> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-comparing-trifarotene-cream-0-005-to-aklief-cream-in-8c339358-1fe0-4cf4-add8-468f4b7cf3e9 > Record changed: 2026-10-13 # A Study Comparing Trifarotene Cream 0.005% to AKLIEF® Cream in the Treatment of Acne Vulgaris NCT06063473 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473) Participants 762 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473) Lead sponsor Sun Pharmaceutical Industries, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473) Start date 2023-02-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473) ## Title and summary **Summary** To demonstrate therapeutic equivalence and safety of Trifarotene cream 0.005% (Taro Pharmaceuticals U.S.A., Inc.) and AKLIEF® cream in the treatment of acne vulgaris Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473) **Short title** A Study Comparing Trifarotene Cream 0.005% to AKLIEF® Cream in the Treatment of Acne Vulgaris Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473) **Official title** A Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-group Study, Comparing Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A, Inc.) and to AKLIEF® Cream (Trifarotene 0.005%,Galderma) and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473) ## Dates **Completion date** 2023-07-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473) **First posted** 2023-10-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473) **Registry last updated** 2023-10-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473) **Primary completion date** 2023-07-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473) **Start date** 2023-02-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473) ## Size and sites **Actual participants** 762 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473) **Participants** 762 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473) **Lead sponsor** Sun Pharmaceutical Industries, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473) ## Identifiers **Registry ID** NCT06063473 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473) **ClinicalTrials.gov ID** NCT06063473 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Single masking **Masked roles** Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473) ## Outcomes ### Primary outcomes 1. Demonstration in Therapeutic Equivalence & Safety of the Investigational Product Timeframe: Baseline to Week 12 Percent change in the inflammatory (papules and pustules) \\& non-inflammatory (open and closed comedones) lesion counts Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473) ## 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 (up to the age of 40) must have provided IRB approved written informed consent. Subjects ages 12 to 17 years of age inclusive must have provided IRB approved written assent; - Subjects must have a definite clinical diagnosis of acne vulgaris of 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). Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473) ## Sites - Taro Pharmaceuticals USA Inc.Hawthorne, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473) ## Related records ### Drugs (1) - [Trifarotene](https://trialight.com/data/asset/trifarotene-374e6666-2c7c-4657-8768-537a166f52b8.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 (1) - [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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