{"id":"ingenol-mebutate-0-05-gel","safety":{"commonSideEffects":[{"rate":"80-90","effect":"Application site erythema"},{"rate":"50-70","effect":"Application site pain"},{"rate":"40-60","effect":"Application site edema"},{"rate":"30-50","effect":"Application site erosion"},{"rate":"20-40","effect":"Application site exfoliation"},{"rate":"5-10","effect":"Headache"}]},"_chembl":{"chemblId":"CHEMBL1863513","moleculeType":"Small molecule","molecularWeight":"430.54"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Ingenol mebutate is a diterpene ester that binds to and activates protein kinase C (PKC), leading to direct cytotoxic effects on keratinocytes and induction of local inflammation. This dual mechanism—direct cell death combined with immune activation—results in clearance of actinic keratosis lesions. The drug also appears to promote differentiation and apoptosis of abnormal skin cells.","oneSentence":"Ingenol mebutate activates protein kinase C (PKC) to induce rapid necrosis of actinic keratosis cells and promote immune-mediated clearance of damaged skin.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:48:50.132Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Actinic keratosis (field treatment on face or scalp)"}]},"trialDetails":[{"nctId":"NCT01449513","phase":"PHASE1","title":"PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Reflectance Confocal Microscopy","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2011-09","conditions":"Actinic Keratosis","enrollment":24},{"nctId":"NCT01703078","phase":"PHASE1","title":"Safety and Tolerability of Different Concentrations of an Ingenol Derivative Field Therapy in the Treatment of Actinic Keratosis","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2012-11","conditions":"Actinic Keratosis","enrollment":41},{"nctId":"NCT01892137","phase":"PHASE1","title":"Histological Confirmation of Clinical Clearance of Actinic Keratoses Following Treatment With Ingenol Mebutate Gel, 0.05%","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2013-07","conditions":"Actinic Keratosis","enrollment":137},{"nctId":"NCT01387711","phase":"PHASE1","title":"PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Histology","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2011-08","conditions":"Actinic Keratosis","enrollment":27},{"nctId":"NCT01803477","phase":"PHASE1, PHASE2","title":"Safety and Dose Finding Study of New Vehicle Formulations Containing Ingenol Mebutate to Treat Actinic Keratosis on the Forearm","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2013-02","conditions":"Actinic Keratosis","enrollment":37},{"nctId":"NCT01787383","phase":"PHASE3","title":"A Simultaneous Treatment Regimen Compared to a Sequential Treatment Regimen With Ingenol Mebutate Gel 0.015% and 0.05% of Two Areas With Actinic Keratosis on Face/Scalp and Trunk/Extremities","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2013-02","conditions":"Actinic Keratosis","enrollment":200},{"nctId":"NCT03546166","phase":"PHASE2","title":"Study Evaluating the Efficacy and Safety of 0.05% Ingenol Mebutate (Picato® 500) in the Treatment of Basal Cell Carcinoma","status":"COMPLETED","sponsor":"Centre Hospitalier Universitaire de Nice","startDate":"2018-07-26","conditions":"Carcinoma","enrollment":24},{"nctId":"NCT03336372","phase":"EARLY_PHASE1","title":"Picato for the Treatment of Molluscum Contagiosum in Immunocompromised Patients","status":"WITHDRAWN","sponsor":"Center for Clinical Studies, Texas","startDate":"2017-12-20","conditions":"Molluscum Contagiosum","enrollment":""},{"nctId":"NCT02654769","phase":"PHASE3","title":"A Study of Equivalence of Generic Ingenol Mebutate Gel 0.05% and Picato Gel 0.05% in Subjects With Actinic Keratosis","status":"COMPLETED","sponsor":"Actavis Inc.","startDate":"2015-02","conditions":"Actinic Keratosis","enrollment":441},{"nctId":"NCT02421471","phase":"","title":"PMS to Evaluate the Safety and Efficacy of Picato® Gel","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2014-09","conditions":"Actinic Keratosis","enrollment":1324},{"nctId":"NCT03452566","phase":"PHASE1, PHASE2","title":"Evaluation of Ingenol Mebutate for Actinic Cheilitis Treatment","status":"WITHDRAWN","sponsor":"Instituto Nacional de Cancer, Brazil","startDate":"2020-02","conditions":"Actinic Cheilitis","enrollment":""},{"nctId":"NCT02594436","phase":"","title":"The Use of Picato® (Ingenol Mebutate) to Treat Actinic Keratosis in Standard Clinical Practice","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2015-12-01","conditions":"Actinic Keratosis","enrollment":440},{"nctId":"NCT02473848","phase":"PHASE3","title":"Ingenol Mebutate Gel 0.05% in Kidney Transplant Recipients With Actinic Keratoses","status":"TERMINATED","sponsor":"Günther Hofbauer","startDate":"2015-06","conditions":"Actinic Keratosis","enrollment":3},{"nctId":"NCT02716714","phase":"PHASE4","title":"Clinical Trial of Ingenol Mebutate Gel 0.015% & 0.05% in Actinic Keratosis","status":"COMPLETED","sponsor":"Korea University","startDate":"2015-04","conditions":"Actinic Keratosis","enrollment":77},{"nctId":"NCT02748902","phase":"PHASE1","title":"Exploratory Study of Efficacy and Safety of Ingenol Mebutate 0.05% Gel for Common Warts on the Hands.","status":"COMPLETED","sponsor":"Neal D. Bhatia, MD","startDate":"2016-04-27","conditions":"Verruca Vulgaris, Common Warts","enrollment":16},{"nctId":"NCT02251652","phase":"PHASE4","title":"Safety and Efficacy of Ingenol Mebutate 0.05% Gel When Used After Cryotherapy in the Hypertrophic Actinic Keratoses","status":"COMPLETED","sponsor":"Icahn School of Medicine at Mount Sinai","startDate":"2013-04","conditions":"Actinic Keratoses","enrollment":16},{"nctId":"NCT01325688","phase":"PHASE2","title":"PEP005 Gel - Evaluation of the Safety and Efficacy of Ingenol Mebutate Gel on a Superficial Basal Cell Carcinoma on the Trunk or Extremities","status":"COMPLETED","sponsor":"Peplin","startDate":"2011-04","conditions":"Superficial Basal Cell Carcinoma","enrollment":75},{"nctId":"NCT00375739","phase":"PHASE2","title":"Study to Determine the Safety of PEP005 0.025% and 0.05% Topical Gel in Patients With Actinic Keratoses","status":"COMPLETED","sponsor":"Peplin","startDate":"2006-09","conditions":"Actinic Keratosis","enrollment":200},{"nctId":"NCT00546611","phase":"PHASE1","title":"The Purpose of This Study is to Determine Whether Topical Application of PEP005 is Safe for the Treatment of Common Wart(s)","status":"WITHDRAWN","sponsor":"Peplin","startDate":"2007-10","conditions":"Warts","enrollment":""},{"nctId":"NCT01302925","phase":"PHASE1","title":"PEP005 Gel - Evaluation of Local Tolerability After Exposure to Ingenol Mebutate Gel Followed by Hand Washing in Healthy Subjects","status":"COMPLETED","sponsor":"Peplin","startDate":"2011-02","conditions":"Healthy, Actinic Keratosis","enrollment":100},{"nctId":"NCT00659893","phase":"PHASE1","title":"Safety and Toleration of PEP005 Topical Gel When Applied to a Treatment Area of up to 100cm2","status":"COMPLETED","sponsor":"Peplin","startDate":"2008-04","conditions":"Actinic Keratosis","enrollment":64},{"nctId":"NCT00917306","phase":"PHASE3","title":"A Multi-center Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on Non-head Locations (Trunk and Extremities)","status":"COMPLETED","sponsor":"Peplin","startDate":"2009-06","conditions":"Actinic Keratosis","enrollment":102},{"nctId":"NCT00544297","phase":"PHASE2","title":"A Study to Examine the Safety and Toleration of PEP005 Topical Gel in Patients With Actinic Keratoses on the Top of the Hand","status":"COMPLETED","sponsor":"Peplin","startDate":"2007-10","conditions":"Actinic Keratosis","enrollment":12},{"nctId":"NCT00107965","phase":"PHASE2","title":"Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Actinic Keratoses","status":"COMPLETED","sponsor":"Peplin","startDate":"2005-03","conditions":"Actinic Keratosis","enrollment":60},{"nctId":"NCT00742391","phase":"PHASE3","title":"A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations","status":"COMPLETED","sponsor":"Peplin","startDate":"2008-09","conditions":"Actinic Keratoses","enrollment":255},{"nctId":"NCT00942604","phase":"PHASE3","title":"A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations","status":"COMPLETED","sponsor":"Peplin","startDate":"2009-07","conditions":"Actinic Keratoses","enrollment":203},{"nctId":"NCT00852137","phase":"PHASE2","title":"A Study to Evaluate the Pharmacokinetics of PEP005 (Ingenol Mebutate) Gel, 0.05%, When Applied in a Maximal Use Setting to the Dorsal Aspect of the Forearm in Patients With Actinic Keratosis","status":"COMPLETED","sponsor":"Peplin","startDate":"2009-03","conditions":"Actinic Keratosis","enrollment":16},{"nctId":"NCT00544258","phase":"PHASE1","title":"Pharmacokinetic Study to Evaluate the Extent of Systemic Absorption of PEP005","status":"COMPLETED","sponsor":"Peplin","startDate":"2007-10","conditions":"Actinic Keratoses","enrollment":8},{"nctId":"NCT00108121","phase":"PHASE2","title":"Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Nodular Basal Cell Carcinoma","status":"COMPLETED","sponsor":"Peplin","startDate":"2005-03","conditions":"Basal Cell Carcinoma","enrollment":60},{"nctId":"NCT00329121","phase":"PHASE2","title":"Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Cutaneous Squamous Cell Carcinoma In Situ","status":"COMPLETED","sponsor":"Peplin","startDate":"2006-05","conditions":"Carcinoma, Squamous Cell","enrollment":24},{"nctId":"NCT01214564","phase":"PHASE2","title":"Study to Evaluate the Safety and Efficacy of PEP005(Ingenol Mebutate) Gel, 0.05%, in Patients With Seborrhoeic Keratosis","status":"COMPLETED","sponsor":"Peplin","startDate":"2010-10","conditions":"Seborrheic Keratosis","enrollment":24},{"nctId":"NCT00108134","phase":"PHASE2","title":"Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Superficial Basal Cell Carcinoma","status":"COMPLETED","sponsor":"Peplin","startDate":"2005-03","conditions":"Basal Cell Carcinoma","enrollment":60}],"_emaApprovals":[],"_faersSignals":[],"_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":["Picato®","Picato® gel"],"phase":"marketed","status":"active","brandName":"ingenol mebutate 0.05% gel","genericName":"ingenol mebutate 0.05% gel","companyName":"Neal D. 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