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

Primary Purpose

Scalp Psoriasis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Betamethasone Scalp Suspension 0.064%;0.0005%
Taclonex®
Placebo topical suspension
Sponsored by
Taro Pharmaceuticals USA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scalp Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Catawba Research, LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Test Product

Reference Product

Placebo

Arm Description

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

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

Vehicle of the test product (Taro Pharmaceuticals Inc.)

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Full Information

First Posted
March 15, 2019
Last Updated
March 15, 2019
Sponsor
Taro Pharmaceuticals USA
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1. Study Identification

Unique Protocol Identification Number
NCT03880357
Brief Title
To Evaluate the Therapeutic Equivalence and Safety in Treatment of Scalp Psoriasis
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 22, 2018 (Actual)
Primary Completion Date
March 15, 2019 (Actual)
Study Completion Date
March 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taro Pharmaceuticals USA

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scalp Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
485 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test Product
Arm Type
Experimental
Arm Description
Betamethasone Scalp Suspension 0.064%;0.0005% (Taro Pharmaceuticals Inc.)
Arm Title
Reference Product
Arm Type
Active Comparator
Arm Description
Taclonex® (Calcipotriene Hydrate and Betamethasone Dipropionate) Topical suspension 0.005%/0.064% (LEO PHARMA)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Vehicle of the test product (Taro Pharmaceuticals Inc.)
Intervention Type
Drug
Intervention Name(s)
Betamethasone Scalp Suspension 0.064%;0.0005%
Other Intervention Name(s)
Taclonex
Intervention Description
applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Taclonex®
Other Intervention Name(s)
Calcipotriene and Betamethasone Dipropionate
Intervention Description
applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo topical suspension
Other Intervention Name(s)
Vehicle
Intervention Description
applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.
Primary Outcome Measure Information:
Title
treatment success on the Physician's Global Assessment (PGA) of disease severity
Description
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
Time Frame
Study Week 4 (Day 28 ± 4 days)
Title
clinical success on the Physician's Global Assessment (PASI) of disease severity
Description
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.
Time Frame
Study Week 4 (Day 28 ± 4 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalie Yantovskiy
Organizational Affiliation
Taro Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Catawba Research, LLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28217
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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