NCT03731091

To Study Generic Calcipotriene and Betamethasone Dipropionate Topical Foam, 0.005%/0.064%, in the Treatment of Psoriasis Vulgaris (Plaque Psoriasis).

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Calcipotriene and Betamethasone Dipropionate Topical Foam, 0.005%/0.064% (Glenmark Pharmaceuticals Ltd) to the Marketed Product Enstilar® Foam (LEO Pharma Inc.) in the Treatment of Psoriasis Vulgaris (Plaque Psoriasis)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 494 (actual)
• Sponsor: Glenmark Pharmaceuticals Ltd. India · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Calcipotriene and Betamethasone Dipropionate Topical Foam, 0.005%/0.064% (Glenmark Pharmaceuticals Ltd) to the Marketed Product Enstilar® Foam (LEO Pharma Inc.) in the Treatment of Psoriasis Vulgaris (Plaque Psoriasis)

Conditions

• Psoriasis Vulgaris

Interventions

Type	Name	Description
DRUG	Calcipotriene/ betamethasone dipropionate topical foam, 0.005%/0.064%	Once daily for 4 weeks (28 days)
DRUG	Enstilar® foam (LEO Pharma Inc.)	Once daily for 4 weeks (28 days)
OTHER	Placebo of Calcipotriene/ betamethasone dipropionate topical foam	Once daily for 4 weeks (28 days)

Timeline

• Start date: 2018-10-31
• Primary completion: 2020-03-17
• Completion: 2020-03-17
• First posted: 2018-11-06
• Last updated: 2020-08-19

Locations

30 sites across 1 country: United States

Regulatory

• FDA-regulated drug study