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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

Information source: Taro Pharmaceuticals USA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acne Vulgaris

Intervention: Tazarotene Cream 0.1% (Drug); Tazorac® (Drug); Placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Taro Pharmaceuticals USA

Official(s) and/or principal investigator(s):
Natalie Yantovskiy, Study Director, Affiliation: Taro

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%).

Clinical Details

Official title: A Multiple-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.1% to Tazorac (Tazarotene Cream 0.1%) and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Change in inflammatory lesion counts

Change in non-inflammatory lesion counts

Secondary outcome: Clinical response of success

Detailed description: The purpose of this study is to evaluate the therapeutic equivalence and safety of Tazarotene Cream 0. 1% and Tazorac (tazarotene cream 0. 1%) in the treatment of acne vulgaris and to demonstrate the superiority of the test and reference products over the placebo control.

Eligibility

Minimum age: 12 Years. Maximum age: 40 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical

diagnosis of acne vulgaris.

- Subjects aged 18 years and older must have provided written consent. Subjects aged 12

to 17 years must have provided written assent accompanied by written consent from their legally acceptable representative. All subjects or their legally acceptable representatives must sign Health Insurance Portability and Accountability Act authorization.

- 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.

Locations and Contacts

Additional Information

Starting date: June 2014
Last updated: April 7, 2015

Page last updated: August 23, 2015

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