{"id":"trifarotene-cream","safety":{"commonSideEffects":[{"rate":null,"effect":"Erythema"},{"rate":null,"effect":"Scaling/peeling"},{"rate":null,"effect":"Dryness"},{"rate":null,"effect":"Pruritus"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Trifarotene selectively activates retinoid X receptors (RXR), which are nuclear receptors involved in regulating genes associated with inflammation, sebum production, and keratinocyte differentiation. By binding to RXR, it reduces inflammatory cytokines and normalizes follicular keratinization, addressing multiple pathogenic factors in acne. This mechanism differs from traditional retinoids like tretinoin, which bind to retinoic acid receptors (RAR).","oneSentence":"Trifarotene is a selective retinoid X receptor (RXR) agonist that modulates gene expression to reduce inflammation and normalize skin cell differentiation in acne.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:14:32.070Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Acne vulgaris"}]},"trialDetails":[{"nctId":"NCT07186413","phase":"PHASE3","title":"A Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne Vulgaris","status":"RECRUITING","sponsor":"Galderma R&D","startDate":"2025-09-23","conditions":"Acne Vulgaris","enrollment":561},{"nctId":"NCT06733402","phase":"PHASE1","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","status":"COMPLETED","sponsor":"Sun Pharmaceutical Industries, Inc.","startDate":"2024-06-20","conditions":"Acne Vulgaris","enrollment":1000},{"nctId":"NCT05550337","phase":"PHASE3","title":"Study Comparing Trifarotene Cream, 0.005% To AKLIEF ® (Trifarotene 0.005% Cream) In The Treatment Of Acne Vulgaris","status":"COMPLETED","sponsor":"Teva Pharmaceuticals USA","startDate":"2022-09-19","conditions":"Acne Vulgaris","enrollment":807},{"nctId":"NCT04856904","phase":"PHASE4","title":"Study of Trifarotene Cream to Assess Risk of a Trophic Acne Scar Formation","status":"COMPLETED","sponsor":"Galderma R&D","startDate":"2021-05-28","conditions":"Acne Vulgaris","enrollment":121},{"nctId":"NCT05089708","phase":"PHASE4","title":"AkLief Evaluation in Acne-induced Post-Inflammatory Hyperpigmentation","status":"COMPLETED","sponsor":"Galderma R&D","startDate":"2021-12-22","conditions":"Acne Vulgaris","enrollment":123},{"nctId":"NCT06063473","phase":"PHASE1","title":"A Study Comparing Trifarotene Cream 0.005% to AKLIEF® Cream in the Treatment of Acne Vulgaris","status":"COMPLETED","sponsor":"Sun Pharmaceutical Industries, Inc.","startDate":"2023-02-22","conditions":"Acne Vulgaris","enrollment":762},{"nctId":"NCT03738800","phase":"PHASE2","title":"A Safety, Efficacy and Systemic Exposure Study of CD5789 Cream in Adults and Adolescents With Lamellar Ichthyosis","status":"TERMINATED","sponsor":"Mayne Pharma International Pty Ltd","startDate":"2019-05-01","conditions":"Lamellar Ichthyosis","enrollment":65},{"nctId":"NCT04451330","phase":"PHASE4","title":"A Study to Compare Efficacy and Safety of Trifarotene Cream When Used With an Oral Antibiotic for the Treatment of Severe Acne Vulgaris (AV)","status":"COMPLETED","sponsor":"Galderma R&D","startDate":"2020-07-29","conditions":"Acne Vulgaris","enrollment":202},{"nctId":"NCT03915860","phase":"PHASE3","title":"Participant Reported Outcomes With Use of Trifarotene 50 μg/g Cream in the Treatment of Moderate Facial and Truncal Acne Vulgaris","status":"COMPLETED","sponsor":"Galderma R&D","startDate":"2019-03-27","conditions":"Acne Vulgaris","enrollment":47},{"nctId":"NCT01616654","phase":"PHASE2","title":"Dose Range Study of CD5789 in Acne Vulgaris","status":"COMPLETED","sponsor":"Galderma R&D","startDate":"2012-06-20","conditions":"Acne Vulgaris","enrollment":304},{"nctId":"NCT02189629","phase":"PHASE3","title":"CD5789 (Trifarotene) Long Term Safety Study on Acne Vulgaris","status":"COMPLETED","sponsor":"Galderma R&D","startDate":"2015-02-23","conditions":"Acne Vulgaris","enrollment":453},{"nctId":"NCT02556788","phase":"PHASE3","title":"Double-Blind Efficacy and Safety of CD5789 (Trifarotene) 50µg/g Cream Versus Vehicle Cream in Acne Vulgaris","status":"COMPLETED","sponsor":"Galderma R&D","startDate":"2015-11","conditions":"Acne Vulgaris","enrollment":1212},{"nctId":"NCT02566369","phase":"PHASE3","title":"Efficacy and Safety of CD5789 (Trifarotene) 50μg/g Cream Versus Vehicle Cream in Acne Vulgaris","status":"COMPLETED","sponsor":"Galderma R&D","startDate":"2015-11-30","conditions":"Acne Vulgaris","enrollment":1208},{"nctId":"NCT01804335","phase":"PHASE1","title":"CD5789 in Early Cutaneous T-Cell Lymphoma (CTCL)","status":"COMPLETED","sponsor":"M.D. Anderson Cancer Center","startDate":"2013-02","conditions":"Lymphoma","enrollment":11}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":6,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["AKLIEF","Aklief","AKLIEF®"],"phase":"marketed","status":"active","brandName":"Trifarotene cream","genericName":"Trifarotene cream","companyName":"Galderma R&D","companyId":"galderma-r-d","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Trifarotene is a selective retinoid X receptor (RXR) agonist that modulates gene expression to reduce inflammation and normalize skin cell differentiation in acne. Used for Acne vulgaris.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}