A Study to Determine the Efficacy and Safety of Halobetasol Propionate Lotion 0.05% in Subjects With Plaque Psoriasis

Study Overview
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Brief Summary
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This is a double-blind, multicenter, vehicle-controlled, parallel group comparison study to determine and compare the efficacy and safety of HBP Lotion 0.05% and Vehicle Lotion applied twice daily for two weeks in subjects with moderate to severe plaque psoriasis. Eligible subjects will be randomized (1:1) to one of two treatment groups - HBP Lotion 0.05% or Vehicle Lotion. The maximum amount of test article to be applied per week should not exceed 50 grams.

Official Title
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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

Conditions
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Psoriasis, Plaque Psoriasis

Intervention / Treatment
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* Drug: Halobetasol Propionate Lotion 0.05%
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is Male or non-pregnant female; 18 years of age at time of Screening. Subject is willing and able to give written informed consent. subject is willing and able to apply the test article(s) as directed, comply with study instructions and commit to all follow-up visits for the duration of the study. Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2% and no more than approximately 10% body surface area (BSA) (excluding the face, scalp, groin, axillae and other intertriginous areas). Subject has an Overall Disease Severity (ODS) score for the Treatment Area of at least three (3) at the Baseline Visit. If subject is a woman of childbearing potential (WOCBP) , she must have a negative urine pregnancy test (UPT) and agree to use an effective form of birth control for the duration of the study (i.e., abstinence, stabilized on hormonal contraceptives [oral, injectable, transdermal or intravaginal] or IUD for at least three months prior to test article application, condom and a spermicidal, or diaphragm and a spermicidal). Abstinence is an acceptable form of birth control for subjects who are not sexually active. Subjects who become sexually active during the trial must agree to use an effective form of birth control for the duration of the study. Exclusion Criteria: Subject has spontaneously improving or rapidly deteriorating plaque psoriasis. Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis. Subject has a physical condition which, in the investigator's opinion, might impair evaluation of plaque psoriasis, or which exposes the subject to an unacceptable risk by study participation. Subject has used any phototherapy (including laser), photo-chemotherapy or systemic corticosteroid therapy (such as systemic corticosteroids [including intralesional, intra-articular, and intramuscular corticosteroids]) within 30 days prior to the Baseline Visit. Subject has used any systemic methotrexate, retinoids, cyclosporine or analogous products within 90 days prior to the Baseline Visit. Subject has used any systemic biologic therapy (i.e., FDA approved or experimental therapy) within five (5) half-lives of the biologic prior to the Baseline Visit. Published or documented half-life of the product provided by the commercial supplier or Sponsor should be used to establish this value. Subject had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to the Baseline Visit or is intending to have such exposure during the study that is thought by the investigator likely to modify the subject's disease. Subject has used topical body (excluding the scalp) psoriasis therapy including coal tar, anthralin, steroids, retinoids, vitamin D analogs (e.g., Dovonex®) within 14 days prior to the Baseline Visit. Subject has used emollients/moisturizers on areas to be treated within four hours prior to clinical evaluation at the Baseline Visit. Subject is currently using lithium or Plaquenil (hydroxychloroquine). Subject is currently using a beta-blocking medication (e.g., propanolol) or angiotensin converting enzyme (ACE) inhibitor at a dose that has not been stabilized, in the opinion of the investigator. Subject has a history of sensitivity to any of the ingredients in the test article. Subject is pregnant, lactating, or is planning to become pregnant during the study. Subject is currently enrolled in an investigational drug or device study. Subject has used an investigational drug or investigational device treatment within 30 days prior to the Baseline Visit. Subject has been previously enrolled in this study and treated with a test article. Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Halobetasol Propionate Lotion 0.05%<br>Topical lotion, applied twice daily | Drug: Halobetasol Propionate Lotion 0.05%<br>* Apply twice daily for 1-2 weeks, not to exceed 50 grams per week<br>|
| Placebo Comparator: Vehicle Lotion<br>Topical lotion, applied twice daily | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Body Surface Area | Changes in percent BSA with active psoriasis in the Treatment Area | Baseline, Days 8 and 15 | 
| 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. | Days 8 and 15 | 
| 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. | Days 8 and 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis, Skin Diseases, Halobetasol, Vasoconstrictor Agents, Therapeutic Uses, Pharmacologic Actions, Anti-Inflammatory Agents, Physiological Effects of Drugs