{"id":"fluorouracil-calcipotriene","safety":{"commonSideEffects":[{"rate":null,"effect":"Local skin irritation"},{"rate":null,"effect":"Erythema"},{"rate":null,"effect":"Burning/stinging"},{"rate":null,"effect":"Hypercalcemia (with systemic absorption)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This combination pairs fluorouracil, a pyrimidine antimetabolite that blocks nucleotide synthesis and induces apoptosis in rapidly dividing cells, with calcipotriene, a vitamin D analog that enhances differentiation and has immunomodulatory properties. When combined topically, they work synergistically to target skin cancers by both direct cytotoxic and differentiation-promoting mechanisms.","oneSentence":"Fluorouracil inhibits thymidylate synthase to disrupt DNA synthesis, while calcipotriene promotes keratinocyte differentiation and immune modulation for topical anticancer effect.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:13:00.135Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Actinic keratosis"},{"name":"Non-melanoma skin cancer (investigational)"}]},"trialDetails":[{"nctId":"NCT07352566","phase":"PHASE4","title":"Utilization of a Microdevice for Psoriasis and Atopic Dermatitis","status":"NOT_YET_RECRUITING","sponsor":"University of California, San Francisco","startDate":"2026-01-01","conditions":"Psoriasis, Atopic Dermatitis","enrollment":10},{"nctId":"NCT06737406","phase":"NA","title":"Topical 5-Fluorouracil (5FU) Plus Calcipotriol in Children With Palmoplantar Wart","status":"RECRUITING","sponsor":"Mazandaran University of Medical Sciences","startDate":"2025-05-30","conditions":"Common Warts","enrollment":60},{"nctId":"NCT05381597","phase":"PHASE2, PHASE3","title":"5-Fluorouracil and Calcipotriene for Treatment of Low Grade Skin Cancer","status":"RECRUITING","sponsor":"Boston University","startDate":"2022-10-15","conditions":"Superficial Basal Cell Carcinoma, Squamous Cell Carcinoma in Situ","enrollment":200},{"nctId":"NCT06851507","phase":"PHASE3","title":"A Pilot Clinical Trial Comparing Topical Fluorouracil to Fluorouracil Plus Calcipotriene Field Treatments in Patients With Multiple Actinic Keratoses","status":"RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2025-10-06","conditions":"Multiple Actinic Keratoses","enrollment":30},{"nctId":"NCT05699603","phase":"PHASE2","title":"Testing the Efficacy of Topical Calcipotriene Plus 5-Fluorouracil Combination to Activate the Immune System Against Precancerous Skin Lesions in Organ Transplant Recipients","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Arizona","startDate":"2024-07-02","conditions":"Actinic Keratosis","enrollment":56},{"nctId":"NCT03370406","phase":"PHASE1","title":"Intralesional 5-Fluorouracil (5FU), Topical Calcipotriene Treatment for SCC","status":"RECRUITING","sponsor":"Melissa Pugliano-Mauro","startDate":"2018-08-03","conditions":"Carcinoma, Squamous Cell","enrollment":30},{"nctId":"NCT06499415","phase":"PHASE4","title":"Combination Therapy of 5-Fluorouracil and CALcipotriol Versus 5-Fluorouracil in the Treatment of Actinic Keratosis","status":"RECRUITING","sponsor":"Maastricht University Medical Center","startDate":"2024-09-04","conditions":"Actinic Keratoses","enrollment":232},{"nctId":"NCT04329221","phase":"PHASE2","title":"Immunotherapy Before Transplantation for Skin Cancer Prevention in Organ Transplant Recipients","status":"WITHDRAWN","sponsor":"Massachusetts General Hospital","startDate":"2026-01-01","conditions":"Cutaneous Squamous Cell Carcinoma, Actinic Keratoses, Skin Cancer","enrollment":""},{"nctId":"NCT04642287","phase":"PHASE2","title":"Immunotherapy After Transplantation for Skin Cancer Prevention in Organ Transplant Recipients","status":"WITHDRAWN","sponsor":"Massachusetts General Hospital","startDate":"2026-01","conditions":"Immunotherapy, Cutaneous Squamous Cell Carcinoma, Actinic Keratoses","enrollment":""},{"nctId":"NCT06685588","phase":"NA","title":"Efficacy of Topical 5-Fluorouracil Vs Calcipotriol As Photodynamic Therapy Pre-treatment for Field Actinic Keratoses","status":"NOT_YET_RECRUITING","sponsor":"St Vincent's University Hospital, Ireland","startDate":"2025-01","conditions":"Actinic Keratosis of Face and Scalp, Actinic Keratoses","enrollment":50},{"nctId":"NCT04839731","phase":"EARLY_PHASE1","title":"Combination 5-FU / Calcipotriene Cream for SCCIS/SCC","status":"UNKNOWN","sponsor":"Carilion Clinic","startDate":"2021-04-14","conditions":"Squamous Cell Carcinoma","enrollment":30},{"nctId":"NCT03996252","phase":"EARLY_PHASE1","title":"Combination Topical Therapy for Treatment of Scalp Actinic Keratoses","status":"TERMINATED","sponsor":"Tulane University","startDate":"2019-07-01","conditions":"Actinic Keratoses","enrollment":15},{"nctId":"NCT02019355","phase":"EARLY_PHASE1","title":"Actinic Keratosis Study","status":"COMPLETED","sponsor":"Washington University School of Medicine","startDate":"2013-10","conditions":"Actinic Keratosis","enrollment":132}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":11,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Fluorouracil/Calcipotriene","genericName":"Fluorouracil/Calcipotriene","companyName":"M.D. Anderson Cancer Center","companyId":"m-d-anderson-cancer-center","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Fluorouracil inhibits thymidylate synthase to disrupt DNA synthesis, while calcipotriene promotes keratinocyte differentiation and immune modulation for topical anticancer effect. Used for Actinic keratosis, Non-melanoma skin cancer (investigational).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}