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

Stiefel, a GSK Company34 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Plaque-Type Psoriasis

Interventions

Olux-E FoamDRUG

Olux-E (clobetasol propionate 0.05%) foam. Starting at baseline, subjects were to apply twice daily Olux-E foam to the affected elbows and/or knees up to day 15.

Clobex lotionDRUG

Clobetasol propionate 0.05% lotion. Starting at baseline, subjects were to apply twice daily Clobex lotion to the affected elbows and/or knees up to day 15

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Wake Forest University Health Sciences Department of Dermatology

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

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

Number of participants who achieved a minimum 1-grade improvement in elbow and/or knee lesion using the Psoriasis Grading Scale for Target Lesion Score: 0 = No evidence of scaling, erythema, or elevation. 1 = Minimal; occasional scale, faint erythema, slight elevation. 2 = Mild; fine scales, light red color, slight elevation. 3 = Moderate; coarse scales, moderate red coloration and elevation . 4 = Marked; thick scale, bright red coloration, marked elevation. 5 = Severe; very thick tenacious scale predominates, dusky to deep red coloration, very marked elevation.

Time frame: Baseline to day 15

Secondary Outcomes

At Least 1 Grade Improvement Psoriasis Grading Scale

Number of participants who achieve a minimum one grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion. The scale is the same as used for the primary outcome (0 through 5).

Time frame: Baseline, days 3 and 8

At Least a 2 Grade Improvement Psoriasis Grading Scale

Number of participants who achieve a minimum two grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion. The scale is the same as used for the primary outcome (0 through 5).