Status:
COMPLETED
Evaluation of the Efficacy and Tolerability of Clobetasol Propionate Foam Compared to Vehicle Foam
Lead Sponsor:
Stiefel, a GSK Company
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Psoriasis
Eligibility:
All Genders
12+ years
Phase:
PHASE4
Brief 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.
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, doubl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00842153
Start Date
November 1 2007
End Date
January 1 2008
Last Update
October 9 2017
Active Locations (2)
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1
Center for Dermatology, Cosmetic and Laser
Fremont, California, United States, 94538
2
Dermatology Specialists
Louisville, Kentucky, United States, 40202