SADBE for Congenital Melanocytic Nevi

Starting soon · Early Phase 1 · Has a placebo group

Conditions studied: Congenital Melanocytic Nevus

In brief

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

Key facts

Study ID

NCT04999631

Run by

Massachusetts General Hospital

People needed

30

Starts

2027-01-01

Expected to finish

2030-06-01

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.