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

CompletedPhase 4

Sponsor: Stiefel, a GSK Company

Conditions: Psoriasis

Interventions: Clobetasol propionate foam, Vehicle foam

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 12 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (2)

Fremont, California, United States
Louisville, Kentucky, United States