To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.05% and RLD in the Treatment of Acne Vulgaris

• ClinicalTrials.gov Identifier: NCT03433378
• Recruitment Status: Completed
• First Posted: February 14, 2018
• Last Update Posted: May 18, 2018
• Sponsor: Taro Pharmaceuticals USA
• Information provided by (Responsible Party): Taro Pharmaceuticals USA

Tracking Information

• First Submitted Date: January 29, 2018
• First Posted Date: February 14, 2018
• Last Update Posted Date: May 18, 2018
• Actual Study Start Date: August 4, 2017
• Actual Primary Completion Date: January 26, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (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: To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.05% and RLD in the Treatment of Acne Vulgaris
• Official Title: 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: Interventional
• Study Phase: Early Phase 1

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Bioequivalence

Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment

• Condition: Acne Vulgaris

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 7, 2018): 700
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: January 26, 2018
• Actual Primary Completion Date: January 26, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 12 Years to 40 Years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03433378
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Taro Pharmaceuticals USA
• Original Responsible Party: Same as current
• Current Study Sponsor: Taro Pharmaceuticals USA
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Natalie Yantovskiy; Taro Pharmaceuticals Inc

• PRS Account: Taro Pharmaceuticals USA
• Verification Date: May 2018