Neoadjuvant Squaric Acid Dibutylester Treatment of Melanocytes in Congenital Melanocytic Nevi
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Number of melanocytes per mm2
研究概览
简要总结
A study to evaluate the safety and efficacy topical squaric acid dibutylester (SADBE) for the neoadjuvant treatment of congenital melanocytic nevi (CMN).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessors will be blinded on what area received the study cream and what area received the placebo ethanol solution.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Control
Subject will apply an ethanol solution to a specified area of the nevus.
干预措施: Ethanol Solution (Drug)
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.
干预措施: Squaric Acid Dibutyl Ester (Drug)
结局指标
主要结局
Number of melanocytes per mm2
时间窗: 12 weeks
The number of melanocytes present in the biopsy specimen will be measured. b. Assessment of pigment within stratum corneum, epidermis, and dermis
次要结局
- Incidence of Treatment-Emergent Adverse Events(12 weeks)
研究者
Elena Hawryluk
Principal Investigator
Massachusetts General Hospital