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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

Study Description
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Brief Summary:
Bioequivalence study comparing Tretinoin Cream, 0.05% to RETIN-A®.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Tretinoin cream, 0.05% Drug: RETIN-A® (tretinoin) cream, 0.05% Drug: Vehicle of the test product Early Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Bioequivalence
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : August 4, 2017
Actual Primary Completion Date : January 26, 2018
Actual Study Completion Date : January 26, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
Drug Information available for: Tretinoin

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Tretinoin cream, 0.05%
Apply once a day application, under at-home use conditions.
 Drug: Tretinoin cream, 0.05%
Tretinoin cream, 0.05%
Other Name: Tretinoin
Active Comparator: RETIN-A® (tretinoin) cream, 0.05%
Apply once a day application, under at-home use conditions.
 Drug: RETIN-A® (tretinoin) cream, 0.05%
RETIN-A® (tretinoin) cream, 0.05%
Other Name: Tretinoin
Placebo Comparator: Vehicle of the test product
Apply once a day application, under at-home use conditions.
 Drug: Vehicle of the test product
Vehicle of the test product
Other Name: placebo


Outcome Measures
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Primary Outcome Measures :
  1. Demonstration of Bioequivalence [ Time Frame: 12 weeks ]
    Demonstration of Bioequivalence in Percent change in inflammatory and non-inflammatory lesion counts


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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): NCT03433378


Locations
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United States, North Carolina
Catawba Research, LLC
Charlotte, North Carolina, United States, 28217
Sponsors and Collaborators
Taro Pharmaceuticals USA
Investigators
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Study Director: Natalie Yantovskiy Taro Pharmaceuticals Inc
More Information
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Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT03433378    
Other Study ID Numbers: TRTC 1623
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018

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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
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
 Tretinoin
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents