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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Clobetasol Propionate 0.05% lotion, single exposure; Drug: Clobex TM 0.05% Lotion, single exposure

• Registration Number: NCT00864500
• Lead Sponsor: Actavis Inc.

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2005-11
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Study First Submitted: 2009-03-17
• Study First Submitted QC: 2009-03-17
• Study First Posted: 2009-03-18
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-08
• Last Update Posted: 2019-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 224

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	Clobetasol Propionate 0.05% lotion, single exposure	Clobetasol Propionate 0.05% lotion, single exposure
B	Clobex TM 0.05% Lotion, single exposure	Clobex TM 0.05% Lotion, single exposure

Primary Outcome Measures

Name	Time	Method
Vasoconstrictor Response	24 hours

Trial Locations

Locations (1)

Novum Pharmaceutical Research Services; 🇺🇸 Houston, Texas, United States