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

Phase 1

Completed

• Conditions: Scalp Psoriasis
• Interventions: Drug: Betamethasone Scalp Suspension 0.064%;0.0005%; Drug: Placebo topical suspension; Drug: Taclonex®

• Registration Number: NCT03880357
• Lead Sponsor: Taro Pharmaceuticals USA

Brief 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

Study Timeline

• Study Start: 2018-10-22
• Status Verified: 2019-03
• Primary Completion: 2019-03-15
• Study Completion: 2019-03-15
• Study First Submitted: 2019-03-15
• Study First Submitted QC: 2019-03-15
• Last Update Submitted: 2019-03-15
• Study First Posted: 2019-03-19
• Last Update Posted: 2019-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 485

Inclusion Criteria

• Healthy male or non-pregnant female aged ≥18 years
• All male subjects had to agree to use accepted methods of birth control with their partners, from the day of the first application of the study drug to 30 days after the last application of the study drug
• Willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits
• A clinical diagnosis of stable (at least 6 months) scalp psoriasis involving at least 10% of the scalp

Exclusion Criteria

• Female subjects who were pregnant, nursing, or planning to become pregnant during study participation
• Known hypersensitivity to calcipotriene, betamethasone dipropionate, other corticosteroids, or to any ingredients in the study drugs
• Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative, or pustular psoriasis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test Product	Betamethasone Scalp Suspension 0.064%;0.0005%	Betamethasone Scalp Suspension 0.064%;0.0005% (Taro Pharmaceuticals Inc.)
Placebo	Placebo topical suspension	Vehicle of the test product (Taro Pharmaceuticals Inc.)
Reference Product	Taclonex®	Taclonex® (Calcipotriene Hydrate and Betamethasone Dipropionate) Topical suspension 0.005%/0.064% (LEO PHARMA)

Primary Outcome Measures

Name	Time	Method
clinical success on the Physician's Global Assessment (PASI) of disease severity	Study Week 4 (Day 28 ± 4 days)	The proportion of subjects in each treatment group with "clinical success" (defined as clear or almost clear, a score of 0 or 1, at the target lesion site) on the PASI. Each psoriatic sign of scaling, erythema and plaque elevation should have a score of 0 or 1 for the subject to be considered a clinical success. The target lesion is to be identified at Baseline as the most severe lesion.
treatment success on the Physician's Global Assessment (PGA) of disease severity	Study Week 4 (Day 28 ± 4 days)	The proportion of subjects in each treatment group with "treatment success" (defined as none or minimal, a score of 0 or 1, within the treatment area) on the PGA of disease severity

Trial Locations

Locations (1)

Catawba Research, LLC; 🇺🇸 Charlotte, North Carolina, United States