Clinical trial NCT00733954: Efficacy/Safety/Subject Satisfaction/Duration of Response of Clobetasol Propionate Spray vs Ointment in Plaque Psoriasis
Official title: A Comparison Between Clobetasol Propionate (Clobex®) Spray and Clobetasol Propionate Ointment With Regard to Efficacy, Safety, Subject Satisfaction and Duration of Response in Moderate to Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Plaque Psoriasis
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2008-08-13
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a comparison between Clobetasol Propionate Spray and Clobetasol Propionate Ointment with Regard to Efficacy, Safety, Subject Satisfaction and Duration of Response in Moderate to Severe Stable Plaque Psoriasis. Subjects will be enrolled and randomized into one of two groups: clobetasol propionate Spray for 4 weeks of treatment or clobetasol propionate ointment for 2 weeks of treatment with a 2 week follow-up visit for each group.

Detailed description: Same as above.

Eligibility criteria: Inclusion Criteria:

* Subjects with a diagnosis of moderate to severe plaque psoriasis, defined as 3% - 20% of the body surface area. For the purposes of study treatment, most areas will be treated with the exception of face, scalp, groin, axillae and other intertriginous areas
* Overall disease severity is at least 3 (moderate)

Exclusion Criteria:

* Subjects who have surface area involvement too large that would require more than 50 grams per week of clobetasol propionate spray or more than 50 grams per week of clobetasol propionate ointment
* Subjects whose psoriasis involves only the scalp, face or groin
* Subjects with non-plaque psoriasis or other related diseases not classified as plaque psoriasis

Primary outcomes:
measure: Number of Participants Who Are Clear/Almost Clear of Plaque Psoriasis From Baseline to End of Treatment Based on the Overall Disease Severity (ODS) Scale
timeFrame: Baseline and Week 2 and Baseline and Week 4
Secondary outcomes:
measure: Number of Participants Who Are Clear/Almost Clear of Plaque Psoriasis From Baseline to After Two Weeks of Treatment Based on the Overall Disease Severity (ODS) Scale
timeFrame: Baseline and Week 2
measure: Number of Participants Who Are Clear/Almost Clear of Plaque Psoriasis From Baseline to 2 Weeks Post Treatment Based on the Overall Disease Severity (ODS) Scale
timeFrame: Baseline and Week 4 and Baseline and Week 6
measure: Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to After Two Weeks of Treatment
timeFrame: Baseline and Week 2
measure: Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to After Two Weeks of Treatment
timeFrame: Baseline and Week 2
measure: Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to After Two Weeks of Treatment
timeFrame: Baseline and Week 2
measure: Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to End of Treatment
timeFrame: Baseline and Week 2 and Baseline and Week 4
measure: Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to End of Treatment
timeFrame: Baseline and Week 2 and Baseline and Week 4
measure: Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to End of Treatment
timeFrame: Baseline and Week 2 and Baseline and Week 4
measure: Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to Two Weeks Post Treatment
timeFrame: Baseline and Week 4 and Baseline and Week 6
measure: Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to Two Weeks Post Treatment
timeFrame: Baseline and Week 4 and Baseline and Week 6
measure: Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to Two Weeks Post Treatment
timeFrame: Baseline and Week 4 and Baseline and Week 6
measure: Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to After Two Weeks of Treatment
timeFrame: Baseline and Week 2
measure: Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to After Two Weeks of Treatment
timeFrame: Baseline and Week 2
measure: Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to End of Treatment
timeFrame: Baseline and Week 2 and Baseline and Week 4
measure: Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to End of Treatment
timeFrame: Baseline and Week 2 and Baseline and Week 4
measure: Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to Two Weeks Post Treatment
timeFrame: Baseline and Week 4 and Baseline and Week 6
measure: Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to Two Weeks Post Treatment
timeFrame: Baseline and Week 4 and Baseline and Week 6
measure: Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Two Weeks Post Treatment
timeFrame: Baseline and Week 4 and Baseline and Week 6
Other outcomes:
Locations:
city: Fremont
country: United States
facility: East Bay Dermatology Medical Group, Inc.
state: California
city: Vallejo
country: United States
facility: Solano Clinical Research
state: California
city: Detroit
country: United States
facility: Henry Ford Medical Center
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Rochester
country: United States
facility: Dermatology Associates of Rochester
state: New York
city: Dallas
country: United States
facility: Baylor Research Institute - Dermatology Research
state: Texas
Study officials:
affiliation: Galderma R&D
name: Ronald W Gottschalk, MD
role: STUDY_DIRECTOR
References: