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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

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ClinicalTrials.gov Identifier: NCT02886715
Recruitment Status : Completed
First Posted : September 1, 2016
Results First Posted : August 17, 2018
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Fougera Pharmaceuticals Inc.

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

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Tazarotene Cream 0.1% Drug: Tazorac® Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : September 21, 2016
Actual Primary Completion Date : May 31, 2017
Actual Study Completion Date : May 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
Drug Information available for: Tazarotene

Arm Intervention/treatment
Experimental: Test
Tazarotene Cream 0.1% (Fougera Pharmaceuticals Inc.)
Drug: Tazarotene Cream 0.1%
Tazarotene Cream 0.1% applied to cover the affected areas of the face once daily for 84 +/- 4 days.
Other Name: Tazarotene

Active Comparator: Reference
TAZORAC® (tazarotene) Cream, 0.1% (Allergan, Inc.)
Drug: Tazorac®
Tazorac® applied to cover the affected areas of the face once daily for 84 +/- 4 days.
Other Name: Tazarotene

Placebo Comparator: Placebo
Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
Drug: Placebo
Placebo (vehicle of the test product) applied to cover the affected areas of the face once daily for 84 +/- 4 days.
Other Name: Vehicle




Primary Outcome Measures :
  1. Change in Inflammatory Lesion Counts [ Time Frame: Week 12 ]
    Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts

  2. Change in Non-inflammatory Lesion Counts [ Time Frame: Week 12 ]
    Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts


Secondary Outcome Measures :
  1. Clinical Response of Success [ Time Frame: Week 12 ]
    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



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Ages Eligible for Study:   12 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT02886715


Locations
United States, Arizona
Fougera Investigational Site
Tucson, Arizona, United States, 85712
United States, Arkansas
Fougera Investigational Site
Conway, Arkansas, United States, 72034
Fougera Investigational Site
Hot Springs, Arkansas, United States, 71913
United States, California
Fougera Investigational Site
Anaheim, California, United States, 92801
Fougera Investigational Site
La Mesa, California, United States, 91942
Fougera Investigational Site
Long Beach, California, United States, 90806
Fougera Investigational Site
Long Beach, California, United States, 90813
Fougera Investigational Site
Los Angeles, California, United States, 90010
Fougera Investigational Site
North Hollywood, California, United States, 91606
Fougera Investigational Site
San Diego, California, United States, 92108
Fougera Investigational Site
San Ramon, California, United States, 94582
Fougera Investigational Site
Upland, California, United States, 91786
Fougera Investigational Site
West Covina, California, United States, 91790
United States, Florida
Fougera Investigational Site
Coral Gables, Florida, United States, 33134
Fougera Investigational Site
Miami Gardens, Florida, United States, 33169
Fougera Investigational Site
Miami, Florida, United States, 33015
Fougera Investigational Site
Miami, Florida, United States, 33175
Fougera Investigational Site
Miramar, Florida, United States, 33027
Fougera Investigational Site
Sweetwater, Florida, United States, 33172
United States, Indiana
Fougera Investigational Site
Plainfield, Indiana, United States, 46168
United States, North Carolina
Fougera Investigational Site
High Point, North Carolina, United States, 27262
United States, Pennsylvania
Fougera Investigational Site
Hazleton, Pennsylvania, United States, 18201
Fougera Investigational Site
Upper Saint Clair, Pennsylvania, United States, 15241
United States, Tennessee
Fougera Investigational Site
Chattanooga, Tennessee, United States, 37421
United States, Texas
Fougera Investigational Site
Austin, Texas, United States, 78759
Sponsors and Collaborators
Fougera Pharmaceuticals Inc.
Investigators
Study Director: Angela C. Kaplan Fougera Pharmaceuticals Inc.
  Study Documents (Full-Text)

Documents provided by Fougera Pharmaceuticals Inc.:
Study Protocol  [PDF] December 22, 2016
Statistical Analysis Plan  [PDF] April 26, 2017


Responsible Party: Fougera Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT02886715     History of Changes
Other Study ID Numbers: 0454-01-01
0454 ( Other Identifier: Fougera Pharmaceuticals Inc. )
First Posted: September 1, 2016    Key Record Dates
Results First Posted: August 17, 2018
Last Update Posted: August 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Tazarotene
Nicotinic Acids
Dermatologic Agents
Keratolytic Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs