> 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-us-b331bee6-fb6a-4c0a-aa75-5a4a9bf31b9e > Record changed: 2026-10-13 # A Study Comparing Trifarotene Cream 0.005% to AKLIEF® CREAM (US REFERENCE LISTED DRUG), AKLIEF™ CREAM (CANADIAN REFERENCE PRODUCT) in the Treatment of Acne Vulgaris NCT06733402 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06733402) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06733402) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06733402) Participants 1,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06733402) Lead sponsor Sun Pharmaceutical Industries, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06733402) Start date 2024-06-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06733402) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06733402) ## Title and summary **Summary** To demonstrate the efficacy, therapeutic equivalence and safety of Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A., Inc.) and US Reference Listed Drug, Canadian Reference Product over the placebo control in the treatment of acne vulgaris. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06733402) **Short title** A Study Comparing Trifarotene Cream 0.005% to AKLIEF® CREAM (US REFERENCE LISTED DRUG), AKLIEF™ CREAM (CANADIAN REFERENCE PRODUCT) in the Treatment of Acne Vulgaris Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06733402) **Official title** A Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-group Study, Comparing Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A, Inc.) to Aklief® Cream (US REFERENCE LISTED DRUG), Aklief Cream (REFERENCE PRODUCT) and Each Active Treatment to a Placebo Control in the Treatment of Acne Vulgaris. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06733402) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06733402) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06733402) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06733402) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06733402) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06733402) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06733402) ## Dates **Completion date** 2024-11-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06733402) **First posted** 2024-12-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06733402) **Registry last updated** 2024-12-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06733402) **Primary completion date** 2024-06-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06733402) **Start date** 2024-06-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06733402) ## Size and sites **Actual participants** 1,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06733402) **Participants** 1,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06733402) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06733402) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06733402) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06733402) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06733402) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06733402) **Lead sponsor** Sun Pharmaceutical Industries, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06733402) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06733402) ## Identifiers **Registry ID** NCT06733402 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06733402) **ClinicalTrials.gov ID** NCT06733402 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06733402) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06733402) ## 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/NCT06733402) ## Outcomes ### Primary outcomes 1. Demonstrate the therapeutic equivalence, efficacy and safety of the Investigational Product Timeframe: Baseline to Week 12 Percentage change in the inflammatory (papules and pustules) \\& non-inflammatory (open and closed comedones) of the lesion counts. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06733402) ## Eligibility **Sex** All **Age groups** Children, Adults **Minimum age** 12 Years **Maximum age** 40 Years **Healthy volunteers** No ### Inclusion criteria - Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris. - 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. - Subjects must be willing to refrain from using all other topical acne medications or antibiotics for acne vulgaris during the 12-week treatment period, other than the investigational product. ### 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 Trifarotene, retinoids and/or any of the study medication ingredients. - Subjects with excessive facial hair (e.g. beards, sideburns, mustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris. - Subjects with a baseline irritation score of 3 = severe (marked, intense). Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06733402) ## Sites - Taro Pharmaceuticals USA Inc.Hawthorne, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06733402) ## 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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