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

NCT ID: NCT00864500

Last Updated: 2019-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2006-02-28

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

A

Clobetasol Propionate 0.05% lotion, single exposure

Group Type: EXPERIMENTAL

Clobetasol Propionate 0.05% lotion, single exposure

Intervention Type: DRUG

A: Experimental Subjects received Alpharma USPD, Inc formulated products

B

Clobex TM 0.05% Lotion, single exposure

Group Type: ACTIVE_COMPARATOR

Clobex TM 0.05% Lotion, single exposure

Intervention Type: DRUG

B:Active Comparator Subjects received Galderma Laboratories, L.P. formulated products

Interventions

Clobetasol Propionate 0.05% lotion, single exposure

A: Experimental Subjects received Alpharma USPD, Inc formulated products

Intervention Type: DRUG

Clobex TM 0.05% Lotion, single exposure

B:Active Comparator Subjects received Galderma Laboratories, L.P. formulated products

Intervention Type: DRUG

Other Intervention Names

Clobetasol; Clobetasol

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Actavis Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Actavis Inc

Principal Investigators

Soran Hong,, M.D.

Role: PRINCIPAL_INVESTIGATOR

Novum Pharmaceutical Research Services

Locations

Novum Pharmaceutical Research Services

Houston, Texas, United States

Countries

United States

Other Identifiers

10504910

Identifier Type: -

Identifier Source: org_study_id