Page last updated: 2024-11-10

halobetasol

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

Description

halobetasol: used in ointment to treat psoriasis; Ulobetasol cream contains 0.05% 6-fluoroclobetasol 17-propionate [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID5311167
CHEMBL ID1201360
CHEBI ID197151
SCHEMBL ID4679
MeSH IDM0438588

Synonyms (35)

Synonym
cgp 14458
halobetasol
DB00596
21-chloro diflorasone
ulobetasol
idp-122
D08660
ulobetasol (inn)
98651-66-2
(6s,8s,9r,10s,11s,13s,14s,16s,17r)-17-(2-chloroacetyl)-6,9-diluoro-11,17-dihydroxy-10,13,16-trimethyl-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-3-one
CHEBI:197151
(6s,8s,9r,10s,11s,13s,14s,16s,17r)-17-(2-chloroacetyl)-6,9-difluoro-11,17-dihydroxy-10,13,16-trimethyl-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-3-one
CHEMBL1201360
halobetasol [usan]
ulobetasol [inn]
9p6159hm7t ,
unii-9p6159hm7t
ulobetasol [who-dd]
halobetasol propionate impurity, 21-chloro diflorasone- [usp impurity]
21-chloro-6.alpha.,9-difluoro-11.beta.,17-dihydroxy-16.beta.-methylpregna-1,4-diene-3,20-dione
halobetasol [vandf]
SCHEMBL4679
LEHFPXVYPMWYQD-XHIJKXOTSA-N
DTXSID60243759 ,
Q7879715
(6alpha,11beta,16beta)-21-chloro-6,9-difluoro-11,17-dihydroxy-16-methylpregna-1,4-diene-3,20-dione
pregna-1,4-diene-3,20-dione,21-chloro-6,9-difluoro-11,17-dihydroxy-16-methyl-, (6a,11b,16b)-
EN300-19768053
(1r,2s,3as,3bs,5s,9as,9br,10s,11as)-1-(2-chloroacetyl)-5,9b-difluoro-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
21-chloro-6alpha,9-difluoro-11beta,17-dihydroxy-16beta-methylpregna-1,4-diene-3,20-dione
dtxcid40166250
ulobetasolum
d07ac21
HY-113783
CS-0063401

Research Excerpts

Toxicity

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
)
0.64
"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
" 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
)
0.66
" 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
)
0.74
" 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
)
0.74
" 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
)
0.76
" 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
)
0.82
" 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
)
0.78
" 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
)
0.87

Dosage Studied

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.

ExcerptRelevanceReference
"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
)
0.95
"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
)
1.04
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Drug Classes (1)

ClassDescription
corticosteroid hormoneAny of a class of steroid hormones that are produced in the adrenal cortex.
[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]

Bioassays (6)

Assay IDTitleYearJournalArticle
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.
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.
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.
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.
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.
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.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (89)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's22 (24.72)18.2507
2000's15 (16.85)29.6817
2010's27 (30.34)24.3611
2020's25 (28.09)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 79.94

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 Index79.94 (24.57)
Research Supply Index4.90 (2.92)
Research Growth Index4.92 (4.65)
Search Engine Demand Index144.37 (26.88)
Search Engine Supply Index2.08 (0.95)

This Compound (79.94)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials40 (43.01%)5.53%
Reviews15 (16.13%)6.00%
Case Studies8 (8.60%)4.05%
Observational0 (0.00%)0.25%
Other30 (32.26%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (24)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Open Label Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of Twice Daily Halobetasol Propionate Foam, 0.05% in Subjects 12 to Less Than 18 Years of Age With Plaque Psoriasis Receiving Two Weeks of Treatment [NCT03992261]Phase 424 participants (Actual)Interventional2019-06-14Completed
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
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 Single-blind, Single Exposure Study, to Evaluate the Vasoconstriction Activity of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects: Dose Ranging Study [NCT00865267]Phase 120 participants (Actual)Interventional2003-12-31Completed
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)
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 (Sun Pharmaceuticals Industries Limited) in Patients With Moderate to [NCT03245385]Phase 220 participants (Actual)Interventional2017-07-24Terminated(stopped due to Sponsors decision)
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 Demonstration of the Hair and Scalp Benefits of 0.045% Tazarotene/0.01% Halobetasol Lotion in Scalp Psoriasis [NCT05872256]Phase 420 participants (Actual)Interventional2023-06-01Completed
[NCT01166646]Phase 243 participants (Actual)Interventional2010-07-31Completed
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
Investigator-Initiated, Open Label Trial of a Combination of Halobetasol Propionate 0.01% Andtazarotene 0.045% Lotion (Duobrii®) for Plaque Type Psoriasis of the Hands and/or Feet [NCT04720105]Phase 422 participants (Actual)Interventional2020-11-19Completed
An Investigator-Initiated, Double-Blind, Vehicle-Controlled Study: Assessment for Tachyphylaxis to Topical Corticosteroids in the Treatment of Psoriasis [NCT01404338]Phase 110 participants (Actual)Interventional2011-06-30Completed
Bioequivalence of Three Halobetasol Propionate 0.05% Topical Creams [NCT00803166]60 participants (Actual)Observational2004-01-31Completed
Efficacy and Safety of Sorilux in Maintenance Treatment of Moderate Type Plaque Psoriasis After Combination Treatment of Lexette and Sorilux for 2 Weeks [NCT04571151]Phase 430 participants (Anticipated)Interventional2021-01-31Not yet recruiting
A Randomized, Double-blind Study to Evaluate the Efficacy of Ammonium Lactate Lotion 12% (Lac-hydrin®) and Halobetasol Propionate Ointment 0.05% (Ultravate®) in the Treatment and Maintenance of Psoriasis. [NCT01111123]Phase 455 participants (Actual)Interventional2009-01-31Completed
Bioequivalence of Two Halobetasol Propionate 0.05% Topical Ointments [NCT00802958]76 participants (Actual)Observational2003-07-31Completed
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
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 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
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 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
A Double-blind, Randomized, Multicenter, Vehicle-Controlled Parallel Group Study to Determine the Efficacy and Safety of Halobetasol Propionate Lotion 0.05% in Subjects With Plaque Psoriasis Receiving Two Weeks of Treatment [NCT01610596]Phase 272 participants (Actual)Interventional2011-11-30Completed
Efficacy and Safety of Duobrii in the Management of Acne Keloidalis Nuchae (AKN) [NCT05608499]Phase 330 participants (Anticipated)Interventional2022-10-26Recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00990561 (1) [back to overview]Change in Modified Psoriasis Area Severity Index (PASI) Score
NCT01111123 (2) [back to overview]Physical Global Assessment
NCT01111123 (2) [back to overview]Signs of Psoriasis, Atrophy or Telangiectasis
NCT01166646 (6) [back to overview]Changes in Disease Severity (Success)
NCT01166646 (6) [back to overview]Pharmacokinetic Properties (AUC)
NCT01166646 (6) [back to overview]Pharmacokinetic Properties (Cmax)
NCT01166646 (6) [back to overview]Pharmacokinetic Properties (Tmax)
NCT01166646 (6) [back to overview]"Number of Subjects Whose Signs of Psoriasis Was Designated Success"
NCT01166646 (6) [back to overview]Adrenal Suppression Potential
NCT01610596 (4) [back to overview]Overall Disease Severity Score (Success)
NCT01610596 (4) [back to overview]Clinical Signs and Symptoms of Psoriasis
NCT01610596 (4) [back to overview]Overall Disease Severity Score (Improvement)
NCT01610596 (4) [back to overview]Percent Body Surface Area
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
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
NCT03992261 (1) [back to overview]Plasma Concentration of HBP at Screening, Day 8 and Day 15
NCT04720105 (3) [back to overview]Dermatology Quality of Life Index (DLQI)
NCT04720105 (3) [back to overview]Numerical Rating Scale (NRS)
NCT04720105 (3) [back to overview]Palmoplantar Physician Global Assessment (ppPGA)

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]

Physical Global Assessment

Physician global assessment (PGA) score - the physician's impression of the disease at a single time point rated as: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, and 5=very severe. (NCT01111123)
Timeframe: During the maintenance phase, from 2 weeks up to 26 weeks

,
Interventionparticipants (Number)
Category 0 or 1Category ≥ 2
Ammoium Lactate + Placebo020
Ammonium Lactate + Ultravate129

[back to top]

Signs of Psoriasis, Atrophy or Telangiectasis

Signs of psoriasis (erythema, induration, and scale) - physician's assessment of the severity of each of the three key characteristics of psoriatic lesions rated as: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, and 5=very severe, combined into one score. (NCT01111123)
Timeframe: During the maintenance phase, from 2 weeks up to 26 weeks

,
Interventionparticipants (Number)
category 0 or 1category ≥ 2
Lac-hydrin + Placebo020
Lac-hydrin + Ultravate129

[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]

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]

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 (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]

"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]

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]

Overall Disease Severity Score (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. The primary efficacy endpoint was the percentage of subjects with ODS treatment success at end of treatment (Day 15). Success was defined as a grade of 0 or 1 on the ODS scale." (NCT01610596)
Timeframe: Day 15

Interventionpercentage of participants (Number)
Halobetasol Propionate Lotion 0.05%30.6
Vehicle Lotion0.0

[back to top]

Clinical Signs and Symptoms of Psoriasis

"The proportion of subjects rated a treatment success for each of the clinical signs and symptoms of psoriasis: scaling, erythema, plaque elevation and pruritis. Treatment success is defined as a score of 0 or 1 on a five-point scale ranging from 0 = clear to 4 = severe/very severe." (NCT01610596)
Timeframe: Days 8 and 15

,
Interventionpercentage of participants (Number)
Scaling (Day 8)Scaling (Day 15)Erythema (Day 8)Erythema (Day 15)Plaque elevation (Day 8)Plaque elevation (Day 15)
Halobetasol Propionate Lotion 0.05%25.061.12.913.911.138.9
Vehicle Lotion8.611.40.02.90.02.9

[back to top]

Overall Disease Severity Score (Improvement)

"The proportion of subjects rated a improved for ODS at Day 8 and Day 15. Improvement is defined as at least a two (2) grade decrease in severity score relative to baseline using a five-point scale ranging from 0 = clear to 4 = severe/very severe." (NCT01610596)
Timeframe: Days 8 and 15

,
Interventionpercentage of participants (Number)
at Day 8at Day 15
Halobetasol Propionate Lotion 0.05%13.944.4
Vehicle Lotion0.00.0

[back to top]

Percent Body Surface Area

Changes in percent BSA with active psoriasis in the Treatment Area (NCT01610596)
Timeframe: Baseline, Days 8 and 15

,
InterventionChange in %BSA (Mean)
at Day 8at Day 15
Halobetasol Propionate Lotion 0.05%-0.3-1.3
Vehicle Lotion-0.1-0.2

[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]

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

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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

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Plasma Concentration of HBP at Screening, Day 8 and Day 15

Morning trough concentrations of HBP in plasma at Screening, Day 8, and Day 15 were summarized for the PK population using geometric mean, coefficient of variation in addition to n, mean, median, standard deviation (SD), minimum, and maximum. (NCT03992261)
Timeframe: 15 days

InterventionParticipants (Count of Participants)
Baseline number of participants with plasma morning trough concentrations below limitsDay 8 number of participants with plasma morning trough concentrations below limitsDay 15/EOS number of participants with plasma morning trough concentrations below limitsDay 8 Subjects with measurable levels of HBP at morning troughDay 15/EOS Subjects with measurable levels of HBP at morning trough
Halobetasol Propionate Foam, 0.05%23141396

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Dermatology Quality of Life Index (DLQI)

Patient-reported outcomes evaluated by Dermatology Quality of Life Index (DLQI). DLQi is a 10-item questionnaire, each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life). Higher score indicates poorer health outcome. (NCT04720105)
Timeframe: Baseline and Week 24

Interventionscore on a scale (Mean)
BaselineWeek 24
Participants With Plaque Type Psoriasis6.244.94

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Numerical Rating Scale (NRS)

Treatment satisfaction evaluated by a Numerical Rating Scale (NRS). Full scale from 0 to 10, higher score indicates poorer health outcome. (NCT04720105)
Timeframe: Baseline and Week 24

Interventionscore on a scale (Mean)
BaselineWeek 24
Participants With Plaque Type Psoriasis1.351.29

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Palmoplantar Physician Global Assessment (ppPGA)

Number of participants achieving Palmoplantar Physician Global Assessment (ppPGA) of 0 (clear) or 1 (almost clear/minimal) after 24 weeks of treatment. The ppPGA is based on the Investigators Global Assessment (IGA) modified version 11, specifically applied to the hands and/or feet: 0 (clear), 1 (almost clear/minimal), 2 (mild), 3 (moderate), 4 (marked/moderate-to-severe), 5 (severe) (NCT04720105)
Timeframe: Baseline and Week 24

Interventionscore on a scale (Mean)
BaselineWeek 24
Participants With Plaque Type Psoriasis3.472.24

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