,
Interventionunits on a scale (Mean)
Day 3, n=16, 17Day 8, n=17, 17Day 15, n=17, 17
Clobex Lotion1.410.880.82
Olux-E Foam0.560.530.53

[back to top]

Dermatology Quality of Life - Leisure

"Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.~Sum of scores for questions 5 and 6. Score range from 0 to 6. A higher score denotes a more impaired quality of life" (NCT00852761)
Timeframe: Baseline, Days 3, 8, 15

,
Interventionunits on a scale (Mean)
Day 3, n=16, 17Day 8, n=17, 17Day 15, n=17, 17
Clobex Lotion0.940.410.24
Olux-E Foam0.50.470.35

[back to top]

Dermatology Quality of Life - Personal Relationships

"Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.~Sum of scores for questions 8 and 9. Score range from 0 to 6. A higher score denotes a more impaired quality of life" (NCT00852761)
Timeframe: Baseline, Days 3, 8, 15

,
Interventionunits on a scale (Mean)
Day 3, n=15, 17Day 8, n=16, 17Day 15, n=17, 17
Clobex Lotion0.410.290.12
Olux-E Foam0.330.250.18

[back to top]

Dermatology Quality of Life - Symptoms and Feelings

"Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.~Sum of scores for questions 1 and 2. Score range from 0 to 6. A higher score denotes a more impaired quality of life" (NCT00852761)
Timeframe: Baseline, Days 3, 8, 15

,
Interventionunits on a scale (Mean)
Day 3, n=16, 17Day 8, n=17, 17Day 15, n=17, 17
Clobex Lotion2.411.350.94
Olux-E Foam1.941.060.82

[back to top]

Dermatology Quality of Life - Treatment

"Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.~Sum of scores for question 10. Score range from 0 to 3. A higher score denotes a more impaired quality of life" (NCT00852761)
Timeframe: Baseline, Days 3, 8, 15

,
Interventionunits on a scale (Mean)
Day 3, n=16, 17Day 8, n=17, 17Day 15, n=17, 17
Clobex Lotion0.350.240.24
Olux-E Foam0.310.290.18

[back to top]

Dermatology Quality of Life - Work and School

"Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.~Sum of scores for questions 7. Score range from 0 to 3. A higher score denotes a more impaired quality of life" (NCT00852761)
Timeframe: Baseline, Days 3, 8, 15

,
Interventionunits on a scale (Mean)
Day 3, n=15, 17Day 8, n=16, 17Day 15, n=17, 17
Clobex Lotion0.240.120.06
Olux-E Foam0.130.060.06

[back to top]

Median Change in Psoriasis Grading Scale

Median improvement in elbow and/or knee lesion using the Psoriasis Grading Scale for Target Lesion Score: 0 = No evidence of scaling, erythema, or elevation. 1 = Minimal; occasional scale, faint erythema, slight elevation. 2 = Mild; fine scales, light red color, slight elevation. 3 = Moderate; coarse scales, moderate red coloration and elevation . 4 = Marked; thick scale, bright red coloration, marked elevation. 5 = Severe; very thick tenacious scale predominates, dusky to deep red coloration, very marked elevation. (NCT00852761)
Timeframe: Baseline, Days 3, 8, 15

,
Interventionunites on a scale (Median)
Day 3Day 8Day 15
Clobex Lotion-1-2-2
Olux-E Foam-1-1-1

[back to top]

Total Dermatology Life Quality Index (DLQI) Score

"Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.~Sum of scores for all questions. Score range from 0 to 30. A higher score denotes a more impaired quality of life" (NCT00852761)
Timeframe: Baseline, Days 3, 8, 15

,
Interventionunits on a scale (Mean)
Day 3Day 8Day 15
Clobex Lotion5.763.292.41
Olux-E Foam3.752.652.12

[back to top]

At Least a 2 Grade Improvement in Subject's Global Assessment

Number of participants who achieve treatment success (minimum two grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques. (NCT00852761)
Timeframe: Baseline, days 3, 8, 15

,
Interventionparticipants (Number)
Day 3Day 8Day 15
Clobex Lotion31114
Olux-E Foam41013

[back to top]

At Least 1 Grade Improvement Psoriasis Grading Scale

"Number of participants who achieve a minimum one grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion.~The scale is the same as used for the primary outcome (0 through 5)." (NCT00852761)
Timeframe: Baseline, days 3 and 8

,
Interventionparticipants (Number)
Day 3Day 8
Clobex Lotion1014
Olux-E Foam914

[back to top]

At Least a 3 Grade Improvement Psoriasis Grading Scale

"Number of participants who achieve a minimum of three grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion.~The scale is the same as used for the primary outcome (0 through 5)." (NCT00852761)
Timeframe: Baseline, days 3, 8, 15

,
Interventionparticipants (Number)
Day 8Day 15
Clobex Lotion24
Olux-E Foam00

[back to top]

Total Severity Score (TSS): Percent Change From Baseline at Week 4

Total Severity Score (TSS) is sum of erythema, scaling and pruritus severity scores of the lesions evaluated each on a 4-point scale from 0 = None to 3 = Severe by the investigator. So minimum TSS can be 0 and maximum 9. (NCT00862654)
Timeframe: baseline and week 4

InterventionPercent change (Median)
C Propionate 4/Week + Ketoconazole 2/Week-71.4
C Propionate 2/Week + Ketoconazole 2/Week-66.7
C Propionate 2/Week-66.7
Ketakonazol 2/Week-57.1

[back to top]

Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4

Number of participants in each category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at baseline and end of treatment (week 4 or week 2 if GSS is Clear). Individual Sign Scores are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe and 4 = Very Severe) with 0 being best and 4 being worst. (NCT00881868)
Timeframe: baseline to week 4

,
Interventionparticipants (Number)
Scaling Baseline None (0)Scaling Week 4 None (0)Scaling Baseline Mild (1)Scaling Week 4 Mild (1)Scaling Baseline Moderate (2)Scaling Week 4 Moderate (2)Scaling Baseline Severe (3)Scaling Week 4 Severe (3)Scaling Baseline Very Severe (4)Scaling Week 4 Very Severe (4)Erythema Baseline None (0)Erythema Week 4 None (0)Erythema Baseline Mild (1)Erythema Week 4 Mild (1)Erythema Baseline Moderate (2)Erythema Week 4 Moderate (2)Erythema Baseline Severe (3)Erythema Week 4 Severe (3)Erythema Baseline Very Severe (4)Erythema Week 4 Very Severe (4)Plaque Elevation Baseline None (0)Plaque Elevation Week 4 None (0)Plaque Elevation Baseline Mild (1)Plaque Elevation Week 4 Mild (1)Plaque Elevation Baseline Moderate (2)Plaque Elevation Week 4 Moderate (2)Plaque Elevation Baseline Severe (3)Plaque Elevation Week 4 Severe (3)Plaque Elevation Baseline Very Severe (4)Plaque Elevation Week 4 Very Severe (4)
Clobex Spray02441522112130024314303800002671319113120
Vehicle Spray0329262111710134112620960007212271911200

[back to top]

Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4

Number of participants in each category of the Extent of Scalp Involvement Index at end of treatment (week 4 or week 2 if GSS was Clear). The Extent of Scalp Involvement Index is evaluated on a scale from 0 - 5 (0 = None, 2 = <20%, 2 = 20-39%, 3 = 40-59%, 4 = 60-79% and 5 = 80-100%) with 0 being best and 5 being worst. (NCT00881868)
Timeframe: baseline to week 4

,
Interventionparticipants (Number)
Extent of Scalp Involvement Baseline NoneExtent of Scalp Involvement Week 4 NoneExtent of Scalp Involvement Baseline <20%Extent of Scalp Involvement Week 4 <20%Extent of Scalp Involvement Baseline 20-39%Extent of Scalp Involvement Week 4 20-39%Extent of Scalp Involvement Baseline 40-59%Extent of Scalp Involvement Week 4 40-59%Extent of Scalp Involvement Baseline 60-79%Extent of Scalp Involvement Week 4 60-79%Extent of Scalp Involvement Baseline 80-100%Extent of Scalp Involvement Week 4 80-100%
Clobex Spray0211616541206020
Vehicle Spray0112166121445532

[back to top]

Number of Participants in Each Category of Pruritus at Baseline and Week 4

Number of participants in each category of Pruritus at end of treatment (week 4 or week 2 if GSS was Clear). Pruritus is evaluated on a scale from 0 - 3 (0 = None, 1 = Mild, 2 = Moderate and 3 = Severe) with 0 being best and 3 being worst. (NCT00881868)
Timeframe: baseline to week 4

,
Interventionparticipants (Number)
Pruritus Baseline None (0)Pruritus Week 4 None (0)Pruritus Baseline Mild (1)Pruritus Week 4 Mild (1)Pruritus Baseline Moderate (2)Pruritus Week 4 Moderate (2)Pruritus Baseline Severe (3)Pruritus Week 4 Severe (3)
Clobex Spray42851229130
Vehicle Spray181014241454

[back to top]

Number of Participants Who Were a Success or Failure Based on the Global Severity Score (GSS) of Scalp Psoriasis From Baseline to End of Treatment (Week 4 or Week 2 if Clear)

Number of participants who were a success or failure based on the Global Severity Score (GSS) of Scalp Psoriasis from baseline to end of treatment (Week 4 or Week 2 if Clear). GSS is evaluated on a scale from 0 - 5 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Very Severe) with 0 being best and 5 being worst. Success is defined as Clear or Almost Clear. (Note: 5 Clobex Spray subjects and 0 Vehicle Spray subjects were Clear at week 2 and their results were carried forward to week 4). (NCT00881868)
Timeframe: baseline to week 4

,
Interventionparticipants (Number)
SuccessFailure
Clobex Spray356
Vehicle Spray535

[back to top]

Median Percent (%) Change From Baseline in % Treatable BSA (Body Surface Area) From Baseline to Week 4

Median percent (%) change from baseline in % treatable BSA (Body Surface Area) from Baseline to Week 4 (NCT00988637)
Timeframe: Baseline to Week 4

InterventionPercent change (Median)
Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)-33.3
Clobex® Spray (Morning) and Vectical® Ointment (Evening)-50.0

[back to top]

Number of Participants Who Were a Success (Clear/Almost Clear) of Plaque Psoriasis at Week 2 Based on the Overall Disease Severity (ODS), Dichotomized Scale From Baseline to Week 2

Number of participants who were a success (Clear/Almost Clear) of Plaque Psoriasis at Week 2 based on the Overall Disease Severity (ODS), dichotomized scale from Baseline to Week 2. Overall Disease Severity is evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst. (NCT00988637)
Timeframe: Baseline to week 2

Interventionparticipants (Number)
Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)9
Clobex® Spray (Morning) and Vectical® Ointment (Evening)14

[back to top]

Number of Participants Who Were a Success (Clear/Almost Clear) of Plaque Psoriasis at Week 4 Based on the Overall Disease Severity (ODS), Full Ordinal Scale From Baseline to Week 4

Number of participants who were a success (Clear/Almost Clear) of Plaque Psoriasis at week 4 based on the Overall Disease Severity (ODS), full ordinal scale from baseline to week 4. Overall Disease Severity is evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst. (NCT00988637)
Timeframe: Baseline to Week 4

Interventionparticipants (Number)
Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)14
Clobex® Spray (Morning) and Vectical® Ointment (Evening)28

[back to top]

Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Week 4

Number of participants with Tolerability Assessments resulting in Adverse Events from baseline to week 4. Tolerability assessments (Pruritus, telangiectasias, and stinging/burning) are evaluated on a scale from 0 - 3 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 3 being worst. Skin atrophy and folliculitis are evaluated as absent or present. Changes in tolerability assessments that require a dose modification or concomitant medications/therapy are recorded as adverse events. (NCT00988637)
Timeframe: Baseline to Week 4

Interventionparticipants (Number)
Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)4
Clobex® Spray (Morning) and Vectical® Ointment (Evening)2

[back to top]

"Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question I am Satisfied With my Appearance at Week 4"

"Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question I am Satisfied with my Appearance at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree." (NCT00988637)
Timeframe: Week 4

,
Interventionparticipants (Number)
Strongly agreeModerately agreeNo opinionModerately disagreeStrongly disagreeMissing
Clobex® Spray (Morning) and Vectical® Ointment (Evening)25324511
Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)10396933

[back to top]

"Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question I am Satisfied With the Results of This Treatment Program at Week 4"

"Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question I am satisfied with the results of this treatment program at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree." (NCT00988637)
Timeframe: Week 4

,
Interventionparticipants (Number)
Strongly agreeModerately agreeNo opinionModerately disagreeStrongly disagreeMissing
Clobex® Spray (Morning) and Vectical® Ointment (Evening)42201401
Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)23355313

[back to top]

"Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question I Would Use This Treatment Program Again if Recommended by the Dermatologist at Week 4"

"Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question I would use this treatment program again if recommended by the dermatologist at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree." (NCT00988637)
Timeframe: Week 4

,
Interventionparticipants (Number)
Strongly agreeModerately agreeNo opinionModerately disagreeStrongly disagreeMissing
Clobex® Spray (Morning) and Vectical® Ointment (Evening)50160101
Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)37213243

[back to top]

"Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question The Treatment Program Was Easy to Follow at Week 4"

"Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question The treatment program was easy to follow at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree." (NCT00988637)
Timeframe: Baseline and Week 4

,
Interventionparticipants (Number)
Strongly agreeModerately agreeNo opinionModerately disagreeStrongly disagreeMissing
Clobex® Spray (Morning) and Vectical® Ointment (Evening)5980001
Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)6122203

[back to top]

Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4

Number of participants in each category of the Global Assessment of Improvement (GAI) Scale from Baseline to Week 4. The Global Assessment of Improvement is evaluated on a scale from -1 to 4 (-1 = Symptoms worse, 0 = No change, 1 = Minimal Improvement, 2 = Definite Improvement, 3 = Considerable Improvement and 4 = Clearing) with -1 being worst and 4 being best. (NCT00988637)
Timeframe: Baseline to Week 4

,
Interventionparticipants (Number)
Symptoms worse (-1)No change (0)Minimal Improvement (1)Definite Improvement (2)Considerable Improvement (3)Clearing (4)Missing
Clobex® Spray (Morning) and Vectical® Ointment (Evening)0661018253
Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)1292519131

[back to top]

Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) Scores From Baseline to Week 4

Number of participants with decrease in Signs of Psoriasis (Plaque Elevation) scores from Baseline to Week 4. Signs of Psoriasis (Plaque Elevation) are evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst. (NCT00988637)
Timeframe: Baseline to Week 4

,
Interventionparticipants (Number)
Clear (0)Almost Clear (1)Mild (2)Moderate (3)Severe/Very Severe (4)
Clobex® Spray (Morning) and Vectical® Ointment (Evening)11242670
Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)61533160

[back to top]

Number of Participants With Decrease in Signs of Psoriasis (Scaling) Scores From Baseline to Week 4

Number of participants with decrease in Signs of Psoriasis (Scaling) scores from Baseline to Week 4. Signs of Psoriasis (Scaling) are evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst. (NCT00988637)
Timeframe: Baseline to Week 4

,
Interventionparticipants (Number)
Clear (0)Almost Clear (1)Mild (2)Moderate (3)Severe (4)
Clobex® Spray (Morning) and Vectical® Ointment (Evening)20202350
Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)12242860

[back to top]

Number of Participants With a Decrease in Signs of Psoriasis (Erythema) Scores From Baseline to Week 4

Number of participants with a decrease in Signs of Psoriasis (Erythema) scores from Baseline to Week 4. Signs of Psoriasis (Erythema) are evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe with 0 being best and 4 being worst. (NCT00988637)
Timeframe: Baseline to Week 4

,
Interventionparticipants (Number)
Clear (0)Almost Clear (1)Mild (2)Moderate (3)Severe/Very Severe (4)
Clobex® Spray (Morning) and Vectical® Ointment (Evening)41532170
Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)5631280

[back to top]

Mean Change From Baseline Scores for the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) From Baseline to Week 4

Mean change from baseline scores for the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) from Baseline to Week 4. The Koo-Menter Psoriasis Index is a questionnaire with 12 questions that can be used to assess the effect that psoriasis has on a patient's overall quality of life. The questions are answered on a scale from 0 to 10 with 0 being best and 10 being worst. (NCT00988637)
Timeframe: Baseline to Week 4

InterventionUnits on a scale (Mean)
Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)-24.8
Clobex® Spray (Morning) and Vectical® Ointment (Evening)-27.5

[back to top]

Change in Modified Psoriasis Area Severity Index (PASI) Score

PASI is a scale that measures psoriasis severity based on erythema, induration, scaling, and body surface area covered. It ranges from 0 (no disease) to 72 (most extensive). (NCT00990561)
Timeframe: 2 weeks

Interventionunits on a scale (Mean)
Ultravate 0.05% Ointment Twice Daily2.6
Ultravate 0.05% Ointment Once Daily3

[back to top]

A Tertiary Endpoint Will be the Percentage of Patients Achieving 90% Reduction in Psoriasis Area and Severity Index at Week 12.

(NCT01012713)
Timeframe: 12 weeks

Interventionpercent (Number)
Open-Label Treatment45

[back to top]

The Secondary Endpoint Will be the Percentage of Patients Achieving a 75% Reduction in Psoriasis Area and Severity Index at Weeks 4 and 8.

(NCT01012713)
Timeframe: 8 weeks

Interventionpercent (Number)
Week 8Week 4
Open-Label Treatment7245

[back to top]

The Primary Endpoint Will be the Percentage of Patients Achieving a 75% Reduction in the Psoriasis Area and Severity Index at Week 12.

(NCT01012713)
Timeframe: 12 weeks

Interventionpercent (Number)
Open-Label Treatment83

[back to top]

Adrenal Suppression Potential

Hypothalamic Pituitary-Adrenal (HPA)-Axis responses to Cosyntropin Stimulation Testing (CST) were dichotomized to normal and abnormal. An abnormal HPA Axis response (HPA Suppression) was defined as a 30-minute post-stimulation serum cortisol level of ≤18 μg/dL at the end of treatment. (NCT01166646)
Timeframe: After 1-2 weeks dose

,
Interventionparticipants (Number)
NormalAbnormal
Halobetasol Proprionate Cream 0.05%183
Halobetasol Proprionate Lotion 0.05%165

[back to top]

"Number of Subjects Whose Signs of Psoriasis Was Designated Success"

"Signs of psoriasis including scaling, erythema, and plaque elevation will be recorded at baseline, Day 8, and Day 15 on a 0 (clear) to 4 (severe/very severe) point scale. Each of the signs of psoriasis will be dichotomized to a) success and failure with success defined as a grade of 1 or 0 at the End of Treatment (EOT; i.e., the visit at which psoriasis has cleared [Day 8 or Day 15] or end of the assigned treatment period)." (NCT01166646)
Timeframe: Day 15

,
Interventionparticipants (Number)
ScalingErythemaPlaque elevation
Halobetasol Proprionate Cream 0.05%1167
Halobetasol Proprionate Lotion 0.05%622

[back to top]

Pharmacokinetic Properties (Tmax)

Comparison of PK results (time to peak concentration [Tmax]) between the two Treatment Groups will be conducted following the last application of the medication on Day 8. (NCT01166646)
Timeframe: Day 8

InterventionHours (Geometric Mean)
Halobetasol Proprionate Lotion 0.05%3
Halobetasol Proprionate Cream 0.05%3

[back to top]

Pharmacokinetic Properties (Cmax)

Comparison of PK results (peak concentration in plasma [Cmax]) between the two Treatment Groups will be conducted following the last application of the medication on Day 8. (NCT01166646)
Timeframe: Day 8

Interventionpg/mL (Geometric Mean)
Halobetasol Proprionate Lotion 0.05%145.9
Halobetasol Proprionate Cream 0.05%136.2

[back to top]

Pharmacokinetic Properties (AUC)

Comparison of PK results (area under the curve [AUC] from time 0 to infinity) between the two Treatment Groups will be conducted following the last application of the medication on Day 8. (NCT01166646)
Timeframe: Day 8

Interventionpg*h/mL (Geometric Mean)
Halobetasol Proprionate Lotion 0.05%1267.7
Halobetasol Proprionate Cream 0.05%1229.8

[back to top]

Changes in Disease Severity (Success)

"Overall disease severity (ODS) will be recorded at baseline, Day 8, and Day 15 on a 0 (clear) to 4 (severe/very severe) point scale. ODS evaluations will be dichotomized to success and failure with success defined as a grade of 1 or 0 at the end of treatment (EOT)." (NCT01166646)
Timeframe: Day 15

Interventionparticipants (Number)
Halobetasol Proprionate Lotion 0.05%1
Halobetasol Proprionate Cream 0.05%5

[back to top]

sPGA (0,1) at Week 24

The percentage of participants achieving sPGA 0 or 1 at week 24. Static physician global assessment of psoriasis (sPGA) is a physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA of psoriasis comprises a 6-point scale ranging from 0 (clear) to 5 with increasing severity. (NCT01235442)
Timeframe: Week 24

InterventionPercentage of participants (Number)
Etanercept Monotherapy54.8
Etanercept + Clobetasol Propionate Foam61.7

[back to top]

sPGA (0,1) at Week 12

The percentage of participants achieving sPGA 0 or 1 at week 12. Static physician global assessment of psoriasis (sPGA) is a physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA of psoriasis comprises a 6-point scale ranging from 0 (clear) to 5 with increasing severity. (NCT01235442)
Timeframe: Week 12

InterventionPercentage of participants (Number)
Etanercept Monotherapy47.3
Etanercept + Clobetasol Propionate Foam63.1

[back to top]

Percent PASI Improvement From Baseline at Week 12

The percentage of the improvement in PASI score at week 12 from baseline. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. (NCT01235442)
Timeframe: Week 12

InterventionPercentage of Improvement in PASI score (Mean)
Etanercept Monotherapy68.18
Etanercept + Clobetasol Propionate Foam76.46

[back to top]

PASI 90 at Week 12

The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 90 responses at week 12. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 90% reduction in the PASI score from Baseline. (NCT01235442)
Timeframe: Week 12

InterventionPercentage of participants (Number)
Etanercept Monotherapy19.4
Etanercept + Clobetasol Propionate Foam29.7

[back to top]

PASI 75 at Week 24

The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 75 responses at week 24. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 75% reduction in the PASI score from Baseline. (NCT01235442)
Timeframe: Week 24

InterventionPercentage of participants (Number)
Etanercept Monotherapy63.6
Etanercept + Clobetasol Propionate Foam69.3

[back to top]

PASI 75 at Week 12

The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 75 responses at week 12. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 75% reduction in the PASI score from Baseline. (NCT01235442)
Timeframe: Week 12

InterventionPercentage of participants (Number)
Etanercept Monotherapy48.3
Etanercept + Clobetasol Propionate Foam65.2

[back to top]

Patient Satisfaction at Week 12

"Patient assessment of treatment satisfaction status at week 12. It is a measure of a participant's level of satisfaction with the medication's control of psoriasis, ranging from very satisfied to very dissatisfied." (NCT01235442)
Timeframe: Week 12

,
InterventionPercentage of participants (Number)
Very dissatisfiedDissatisfiedNeither satisfied nor dissatisfiedSatisfiedVery satisfied
Etanercept + Clobetasol Propionate Foam3.94.35.334.851.8
Etanercept Monotherapy2.84.914.738.139.5

[back to top]

Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15

On Days 1, 3, 8, and 15, participants assessed the pruritis (itching), stinging (piercing pain), burning, and pain of the target hand. Participants were instructed to assess the level/severity of the indicated symptoms over the previous 24 hours using a scale ranging from 0 (none) to 10 (unbearable). Percent change from baseline was calculated as value at Days 3, 8, and 15 minus the value at Baseline divided by the Baseline value * 100. (NCT01323673)
Timeframe: Baseline (Day 1) and Days 3, 8, and 15

,
InterventionPercent change in scores on a scale (Mean)
Pruritus, Day 3, n=58, 58Pruritus, Day 8, n=57, 57Pruritus, Day 15, n=60, 59Stinging, Day 3, n=57, 60Stinging, Day 8, n=56, 58Stinging, Day 15, n=58, 59Burning, Day 3, n=57, 59Burning, Day 8, n=55, 58Burning, Day 15, n=59, 60Pain, Day 3, n=56, 58Pain, Day 8, n=57, 56Pain, Day 15, n=60, 59
Olux-E Foam-29.4-48.3-65.7-27.8-49.2-63.1-26.4-49.7-63.2-22.9-40.2-60.6
Vehicle Foam-11.5-20.3-25.3-1.84-22.9-28.9-10.4-26.1-31.1-21.0-21.5-35.5

[back to top]

Number of Participants With an ISGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15

The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting. (NCT01323673)
Timeframe: Days 3, 8, and 15

,
Interventionparticipants (Number)
Day 3Day 8Day 15
Olux-E Foam21124
Vehicle Foam2917

[back to top]

Number of Participants With an Improvement of at Least 1 Grade in the Subject Global Assessment (SGA) (Target Hand) Score From Baseline to Days 3, 8, and 15

On Days 1, 3, 8, and 15 prior to the investigator assessment, participants rated chronic hand dermatitis of the target hand using the 5-point SGA: 0=skin is clear; 1=dermatitis in minimal, there may be a few light-pink areas; 2=dermatitis is mild, there may be occasional light-pink areas; 3=dermatitis is moderate, there may be easily noticeable pink-red areas; 4=dermatitis is severe, there may be deep or bright-red areas that may be warm to the touch. (NCT01323673)
Timeframe: Baseline (Day 1) and Days 3, 8, and 15

,
Interventionparticipants (Number)
Day 3Day 8Day 15
Olux-E Foam284451
Vehicle Foam253533

[back to top]

Number of Participants With an Improvement of at Least 1 Grade in the ISGA (Target Hand) Score From Baseline to Day 15

The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting. (NCT01323673)
Timeframe: Baseline (Day 1) and Day 15

Interventionparticipants (Number)
Olux-E Foam45
Vehicle Foam38

[back to top]

Number of Participants With an SGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15

On Days 1, 3, 8, and 15 prior to the investigator assessment, participants rated chronic hand dermatitis of the target hand using the 5-point SGA: 0=skin is clear; 1=dermatitis in minimal, there may be a few light-pink areas; 2=dermatitis is mild, there may be occasional light-pink areas; 3=dermatitis is moderate, there may be easily noticeable pink-red areas; 4=dermatitis is severe, there may be deep or bright-red areas that may be warm to the touch. (NCT01323673)
Timeframe: Days 3, 8, and 15

,
Interventionparticipants (Number)
Day 3Day 8Day 15
Olux-E Foam71632
Vehicle Foam41014

[back to top]

Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) (Target Hand) Score From Baseline to Day 15

The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting. (NCT01323673)
Timeframe: Baseline (Day 1) and Day 15

Interventionparticipants (Number)
Olux-E Foam26
Vehicle Foam18

[back to top]

Number of Participants With an Improvement of at Least 1 Grade in the ISGA (Target Hand) Score From Baseline to Day 3 and and to Day 8

The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting. (NCT01323673)
Timeframe: Baseline (Day 1), Day 3, and Day 8

,
Interventionparticipants (Number)
Day 3Day 8
Olux-E Foam2436
Vehicle Foam1432

[back to top]

Number of Participants With an Improvement of at Least 2 Grades in the ISGA (Target Hand) Score From Baseline to Day 3 and to Day 8

The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting. (NCT01323673)
Timeframe: Baseline (Day 1), Day 3, and Day 8

,
Interventionparticipants (Number)
Day 3Day 15
Olux-E Foam212
Vehicle Foam311

[back to top] [back to top]

Time to Maximum Plasma Concentration (Cmax) of Clobetasol

Steady-state pharmacokinetics of systemic clobetasol were assessed following a single 2 min oral rinse of 0.05% clobetasol on day 14 (1 patient collected on day 12). A noncompartmental pharmacokinetic assessment was performed using WinNonlin v5 (Pharsight Corp, Mountain View, CA) from three sampling times (pre-rinse, 15-45 min post-rinse, and 90-120 min post-rinse). Plasma concentrations of clobetasol were measured using a newly designed and validated LC-MS/MS assay, with a lower limit of quantification of 0.05 ng/mL. The maximum plasma concentrations (CMAX) were recorded as observed values and the area under the plasma-concentration time curve using all three sampling time points (AUCALL) was calculated using the Linear Trapezoidal rule. (NCT01557517)
Timeframe: pre-rinse, 15-45 min post-rinse, and 90-120 min post-rinse

Interventionhours (Mean)
Clobetasol1.27

[back to top] [back to top]

Percentage of Participants With a Response as Assessed by the 273-point Oral Mucositis Rating Scale (OMRS) Who Received Topical Clobetasol 0.05% Oral Rinse for Oral Chronic Graft-versus-host-disease (cGVHD) During a Four-week Treatment Period

Mucosal changes were assessed by the Oral Mucositis Rating Scale. The primary endpoint was evaluated using the OMRS. Oral tissue changes are rated on a scale of 0-3 compared with normal oral tissue (0-normal/no change, 1-mild change, 2-moderate change, and 3-severe change). Total score is the sum of all OMRS items with a possible range of 0. Total score is the sum of all OMRS items with a possible range of 0-273. Lower score=more normal oral mucosa. There is no standard definition of response in this field. Definitions we used in this pilot study to grade the response to study intervention are: Progress of 25% of initial score (rounded to the closest number) on the OMRS scale. Completion (PD) is defined as an increase of 25% of initial score (rounded to the closest number). Partial Response (PR) is defined as a decrease Response (CR) is defined as a PR plus a score of 0 on the erythema and ulceration components. Stable Disease (SD) does not meet criteria for progression or response. (NCT01557517)
Timeframe: At 4 weeks on active treatment

,,
Interventionpercentage of participants (Number)
Progressive DiseasePartial ResponseComplete ResponseStable Disease
Clobetasol (2-week)072028
Combined Group 4-week Data072199
Placebo (2-week)09091

[back to top]

Plasma Concentrations of Clobetasol Mouth Rinse in cGVHD Patients at Baseline (Day 0) and Day 28

Peripheral blood was drawn at baseline and day 28 of clobetasol rinse use, and clobetasol levels were measured in the blood sample. Plasma concentrations of clobetasol were measured using a validated LC-MS/MS assay with a lower limit of quantification of 0.05 ng/mL. Any values below detectable limit or with no peak were adjusted to 0. (NCT01557517)
Timeframe: Baseline Day 0 and Day 28

Interventionng/mL (Mean)
Baseline (Day 0)Day 28
Combined Group 4-week Data0.01460.329

[back to top]

Area Under the Plasma Concentration vs Time Curve for All Time Points

Steady-state pharmacokinetics of systemic clobetasol were assessed following a single 2 min oral rinse of 0.05% clobetasol on day 14 (1 patient collected on day 12). A noncompartmental pharmacokinetic assessment was performed using WinNonlin v5 (Pharsight Corp, Mountain View, CA) from three sampling times (pre-rinse, 15-45 min post-rinse, and 90-120 min post-rinse). Plasma concentrations of clobetasol were measured using a newly designed and validated LC-MS/MS assay, with a lower limit of quantification of 0.05 ng/mL. The maximum plasma concentrations (CMAX) were recorded as observed values and the area under the plasma-concentration time curve using all three sampling time points (AUCALL) was calculated using the Linear Trapezoidal rule. (NCT01557517)
Timeframe: pre-rinse, 15-45 min post-rinse, and 90-120 min post-rinse

InterventionHr*ng/mL (Mean)
Clobetasol0.974

[back to top]

Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT01557517)
Timeframe: Date treatment consent signed to date off study, approximately 62 months and 12 days.

InterventionParticipants (Count of Participants)
Clobetasol17
Placebo First (During Clobetasol Phase Only)21
Placebo (During 2-week Placebo Phase Only)6

[back to top]

Maximum Plasma Concentration (Cmax) of Clobetasol During Pharmacokinetic Testing

Steady-state pharmacokinetics of systemic clobetasol were assessed following a single 2 min oral rinse of 0.05% clobetasol on day 14 (1 patient collected on day 12). A noncompartmental pharmacokinetic assessment was performed using WinNonlin v5 (Pharsight Corp, Mountain View, CA) from three sampling times (pre-rinse, 15-45 min post-rinse, and 90-120 min post-rinse). Plasma concentrations of clobetasol were measured using a newly designed and validated LC-MS/MS assay, with a lower limit of quantification of 0.05 ng/mL. The maximum plasma concentrations (CMAX) were recorded as observed values and the area under the plasma-concentration time curve using all three sampling time points (AUCALL) was calculated using the Linear Trapezoidal rule. (NCT01557517)
Timeframe: pre-rinse, 15-45 min post-rinse, and 90-120 min post-rinse

Interventionng/mL (Mean)
Clobetasol0.818

[back to top] [back to top]

Physician Global Assessement

"Percentage of participants with clear or almost clear skin on the PGA scale. 0 = clear~= almost clear~= mild~= moderate~= severe" (NCT01745133)
Timeframe: 10 weeks

Interventionpercentage of patients (Number)
Vehicle 68%68
Calcipotriene 80%80
Calcipotriene + Clobetasol Propionate 79%79

[back to top]

Investigator Reported Target Lesion Severity Score

Investigator reported mean scores of the target lesion numeric rating scale (TL-NRS; scale of 0 (no psoriasis) to 10 (very severe psoriasis)) at end of study (NCT01893567)
Timeframe: 2 weeks

Interventionunits on a scale (Mean)
Clobex Spray3.3

[back to top]

Subject Reported Target Lesion Severity Score.

Subject reported mean scores of the target lesion numeric rating scale (TL-NRS; scale of 0 (no psoriasis) to 10 (very severe psoriasis)) at end of study. (NCT01893567)
Timeframe: 2 weeks

Interventionunits on a scale (Mean)
Clobex Spray4.0

[back to top]

The Percentage of Subjects With HPA Axis Suppression.

HPA axis suppression as measured by serum cortisol levels post cosyntropin test (ACTH test) (NCT02131324)
Timeframe: Day 15

Interventionpercentage of participants (Number)
Clobetasol Propionate Cream, 0.05%36.4
DFD06 Cream12.5

[back to top]

Changes in QOL (According to the Linear Analogue Self-Assessment [LASA] Questionnaire)

Changes in QOL (according to the LASA questionnaire as measured by the overall QOL question) from baseline will be compared between the treatment arms using the Kruskal-Wallis test. (NCT02368886)
Timeframe: Baseline to 8 weeks

InterventionLASA overall score change from baseline (Mean)
Arm A1 (Regorafenib Dose Escalation + Pre-emptive Strategy)-0.9
Arm A2 (Regorafenib Dose Escalation + Reactive Strategy)-0.3
Arm B1 (Regorafenib Standard Dose + Pre-emptive Strategy)-0.7
Arm B2 (Regorafenib Standard Dose + Reactive Strategy)-0.9

[back to top]

Dose Intensity of Regorafenib Received by Patients in the First Two Cycles as Measured by the Percentage of Planned Dose Received

Dose intensity of regorafenib received by patients in the first two cycles as measured by the percentage (%) of planned dose received (NCT02368886)
Timeframe: Up to 8 weeks

Interventionpercentage of planned dose received (Median)
Regorafenib Dose Escalation Group76.2
Regorafenib Standard Dose Group76.0

[back to top]

Overall Survival (OS)

OS is defined as the time from randomization to death due to any cause and will be estimated with Kaplan-Meier survival curves and differences between regorafenib arms (A vs. B) tested using log-rank tests, though these analyses are not powered for formal non-inferiority assessments. (NCT02368886)
Timeframe: Time from randomization to death due to any cause, assessed up to 2 years

Interventionmonths (Median)
Regorafenib Dose Escalation Group9.8
Regorafenib Standard Dose Group6.0

[back to top]

Progression Free Survival (PFS)

PFS is defined as the time from randomization to the earlier of disease progression or death due to any cause, where progressed disease (PD) is defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and will be estimated with Kaplan-Meier survival curves and differences between regorafenib arms (A vs. B) tested using log-rank tests, though these analyses are not powered for formal non-inferiority assessments. (NCT02368886)
Timeframe: Time from randomization to the earlier of disease progression or death due to any cause, where progressed disease (PD) is defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, assessed up to 2 years

Interventionmonths (Median)
Regorafenib Dose Escalation Group2.8
Regorafenib Standard Dose Group2.0

[back to top]

Proportion of Patients in Each Arm Who Complete 2 Cycles of Protocol Treatment and Initiate Cycle 3

Fisher exact test will be used to detect a difference course 3 between arms (starting low dose [pooled arm A1 and A2] versus [vs.] standard dose [pooled arm B1 and B2]). The proportion of patients who complete 2 courses of protocol treatment and initiate course 3 will be computed by arm with its 95% confidence interval using exact method. (NCT02368886)
Timeframe: At 8 weeks

Interventionproportion of patients (Number)
Regorafenib Dose Escalation Group0.43
Regorafenib Standard Dose Group0.26

[back to top]

Time to Progression (TTP)

TTP is defined as the time from randomization to disease progression, where PD is defined by RECIST 1.1 and will be estimated with Kaplan-Meier survival curves and differences between regorafenib arms (A vs. B) tested using log-rank tests, though these analyses are not powered for formal non-inferiority assessments. (NCT02368886)
Timeframe: Time from randomization to disease progression, where PD is defined by RECIST 1.1, assessed up to 2 years

Interventionmonths (Median)
Regorafenib Dose Escalation Group2.8
Regorafenib Standard Dose Group2.0

[back to top]

Cumulative (Total) Dose of Regorafenib Received by Patients in the First Two Cycles

Will be summarized with descriptive statistics and compared between regorafenib arms (A vs. B). (NCT02368886)
Timeframe: Up to 8 weeks

,
Interventionmg/day (Mean)
Cycle 1Cycle 2
Regorafenib Dose Escalation Group91.8121.3
Regorafenib Standard Dose Group133.1117.3

[back to top]

The Percentage of Subjects With Treatment Success at the Day 8 Visit.

"The percentage of subjects with treatment success (defined as IGA = 0 or 1 and at least a 2 grade reduction from Baseline) at Day 8.~The analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets." (NCT02445807)
Timeframe: At Day 8 Visit

Interventionpercentage of participants (Number)
DFD-06 Cream14.2
Vehicle Cream1.6

[back to top]

The Percent Change in Body Surface Area of Psoriasis

The percent change from baseline in Body Surface Area at Day 15. The analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets. (NCT02445807)
Timeframe: From Baseline to Day 15

Interventionpercentage change in body surface area (Mean)
DFD-06 Cream-25.1
Vehicle Cream-7.4

[back to top]

Efficacy (Percentage of Subjects With Treatment Success)

"The primary efficacy endpoint is the percentage of subjects with treatment success (defined as IGA = 0 or 1 and at least a 2 grade reduction from Baseline) at the Day 15 visit.~The primary analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets." (NCT02445807)
Timeframe: Day 15 Visit

Interventionpercentage of participants (Number)
DFD-06 Cream30.1
Vehicle Cream9.7

[back to top]

Number of Patients With Adverse Outcomes

Total number for adverse outcomes (of any severity) to include description of pain, infection, de novo or worsening dyspareunia, contact dermatitis and burns from treatment. (NCT02573883)
Timeframe: 12 Weeks from treatment

InterventionParticipants (Count of Participants)
Fractionated Carbon Dioxide Laser1
Clobetasol Propionate1

[back to top]

Number of Patients With Adverse Outcomes

Total number for adverse outcomes (of any severity) to include description of pain, infection, de novo or worsening dyspareunia, contact dermatitis and burns from treatment. (NCT02573883)
Timeframe: 12 Weeks to Six months from treatment

InterventionParticipants (Count of Participants)
Fractionated Carbon Dioxide Laser0
Clobetasol Propionate0

[back to top]

Change Objective Provider VAS Visual Analog Scale

Provider scored objective appearance of vulvar Lichen Sclerosus. Each item scaled 0-10 with greater severity of appearance indicated by higher score. Results expressed as change with more negative values indicating greater improvement. (NCT02573883)
Timeframe: Baseline to Six months from treatment

,
Interventionscore on a scale (Mean)
White PlaqueCigarette PaperIntroital NarrowingPerianal InvolvementLoss of Labial MinoraFusion of Labia MinoraPhimosisFissureErosion
Clobetasol Propionate-1.3-1.5-0.70-1.77-0.780.350.22-1.78-0.57
Fractionated Carbon Dioxide Laser-1.81-2.58-1.73-0.73-0.96-0.5-1.28-2.12-2.08

[back to top]

Change Objective Provider VAS Visual Analog Scale

Provider scored objective appearance of vulvar Lichen Sclerosus. Each item scaled 0-10 with greater severity of appearance indicated by higher score. Results expressed as change with more negative values indicating greater improvement. (NCT02573883)
Timeframe: Six months to One Year from treatment

,,,
Interventionscore on a scale (Mean)
White PlaqueCigarette PaperIntroital NarrowingPerianal InvolvementLoss of Labial MinoraFusion of Labia MinoraPhimosisFissureErosion
Clobetasol Propionate to Laser Crossover-0.27-0.45-0.180.640.73-1.09-0.18-0.45-0.36
Clobetasol Propionate- No Crossover-1.250.380.880.29-0.5-0.25-0.50.620.12
Fractionated Carbon Dioxide Laser to Clobetasol Crossover-0.22-0.2-0.1-1.41.2-10.2-1.4-0.6
Fractionated Carbon Dioxide Laser- No Crossover-0.710.070-0.770.50.141.430.071

[back to top]

Change Vulvar Symptom Visual Analog Scale (VAS) Score

Patient subjective scale of symptoms of Lichen Sclerosus. Each item scaled 0-10 with greater severity of symptoms indicated by higher score. Results expressed as change with more negative values indicating greater improvement in symptoms (better outcome). (NCT02573883)
Timeframe: Six months to one year after treatment

,,,
Interventionscore on a scale (Mean)
ItchingBurningIrritation or tearingPain with sexTearing of vulvar skinDysuriaPainful defecation
Clobetasol Propionate to Laser Crossover-1.82-0.73-1.64-1.62-2.12-1.27-0.09
Clobetasol Propionate- No Crossover-0.1-1.5-10-0.8-0.2-0.57
Fractionated Carbon Dioxide Laser to Clobetasol Crossover0.89-0.90.67-2-0.22-0.4-0.89
Fractionated Carbon Dioxide Laser- No Crossover-0.8-0.73-0.38-1.12-0.14-0.50

[back to top]

Change Vulvar Symptom Visual Analog Scale (VAS) Score

Patient subjective scale of symptoms of Lichen Sclerosus. Each item scaled 0-10 with greater severity of symptoms indicated by higher score. Results expressed as change with more negative values indicating greater improvement. (NCT02573883)
Timeframe: Baseline to 6 months after treatment

,
Interventionscore on a scale (Mean)
ItchingBurningIrritationPain with sexTearing of vulvar skinDysuriaPain defecation
Clobetasol Propionate-1.83-1.00-1.32-0.14-1.32-0.78-0.78
Fractionated Carbon Dioxide Laser-3.26-2.78-4.15-0.69-1.77-2.11-1.11

[back to top]

Change in SkinDEX-29 Score

The Skindex-29 is a validated questionnaire for assessing acute dermatologic symptoms over a 4-week period. The Skindex-29 is a 29 question version of the original SkinDEX questionnaire. Total numeric score is reported ranging from 0-100. Scores reported as a change between six months and baseline with more negative scores indicating greater improvement in symptoms (better outcome). (NCT02573883)
Timeframe: Change from baseline score to score at six months

Interventionscore on a scale (Mean)
Fractionated Carbon Dioxide Laser-16.83
Clobetasol Propionate-5.92

[back to top]

Change in Subjective Vulvovaginal Symptoms Questionnaire (VSQ)

Subjective measure of vulvar symptoms of itching, burning, dyspareunia of Lichen Sclerosus. VSQ is a 21-item instrument and scores range from 0 to 20 with increased scores indicating increased vulvovaginal symptom bother. The change in VSQ is reported with more negative scores indicating greater improvement. (NCT02573883)
Timeframe: Baseline to six months

Interventionscore on a scale (Mean)
Fractionated Carbon Dioxide Laser-3.92
Clobetasol Propionate-0.58

[back to top]

Change in Subjective Vulvovaginal Symptoms Questionnaire (VSQ)

Subjective measure of vulvar symptoms of itching, burning, dyspareunia of Lichen Sclerosus. VSQ is a 21-item instrument and scores range from 0 to 20 with increased scores indicating increased vulvovaginal symptom bother. The change in VSQ is reported with more negative scores indicating greater improvement. (NCT02573883)
Timeframe: Six month to one year after treatment

Interventionscore on a scale (Mean)
Fractionated Carbon Dioxide Laser- No Crossover0.44
Clobetasol Propionate- No Crossover0.3
Clobetasol Propionate to Laser Crossover-1.82
Fractionated Carbon Dioxide Laser to Clobetasol Crossover-2.9

[back to top]

Change SkinDEX-29 Score

The Skindex-29 is a validated questionnaire for assessing acute dermatologic symptoms over a 4-week period. The Skindex-29 is a 29 question version of the original SkinDEX questionnaire. Total numeric score is reported ranging from 0-100. Scores reported as a change between six months and baseline with more negative scores indicating greater improvement. (NCT02573883)
Timeframe: Six months to one year from treatment

Interventionscore on a scale (Mean)
Fractionated Carbon Dioxide Laser- No Crossover-0.78
Clobetasol Propionate- No Crossover-7.05
Clobetasol Propionate to Laser Crossover-10.23
Fractionated Carbon Dioxide Laser to Clobetasol Crossover-1.52

[back to top]

Change Vaginal Health Index (VHI) Score

The Vaginal Health Index is a five item scale with scores ranging from 5-25 with lower scores indicating greater urogenital atrophy. The change in VHI is express with more negative scores indicating greater improvement between study time points. (NCT02573883)
Timeframe: Baseline to 6 months after treatment

Interventionscore on a scale (Mean)
Fractionated Carbon Dioxide Laser1.92
Clobetasol Propionate-0.43

[back to top]

Change Vaginal Health Index (VHI) Score

The Vaginal Health Index is a five item scale with scores ranging from 5-25 with lower scores indicating greater urogenital atrophy. The change in VHI is express with more negative scores indicating greater improvement between study time points. (NCT02573883)
Timeframe: Six month to one year after treatment

Interventionscore on a scale (Mean)
Fractionated Carbon Dioxide Laser- No Crossover-2.86
Clobetasol Propionate- No Crossover1.44
Clobetasol Propionate to Laser Crossover1.73
Fractionated Carbon Dioxide Laser to Clobetasol Crossover1.3

[back to top] [back to top] [back to top]

Number of Patients With Adverse Outcomes

Total number for adverse outcomes (of any severity) to include description of pain, infection, de novo or worsening dyspareunia, contact dermatitis and burns from treatment (NCT02573883)
Timeframe: Six Month to One Year from treatment

InterventionParticipants (Count of Participants)
Fractionated Carbon Dioxide Laser- No Crossover0
Clobetasol Propionate- No Crossover0
Clobetasol Propionate to Laser Crossover0
Fractionated Carbon Dioxide Laser to Clobetasol Crossover0

[back to top]

Percent Change From Baseline in Body Surface Area at Day 15

Percent change from baseline in body surface area affected by psoriasis at Day 15. The analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets. (NCT02635204)
Timeframe: Baseline and Day 15

Interventionpercentage change in body surface area (Mean)
DFD-06 Cream-28.9
Vehicle Cream-6.1

[back to top]

Percent of Subjects With Treatment Success at Day 8 Visit

Percent of subjects with treatment success at Day 8 Visit defined as an IGA of 0 or 1 with at least a 2 grade reduction from baseline. The analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets. (NCT02635204)
Timeframe: Baseline and Day 8

Interventionpercentage of subject (Number)
DFD-06 Cream15.7
Vehicle Cream5.6

[back to top]

Percentage of Subjects With Treatment Success at Day 15

The percentage of subjects with treatment success (defined as IGA = 0 or 1 and at least a 2-grade reduction from baseline) at the Day 15 visit. Primary analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets. (NCT02635204)
Timeframe: Day 15 Visit

Interventionpercentage of participants (Number)
DFD-06 Cream30.2
Vehicle Cream9.0

[back to top]

Percent of Subjects With Treatment Success

"Treatment success defined as at least a 2-grade improvement from Baseline in the Investigator's Global Assessment (IGA) score and an IGA score equating to clear or almost clear. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe)." (NCT02785172)
Timeframe: 2 weeks

Interventionpercentage of participants (Number)
IDP-118 Lotion32.79
Ultravate Cream33.97
IDP-118 Vehicle Lotion0
IDP-118 Vehicle Cream7.14

[back to top]

Percentage of Participants With Treatment Success of a 2-Grade IGA Score Improvement From Baseline and an IGA Score of Clear or Almost Clear at Week 2

"Treatment success defined as at least a 2-grade improvement from Baseline in the Investigator's Global Assessment (IGA) score and an IGA score equating to clear or almost clear at Week 2. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe)." (NCT02785185)
Timeframe: 2 weeks

InterventionParticipants (Count of Participants)
IDP-122 Lotion18
Ultravate Cream18
IDP-122 Vehicle Lotion3
IDP-122 Vehicle Cream1

[back to top]

Plasma Concentration of Clobetasol Propionate

Plasma concentrations of clobetasol propionate after multiple doses of DFD-06 under maximal use condition with the final-to-be-marketed formulation. (NCT03179605)
Timeframe: Day 15 0 hour, 1 hour, 3 hours, 6 hours after application

Interventionpg/mL (Mean)
0 hour clobetasol plasma level1 hour clobetasol plasma level3 hour clobetasol plasma level6 hour clobetasol plasma levelAverage of 1, 3 and 6 hour
DFD-06 Cream51.48640.37064.25042.14345.47

[back to top]

Percentage of Subjects With HPA Axis Suppression at Day 15

The percentage of subjects with abnormal cortisol response for ACTH stimulation test at Day 15 (cortisol level ≤18 µg/dL at 30 minutes post stimulation) is the primary variable (NCT03179605)
Timeframe: Day 15

InterventionParticipants (Count of Participants)
DFD-06 Cream3

[back to top]

Number of Participants With Improvement in IGA Grade From Baseline

Numbers of subjects with improvements by at least 1 pint in IGA grade will be provided as descriptive statistics. (NCT03179605)
Timeframe: Baseline up to Day 15

Interventionparticipants (Number)
Day 8 1-point improvement in IGADay 8 2-point improvement in IGADay 15 1 point improvement in IGADay 15 2-point improvement in IGADay 15 3-point improvement in IGA
DFD-06 Cream1528102

[back to top]

Number of Subjects With Abnormal Hypothalamus-Pituitary-Adrenal Axis Response

An abnormal Hypothalamus-Pituitary-Adrenal (HPA) axis was response was defined as a 30-minute post-stimulation serum cortisol level of ≤18 μg/dL at end of study (EOS) (NCT03212963)
Timeframe: Day 15

Interventionnumber of subjects (Number)
Halobetasol Lotion Treatment Arm1

[back to top]

Percent Body Surface Area Treated With Test Article

The Percent Body Surface Area Treated with Test Article was defined as the BSA which was affected with psoriasis within the Treatment Area that was treated. (NCT03212963)
Timeframe: Day 8

Interventionpercentage of body surface area (Mean)
Halobetasol Lotion Treatment Arm7.1

[back to top]

Percent BSA Affected With Disease

The Percent Body Surface Area (BSA) Affected with Disease was defined as the BSA which was affected with psoriasis within the Treatment Area. (NCT03212963)
Timeframe: Day 15

Interventionpercentage of body surface area (Mean)
Halobetasol Lotion Treatment Arm2.8

[back to top]

Investigator's Global Assessment

The IGA score (5-point scale of 0 to 4: 0[clear]; 1[almost clear]; 2[mild]; 3[moderate]; 4[severe]) is an evaluation of the overall severity of a subject's psoriasis in the Treatment Area and takes into consideration the 3 individual characteristics of psoriasis (scaling, erythema, and plaque elevation). (NCT03212963)
Timeframe: Day 15

Interventionnumber of subjects (Number)
IGA Grade 0IGA Grade 1IGA Grade 2IGA Grade 3IGA Grade 4
Halobetasol Lotion Treatment Arm53420

[back to top]

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

[back to top]

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

[back to top]

Pain Visual Analogue Scale (VAS) Score

"Percentage of participants with VAS pain score of 0 (no eye pain). Pain was scored by ticking on a continuous scale comprised of a 10 cm horizontal line anchored by two verbal descriptions: no eye pain (score of 0) and worst imaginable eye pain (score of 10)." (NCT04246801)
Timeframe: Day 8

InterventionParticipants (Count of Participants)
Clobetasol Propionate83
Placebo19

[back to top]

Anterior Chamber Cell Grade

"Percentage of participants with anterior chamber cell grade of 0 (absence of cells)" (NCT04246801)
Timeframe: Day 8

InterventionParticipants (Count of Participants)
Clobetasol Propionate67
Placebo18

[back to top]

Pain Visual Analogue Scale (VAS) Score

"Percentage of participants with VAS pain score of 0 (no eye pain)" (NCT04249076)
Timeframe: Day 8

InterventionParticipants (Count of Participants)
Clobetasol Propionate68
Placebo31

[back to top]

Anterior Chamber Cell Grade

"Percentage of participants with anterior chamber cell grade of 0 (absence of cells)" (NCT04249076)
Timeframe: Day 8

InterventionParticipants (Count of Participants)
Clobetasol Propionate38
Placebo7

[back to top]