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

Part of paid clinical trials in Hawthorne, New York.

Sponsor
Sun Pharmaceutical Industries, Inc.
Study ID
NCT07469228
Phase
PHASE1
Status
Completed

Conditions

  • Acne Vulgaris

Eligibility Criteria

Sex
ALL
Age
12 Years - 40 Years
Healthy Volunteers
Accepted

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.
  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Aug 4, 2025
Status verified
Mar 2026
Primary completion
Dec 15, 2025
Completion
Dec 15, 2025

Study Design

Enrollment
1,043 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Demonstrate & evaluate the therapeutic, equivalence and safety of the investigational product [ Time Frame: Baseline to Week 12 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sun Pharmaceutical Industries, Inc.HawthorneNew York10532-

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By research site
Sun Pharmaceutical Industries, Inc.· Hawthorne, NY

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