SADBE for Congenital Melanocytic Nevi

Neoadjuvant Squaric Acid Dibutylester Treatment of Melanocytes in Congenital Melanocytic Nevi

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

Study Overview

• Status: Not yet recruiting
• Conditions: Congenital Melanocytic Nevus
• Intervention / Treatment: Drug: Squaric Acid Dibutyl Ester; Drug: Ethanol Solution

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Elena B. Hawryluk, MD, PhD; Phone Number: 617-726-5066; Email: ehawryluk@partners.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Squaric Acid Dibutyl Ester (SADBE); Following sensitization, subjects will apply 0.2% SADBE in ethanol to a predetermined area of their nevus 3 times per week for 12 weeks, with adjustment of frequency depending on response.	Drug: Squaric Acid Dibutyl Ester; Topical squaric acid dibutyl ester (SADBE) dissolved in ethanol at 0.2% concentration.
Placebo Comparator: Control; Subject will apply an ethanol solution to a specified area of the nevus.	Drug: Ethanol Solution; Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of melanocytes per mm2	The number of melanocytes present in the biopsy specimen will be measured. b. Assessment of pigment within stratum corneum, epidermis, and dermis	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events	The frequency of adverse events from each treatment arm will be compared.	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical appearance of nevi	Treated areas will be compared for pigmentation.	12 weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Elena B. Hawryluk, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): January 1, 2027
• Study Completion (Anticipated): January 1, 2028

Study Registration Dates

• First Submitted: August 2, 2021
• First Submitted That Met QC Criteria: August 2, 2021
• First Posted (Actual): August 11, 2021

Study Record Updates

• Last Update Posted (Actual): October 28, 2021
• Last Update Submitted That Met QC Criteria: October 26, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Nevi and Melanomas; Nevus, Spindle Cell; Nevus; Nevus, Pigmented; Nevus, Epithelioid and Spindle Cell; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Immunologic Factors; Adjuvants, Immunologic; Ethanol; Squaric acid dibutyl ester
• Other Study ID Numbers: CMN001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No