NCT03880357

To Evaluate the Therapeutic Equivalence and Safety in Treatment of Scalp Psoriasis

Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-group Study Comparing Taro Product to RLD and Both Active Treatments to a Placebo Control in the Treatment of Scalp Psoriasis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 485 (actual)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate the superiority of the efficacy of the test and reference products over that of the placebo control in the treatment of scalp psoriasis.

Detailed description

Multi-center, double-blind, randomized, placebo controlled, parallel-group study comparing test and reference products to a placebo control in the treatment of scalp psoriasis

Conditions

• Scalp Psoriasis

Interventions

Type	Name	Description
DRUG	Betamethasone Scalp Suspension 0.064%;0.0005%	applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.
DRUG	Taclonex®	applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.
DRUG	Placebo topical suspension	applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.

Timeline

• Start date: 2018-10-22
• Primary completion: 2019-03-15
• Completion: 2019-03-15
• First posted: 2019-03-19
• Last updated: 2019-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study