{"id":"azelaic-acid-foam","safety":{"commonSideEffects":[{"rate":null,"effect":"Pruritus"},{"rate":null,"effect":"Erythema"},{"rate":null,"effect":"Burning sensation"},{"rate":null,"effect":"Scaling"}]},"_chembl":{"chemblId":"CHEMBL1238","moleculeType":"Small molecule","molecularWeight":"188.22"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Azelaic acid is a dicarboxylic acid that exerts antimicrobial and anti-inflammatory effects on the skin. It inhibits the growth of Cutibacterium acnes and Staphylococcus epidermidis, while also reducing the production of inflammatory mediators and reactive oxygen species. The foam formulation enhances skin penetration and tolerability compared to other delivery forms.","oneSentence":"Azelaic acid reduces inflammation and bacterial growth in the skin by inhibiting mitochondrial enzymes and reducing reactive oxygen species production.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:03:10.710Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Rosacea"},{"name":"Acne vulgaris"},{"name":"Post-inflammatory hyperpigmentation"}]},"trialDetails":[{"nctId":"NCT01257919","phase":"PHASE1","title":"Safety and Pharmacokinetics of Azelaic Acid Foam, 15% in Papulopustular Rosacea","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2011-01","conditions":"Papulopustular Rosacea","enrollment":21},{"nctId":"NCT01555463","phase":"PHASE3","title":"Safety and Efficacy of Azelaic Acid Foam, 15 % in Papulopustular Rosacea","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2012-09","conditions":"Papulopustular Rosacea","enrollment":961},{"nctId":"NCT02800148","phase":"PHASE3","title":"Bioequivalence Study of Two Treatments in the Treatment of Inflammatory Lesions of Rosacea on the Face","status":"COMPLETED","sponsor":"Padagis LLC","startDate":"2016-11","conditions":"Rosacea","enrollment":667},{"nctId":"NCT00617903","phase":"PHASE2","title":"Exploration of Safety and Efficacy of AzA 15% Foam Twice a Day in Rosacea","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2008-01","conditions":"Papulopustular Rosacea","enrollment":83},{"nctId":"NCT03193372","phase":"","title":"A Study of Patient Concerns and Treatment Satisfaction in Patients Being Treated With Finacea Foam for Rosacea","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2017-07-20","conditions":"Rosacea","enrollment":2200},{"nctId":"NCT01430312","phase":"PHASE1","title":"21 Day Irritancy Test of Azelaic Acid Pre-foam Formulation","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2011-09","conditions":"Healthy","enrollment":40},{"nctId":"NCT01430533","phase":"PHASE1","title":"Human Repeated Insult Patch Test (HRIPT) of Azelaic Acid Pre Foam Formulation","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2011-09","conditions":"Healthy","enrollment":240},{"nctId":"NCT01025635","phase":"PHASE2","title":"Safety and Efficacy of Azelaic Acid Foam, 15% in Papulopustular Rosacea","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2009-12","conditions":"Papulopustular Rosacea","enrollment":401},{"nctId":"NCT03287791","phase":"PHASE3","title":"A Study to Evaluate Safety and Equivalence of Generic Azelaic Acid Foam and Finacea® Foam in Participants With Rosacea","status":"COMPLETED","sponsor":"Actavis Inc.","startDate":"2016-07-19","conditions":"Rosacea","enrollment":924},{"nctId":"NCT03418610","phase":"PHASE4","title":"Azelaic Acid Foam 15% in the Treatment of Papulopustular Rosacea","status":"COMPLETED","sponsor":"Clinical Research Center of the Carolinas","startDate":"2017-12-06","conditions":"Rosacea, Papulopustular","enrollment":5},{"nctId":"NCT03689010","phase":"PHASE1","title":"To Evaluate the Therapeutic Equivalence and Safety in Treatment of Moderate Facial Rosacea","status":"COMPLETED","sponsor":"Sun Pharmaceutical Industries, Inc.","startDate":"2017-12-12","conditions":"Rosacea","enrollment":1116}],"_emaApprovals":[],"_faersSignals":[{"count":1,"reaction":"CEREBROVASCULAR ACCIDENT"},{"count":1,"reaction":"DRUG INEFFECTIVE"},{"count":1,"reaction":"DYSGEUSIA"},{"count":1,"reaction":"MYOCARDIAL INFARCTION"},{"count":1,"reaction":"ROSACEA"}],"_approvalHistory":[],"publicationCount":12,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Finacea Foam"],"phase":"phase_3","status":"active","brandName":"Azelaic acid foam","genericName":"Azelaic acid foam","companyName":"Padagis LLC","companyId":"padagis-llc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Azelaic acid reduces inflammation and bacterial growth in the skin by inhibiting mitochondrial enzymes and reducing reactive oxygen species production. Used for Rosacea, Acne vulgaris, Post-inflammatory hyperpigmentation.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}