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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

NCT ID: NCT02886715

Last Updated: 2018-08-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-21

Study Completion Date

2017-05-31

Brief Summary

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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

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TERMINATED PHASE4

Detailed Description

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Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Test

Tazarotene Cream 0.1% (Fougera Pharmaceuticals Inc.)

Group Type EXPERIMENTAL

Tazarotene Cream 0.1%

Intervention Type DRUG

Tazarotene Cream 0.1% applied to cover the affected areas of the face once daily for 84 +/- 4 days.

Reference

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

Group Type ACTIVE_COMPARATOR

Tazorac®

Intervention Type DRUG

Tazorac® applied to cover the affected areas of the face once daily for 84 +/- 4 days.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo (vehicle of the test product) applied to cover the affected areas of the face once daily for 84 +/- 4 days.

Interventions

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Tazarotene Cream 0.1%

Tazarotene Cream 0.1% applied to cover the affected areas of the face once daily for 84 +/- 4 days.

Intervention Type DRUG

Tazorac®

Tazorac® applied to cover the affected areas of the face once daily for 84 +/- 4 days.

Intervention Type DRUG

Placebo

Placebo (vehicle of the test product) applied to cover the affected areas of the face once daily for 84 +/- 4 days.

Intervention Type DRUG

Other Intervention Names

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Tazarotene Tazarotene Vehicle

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fougera Pharmaceuticals Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Angela C. Kaplan

Role: STUDY_DIRECTOR

Fougera Pharmaceuticals Inc.

Locations

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Fougera Investigational Site

Tucson, Arizona, United States

Site Status

Fougera Investigational Site

Conway, Arkansas, United States

Site Status

Fougera Investigational Site

Hot Springs, Arkansas, United States

Site Status

Fougera Investigational Site

Anaheim, California, United States

Site Status

Fougera Investigational Site

La Mesa, California, United States

Site Status

Fougera Investigational Site

Long Beach, California, United States

Site Status

Fougera Investigational Site

Long Beach, California, United States

Site Status

Fougera Investigational Site

Los Angeles, California, United States

Site Status

Fougera Investigational Site

North Hollywood, California, United States

Site Status

Fougera Investigational Site

San Diego, California, United States

Site Status

Fougera Investigational Site

San Ramon, California, United States

Site Status

Fougera Investigational Site

Upland, California, United States

Site Status

Fougera Investigational Site

West Covina, California, United States

Site Status

Fougera Investigational Site

Coral Gables, Florida, United States

Site Status

Fougera Investigational Site

Miami, Florida, United States

Site Status

Fougera Investigational Site

Miami, Florida, United States

Site Status

Fougera Investigational Site

Miami Gardens, Florida, United States

Site Status

Fougera Investigational Site

Miramar, Florida, United States

Site Status

Fougera Investigational Site

Sweetwater, Florida, United States

Site Status

Fougera Investigational Site

Plainfield, Indiana, United States

Site Status

Fougera Investigational Site

High Point, North Carolina, United States

Site Status

Fougera Investigational Site

Hazleton, Pennsylvania, United States

Site Status

Fougera Investigational Site

Upper Saint Clair, Pennsylvania, United States

Site Status

Fougera Investigational Site

Chattanooga, Tennessee, United States

Site Status

Fougera Investigational Site

Austin, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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0454

Identifier Type: OTHER

Identifier Source: secondary_id

0454-01-01

Identifier Type: -

Identifier Source: org_study_id

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