{"id":"epiceram","_chembl":null,"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=EpiCeram","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T06:36:54.725099+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T06:37:00.582223+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=EpiCeram","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T06:37:00.789918+00:00"}},"_dailymed":null,"_scrapedAt":"2026-03-27T23:32:39.653Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T06:37:03.198886+00:00","fieldsConflicting":0,"overallConfidence":0.95},"trialDetails":[{"nctId":"NCT03742414","phase":"PHASE2","title":"Seal, Stopping Eczema and Allergy Study","status":"ACTIVE_NOT_RECRUITING","sponsor":"Kari Nadeau, MD, PhD","startDate":"2021-06-30","conditions":"Eczema, Infantile, Eczema, Atopic Dermatitis Eczema","enrollment":398},{"nctId":"NCT02577120","phase":"PHASE1, PHASE2","title":"Wound Healing Endpoint and Recurrence","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sashwati Roy","startDate":"2019-01-08","conditions":"Chronic Wound, Burn Wound, Diabetic Foot Ulcers","enrollment":100},{"nctId":"NCT05137132","phase":"NA","title":"Unrefined Salmon Oil as Dietary Supplement in Adult Asthmatics","status":"COMPLETED","sponsor":"Hofseth Biocare ASA","startDate":"2022-04-01","conditions":"Asthma","enrollment":70},{"nctId":"NCT05130294","phase":"NA","title":"Unrefined Salmon Oil as Dietary Supplement in Patient With Chronic Obstructive Pulmonary Disease","status":"WITHDRAWN","sponsor":"Hofseth Biocare ASA","startDate":"2025-07","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":""},{"nctId":"NCT05794243","phase":"PHASE1","title":"A Multiple-Dose Study of LY3493269 in Healthy Participants","status":"TERMINATED","sponsor":"Eli Lilly and Company","startDate":"2023-03-23","conditions":"Healthy","enrollment":42},{"nctId":"NCT04793711","phase":"NA","title":"EpiCeram for Skin Protection in Healthcare Workers","status":"TERMINATED","sponsor":"Primus Pharmaceuticals","startDate":"2021-03-15","conditions":"Irritant Contact Dermatitis","enrollment":1},{"nctId":"NCT03667651","phase":"PHASE3","title":"The PEBBLES Study - Testing a Strategy for Preventing Eczema and Food Allergy in High Risk Infants","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Melbourne","startDate":"2018-03-06","conditions":"Eczema, Asthma, Allergy;Food","enrollment":760},{"nctId":"NCT03663673","phase":"PHASE1","title":"Effect of Different Skin Creams on TEWL","status":"COMPLETED","sponsor":"Stanford University","startDate":"2018-09-01","conditions":"Dermatitis, Atopic","enrollment":17},{"nctId":"NCT03359577","phase":"NA","title":"Clinical Study to Investigate Psorax35 Supplementation in Patients With Psoriasis","status":"COMPLETED","sponsor":"Arctic Nutrition AS","startDate":"2017-11-21","conditions":"Psoriasis Vulgaris","enrollment":64},{"nctId":"NCT02883751","phase":"NA","title":"Phototherapy in DM Amputation Ulcers.","status":"WITHDRAWN","sponsor":"University of Nove de Julho","startDate":"2017-01","conditions":"Diabetes Mellitus, Amputation Stumps, Diabetic Foot","enrollment":""},{"nctId":"NCT01093469","phase":"PHASE4","title":"Comparing Aquaphor to Atopiclair and EpiCeram in Children With Mild to Moderate Atopic Dermatitis","status":"COMPLETED","sponsor":"Wake Forest University Health Sciences","startDate":"2009-09","conditions":"Atopic Dermatitis","enrollment":39},{"nctId":"NCT02578953","phase":"PHASE1","title":"Bioequivalence Study of Dutasteride Capsules in Healthy Japanese Male Subjects","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2015-09-09","conditions":"Prostatic Hyperplasia","enrollment":36},{"nctId":"NCT03255889","phase":"PHASE1","title":"Absorption and Tolerability Studies of an Emulsion Containing the Coconut Oil-derived Glycerol Tridecanoate in Healthy Men","status":"WITHDRAWN","sponsor":"National University Hospital, Singapore","startDate":"2017-08-28","conditions":"Polycystic Ovary Syndrome","enrollment":""},{"nctId":"NCT02800538","phase":"NA","title":"The Effects of Intragastric Administration of Nutrients on Executive Control in Healthy Subjects.","status":"COMPLETED","sponsor":"Universitaire Ziekenhuizen KU Leuven","startDate":"2015-05-25","conditions":"Healthy Volunteers","enrollment":26},{"nctId":"NCT02404493","phase":"NA","title":"Test to Determine the Effectiveness of Moisturizing Balm Used on Babies With Dry, Itchy Skin","status":"TERMINATED","sponsor":"Johnson & Johnson Consumer Inc. (J&JCI)","startDate":"2015-03","conditions":"Eczema","enrollment":23},{"nctId":"NCT02691507","phase":"PHASE2","title":"Trial to Determine the Therapeutic Benefit of an OTC Cream on Dry, Itchy Skin of Adults and Children With Eczema","status":"COMPLETED","sponsor":"Johnson & Johnson Consumer Inc. (J&JCI)","startDate":"2016-02","conditions":"Atopic Dermatitis","enrollment":53},{"nctId":"NCT00828412","phase":"PHASE4","title":"Comparison of the Efficacy and Safety of Two Topical Creams for Pediatric Atopic Dermatitis","status":"COMPLETED","sponsor":"Promius Pharma, LLC","startDate":"2009-03","conditions":"Atopic Dermatitis","enrollment":100},{"nctId":"NCT02120833","phase":"PHASE3","title":"A Test to Determine the Usefulness and Safety of a Cream Used on Babies With Dry Itchy Skin","status":"COMPLETED","sponsor":"Johnson & Johnson Consumer and Personal Products Worldwide","startDate":"2014-03","conditions":"Eczema","enrollment":51},{"nctId":"NCT00592072","phase":"NA","title":"Effect of Medium Chain Fatty Acids on Cognitive Function During Acute Hypoglycemia in Patients With Type 1 Diabetes","status":"COMPLETED","sponsor":"Yale University","startDate":"2005-07","conditions":"Diabetes Mellitus, Type 1","enrollment":12},{"nctId":"NCT01326910","phase":"NA","title":"Human Testing of an Over-the-Counter (OTC) Cream in Children With Eczema","status":"COMPLETED","sponsor":"Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.","startDate":"2011-03","conditions":"Atopic Dermatitis","enrollment":90},{"nctId":"NCT00616538","phase":"PHASE4","title":"Epiceram™ Device Versus Mid-Strength Topical Steroid (Fluticasone Propionate 0.05%) for Treatment of Atopic Dermatitis","status":"COMPLETED","sponsor":"Ceragenix Pharmaceuticals","startDate":"2006-12","conditions":"Atopic Dermatitis","enrollment":121},{"nctId":"NCT00460083","phase":"PHASE4","title":"Epiceram Versus Elidel for Treatment of Mild to Moderate Atopic Dermatitis","status":"COMPLETED","sponsor":"Ceragenix Pharmaceuticals","startDate":"2007-04","conditions":"Atopic Dermatitis","enrollment":35}],"_emaApprovals":[],"_faersSignals":[{"count":5,"reaction":"NAUSEA"},{"count":5,"reaction":"PRURITUS"},{"count":5,"reaction":"RASH"},{"count":4,"reaction":"CONDITION AGGRAVATED"},{"count":4,"reaction":"PRODUCT USE IN UNAPPROVED INDICATION"},{"count":3,"reaction":"DRUG INEFFECTIVE"},{"count":3,"reaction":"DRY EYE"},{"count":3,"reaction":"DYSPNOEA"},{"count":3,"reaction":"ECZEMA"},{"count":3,"reaction":"HEADACHE"}],"_approvalHistory":[],"publicationCount":8,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["BRC-Cer"],"phase":"marketed","status":"active","brandName":"EpiCeram","genericName":"EpiCeram","companyName":"Wake Forest University Health Sciences","companyId":"wake-forest-university-health-sciences","modality":"Small molecule","firstApprovalDate":"","aiSummary":"","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":3,"withResults":1},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T06:37:03.198886+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"enriching","dataCompleteness":{"mechanism":false,"indications":false,"safety":false,"trials":true,"score":1}}