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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03880357
Recruitment Status : Completed
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Scalp Psoriasis Drug: Betamethasone Scalp Suspension 0.064%;0.0005% Drug: Taclonex® Drug: Placebo topical suspension Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 485 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 22, 2018
Actual Primary Completion Date : March 15, 2019
Actual Study Completion Date : March 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Test Product
Betamethasone Scalp Suspension 0.064%;0.0005% (Taro Pharmaceuticals Inc.)
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.
Other Name: Taclonex

Active Comparator: Reference Product
Taclonex® (Calcipotriene Hydrate and Betamethasone Dipropionate) Topical suspension 0.005%/0.064% (LEO PHARMA)
Drug: Taclonex®
applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.
Other Name: Calcipotriene and Betamethasone Dipropionate

Placebo Comparator: Placebo
Vehicle of the test product (Taro Pharmaceuticals Inc.)
Drug: Placebo topical suspension
applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.
Other Name: Vehicle




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880357


Locations
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United States, North Carolina
Catawba Research, LLC
Charlotte, North Carolina, United States, 28217
Sponsors and Collaborators
Taro Pharmaceuticals USA
Investigators
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Study Director: Natalie Yantovskiy Taro Pharmaceuticals
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Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT03880357    
Other Study ID Numbers: BTCS 1614
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Calcipotriene
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents