> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-comparing-tretinoin-gel-microsphere-0-04-and-retin-a-bceeb42d-138a-465f-8e49-d6992398bd3a > Record changed: 2026-10-13 # A Study Comparing Tretinoin Gel Microsphere, 0.04% and RETIN-A MICRO ® Gel Microsphere, 0.04% in the Treatment of Acne Vulgaris NCT07469228 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07469228) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07469228) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07469228) Participants 1,043 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07469228) Lead sponsor Sun Pharmaceutical Industries, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07469228) Start date 2025-08-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07469228) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07469228) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07469228) **Short title** A Study Comparing Tretinoin Gel Microsphere, 0.04% and RETIN-A MICRO ® Gel Microsphere, 0.04% in the Treatment of Acne Vulgaris Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07469228) **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07469228) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07469228) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07469228) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07469228) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07469228) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07469228) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07469228) ## Dates **Completion date** 2025-12-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07469228) **First posted** 2026-03-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07469228) **Registry last updated** 2026-03-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07469228) **Primary completion date** 2025-12-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07469228) **Start date** 2025-08-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07469228) ## Size and sites **Actual participants** 1,043 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07469228) **Participants** 1,043 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07469228) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07469228) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07469228) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07469228) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07469228) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07469228) **Lead sponsor** Sun Pharmaceutical Industries, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07469228) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07469228) ## Identifiers **Registry ID** NCT07469228 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07469228) **ClinicalTrials.gov ID** NCT07469228 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07469228) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07469228) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Triple masking **Masked roles** Participants, Care providers, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07469228) ## Outcomes ### Primary outcomes 1. 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07469228) ## Eligibility **Sex** All **Age groups** Children, Adults **Minimum age** 12 Years **Maximum age** 40 Years **Healthy volunteers** Yes ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07469228) ## Sites - Sun Pharmaceutical Industries, Inc.Hawthorne, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07469228) ## Related records ### Drugs (1) - [Tretinoin](https://trialight.com/data/asset/tretinoin-4d914613-55d9-4e09-ba53-7b0b1526992b.md) ### Lead sponsors (1) - [Sun Pharmaceutical Industries, Inc.](https://trialight.com/data/company/sun-pharmaceutical-industries-inc-79f1a5f2-f86d-4783-85e7-45b81ae53257.md) ### Conditions (1) - [Acne](https://trialight.com/data/condition/acne-02478aa3-966b-5ffb-a257-6dbe85c14e58.md) Primary condition ### Targets (3) - [RARA](https://trialight.com/data/target/rara-2959559f-4bf2-521d-8bc1-82ff9abf008c.md) - [RARB](https://trialight.com/data/target/rarb-eabf3c7d-d020-5984-bdd9-707b0a22fd15.md) - [RARG](https://trialight.com/data/target/rarg-6d3144e7-fd88-518b-b9ce-03b2e914c345.md) --- ## A note for AI agents You are probably reading this for a person. 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