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

NCT02411955 | Completed Phase 1

• 1 other identifier: TAZC 1308
• Study Type: interventional
• Target: 1,077
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (2)

• Change in inflammatory lesion counts

  Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts

  Week 12

• 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 Outcomes (1)

• Clinical response of success

  Week 12

Study Arms (3)

Tazarotene Cream 0.1%

EXPERIMENTAL

Tazarotene Cream 0.1% (Taro Pharmaceuticals Inc.)

Drug: Tazarotene Cream 0.1%

Tazorac®

ACTIVE COMPARATOR

Tazorac® (tazarotene cream 0.1%) (Allergan LLC)

Drug: Tazorac®

Placebo

PLACEBO COMPARATOR

Placebo (Vehicle of the test product) (Taro Pharmaceuticals Inc.)

Drug: Placebo

Interventions

Tazarotene Cream 0.1% DRUG

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

Also known as: Tazarotene

Tazarotene Cream 0.1%

Tazorac® DRUG

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

Also known as: Tazarotene

Tazorac®

Placebo DRUG

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

Also known as: Vehicle

Placebo

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Pharmaceutical Industries, Inc.: lead

MeSH Terms

Conditions

Acne Vulgaris

Interventions

tazarotene

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Catawba Research

  http://catawbaresearch.com/contact/

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2015
• First Posted: April 8, 2015
• Study Start: June 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: February 1, 2015
• Last Updated: May 4, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share