Clinical trial NCT00842153: Evaluation of the Efficacy and Tolerability of Clobetasol Propionate Foam Compared to Vehicle Foam
Official title: A Study to Evaluate the Efficacy and Tolerability of Clobetasol Propionate vs. Vehicle in the Treatment of Mild to Moderate Plaque-Type Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Keywords: Psoriasis
Plaque Type Psoriasis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2009-02-12
Enrollment: 58
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With a Target Lesion Global Improvement (TLGI) Score of 0, 1, or 2 at Weeks 1, 2, and 4
timeFrame: Weeks 1, 2, and 4
Secondary outcomes:
measure: Number of Participants With a TLGI Score of 0, 1, 2, or 3 at Weeks 1, 2, and 4
timeFrame: Weeks 1, 2, and 4
measure: Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Week 2
timeFrame: Week 2
measure: Number of Participants With an Erythema Score of 0 or 1 at Week 2
timeFrame: Week 2
measure: Number of Participants With a Scaling Score of 0 or 1 at Week 2
timeFrame: Week 2
measure: Number of Participants With a Plaque Thickness Score of 0 or 1 at Week 2
timeFrame: Week 2
measure: Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Week 2
timeFrame: Week 2
measure: Mean Percent Change From Baseline to Week 2 in Pruritus (Target Lesion)
timeFrame: Baseline (Week 0) and Week 2
measure: Mean Percent Change From Baseline to Week 2 in Percent (%) of Body Surface Area (BSA) Affected
timeFrame: Baseline (Week 0) and Week 2
measure: Number of Participants With a TLGI Score of 0, 1, or 2 at Week 1 and Week 4
timeFrame: Week 1 and Week 4
measure: Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Baseline and Week 4
timeFrame: Baseline (Week 0) and Week 4
measure: Number of Participants With an Erythema Score of 0 or 1 at Baseline and Week 4
timeFrame: Baseline (Week 0) and Week 4
measure: Number of Participants With a Scaling Score of 0 or 1 at Baseline and Week 4
timeFrame: Baseline (Week 0) and Week 4
measure: Number of Participants With a Plaque Thickness Score of 0 or 1 at Baseline and Week 4
timeFrame: Baseline (Week 0) and Week 4
measure: Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Baseline and Week 4
timeFrame: Baseline (Week 0) and Week 4
measure: Mean Percent Change From Baseline to Week 4 in Pruritus (Target Lesion)
timeFrame: Baseline (Week 0) and Week 4
measure: Mean Percent Change From Baseline to Week 4 in Percent (%) of Body Surface Area (BSA) Affected
timeFrame: Baseline (Week 0) and Week 4
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Center for Dermatology, Cosmetic and Laser
state: California
city: Louisville
country: United States
facility: Dermatology Specialists
state: Kentucky
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: