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A Study Comparing Tazarotene Cream 0.05% to TAZORAC® (Tazarotene) Cream 0.05% and Both to a Placebo Control in the Treatment of Plaque Psoriasis

Primary Purpose

Plaque Psoriasis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tazarotene Cream 0.05%
TAZORAC® (tazarotene) Cream 0.05%
Placebo
Sponsored by
Fougera Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis

Eligibility Criteria

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

Inclusion Criteria:

  • Have a definite clinical diagnosis of stable (at least 6 months) plaque psoriasis, involving at least 2% and no more than 20% of the body surface area (BSA) (not including the scalp and intertriginous areas)
  • Have a minimum plaque elevation at the target lesion site of at least moderate severity (grade ≥ 3 on the Psoriasis Area Severity Index [PASI]). The most severe lesion at baseline should be identified as the target lesion
  • Have an Investigator's Global Assessment (IGA) of disease severity of at least moderate (score ≥ 3) as an overall assessment of all lesions to be treated.

Exclusion Criteria:

  • A female subject who is pregnant, nursing, planning a pregnancy, or does not agree to use an acceptable form of birth control within the study participation period
  • Have a current diagnosis of unstable forms of psoriasis in the treatment area, including pustular, guttate, exfoliative or erythrodermic psoriasis
  • Have a history of psoriasis unresponsive to topical treatments

Sites / Locations

  • Fougera Investigational Site
  • Fougera Investigational Site
  • Fougera Investigational Site
  • Fougera Investigational Site
  • Fougera Investigational Site
  • Fougera Investigational Site
  • Fougera Investigational Site
  • Fougera Investigational Site
  • Fougera Investigational Site
  • Fougera Investigational Site
  • Fougera Investigational Site
  • Fougera Investigational Site
  • Fougera Investigational Site
  • Fougera Investigational Site
  • Fougera Investigational Site
  • Fougera Investigational Site
  • Fougera Investigational Site
  • Fougera Investigational Site
  • Fougera Investigational Site
  • Fougera Investigational Site
  • Fougera Investigational Site
  • Fougera Investigational Site
  • Fougera Investigational Site
  • Fougera Investigational Site
  • Fougera Investigational Site
  • Fougera Investigational Site
  • Fougera Investigational Site
  • Fougera Investigational Site
  • Fougera Investigational Site
  • Fougera Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Test

Reference

Placebo

Arm Description

Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.)

TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.)

Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)

Outcomes

Primary Outcome Measures

Treatment Success Assessed by IGA
Proportion of subjects with treatment success (defined as none, minimal or mild disease, a score of 0, 1 or 2 within the treatment area) on the "Investigator's Global Assessment of Disease Severity" (IGA) at the Week 12 visit (Day 85 ± 4 days, End of Study).

Secondary Outcome Measures

Disease Severity None or Minimal on IGA
Proportion of subjects with none or minimal disease, a score of 0 or 1 on the IGA at the Week 12 visit (Day 85 ± 4 days, End of Study).
Target Site Plaque Elevation, Scaling and Erythema Scores of Less Than or Equal to 1 on the PASI
Proportion of subjects with target site plaque elevation, scaling and erythema scores of less than or equal to 1 (Clear or Almost Clear) on the Psoriasis Area Severity Index (PASI) at the Week 12 visit (Day 85 ± 4 days, End of Study).

Full Information

First Posted
August 29, 2016
Last Updated
July 30, 2018
Sponsor
Fougera Pharmaceuticals Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02886702
Brief Title
A Study Comparing Tazarotene Cream 0.05% to TAZORAC® (Tazarotene) Cream 0.05% and Both to a Placebo Control in the Treatment of Plaque Psoriasis
Official Title
A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.05% to TAZORAC® (Tazarotene) Cream 0.05% and Both Active Treatments to a Vehicle Control in the Treatment of Stable Plaque Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
September 19, 2016 (Actual)
Primary Completion Date
August 2, 2017 (Actual)
Study Completion Date
August 2, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fougera Pharmaceuticals Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.05% to TAZORAC® (tazarotene) Cream 0.05% and Both Active Treatments to a Vehicle Control in the Treatment of Stable Plaque Psoriasis

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
855 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test
Arm Type
Experimental
Arm Description
Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.)
Arm Title
Reference
Arm Type
Active Comparator
Arm Description
TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
Intervention Type
Drug
Intervention Name(s)
Tazarotene Cream 0.05%
Other Intervention Name(s)
Tazarotene
Intervention Description
Tazarotene Cream 0.05% to cover only the lesions with a thin film.
Intervention Type
Drug
Intervention Name(s)
TAZORAC® (tazarotene) Cream 0.05%
Other Intervention Name(s)
Tazarotene
Intervention Description
TAZORAC® (tazarotene) Cream 0.05% to cover only the lesions with a thin film.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Vehicle
Intervention Description
Placebo (vehicle of the test product) to cover only the lesions with a thin film.
Primary Outcome Measure Information:
Title
Treatment Success Assessed by IGA
Description
Proportion of subjects with treatment success (defined as none, minimal or mild disease, a score of 0, 1 or 2 within the treatment area) on the "Investigator's Global Assessment of Disease Severity" (IGA) at the Week 12 visit (Day 85 ± 4 days, End of Study).
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Disease Severity None or Minimal on IGA
Description
Proportion of subjects with none or minimal disease, a score of 0 or 1 on the IGA at the Week 12 visit (Day 85 ± 4 days, End of Study).
Time Frame
Week 12
Title
Target Site Plaque Elevation, Scaling and Erythema Scores of Less Than or Equal to 1 on the PASI
Description
Proportion of subjects with target site plaque elevation, scaling and erythema scores of less than or equal to 1 (Clear or Almost Clear) on the Psoriasis Area Severity Index (PASI) at the Week 12 visit (Day 85 ± 4 days, End of Study).
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have a definite clinical diagnosis of stable (at least 6 months) plaque psoriasis, involving at least 2% and no more than 20% of the body surface area (BSA) (not including the scalp and intertriginous areas) Have a minimum plaque elevation at the target lesion site of at least moderate severity (grade ≥ 3 on the Psoriasis Area Severity Index [PASI]). The most severe lesion at baseline should be identified as the target lesion Have an Investigator's Global Assessment (IGA) of disease severity of at least moderate (score ≥ 3) as an overall assessment of all lesions to be treated. Exclusion Criteria: A female subject who is pregnant, nursing, planning a pregnancy, or does not agree to use an acceptable form of birth control within the study participation period Have a current diagnosis of unstable forms of psoriasis in the treatment area, including pustular, guttate, exfoliative or erythrodermic psoriasis Have a history of psoriasis unresponsive to topical treatments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela C. Kaplan
Organizational Affiliation
Fougera Pharmaceuticals Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Fougera Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Fougera Investigational Site
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Fougera Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Fougera Investigational Site
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Fougera Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Fougera Investigational Site
City
San Ramon
State/Province
California
ZIP/Postal Code
94582
Country
United States
Facility Name
Fougera Investigational Site
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Fougera Investigational Site
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Fougera Investigational Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Fougera Investigational Site
City
Miami Gardens
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
Fougera Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
Fougera Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Fougera Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Fougera Investigational Site
City
Miramar
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Fougera Investigational Site
City
Sweetwater
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
Fougera Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33618
Country
United States
Facility Name
Fougera Investigational Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33406
Country
United States
Facility Name
Fougera Investigational Site
City
Macon
State/Province
Georgia
ZIP/Postal Code
31217
Country
United States
Facility Name
Fougera Investigational Site
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Fougera Investigational Site
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Fougera Investigational Site
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Fougera Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Fougera Investigational Site
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70605
Country
United States
Facility Name
Fougera Investigational Site
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
91606
Country
United States
Facility Name
Fougera Investigational Site
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Fougera Investigational Site
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Fougera Investigational Site
City
Salem
State/Province
Oregon
ZIP/Postal Code
97302
Country
United States
Facility Name
Fougera Investigational Site
City
Hazleton
State/Province
Pennsylvania
ZIP/Postal Code
18201
Country
United States
Facility Name
Fougera Investigational Site
City
Upper Saint Clair
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
Fougera Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study Comparing Tazarotene Cream 0.05% to TAZORAC® (Tazarotene) Cream 0.05% and Both to a Placebo Control in the Treatment of Plaque Psoriasis

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