SADBE for Congenital Melanocytic Nevi
ConditionCongenital Melanocytic Nevus
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
A study to evaluate the safety and efficacy topical squaric acid dibutylester (SADBE) for the neoadjuvant treatment of congenital melanocytic nevi (CMN).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Squaric Acid Dibutyl Ester
- Ethanol Solution
Treatment groups
30 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov