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To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.1% and RLD in the Treatment of Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT03427554
Recruitment Status : Completed
First Posted : February 9, 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, 0.1% to RETIN-A®.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Tretinoin cream 0.1% Drug: RETIN-A® Cream 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, 0.1% (TARO PHARMACEUTICALS U.S.A., INC.) to RETIN-A® (TRETINOIN) CREAM, 0.1% (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 : 455 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing TRETINOIN CREAM, 0.1% to RETIN-A® (TRETINOIN) CREAM, 0.1% and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris
Actual Study Start Date : August 21, 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
Experimental: Tretinoin cream 0.1%
Once daily at home, to apply the entire affected areas of the face.
 Drug: Tretinoin cream 0.1%
Tretinoin cream 0.1% (Taro Pharmaceuticals Inc.)
Other Name: Tretinoin
Active Comparator: RETIN-A® Cream
Once daily at home, to apply the entire affected areas of the face.
 Drug: RETIN-A® Cream
RETIN-A® (Tretinoin) Cream (Valeant)
Other Name: Tretinoin
Placebo Comparator: Vehicle of the test product
Once daily at home, to apply the entire affected areas of the face.
 Drug: Vehicle of the test product
Vehicle for Tretinoin cream 0.1% (Taro Pharmaceuticals Inc.)
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).
  • Subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits.

Exclusion Criteria:

  • Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
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): NCT03427554


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: Zaidoon A Al-Zubaidy Catawba Research
More Information
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Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT03427554    
Other Study ID Numbers: TRTC 1622
First Posted: February 9, 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: No
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