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

NCT07469228 | Completed Phase 1 FDA Drug

• 1 other identifier: TRTN-1620
• Study Type: interventional
• Target: 1,043
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Demonstrate & evaluate the therapeutic, equivalence and safety of the investigational product

  Mean Percentage change in the inflammatory (papules and pustules) \& non-inflammatory (comedones) lesion counts

  Baseline to Week 12

Study Arms (3)

Tretinoin Gel Microsphere, 0.04%

EXPERIMENTAL

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%

RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.04%

ACTIVE COMPARATOR

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%

Placebo Control

PLACEBO COMPARATOR

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

Interventions

Tretinoin Gel Microsphere, 0.04% DRUG

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.

Also known as: Test Product

Tretinoin Gel Microsphere, 0.04%

RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.04% DRUG

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.

Also known as: Reference Product

RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.04%

Placebo Control DRUG

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.

Also known as: Vehicle of the test product

Placebo Control

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Pharmaceutical Industries, Inc.: lead

Study Sites (1)

Sun Pharmaceutical Industries, Inc.

Hawthorne, New York, 10532, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Tretinoin

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Officials

• Natalie Yantovskiy

  Sun Pharmaceuticals Industries, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 13, 2026
• Study Start: August 4, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)