Congenital Melanocytic Nevus
Conditions
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.
Interventions
Topical squaric acid dibutyl ester (SADBE) dissolved in ethanol at 0.2% concentration.
DRUGEthanol Solution
Control
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessors will be blinded on what area received the study cream and what area received the placebo ethanol solution.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | 12 weeks | The frequency of adverse events from each treatment arm will be compared. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinical appearance of nevi | 12 weeks | Treated areas will be compared for pigmentation. |
Contacts
Primary ContactElena B. Hawryluk, MD, PhD
Outcome results
None listed