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

NCT03880357 | Completed Phase 1 FDA Drug

• 1 other identifier: BTCS 1614
• Study Type: interventional
• Target: 485
• Locations: 1 country
• Sites: 1

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.

Conditions

Scalp Psoriasis

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Study Arms (3)

Test Product

EXPERIMENTAL

Betamethasone Scalp Suspension 0.064%;0.0005% (Taro Pharmaceuticals Inc.)

Drug: Betamethasone Scalp Suspension 0.064%;0.0005%

Reference Product

ACTIVE COMPARATOR

Taclonex® (Calcipotriene Hydrate and Betamethasone Dipropionate) Topical suspension 0.005%/0.064% (LEO PHARMA)

Drug: Taclonex®

Placebo

PLACEBO COMPARATOR

Vehicle of the test product (Taro Pharmaceuticals Inc.)

Drug: Placebo topical suspension

Interventions

Betamethasone Scalp Suspension 0.064%;0.0005% DRUG

applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.

Also known as: Taclonex

Test Product

Taclonex® DRUG

applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.

Also known as: Calcipotriene and Betamethasone Dipropionate

Reference Product

Placebo topical suspension DRUG

applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.

Also known as: Vehicle

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Pharmaceutical Industries, Inc.: lead

Study Sites (1)

Catawba Research, LLC

Charlotte, North Carolina, 28217, United States

Location

MeSH Terms

Interventions

betamethasone dipropionate, calcipotriol drug combination

Study Officials

• Natalie Yantovskiy

  Taro Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: March 19, 2019
• Study Start: October 22, 2018
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2019
• Last Updated: March 19, 2019

Record last verified: 2019-03

Locations

US (1)