NCT03331523

To Study Generic Calcipotriene and Betamethasone Dipropionate Topical Suspension, 0.005%/0.064%, in the Treatment of Scalp 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 Suspension, 0.005%/0.064% (Glenmark Pharmaceuticals Ltd) to the Marketed Product Taclonex® Topical Suspension (LEO Pharma Inc.) in the Treatment of Scalp Psoriasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 643 (actual)
• Sponsor: Glenmark Pharmaceuticals Ltd. India · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase III, randomized, double-blind, placebo-controlled, parallel- group, multiple-site study to evaluate the therapeutic equivalence of generic calcipotriene and betamethasone dipropionate topical suspension, 0.005%/0.064% of Glenmark Pharmaceuticals Ltd to that of the marketed product Taclonex® topical suspension of Leo Pharma Inc. in the treatment of scalp psoriasis.

Conditions

• Scalp Psoriasis

Interventions

Type	Name	Description
DRUG	Calcipotriene/Betamethasone Dipropionate	Topical suspension 0.005%/0.064% (Glenmark Pharmaceuticals Ltd)
DRUG	Taclonex®	Calcipotriene/ betamethasone dipropionate topical suspension, 0.005%/0.064% (LEO Pharma Inc.)
DRUG	Placebo	Placebo of Calcipotriene/ betamethasone dipropionate topical suspension, 0.005%/0.064% (Glenmark Pharmaceuticals Ltd.)

Timeline

• Start date: 2017-10-20
• Primary completion: 2018-10-25
• Completion: 2018-10-25
• First posted: 2017-11-06
• Last updated: 2018-12-21

Locations

31 sites across 1 country: United States

Regulatory

• FDA-regulated drug study