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A Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both to a Placebo Control in the Treatment of Acne Vulgaris

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tazarotene Cream 0.1%
Tazorac®
Placebo
Sponsored by
Fougera Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

12 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
  • Must have a minimum of ≥ 25 non-inflammatory lesions and ≥ 20 inflammatory lesions and ≤ 2 nodulocystic lesions at baseline on the face.
  • Must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment.

Exclusion Criteria:

  • Female subjects who are pregnant, nursing or planning to become pregnant during study participation.
  • Have a history of hypersensitivity or allergy to tazarotene, retinoids and/or any of the study medication ingredients.
  • Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris.

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

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 0.1% (Fougera Pharmaceuticals Inc.)

TAZORAC® (tazarotene) Cream, 0.1% (Allergan, Inc.)

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

Outcomes

Primary Outcome Measures

Change in Inflammatory Lesion Counts
Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts
Change in Non-inflammatory Lesion Counts
Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts

Secondary Outcome Measures

Clinical Response of Success
The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment

Full Information

First Posted
August 29, 2016
Last Updated
July 19, 2018
Sponsor
Fougera Pharmaceuticals Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02886715
Brief Title
A Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both to a Placebo Control in the Treatment of Acne Vulgaris
Official Title
A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both Active Treatments to a Vehicle Control in the Treatment of Acne Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
September 21, 2016 (Actual)
Primary Completion Date
May 31, 2017 (Actual)
Study Completion Date
May 31, 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 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both Active Treatments to a Vehicle Control in the Treatment of Acne Vulgaris

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test
Arm Type
Experimental
Arm Description
Tazarotene Cream 0.1% (Fougera Pharmaceuticals Inc.)
Arm Title
Reference
Arm Type
Active Comparator
Arm Description
TAZORAC® (tazarotene) Cream, 0.1% (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 0.1%
Other Intervention Name(s)
Tazarotene
Intervention Description
Tazarotene Cream 0.1% applied to cover the affected areas of the face once daily for 84 +/- 4 days.
Intervention Type
Drug
Intervention Name(s)
Tazorac®
Other Intervention Name(s)
Tazarotene
Intervention Description
Tazorac® applied to cover the affected areas of the face once daily for 84 +/- 4 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Vehicle
Intervention Description
Placebo (vehicle of the test product) applied to cover the affected areas of the face once daily for 84 +/- 4 days.
Primary Outcome Measure Information:
Title
Change in Inflammatory Lesion Counts
Description
Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts
Time Frame
Week 12
Title
Change in Non-inflammatory Lesion Counts
Description
Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Clinical Response of Success
Description
The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris. Must have a minimum of ≥ 25 non-inflammatory lesions and ≥ 20 inflammatory lesions and ≤ 2 nodulocystic lesions at baseline on the face. Must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment. Exclusion Criteria: Female subjects who are pregnant, nursing or planning to become pregnant during study participation. Have a history of hypersensitivity or allergy to tazarotene, retinoids and/or any of the study medication ingredients. Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris.
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
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Fougera Investigational Site
City
Conway
State/Province
Arkansas
ZIP/Postal Code
72034
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
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Fougera Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Fougera Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Fougera Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90010
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
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Fougera Investigational Site
City
West Covina
State/Province
California
ZIP/Postal Code
91790
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
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
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
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
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
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
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Fougera Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both to a Placebo Control in the Treatment of Acne Vulgaris

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