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SADBE for Congenital Melanocytic Nevi

NCT ID: NCT04999631

Last Updated: 2021-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2028-01-01

Brief Summary

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

Detailed Description

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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

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Congenital Melanocytic Nevus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Assessors will be blinded on what area received the study cream and what area received the placebo ethanol solution.

Study Groups

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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.

Group Type EXPERIMENTAL

Squaric Acid Dibutyl Ester

Intervention Type DRUG

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

Control

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

Group Type PLACEBO_COMPARATOR

Ethanol Solution

Intervention Type DRUG

Control

Interventions

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Squaric Acid Dibutyl Ester

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

Intervention Type DRUG

Ethanol Solution

Control

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Elena Hawryluk

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elena B. Hawryluk

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Central Contacts

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Elena B. Hawryluk, MD, PhD

Role: CONTACT

Phone: 617-726-5066

Email: [email protected]

Other Identifiers

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CMN001

Identifier Type: -

Identifier Source: org_study_id