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

Condition(s) targeted: Plaque-Type Psoriasis

Intervention: Olux-E Foam (Drug); Clobex lotion (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Stiefel, a GSK Company

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Official title: A Study to Evaluate Safety and Efficacy of Clobetasol Propionate for Treatment of Plaque-Type Psoriasis in Adult Subjects.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: At Least a One Grade Improvement for the Target Psoriasis Lesion on the Elbow or Knee (Psoriasis Grading Scale)

Secondary outcome:

At Least 1 Grade Improvement Psoriasis Grading Scale

At Least a 2 Grade Improvement Psoriasis Grading Scale

At Least a 3 Grade Improvement Psoriasis Grading Scale

At Least 1 Grade Improvement in the Psoriasis Global Assessment

At Least a 2 Grade Improvement in the Psoriasis Global Assessment

At Least a 3 Grade Improvement in the Psoriasis Global Assessment

At Least 1 Grade Improvement in Subject's Global Assessment

At Least a 2 Grade Improvement in Subject's Global Assessment

At Least a 3 Grade Improvement in Subject's Global Assessment

Median Change in Psoriasis Grading Scale

Dermatology Quality of Life - Symptoms and Feelings

Dermatology Quality of Life - Daily Activities

Dermatology Quality of Life - Leisure

Dermatology Quality of Life - Work and School

Dermatology Quality of Life - Personal Relationships

Dermatology Quality of Life - Treatment

Total Dermatology Life Quality Index (DLQI) Score

Dermatology Life Quality Index (DLQI) Categories

Detailed 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Wake Forest University Health Sciences Department of Dermatology, Winston-Salem, North Carolina 27157, United States

Starting date: March 2009
Last updated: April 19, 2012