Overview

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

Status:
Completed
Trial end date:
2008-01-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Stiefel, a GSK Company
Collaborator:
GlaxoSmithKline
Treatments:
Clobetasol
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