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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02411955
• Other study ID #: TAZC 1308
• Status: Completed
• Phase: Phase 1
• First received: April 4, 2015
• Last updated: May 3, 2017
• Start date: June 2014
• Est. completion date: February 2015

Study information

• Verified date: May 2017
• Source: Taro Pharmaceuticals USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1077
• Est. completion date: February 2015
• Est. primary completion date: January 2015
• 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.

• 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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Tazarotene Cream 0.1%
Tazarotene Cream 0.1% applied to lightly cover the entire face once daily for 84 consecutive days.
• Tazorac®
Tazorac® applied to lightly cover the entire face once daily for 84 consecutive days.
• Placebo
Placebo (vehicle of the test product) applied to lightly cover the entire face once daily for 84 consecutive days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taro Pharmaceuticals USA

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