Back to resultsSADBE for Congenital Melanocytic Nevi
Primary Purpose
Congenital Melanocytic Nevus
Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Squaric Acid Dibutyl Ester
Ethanol Solution
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Melanocytic Nevus
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Squaric Acid Dibutyl Ester (SADBE)
Control
Arm Description
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.
Subject will apply an ethanol solution to a specified area of the nevus.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Incidence of Treatment-Emergent Adverse Events
The frequency of adverse events from each treatment arm will be compared.
Full Information
NCT ID
NCT04999631
First Posted
August 2, 2021
Last Updated
October 26, 2021
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04999631
Brief Title
SADBE for Congenital Melanocytic Nevi
Official Title
Neoadjuvant Squaric Acid Dibutylester Treatment of Melanocytes in Congenital Melanocytic Nevi
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2022 (Anticipated)
Primary Completion Date
January 1, 2027 (Anticipated)
Study Completion Date
January 1, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Melanocytic Nevus
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
Assessors will be blinded on what area received the study cream and what area received the placebo ethanol solution.
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Squaric Acid Dibutyl Ester (SADBE)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Subject will apply an ethanol solution to a specified area of the nevus.
Intervention Type
Drug
Intervention Name(s)
Squaric Acid Dibutyl Ester
Intervention Description
Topical squaric acid dibutyl ester (SADBE) dissolved in ethanol at 0.2% concentration.
Intervention Type
Drug
Intervention Name(s)
Ethanol Solution
Intervention Description
Control
Primary Outcome Measure Information:
Title
Number of melanocytes per mm2
Description
The number of melanocytes present in the biopsy specimen will be measured. b. Assessment of pigment within stratum corneum, epidermis, and dermis
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events
Description
The frequency of adverse events from each treatment arm will be compared.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Clinical appearance of nevi
Description
Treated areas will be compared for pigmentation.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elena B. Hawryluk, MD, PhD
Phone
617-726-5066
Email
ehawryluk@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena B. Hawryluk
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
SADBE for Congenital Melanocytic Nevi
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