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A Study Comparing Tretinoin Gel Microsphere, 0.1% and RETIN-A MICRO ® Gel Microsphere, 0.1% 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: NCT04883736
Recruitment Status : Completed
First Posted : May 12, 2021
Last Update Posted : May 12, 2021
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA

Brief Summary:
To demonstrate the therapeutic equivalence and safety of Tretinoin Gel Microsphere, 0.1% (Taro Pharmaceuticals U.S.A, Inc.) and RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1% (Valeant) in the treatment of acne vulgaris.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Tretinoin Gel Microsphere, 0.1% Drug: RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1% Drug: Placebo Control Early Phase 1

Detailed Description:
A multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing Tretinoin Gel Microsphere, 0.1% (Taro Pharmaceuticals U.S.A, Inc.) and RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1% (Valeant) in the treatment of acne vulgaris.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 973 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 Gel Microsphere, 0.1% (Taro Pharmaceuticals U.S.A, Inc.) to RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1% (Valeant) and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris
Actual Study Start Date : August 31, 2020
Actual Primary Completion Date : April 16, 2021
Actual Study Completion Date : April 16, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
Drug Information available for: Tretinoin

Arm Intervention/treatment
Experimental: Tretinoin Gel Microsphere, 0.1%
The study medication will be self-applied topically, on the affected areas of the face lightly, once daily in the evening, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.
Drug: Tretinoin Gel Microsphere, 0.1%
The study medication will be self-applied topically, on the affected areas of the face lightly, once daily in the evening, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.
Other Name: Test Product

Active Comparator: RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1%
The study medication will be self-applied topically, on the affected areas of the face lightly, once daily in the evening, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.
Drug: RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1%
The study medication will be self-applied topically, on the affected areas of the face lightly, once daily in the evening, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.
Other Name: Reference Product

Placebo Comparator: Placebo Control
The study medication will be self-applied topically, on the affected areas of the face lightly, once daily in the evening, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.
Drug: Placebo Control
The study medication will be self-applied topically, on the affected areas of the face lightly, once daily in the evening, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.
Other Name: Vehicle




Primary Outcome Measures :
  1. The percentage change in the inflammatory and non-inflammatory lesion counts [ Time Frame: Baseline to Week 12 ]
    Demonstration of Therapeutic Equivalence



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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 who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent. Subjects ages 12 to 17 years of age, inclusive, must have provided IRB approved written assent
  • Subjects must have a definite clinical diagnosis of acne vulgaris of severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA)

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.
  • Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).

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): NCT04883736


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
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Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT04883736    
Other Study ID Numbers: TRTN-1619
First Posted: May 12, 2021    Key Record Dates
Last Update Posted: May 12, 2021
Last Verified: May 2021

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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