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To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.05% and RLD 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: NCT03433378
Recruitment Status : Completed
First Posted : February 14, 2018
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA

Tracking Information
First Submitted Date  ICMJE January 29, 2018
First Posted Date  ICMJE February 14, 2018
Last Update Posted Date May 18, 2018
Actual Study Start Date  ICMJE August 4, 2017
Actual Primary Completion Date January 26, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2018)
Demonstration of Bioequivalence [ Time Frame: 12 weeks ]
Demonstration of Bioequivalence in Percent change in inflammatory and non-inflammatory lesion counts
Original Primary Outcome Measures  ICMJE
 (submitted: February 7, 2018)
  • Percent change in inflammatory lesion counts [ Time Frame: 12 weeks ]
    Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts
  • Percent change in non-inflammatory lesion counts [ Time Frame: 12 weeks ]
    Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2018)
Clinical response of success [ Time Frame: 12 weeks ]
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.05% and RLD in the Treatment of Acne Vulgaris
Official Title  ICMJE A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing TRETINOIN CREAM, 0.05% to RETIN-A® (TRETINOIN) CREAM, 0.05% and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris
Brief Summary Bioequivalence study comparing Tretinoin Cream, 0.05% to RETIN-A®.
Detailed Description A Multi-center, Double-Blind, Randomized, Placebo controlled, Parallel-Group study, comparing TRETINOIN CREAM, 0.05% (TARO PHARMACEUTICALS U.S.A., INC.) to RETIN-A® (TRETINOIN) CREAM, 0.05% (VALEANT) and both active treatments to a Placebo Control in the treatment of Acne Vulgaris
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Bioequivalence
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: Tretinoin cream, 0.05%
    Tretinoin cream, 0.05%
    Other Name: Tretinoin
  • Drug: RETIN-A® (tretinoin) cream, 0.05%
    RETIN-A® (tretinoin) cream, 0.05%
    Other Name: Tretinoin
  • Drug: Vehicle of the test product
    Vehicle of the test product
    Other Name: placebo
Study Arms  ICMJE
  • Active Comparator: Tretinoin cream, 0.05%
    Apply once a day application, under at-home use conditions.
    Intervention: Drug: Tretinoin cream, 0.05%
  • Active Comparator: RETIN-A® (tretinoin) cream, 0.05%
    Apply once a day application, under at-home use conditions.
    Intervention: Drug: RETIN-A® (tretinoin) cream, 0.05%
  • Placebo Comparator: Vehicle of the test product
    Apply once a day application, under at-home use conditions.
    Intervention: Drug: Vehicle of the test product
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: February 7, 2018)
700
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 26, 2018
Actual Primary Completion Date January 26, 2018   (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 must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA) (per Table 1 below).

Exclusion Criteria:

  • Female Subjects who are pregnant, nursing or planning to become pregnant during study participation
  • Subjects with a history of hypersensitivity or allergy to tretinoin, retinoids, or any of the study medication ingredients.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03433378
Other Study ID Numbers  ICMJE TRTC 1623
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Taro Pharmaceuticals USA
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Taro Pharmaceuticals USA
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Natalie Yantovskiy Taro Pharmaceuticals Inc
PRS Account Taro Pharmaceuticals USA
Verification Date May 2018

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