SADBE for Congenital Melanocytic Nevi

• Status: Not yet recruiting
• Trial end date: 2028-01-01
• Target enrollment: 0
• Participant gender: All

Summary

A study to evaluate the safety and efficacy topical squaric acid dibutylester (SADBE) for the neoadjuvant treatment of congenital melanocytic nevi (CMN).

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Ethanol; Squaric acid dibutyl ester

Criteria

Inclusion Criteria:

• 18 years of age or older.

• Subject or parents willing and able to give informed consent, and assent as appropriate.

• 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.

Exclusion Criteria:

• Immunosuppressive therapy with glucocorticoid or other systemic immunosuppressant within 4 weeks of recruitment (except for inhaled corticosteroids for asthma).

• History of malignancy.

• History of organ transplantation.

• Known immunosuppressive disease, including infection with HIV.

• 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)

• 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.

• Subjects who have known hypersensitivity to SADBE or any of its components.

• Any condition judged by the investigator to cause this clinical trial to be detrimental to the patient.