NCT03122353

BE Study of Calcipotriene Hydrate and Betamethasone Dipropionate Topical Suspension in the Treatment of Scalp Psoriasis

A Randomized, Double-Blind Study Comparing TOLMAR Calcipotriene and Betamethasone Suspension to Reference Listed Drug in the Treatment of Scalp Psoriasis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 699 (actual)
• Sponsor: Tolmar Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will be conducted to evaluate the therapeutic bioequivalence of a TEST formulation of calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064% to the RLD.

Detailed description

Randomized, Double-Blind, Placebo-Controlled, Multiple-Site, Parallel Design, Bioequivalence with Clinical Endpoints.

Conditions

• Scalp Psoriasis

Interventions

Type	Name	Description
DRUG	Calcipotriene and betamethasone suspension	Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%
DRUG	Taclonex	Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%
DRUG	Placebo	vehicle used as placebo

Timeline

• Start date: 2017-04-11
• Primary completion: 2017-11-15
• Completion: 2017-11-15
• First posted: 2017-04-20
• Last updated: 2018-03-07

Locations

34 sites across 1 country: United States

Regulatory

• FDA-regulated drug study