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

Galderma

Status and phase

Completed

Phase 4

Conditions

Plaque Psoriasis

Treatments

Drug: clobetasol propionate ointment

Drug: clobetasol propionate spray

Study type

Interventional

Funder types

Industry

Identifiers

NCT00733954

US10012

Details and patient eligibility

About

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.

Full description

Same as above.

Enrollment

250 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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