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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02886715
• Other study ID #: 0454-01-01
• Secondary ID: 0454
• Status: Completed
• Phase: Phase 3
• Start date: September 21, 2016
• Est. completion date: May 31, 2017

Study information

• Verified date: July 2018
• Source: Fougera Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1110
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Tazarotene Cream 0.1%
Tazarotene Cream 0.1% applied to cover the affected areas of the face once daily for 84 +/- 4 days.
• Tazorac®
Tazorac® applied to cover the affected areas of the face once daily for 84 +/- 4 days.
• Placebo
Placebo (vehicle of the test product) applied to cover the affected areas of the face once daily for 84 +/- 4 days.

Locations

Country	Name	City	State
United States	Fougera Investigational Site	Anaheim	California
United States	Fougera Investigational Site	Austin	Texas
United States	Fougera Investigational Site	Chattanooga	Tennessee
United States	Fougera Investigational Site	Conway	Arkansas
United States	Fougera Investigational Site	Coral Gables	Florida
United States	Fougera Investigational Site	Hazleton	Pennsylvania
United States	Fougera Investigational Site	High Point	North Carolina
United States	Fougera Investigational Site	Hot Springs	Arkansas
United States	Fougera Investigational Site	La Mesa	California
United States	Fougera Investigational Site	Long Beach	California
United States	Fougera Investigational Site	Long Beach	California
United States	Fougera Investigational Site	Los Angeles	California
United States	Fougera Investigational Site	Miami	Florida
United States	Fougera Investigational Site	Miami	Florida
United States	Fougera Investigational Site	Miami Gardens	Florida
United States	Fougera Investigational Site	Miramar	Florida
United States	Fougera Investigational Site	North Hollywood	California
United States	Fougera Investigational Site	Plainfield	Indiana
United States	Fougera Investigational Site	San Diego	California
United States	Fougera Investigational Site	San Ramon	California
United States	Fougera Investigational Site	Sweetwater	Florida
United States	Fougera Investigational Site	Tucson	Arizona
United States	Fougera Investigational Site	Upland	California
United States	Fougera Investigational Site	Upper Saint Clair	Pennsylvania
United States	Fougera Investigational Site	West Covina	California

Sponsors (1)

Lead Sponsor	Collaborator
Fougera Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Inflammatory Lesion Counts	Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts	Week 12
Primary	Change in Non-inflammatory Lesion Counts	Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts	Week 12
Secondary	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	Week 12