NCT04999631

SADBE for Congenital Melanocytic Nevi

Neoadjuvant Squaric Acid Dibutylester Treatment of Melanocytes in Congenital Melanocytic Nevi

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Patients with CMN and plans for elective surgical resection of their nevi will be enrolled in the study. Two clinically similar areas within the planned excision site will be identified, marked and treated with SADBE or the placebo solution. Following surgical resection, samples from the excised nevi will be taken and assessed for number of melanocytes. Incidence of adverse events will also be collected.

Conditions

• Congenital Melanocytic Nevus

Interventions

Type	Name	Description
DRUG	Squaric Acid Dibutyl Ester	Topical squaric acid dibutyl ester (SADBE) dissolved in ethanol at 0.2% concentration.
DRUG	Ethanol Solution	Control

Timeline

• Start date: 2022-01-01
• Primary completion: 2027-01-01
• Completion: 2028-01-01
• First posted: 2021-08-11
• Last updated: 2021-10-28

Regulatory

• FDA-regulated drug study