SADBE for Congenital Melanocytic Nevi (NCT04999631) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
SADBE for Congenital Melanocytic Nevi
30 participantsStarted 2022-01-01
Plain-language summary
A study to evaluate the safety and efficacy topical squaric acid dibutylester (SADBE) for the neoadjuvant treatment of congenital melanocytic nevi (CMN).
Who can participate
Age range18 Years
SexALL
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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.