SADBE for Congenital Melanocytic Nevi

Early Phase 1

Not yet recruiting

• Conditions: Congenital Melanocytic Nevus
• Interventions: Drug: Ethanol Solution; Drug: Squaric Acid Dibutyl Ester

• Registration Number: NCT04999631
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2021-08-02
• Study First Submitted QC: 2021-08-02
• Study First Posted: 2021-08-11
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-26
• Last Update Posted: 2021-10-28
• Study Start: 2022-01-01
• Primary Completion: 2027-01-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Ethanol Solution	Subject will apply an ethanol solution to a specified area of the nevus.
Squaric Acid Dibutyl Ester (SADBE)	Squaric Acid Dibutyl Ester	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	12 weeks	The frequency of adverse events from each treatment arm will be compared.