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

Stiefel

Status and phase: Completed; Phase 4

Conditions: Psoriasis

Treatments: Drug: Vehicle foam; Drug: Clobetasol propionate foam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00842153

OEF0701

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

58 participants in 2 patient groups, including a placebo group

Clobetasol Propionate Foam

Experimental group

Description:

Topical foam formulation that includes clobetasol propionate (Steroid)

Treatment:

Drug: Clobetasol propionate foam

Vehicle Foam

Placebo Comparator group

Description:

Vehicle foam is the same as the clobetasol propionate foam except it does not include the active drug.

Treatment:

Drug: Vehicle foam