NCT01139580

The Purpose of This Study is to Demonstrate the Safety and Effectiveness of Calcipotriene Foam in Subjects With Scalp and Body Psoriasis

A Multicenter, Randomized, Double-Blind Study of the Safety and Efficacy of Calcipotriene Foam, 0.005%, Versus Vehicle Foam In The Treatment Of Moderate Plaque-Type Scalp And Body Psoriasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 363 (actual)
• Sponsor: Stiefel, a GSK Company · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and effectiveness in the treatment of psoriasis on the scalp and on the body.

Detailed description

The study subjects must have moderate psoriasis of the body and scalp with an ISGA of 3 at baseline. In addition, the subjects must have an evaluable target lesion of at least 2 cm² on the body with a score of 2 or 3 for erythema, scaling and plaque. All subjects will apply Calcipotriene Foam, 0.005% or vehicle foam topically twice a day (am and pm) to all psoriatic lesions on the body and scalp. Study visits will occur at baseline (day 1) and at weeks 1, 2, 4, and 8.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	Calcipotriene Foam	Calcipotriene Foam 0.005%. All treatments will be administered to the skin twice daily (am-pm) for 8 weeks for subjects in this group
DRUG	Vehicle Foam	Vehicle Foam. All treatments will be administered to the skin twice daily (am-pm) for 8 weeks for subjects in this group

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2010-06-08
• Last updated: 2017-01-18
• Results posted: 2011-09-23

Locations

26 sites across 1 country: United States