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

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galderma Laboratories, L.P.
• Treatments: Clobetasol

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