Clinical trial NCT00852761: A Study to Evaluate the Efficacy and Tolerability of Topical Therapies for the Condition of 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Plaque-Type Psoriasis
Keywords: Psoriasis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2009-02-27
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility 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.

Primary outcomes:
measure: At Least a One Grade Improvement for the Target Psoriasis Lesion on the Elbow or Knee (Psoriasis Grading Scale)
timeFrame: Baseline to day 15
Secondary outcomes:
measure: At Least 1 Grade Improvement Psoriasis Grading Scale
timeFrame: Baseline, days 3 and 8
measure: At Least a 2 Grade Improvement Psoriasis Grading Scale
timeFrame: Baseline, days 3, 8, 15
measure: At Least a 3 Grade Improvement Psoriasis Grading Scale
timeFrame: Baseline, days 3, 8, 15
measure: At Least 1 Grade Improvement in the Psoriasis Global Assessment
timeFrame: Baseline, days 3, 8, 15
measure: At Least a 2 Grade Improvement in the Psoriasis Global Assessment
timeFrame: Baseline, days 3, 8, 15
measure: At Least a 3 Grade Improvement in the Psoriasis Global Assessment
timeFrame: Baseline, days 3, 8, 15
measure: At Least 1 Grade Improvement in Subject's Global Assessment
timeFrame: Baseline, days 3, 8, 15
measure: At Least a 2 Grade Improvement in Subject's Global Assessment
timeFrame: Baseline, days 3, 8, 15
measure: At Least a 3 Grade Improvement in Subject's Global Assessment
timeFrame: Baseline, days 3, 8, 15
measure: Median Change in Psoriasis Grading Scale
timeFrame: Baseline, Days 3, 8, 15
measure: Dermatology Quality of Life - Symptoms and Feelings
timeFrame: Baseline, Days 3, 8, 15
measure: Dermatology Quality of Life - Daily Activities
timeFrame: Baseline, Days 3, 8, 15
measure: Dermatology Quality of Life - Leisure
timeFrame: Baseline, Days 3, 8, 15
measure: Dermatology Quality of Life - Work and School
timeFrame: Baseline, Days 3, 8, 15
measure: Dermatology Quality of Life - Personal Relationships
timeFrame: Baseline, Days 3, 8, 15
measure: Dermatology Quality of Life - Treatment
timeFrame: Baseline, Days 3, 8, 15
measure: Total Dermatology Life Quality Index (DLQI) Score
timeFrame: Baseline, Days 3, 8, 15
measure: Dermatology Life Quality Index (DLQI) Categories
timeFrame: Days 3, 8, 15
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences Department of Dermatology
state: North Carolina
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: