A Study to Evaluate the Efficacy and Tolerability of Topical Therapies for the Condition of Plaque-Type Psoriasis

Stiefel

Status and phase

Completed

Phase 4

Conditions

Plaque-Type Psoriasis

Treatments

Drug: Clobex lotion

Drug: Olux-E Foam

Study type

Interventional

Funder types

Industry

Identifiers

NCT00852761

U0280-402

114569

Details and patient eligibility

About

The purpose of the study is to determine the efficacy and safety of two different forms of a topical steroid (clobetasol propionate) in patients with plaque-type psoriasis.

Full description

This study is being conducted to obtain efficacy and tolerability data for two clobetasol propionate therapies in the treatment of plaque-type psoriasis. Subjects will be randomized to only one of the two therapies for treatment throughout the study.

Enrollment

34 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Body surface area (BSA) affected with psoriasis between 4% and 20% .
Target lesion of at least 2 cm² on the elbow and/or knee, with a score of 2 or 3 on the Psoriasis Grading Scale for Target Lesion.
Elbow and/or knee plaque-type psoriasis with a Psoriasis Global Assessment of mild or moderate (2 or 3).
Definitive diagnosis of elbow and/or knee plaque-type psoriasis.
Capable of understanding and willing to provide a signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures were performed.
Male or female, 18 years of age or older at the time that the consent form was signed.
Able to complete the study and comply with study instructions.
Female subjects of childbearing potential must have had a negative pregnancy test. Sexually active women of childbearing potential participating in the study must have been using a medically acceptable form of contraception.

Exclusion criteria

Use of any emollient applied to psoriasis plaques treated with the study medication during the study.
Other serious skin disorder or any chronic medical condition that is not well controlled.
Female subjects who are pregnant, trying to become pregnant or lactating.
Any major illness within 30 days prior to the baseline visit.
Received any investigational drug or treatment within 30 days of the baseline visit or who are scheduled to receive an investigational drug or treatment other than the study products during the study.