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To Study Generic Calcipotriene and Betamethasone Dipropionate Topical Suspension, 0.005%/0.064%, in the Treatment of Scalp Psoriasis

Primary Purpose

Scalp Psoriasis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Calcipotriene/Betamethasone Dipropionate
Taclonex®
Placebo
Sponsored by
Glenmark Pharmaceuticals Ltd. India
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:

  1. Male or non-pregnant, non-lactating female subjects aged at least 18 years at Visit 1.
  2. A clinical diagnosis of stable (at least 6 months) scalp psoriasis involving at least 10% of the scalp and clinical signs of psoriasis vulgaris on trunk and/or limbs.
  3. A PGA of disease severity of the scalp psoriasis consistent with at least moderate disease severity (Grade ≥ 3).
  4. A plaque elevation of at least moderate severity (Grade ≥ 3) at the scalp target lesion site. The most severe scalp lesion at baseline should be identified as the target lesion.

Exclusion Criteria:

  1. Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative, or pustular psoriasis.
  2. Other inflammatory skin disease in the scalp that may confound the evaluation of the scalp psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea capitis).
  3. Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the scalp that could interfere with the rating of efficacy parameters.
  4. Presence of viral lesions, fungal, bacterial, or parasitic infections and/or atrophic (thinning) skin on the scalp.
  5. History of psoriasis unresponsive to topical treatments.
  6. Subjects with planned phototherapy and/or exposure to ultraviolet A (UVA) and/or UVB during the study.

Sites / Locations

  • Investigational Site 24
  • Investigational Site 3
  • Investigational Site 13
  • Investigational Site 20
  • Investigational Site 32
  • Investigational Site 14
  • Investigational Site 1
  • Investigational Site 30
  • Investigational Site 7
  • Investigational Site 22
  • Investigational Site 15
  • Investigational Site 10
  • Investigational Site 21
  • Investigational Site 6
  • Investigational Site 12
  • Investigational Site 26
  • Investigational Site 17
  • Investigational Site 25
  • Investigational Site 29
  • Investigational Site 28
  • Investigational Site 4
  • Investigational Site 18
  • Investigational Site 27
  • Investigational Site 9
  • Investigational Site 8
  • Investigational Site 5
  • Investigational Site 11
  • Investigational Site 16
  • Investigational Site 19
  • Investigational Site 31
  • Investigational Site 23

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Calcipotriene/betamethasone dipropionate

Taclonex®

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Proportion of subjects in each treatment group with treatment success, defined as a score of 0 or 1, within the treatment area(s) on the PGA scale of disease severity, at the end of study visit.
Proportion of subjects in each treatment group with clinical success, defined as a score of 0 or 1, at the target lesion site on the PASI scale at the end of study visit.

Secondary Outcome Measures

Full Information

First Posted
November 1, 2017
Last Updated
December 20, 2018
Sponsor
Glenmark Pharmaceuticals Ltd. India
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1. Study Identification

Unique Protocol Identification Number
NCT03331523
Brief Title
To Study Generic Calcipotriene and Betamethasone Dipropionate Topical Suspension, 0.005%/0.064%, in the Treatment of Scalp Psoriasis
Official Title
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Calcipotriene and Betamethasone Dipropionate Topical Suspension, 0.005%/0.064% (Glenmark Pharmaceuticals Ltd) to the Marketed Product Taclonex® Topical Suspension (LEO Pharma Inc.) in the Treatment of Scalp Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
October 20, 2017 (Actual)
Primary Completion Date
October 25, 2018 (Actual)
Study Completion Date
October 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glenmark Pharmaceuticals Ltd. India

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a phase III, randomized, double-blind, placebo-controlled, parallel- group, multiple-site study to evaluate the therapeutic equivalence of generic calcipotriene and betamethasone dipropionate topical suspension, 0.005%/0.064% of Glenmark Pharmaceuticals Ltd to that of the marketed product Taclonex® topical suspension of Leo Pharma Inc. 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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
643 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Calcipotriene/betamethasone dipropionate
Arm Type
Experimental
Arm Title
Taclonex®
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Calcipotriene/Betamethasone Dipropionate
Intervention Description
Topical suspension 0.005%/0.064% (Glenmark Pharmaceuticals Ltd)
Intervention Type
Drug
Intervention Name(s)
Taclonex®
Intervention Description
Calcipotriene/ betamethasone dipropionate topical suspension, 0.005%/0.064% (LEO Pharma Inc.)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo of Calcipotriene/ betamethasone dipropionate topical suspension, 0.005%/0.064% (Glenmark Pharmaceuticals Ltd.)
Primary Outcome Measure Information:
Title
Proportion of subjects in each treatment group with treatment success, defined as a score of 0 or 1, within the treatment area(s) on the PGA scale of disease severity, at the end of study visit.
Time Frame
Day 29
Title
Proportion of subjects in each treatment group with clinical success, defined as a score of 0 or 1, at the target lesion site on the PASI scale at the end of study visit.
Time Frame
Day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or non-pregnant, non-lactating female subjects aged at least 18 years at Visit 1. A clinical diagnosis of stable (at least 6 months) scalp psoriasis involving at least 10% of the scalp and clinical signs of psoriasis vulgaris on trunk and/or limbs. A PGA of disease severity of the scalp psoriasis consistent with at least moderate disease severity (Grade ≥ 3). A plaque elevation of at least moderate severity (Grade ≥ 3) at the scalp target lesion site. The most severe scalp lesion at baseline should be identified as the target lesion. Exclusion Criteria: Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative, or pustular psoriasis. Other inflammatory skin disease in the scalp that may confound the evaluation of the scalp psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea capitis). Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the scalp that could interfere with the rating of efficacy parameters. Presence of viral lesions, fungal, bacterial, or parasitic infections and/or atrophic (thinning) skin on the scalp. History of psoriasis unresponsive to topical treatments. Subjects with planned phototherapy and/or exposure to ultraviolet A (UVA) and/or UVB during the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Todd Kays
Organizational Affiliation
Glenmark Pharmaceuticals Inc., USA
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site 24
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Investigational Site 3
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Investigational Site 13
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Investigational Site 20
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Investigational Site 32
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Investigational Site 14
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Investigational Site 1
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Investigational Site 30
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Investigational Site 7
City
Miramar
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Investigational Site 22
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Investigational Site 15
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Investigational Site 10
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Investigational Site 21
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Investigational Site 6
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States
Facility Name
Investigational Site 12
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Investigational Site 26
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Investigational Site 17
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Investigational Site 25
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Investigational Site 29
City
Forest Hills
State/Province
New York
ZIP/Postal Code
11375
Country
United States
Facility Name
Investigational Site 28
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Investigational Site 4
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Investigational Site 18
City
Fountain Inn
State/Province
South Carolina
ZIP/Postal Code
29644
Country
United States
Facility Name
Investigational Site 27
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Investigational Site 9
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
Investigational Site 8
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Investigational Site 5
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Investigational Site 11
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Investigational Site 16
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Investigational Site 19
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
Facility Name
Investigational Site 31
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Investigational Site 23
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

To Study Generic Calcipotriene and Betamethasone Dipropionate Topical Suspension, 0.005%/0.064%, in the Treatment of Scalp Psoriasis

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