SADBE for Congenital Melanocytic Nevi

NCT04999631 | Not Yet Recruiting Early Phase 1 FDA Drug

• 1 other identifier: CMN001
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Congenital Melanocytic Nevus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  12 weeks

Other Outcomes (1)

• Clinical appearance of nevi

  12 weeks

Study Arms (2)

Squaric Acid Dibutyl Ester (SADBE)

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

Subject will apply an ethanol solution to a specified area of the nevus.

Drug: Ethanol Solution

Interventions

Squaric Acid Dibutyl Ester DRUG

Topical squaric acid dibutyl ester (SADBE) dissolved in ethanol at 0.2% concentration.

Squaric Acid Dibutyl Ester (SADBE)

Ethanol Solution DRUG

Control

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

MeSH Terms

Interventions

squaric acid dibutyl ester

Study Officials

• Elena B. Hawryluk

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena B. Hawryluk, MD, PhD

CONTACT

617-726-5066; ehawryluk@partners.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors will be blinded on what area received the study cream and what area received the placebo ethanol solution.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two areas of the subject's nevus will be marked. Study medication will be applied to one area. Placebo ethanol solution will be applied to the other area. Area to be treated will be randomized among subjects. Both areas will be monitored and following surgery, samples will be obtained. Area to be treated vs area that will serve as control will be randomized.

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 11, 2021
• Study Start: January 1, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: October 28, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share