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

NCT02411955 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1077

Last updated 2017-05-04

No results posted yet for this study

Summary

The purpose of this study is to evaluate the therapeutic equivalence and safety of Tazarotene Cream 0.1% and Tazorac® (tazarotene cream 0.1%).

Conditions

  • Acne Vulgaris

Interventions

DRUG

Tazarotene Cream 0.1%

Tazarotene Cream 0.1% applied to lightly cover the entire face once daily for 84 consecutive days.

DRUG

Tazorac®

Tazorac® applied to lightly cover the entire face once daily for 84 consecutive days.

DRUG

Placebo

Placebo (vehicle of the test product) applied to lightly cover the entire face once daily for 84 consecutive days.

Sponsors & Collaborators

  • Sun Pharmaceutical Industries, Inc.

    lead INDUSTRY

Principal Investigators

  • Catawba Research · http://catawbaresearch.com/contact/

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2015-01-31
Completion
2015-02-28

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Drugs

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 NCT02411955 on ClinicalTrials.gov