SADBE for Congenital Melanocytic Nevi
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Squaric Acid Dibutyl Ester, Ethanol Solution.
- Who it may be relevant to
- Registry conditions: Congenital Melanocytic Nevus. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Neoadjuvant Squaric Acid Dibutylester Treatment of Melanocytes in Congenital Melanocytic Nevi
Overview
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
- Drug Squaric Acid Dibutyl Ester
Topical squaric acid dibutyl ester (SADBE) dissolved in ethanol at 0.2% concentration. - Drug Ethanol Solution
Control
Primary outcome measures
- Number of melanocytes per mm2 [Time frame: 12 weeks]
Secondary outcome measures (1)
- Incidence of Treatment-Emergent Adverse Events [Time frame: 12 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT04999631 · CMN001