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

Scalp Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03880357
• Other study ID #: BTCS 1614
• Status: Completed
• Phase: Phase 1
• Start date: October 22, 2018
• Est. completion date: March 15, 2019

Study information

• Verified date: March 2019
• Source: Taro Pharmaceuticals USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 485
• Est. completion date: March 15, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis
• Scalp Psoriasis

Intervention

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.
• Taclonex®
applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.
• Placebo topical suspension
applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.

Locations

Country	Name	City	State
United States	Catawba Research, LLC	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Taro Pharmaceuticals USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	treatment success on the Physician's Global Assessment (PGA) of disease severity	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	Study Week 4 (Day 28 ± 4 days)
Primary	clinical success on the Physician's Global Assessment (PASI) of disease severity	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.	Study Week 4 (Day 28 ± 4 days)