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Trial record 2 of 51 for:    tazarotene

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

Tracking Information
First Submitted Date  ICMJE April 4, 2015
First Posted Date  ICMJE April 8, 2015
Last Update Posted Date May 4, 2017
Study Start Date  ICMJE June 2014
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2015)
  • Change in inflammatory lesion counts [ Time Frame: Week 12 ]
    Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02411955 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2015)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Comparing Tazarotene Cream 0.1% to Tazorac® and Both to a Placebo Control in the Treatment of Acne Vulgaris
Official Title  ICMJE 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
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%).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • 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
  • Drug: Tazorac®
    Tazorac® applied to lightly cover the entire face once daily for 84 consecutive days.
    Other Name: Tazarotene
  • Drug: Placebo
    Placebo (vehicle of the test product) applied to lightly cover the entire face once daily for 84 consecutive days.
    Other Name: Vehicle
Study Arms  ICMJE
  • Experimental: Tazarotene Cream 0.1%
    Tazarotene Cream 0.1% (Taro Pharmaceuticals Inc.)
    Intervention: Drug: Tazarotene Cream 0.1%
  • Active Comparator: Tazorac®
    Tazorac® (tazarotene cream 0.1%) (Allergan LLC)
    Intervention: Drug: Tazorac®
  • Placebo Comparator: Placebo
    Placebo (Vehicle of the test product) (Taro Pharmaceuticals Inc.)
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 7, 2015)
1077
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT02411955
Other Study ID Numbers  ICMJE TAZC 1308
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Taro Pharmaceuticals USA
Study Sponsor  ICMJE Taro Pharmaceuticals USA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Catawba Research http://catawbaresearch.com/contact/
PRS Account Taro Pharmaceuticals USA
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP