A Study Comparing Tretinoin Gel Microsphere, 0.04% and RETIN-A MICRO ® Gel Microsphere, 0.04% in the Treatment of Acne Vulgaris

March 9, 2026 updated by: Sun Pharmaceutical Industries, Inc.

A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study, Comparing Tretinoin Gel Microsphere, 0.04% (Sun Pharmaceutical Industries, Inc.) and RETIN-A MICRO ® (Tretinoin) Gel Microsphere, 0.04% (Reference Listed Drug) in the Treatment of Acne Vulgaris.

To demonstrate the efficacy, therapeutic equivalence and safety of tretinoin gel microsphere, 0.04% (Sun Pharmaceutical Industries, Inc.) and RETIN-A MICRO ® (tretinoin) gel microsphere, 0.04% (Reference Listed Drug) in the treatment of acne vulgaris.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing Tretinoin Gel Microsphere, 0.04% (Sun Pharmaceutical Industries, Inc.) and RETIN-A MICRO ® (Tretinoin) Gel Microsphere, 0.04% (Reference Listed Drug) in the treatment of acne vulgaris.

Study Type

Interventional

Enrollment (Actual)

1043

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Hawthorne, New York, United States, 10532
        • Sun Pharmaceutical Industries, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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 must have provided IRB approved written informed consent.
  • 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 have ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) AND ≥ 20 inflammatory lesions (i.e., papules and pustules) AND ≤ 2 nodulocystic lesions (i.e., nodules and cysts), at baseline on the face.

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).
  • Subjects with a baseline irritation score of 3 = severe (marked, intense).
  • Subjects with eczematous skin.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tretinoin Gel Microsphere, 0.04%
The investigational product will be applied topically to the affected areas of the face lightly once daily at bedtime, avoiding the eyes, mouth, and other mucous membranes for 84 consecutive days.
Drug: Tretinoin Gel Microsphere, 0.04%
The investigational product will be applied topically to the affected areas of the face lightly once daily at bedtime, avoiding the eyes, mouth, and other mucous membranes for 84 consecutive days.
Other Names:
  • Test Product
Active Comparator: RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.04%
The investigational product will be applied topically to the affected areas of the face lightly once daily at bedtime, avoiding the eyes, mouth, and other mucous membranes for 84 consecutive days.
Drug: RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.04%
The investigational product will be applied topically to the affected areas of the face lightly once daily at bedtime, avoiding the eyes, mouth, and other mucous membranes for 84 consecutive days.
Other Names:
  • Reference Product
Placebo Comparator: Placebo Control
The investigational product will be applied topically to the affected areas of the face lightly once daily at bedtime, avoiding the eyes, mouth, and other mucous membranes for 84 consecutive days.
Drug: Placebo Control
The investigational product will be applied topically to the affected areas of the face lightly once daily at bedtime, avoiding the eyes, mouth, and other mucous membranes for 84 consecutive days.
Other Names:
  • Vehicle of the test product

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demonstrate & evaluate the therapeutic, equivalence and safety of the investigational product
Time Frame: Baseline to Week 12
Mean Percentage change in the inflammatory (papules and pustules) & non-inflammatory (comedones) lesion counts
Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Pharmaceutical Industries, Inc.

Investigators

  • Study Director: Natalie Yantovskiy, Sun Pharmaceuticals Industries, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2025

Primary Completion (Actual)

December 15, 2025

Study Completion (Actual)

December 15, 2025

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRTN-1620

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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