Efficacy/Safety/Subject Satisfaction/Duration of Response of Clobetasol Propionate Spray vs Ointment in Plaque Psoriasis

Condition(s) targeted: Plaque Psoriasis

Intervention: clobetasol propionate spray (Drug); clobetasol propionate ointment (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Galderma Laboratories, L.P.

Official(s) and/or principal investigator(s):
Ronald W Gottschalk, MD, Study Director, Affiliation: Galderma Laboratories, L.P.

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.

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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

Secondary outcome:

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

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

Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to After Two Weeks of Treatment

Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to After Two Weeks of Treatment

Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to After Two Weeks of Treatment

Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to End of Treatment

Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to End of Treatment

Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to End of Treatment

Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to Two Weeks Post Treatment

Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to Two Weeks Post Treatment

Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to Two Weeks Post Treatment

Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to After Two Weeks of Treatment

Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to After Two Weeks of Treatment

Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to End of Treatment

Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to End of Treatment

Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to Two Weeks Post Treatment

Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to Two Weeks Post Treatment

Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Two Weeks Post Treatment

Detailed description: Same as above.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

East Bay Dermatology Medical Group, Inc., Fremont, California 94538, United States

Solano Clinical Research, Vallejo, California 94589, United States

Henry Ford Medical Center, Detroit, Michigan 48202, United States

Minnesota Clinical Study Center, Fridley, Minnesota 55432, United States

Dermatology Associates of Rochester, Rochester, New York 14623, United States

Baylor Research Institute - Dermatology Research, Dallas, Texas 75246, United States

Starting date: August 2007
Last updated: April 28, 2014