A Study Comparing Tretinoin Gel Microsphere, 0.04% and RETIN-A MICRO ® Gel Microsphere, 0.04% in the Treatment of Acne Vulgaris
NCT07469228
Phase
Phase 1
Recruitment status
Completed
Participants
1,043
Lead sponsor
Sun Pharmaceutical Industries, Inc.
Start date
2025-08-04
Number of sites
- 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.
- Short title
- A Study Comparing Tretinoin Gel Microsphere, 0.04% and RETIN-A MICRO ® Gel Microsphere, 0.04% in the Treatment of Acne Vulgaris
- Official title
- 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.
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2025-12-15
- First posted
- 2026-03-13
- Registry last updated
- 2026-03-13
- Primary completion date
- 2025-12-15
- Start date
- 2025-08-04
- Actual participants
- 1,043
- Participants
- 1,043
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07469228
- ClinicalTrials.gov ID
- NCT07469228
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Triple masking
- Masked roles
- Participants, Care providers, Investigators
Sources for study design
Demonstrate & evaluate the therapeutic, equivalence and safety of the investigational product
Timeframe: Baseline to Week 12
Mean Percentage change in the inflammatory (papules and pustules) \& non-inflammatory (comedones) lesion counts
Sources for outcomes
- Sex
- All
- Age groups
- Children, Adults
- Minimum age
- 12 Years
- Maximum age
- 40 Years
- Healthy volunteers
- Yes
- 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.
- 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.
Sources for eligibility
- Sun Pharmaceutical Industries, Inc.Hawthorne, United States
Sources for sites
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Acne Primary condition