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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02411955
Recruitment Status : Completed
First Posted : April 8, 2015
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA

Study Description
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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%).

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Tazarotene Cream 0.1% Drug: Tazorac® Drug: Placebo Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1077 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : June 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
Drug Information available for: Tazarotene

Arms and Interventions
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Arm Intervention/treatment
Experimental: Tazarotene Cream 0.1%
Tazarotene Cream 0.1% (Taro Pharmaceuticals Inc.)
 Drug: Tazarotene Cream 0.1%
Tazarotene Cream 0.1% applied to lightly cover the entire face once daily for 84 consecutive days.
Other Name: Tazarotene
Active Comparator: Tazorac®
Tazorac® (tazarotene cream 0.1%) (Allergan LLC)
 Drug: Tazorac®
Tazorac® applied to lightly cover the entire face once daily for 84 consecutive days.
Other Name: Tazarotene
Placebo Comparator: Placebo
Placebo (Vehicle of the test product) (Taro Pharmaceuticals Inc.)
 Drug: Placebo
Placebo (vehicle of the test product) applied to lightly cover the entire face once daily for 84 consecutive days.
Other Name: Vehicle


Outcome Measures
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Primary Outcome Measures :
  1. Change in inflammatory lesion counts [ Time Frame: Week 12 ]
    Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts

  2. Change in non-inflammatory lesion counts [ Time Frame: Week 12 ]
    Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts


Secondary Outcome Measures :
  1. Clinical response of success [ Time Frame: Week 12 ]
    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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02411955


Sponsors and Collaborators
Taro Pharmaceuticals USA
Investigators
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Study Chair: Catawba Research http://catawbaresearch.com/contact/
More Information
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Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT02411955    
Other Study ID Numbers: TAZC 1308
First Posted: April 8, 2015    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Nicotinic Acids
Tazarotene
 Dermatologic Agents
Keratolytic Agents
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs