Evaluation of the Efficacy and Tolerability of Clobetasol Propionate Foam Compared to Vehicle Foam
Status: | Completed |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 12 - Any |
Updated: | 10/11/2017 |
Start Date: | November 2007 |
End Date: | January 2008 |
A Study to Evaluate the Efficacy and Tolerability of Clobetasol Propionate vs. Vehicle in the Treatment of Mild to Moderate Plaque-Type Psoriasis
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.
that of its Vehicle in the treatment of mild to moderate plaque-type psoriasis.
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.
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.
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
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