[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100439233":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":26,"responsibleParty":40,"collaborators":26,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":26,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":26,"enrollmentInfo":52,"targetDuration":26,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":26,"overallStatus":61,"whyStopped":26,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":26},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Squaric Acid Dibutyl Ester (SADBE)","EXPERIMENTAL","Following sensitization, subjects will apply 0.2% SADBE in ethanol to a predetermined area of their nevus 3 times per week for 12 weeks, with adjustment of frequency depending on response.",[13],"Drug: Squaric Acid Dibutyl Ester",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","PLACEBO_COMPARATOR","Subject will apply an ethanol solution to a specified area of the nevus.",[19],"Drug: Ethanol Solution",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Squaric Acid Dibutyl Ester","Topical squaric acid dibutyl ester (SADBE) dissolved in ethanol at 0.2% concentration.",[9],null,{"type":22,"name":28,"description":15,"armGroupLabels":29,"otherNames":26},"Ethanol Solution",[15],[31],{"name":32,"affiliation":5,"role":33},"Elena B. Hawryluk","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":26,"email":39},"Elena B. Hawryluk, MD, PhD","CONTACT","617-726-5066","ehawryluk@partners.org",{"type":33,"investigatorFullName":41,"investigatorTitle":42,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Elena Hawryluk","Principal Investigator","100439233","early-phase-1-sadbe-for-congenital-melanocytic-nevi-100439233",false,"NCT04999631","SADBE for Congenital Melanocytic Nevi","Neoadjuvant Squaric Acid Dibutylester Treatment of Melanocytes in Congenital Melanocytic Nevi","Inclusion Criteria:\n\n* 18 years of age or older.\n* Subject or parents willing and able to give informed consent, and assent as appropriate.\n* Patients who have a clinical diagnosis of CMN with plans for elective non-urgent excision of part or all of their nevus, with nevus surface area of \\> 6 cm2.\n\nExclusion Criteria:\n\n* Immunosuppressive therapy with glucocorticoid or other systemic immunosuppressant within 4 weeks of recruitment (except for inhaled corticosteroids for asthma).\n* History of malignancy.\n* History of organ transplantation.\n* Known immunosuppressive disease, including infection with HIV.\n* Severe medical comorbidities (diabetes mellitus requiring insulin, CHF of any severity, MI, CVA, or TIA within 3 months of screening visit, unstable angina pectoris, oxygen-dependent severe pulmonary disease)\n* Subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit.\n* Subjects who have known hypersensitivity to SADBE or any of its components.\n* Any condition judged by the investigator to cause this clinical trial to be detrimental to the patient.","ALL","18 Years",{"count":53,"type":54},30,"ESTIMATED","INTERVENTIONAL",[57],"EARLY_PHASE1","A study to evaluate the safety and efficacy topical squaric acid dibutylester (SADBE) for the neoadjuvant treatment of congenital melanocytic nevi (CMN).",[60],"Congenital Melanocytic Nevus","NOT_YET_RECRUITING","2026-05-19",{"date":64,"type":65},"2026-05-22","ACTUAL",{"date":67,"type":54},"2027-01-01",{"date":69,"type":54},"2030-06-01",{"name":5,"class":6}]