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By blocking this pathway in a topical formulation, it reduces inflammatory responses in dermatological conditions without the systemic immunosuppression associated with oral calcineurin inhibitors.","oneSentence":"LEO 43204 is a topical calcineurin inhibitor that suppresses local immune responses in the skin.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:18:40.937Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Atopic dermatitis"},{"name":"Eczema"}]},"_fixedFields":["pubmed(6)"],"trialDetails":[{"nctId":"NCT02549352","phase":"PHASE3","title":"Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-up","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2015-11","conditions":"Actinic Keratosis","enrollment":391},{"nctId":"NCT03115476","phase":"PHASE3","title":"A Trial to Compare the Incidence of Squamous Cell Carcinoma (SCC) and Other Skin Neoplasia on Skin Areas Treated With Ingenol Disoxate Gel or Vehicle Gel for Actinic Keratosis on Face and Chest or Scalp","status":"TERMINATED","sponsor":"LEO Pharma","startDate":"2017-06-16","conditions":"Actinic Keratosis, Squamous Cell Carcinoma","enrollment":563},{"nctId":"NCT02547363","phase":"PHASE3","title":"Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-up","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2015-11","conditions":"Actinic Keratosis","enrollment":373},{"nctId":"NCT02547233","phase":"PHASE3","title":"Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Face or Chest Including 12-month Follow-up","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2015-11","conditions":"Actinic Keratosis","enrollment":437},{"nctId":"NCT02549339","phase":"PHASE3","title":"Efficacy and Safety of LEO 43204 in the Field Treatment of Actinic Keratosis on Face or Chest including12-month Follow-up","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2015-11-13","conditions":"Actinic Keratosis","enrollment":383},{"nctId":"NCT02600598","phase":"PHASE1","title":"Biological Effects of LEO 43204 in Actinic Keratosis","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2016-07","conditions":"Actinic Keratosis","enrollment":24},{"nctId":"NCT02650505","phase":"PHASE1","title":"A Clinical Study to Evaluate the Sensitizing Potential of LEO 43204 Gel","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2016-02","conditions":"Actinic Keratosis","enrollment":233},{"nctId":"NCT02424305","phase":"PHASE1","title":"Pharmacokinetics of LEO 43204 Gel in Actinic Keratosis Administered Under Maximal Use Conditions","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2015-05","conditions":"Actinic Keratosis","enrollment":60}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":6,"recentPublications":[{"date":"2017 Dec","pmid":"29399263","title":"Three-day Field Treatment with Ingenol Disoxate (LEO 43204) for Actinic Keratosis: A Phase II Trial.","journal":"The Journal of clinical and aesthetic dermatology"},{"date":"2018 Mar","pmid":"29204958","title":"Pharmacokinetics and Safety of Ingenol Disoxate Gel Administered Under Maximum-Use Conditions to Patients With Actinic Keratosis.","journal":"Clinical drug investigation"},{"date":"2017 Nov","pmid":"28264612","title":"A dose-finding trial with a novel ingenol derivative (ingenol disoxate: LEO 43204) for field treatment of actinic keratosis on full face or 250 cm(2) on the chest.","journal":"The Journal of dermatological treatment"},{"date":"2017 Jun","pmid":"28078678","title":"A seamless phase I/II dose-finding trial assessing ingenol disoxate (LEO 43204) for field treatment of actinic keratosis on the scalp.","journal":"The British journal of dermatology"},{"date":"2016 Dec","pmid":"27503482","title":"Ingenol Disoxate: A Novel 4-Isoxazolecarboxylate Ester of Ingenol with Improved Properties for Treatment of Actinic Keratosis and Other Non-Melanoma Skin Cancers.","journal":"Dermatology and therapy"}],"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Ingenol Disoxate"],"phase":"phase_3","status":"active","brandName":"LEO 43204 gel","genericName":"LEO 43204 gel","companyName":"LEO Pharma","companyId":"leo-pharma","modality":"Small molecule","firstApprovalDate":"","aiSummary":"LEO 43204 is a topical calcineurin inhibitor that suppresses local immune responses in the skin. Used for Atopic dermatitis, Eczema.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}