Evaluation of the Efficacy and Tolerability of Clobetasol Propionate Foam Compared to Vehicle Foam

Condition(s) targeted: Psoriasis

Intervention: Clobetasol propionate foam (Drug); Vehicle foam (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Stiefel, a GSK Company

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

The purpose of the study is to compare the efficacy and safety of Clobetasol propionate to that of its Vehicle in the treatment of mild to moderate plaque-type psoriasis.

Official title: A Study to Evaluate the Efficacy and Tolerability of Clobetasol Propionate vs. Vehicle in the Treatment of Mild to Moderate Plaque-Type Psoriasis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Number of Participants With a Target Lesion Global Improvement (TLGI) Score of 0, 1, or 2 at Weeks 1, 2, and 4

Secondary outcome:

Number of Participants With a TLGI Score of 0, 1, 2, or 3 at Weeks 1, 2, and 4

Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Week 2

Number of Participants With an Erythema Score of 0 or 1 at Week 2

Number of Participants With a Scaling Score of 0 or 1 at Week 2

Number of Participants With a Plaque Thickness Score of 0 or 1 at Week 2

Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Week 2

Mean Percent Change From Baseline to Week 2 in Pruritus (Target Lesion)

Mean Percent Change From Baseline to Week 2 in Percent (%) of Body Surface Area (BSA) Affected

Number of Participants With a TLGI Score of 0, 1, or 2 at Week 1 and Week 4

Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Baseline and Week 4

Number of Participants With an Erythema Score of 0 or 1 at Baseline and Week 4

Number of Participants With a Scaling Score of 0 or 1 at Baseline and Week 4

Number of Participants With a Plaque Thickness Score of 0 or 1 at Baseline and Week 4

Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Baseline and Week 4

Mean Percent Change From Baseline to Week 4 in Pruritus (Target Lesion)

Mean Percent Change From Baseline to Week 4 in Percent (%) of Body Surface Area (BSA) Affected

Detailed description: The purpose of the study is to compare the efficacy and safety of Clobetasol propionate to that of its Vehicle in the treatment of mild to moderate plaque-type psoriasis. This is a multi-center, double blind, randomized, parallel designed study which consists of 2 weeks of treatment and a follow-up visit 2 weeks later.

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Outpatient, male or female of any race, and at least 12 years of age. Female subjects

of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study.

- Mild to moderate, plaque-type psoriasis

- Target lesion on the trunk or extremities (excluding palms/soles, elbows, or knees)

with a score of 2 or 3 for each of erythema, scaling and plaque thickness

- Able to understand the requirements of the study and sign Informed Consent/HIPAA

Authorization Forms. Subjects under the legal age of consent in the state where the study is conducted must also have the written, informed consent of a parent or legal guardian. Exclusion Criteria:

- Female subjects who are pregnant (positive urine pregnancy test) breast feeding or

who are of childbearing potential and not practicing a reliable method of birth control

- Known allergy to clobetasol propionate or other topical corticosteroids; or to any

component of the investigational formulations

- Subjects who have not complied with the proper wash-out periods for prohibited

medications

- Medical condition that in the opinion of the investigator, contraindicates the

subject's participation in the clinical study

- Skin disease/disorder that might interfere with the study related diagnosis or

evaluations

- Evidence of recent alcohol or drug abuse

- History of poor cooperation, non-compliance with medical treatment or unreliability

Center for Dermatology, Cosmetic and Laser, Fremont, California 94538, United States

Dermatology Specialists, Louisville, Kentucky 40202, United States

Starting date: November 2007
Last updated: December 21, 2011