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

NCT00864500 | Completed Phase 1

• 1 other identifier: 10504910
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Bio-Equivalence; Vasoconstriction; Clobetasol; Healthy adult females

Outcome Measures

Primary Outcomes (1)

• Vasoconstrictor Response

  24 hours

Study Arms (2)

A

EXPERIMENTAL

Clobetasol Propionate 0.05% lotion, single exposure

Drug: Clobetasol Propionate 0.05% lotion, single exposure

B

ACTIVE COMPARATOR

Clobex TM 0.05% Lotion, single exposure

Drug: Clobex TM 0.05% Lotion, single exposure

Interventions

Clobetasol Propionate 0.05% lotion, single exposure DRUG

A: Experimental Subjects received Alpharma USPD, Inc formulated products

Also known as: Clobetasol

A

Clobex TM 0.05% Lotion, single exposure DRUG

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

Also known as: Clobetasol

B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Actavis Inc.: lead

Study Sites (1)

Novum Pharmaceutical Research Services

Houston, Texas, 77042-4712, United States

Location

MeSH Terms

Interventions

Clobetasol

Intervention Hierarchy (Ancestors)

Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Soran Hong,, M.D.

  Novum Pharmaceutical Research Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 17, 2009
• First Posted: March 18, 2009
• Study Start: November 1, 2005
• Primary Completion: February 1, 2006
• Study Completion: February 1, 2006
• Last Updated: July 9, 2019

Record last verified: 2019-07

Locations

US (1)