Pivotal Bioequivalence Study of Topically Delivered Clobetasol Propionate Lotion in Healthy Adult Subjects

Study Overview
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Brief Summary
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To compare the relative vasoconstrictive effects of two topical clobetasol propionate 0.05% lotions in asymptomatic subjects.

Detailed Description
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Study Type: Interventional Study Design: An open label, one period, randomized, vasoconstrictor assay study. Official Title: Bioequivalence of two Clobetasol Propionate 0.05% Topical Lotions Further study details as provided by Actavis Elizabeth LLC: Primary Outcome Measures: · Vasoconstrictor Response

Official Title
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Bioequivalence of Two Clobetasol Propionate 0.05% Topical Lotions

Conditions
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Healthy

Intervention / Treatment
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* Drug: Clobetasol Propionate 0.05% lotion, single exposure
* Drug: Clobex TM 0.05% Lotion, single exposure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-tobacco-using female subjects, 18 to 50 years of age, inclusive. A demonstrated blanching response to Clobex TM (clobetasol propionate) Lotion, 0.05 %. A body mass index (BMI) 30 kg/m2 or less as calculated according to Novum Standard Operating Procedures. Good health as determined by lack of clinically significant abnormalities in medical history and clinical assessment, as judged by the Investigator. Signed and dated informed consent form which meets all criteria of current FDA regulations. Exclusion Criteria: History of allergy to any systemic or topical corticosteroid (including clobetasol) or to any cream, lotion, ointment, gel, cotton, soap, cosmetic, rubber, or tape, which in the opinion of the Investigator would compromise the safety of the subject or the study. Presence of any skin condition or coloration that would interfere with placement of test sites or the response or assessment of skin blanching. Significant history or current evidence of chronic infectious disease, system disorder (especially hypertension or circulatory disease), or organ dysfunction. Presence of a medical condition requiring regular treatment with prescription drugs. Drug or alcohol addiction requiring treatment (in-patient or out-patient) in the 12 months prior to dosing. Use of any topical dermatological drug therapy (including topical corticosteroids) on the flexor surface of the ventral forearms in the 30 days prior to dosing. Use of any tobacco products in the 30 days prior to dosing. Receipt of any drug as part of a research study within 30 days prior to initial study dosing. Pregnant or lactating.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Clobetasol Propionate 0.05% lotion, single exposure | Drug: Clobetasol Propionate 0.05% lotion, single exposure<br>* A: Experimental Subjects received Alpharma USPD, Inc formulated products<br>* Other names: Clobetasol;|
| Active Comparator: B<br>Clobex TM 0.05% Lotion, single exposure | Drug: Clobex TM 0.05% Lotion, single exposure<br>* B:Active Comparator Subjects received Galderma Laboratories, L.P. formulated products<br>* Other names: Clobetasol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vasoconstrictor Response |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bio-Equivalence, Vasoconstriction, Clobetasol, Healthy adult females