A Pilot Study Investigating Antitumorigenic Potential of Topical Itraconazole in the Treatment of Basal Cell Carcinoma
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Downregulation in glucagon-like immunoreactivity (GLI) expression
研究概览
简要总结
This research is being done to study the molecular effects of topically applied itraconazole ointment on the growth of basal cell carcinomas.
详细描述
Basal cell carcinoma is the most common type of skin cancer in Caucasians worldwide. Although rarely metastatic, it can be locally destructive causing disfigurement and pain. Current therapies include surgical removal, local destruction, radiotherapy and others.
Advances in understanding the molecular basis behind BCCs indicate that mutations in the hedgehog signaling pathway can lead to the development of many sporadically occurring basal cell carcinomas (BCCs). An oral drug that targets the hedgehog signaling pathway has been shown to be effective in treating patients with metastatic and inoperable BCCs. There is evidence that itraconazole, a commonly prescribed antifungal medication may also affect this pathway. It is not known whether itraconazole ointment applied topically can affect the growth of BCCs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be over the age of 18 years
- •Women who do not have child-bearing potential (history of hysterectomy, post-menopausal)
- •Have a biopsy confirmed BCC that measures at least 6mm in size at the time of the initial evaluation (visit #1);
- •Participant must be willing and comply with the requirements of the protocol;
- •Participant must have the ability to understand and communicate with the investigator;
- •Participant must provide informed consent.
排除标准
- •Subject with significant congestive heart failure (CHF) or history of CHF, chronic renal failure, hepatic failure, neuropathy
- •Subject with current skin diseases that the investigator feels is not safe for study participation including but not limited to severe atopic dermatitis, cutaneous T-cell lymphoma, erythroderma;
- •Subjects on systemic medications known to affect the Hedgehog pathway (see Appendix I)
- •Subjects on cisapride, oral midazolam, nisoldipine, felodipine, pimozide, quinidine, dofetilide, triazolam, methadone, levacetylmethadol (levomethadyl), lovastatin, simvastatin, dihydroergotamine, ergometrine (ergonovine), ergotamine and methylergometrine (methylergonovine), cisapride, pimozide, methadone, levacetylmethadol (levomethadyl), quinidine
- •Subjects with history of hypersensitivity to azoles
- •Subjects with Gorlin syndrome
- •Subjects on chronic immunosuppression, or who have a history of compromised immune function (e.g. history of or current malignancy other than BCC/squamous cell skin cancers)
- •Subjects who do not speak English or have difficulty hearing or are otherwise impaired for providing informed consent and communicating with the investigator;
- •Subjects with a history of keloids or excessive scarring;
- •Subjects with known allergy to lidocaine, epinephrine, itraconazole or petrolatum
- •Women of child-bearing age/potential and/or able to conceive
研究组 & 干预措施
Itraconazole ointment
Patients with histologically proven BCC will be eligible for study enrollment. 50% itraconazole compounded in petrolatum jelly will be applied under occlusion for up to 3 to 7 days.
干预措施: Itraconazole (Drug)
结局指标
主要结局
Downregulation in glucagon-like immunoreactivity (GLI) expression
时间窗: Day 8
We will report the proportion of patients by treatment cohort and overall that had a significant downregulation in GLI.
次要结局
- Incidence, timing, and severity of treatment adverse events(45 days)