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OpenTrials
Completed

NCT Number: NCT03880357

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

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.

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Key information

Conditions

Scalp Psoriasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Catawba Research, LLC

Charlotte, North Carolina, 28217, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Taclonex

Taclonex®

Drug

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

Other names: Calcipotriene and Betamethasone Dipropionate

Placebo topical suspension

Drug

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

Other names: Vehicle

Primary outcomes

  1. treatment success on the Physician's Global Assessment (PGA) of disease severity

    Time frame: 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

  2. clinical success on the Physician's Global Assessment (PASI) of disease severity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 19, 2019
Registry last updated
Mar 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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