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Generic Tazarotene Cream, 0.1% in the Treatment of Acne Vulgaris

NCT02160678 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1741

Last updated 2016-11-03

No results posted yet for this study

Summary

To compare the safety and efficacy profiles of Tazarotene Cream, 0.1 % to the reference listed drug Tazorac® (tazarotene) Cream, 0.1 % in order to demonstrate bioequivalence, and to demonstrate superiority of the 2 active creams over that of the cream vehicle (placebo) in the treatment of acne vulgaris.

Conditions

  • Acne Vulgaris

Interventions

DRUG

Vehicle

Cream Vehicle (placebo) (G \& W Laboratories, Inc.)- vehicle

DRUG

Tazarotene Cream, 0.1 %

Tazarotene Cream, 0.1 % (G \& W Laboratories, Inc.) - test product

DRUG

Tazorac Cream, 0.1%

Tazorac Cream, 0.1% (Allergan, Inc.) - reference product

Sponsors & Collaborators

  • G & W Laboratories Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Bukhalo, MD · Altman Dermatology Associates

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02160678 on ClinicalTrials.gov