A Case Study of the Effects of Topical Itraconazole on Pharmacodynamic Modulation of Hedgehog Target Gene Expression in Basal Cell Carcinomas in Patients
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Percentage change of GLi levels in treated vs untreated tumors
研究概览
简要总结
This phase 0 trial studies how well itraconazole gel works in treating patients with basal cell cancer. Itraconazole gel may help to treat basal cell tumors in patients.
详细描述
PRIMARY OBJECTIVES:
I. To determine if 12 weeks of topical itraconazole gel reduces basal cell carcinoma (BCC) biomarkers (Gli1, the target gene of the Hedgehog pathway).
SECONDARY OBJECTIVES:
I. To determine if topical itraconazole gel will decrease BCC size.
OUTLINE:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject must sign and date all informed consent statements; children will sign the assent form and their guardian will sign the consent form
- •The subject must be willing to apply the medications twice daily for 1 month
- •The subjects must have at least four BCCs in non-cosmetically sensitive sites
- •For women of child-bearing potential, a negative urine pregnancy test
- •Women of child-bearing potential are expected to use an effective method of birth control to prevent exposing a fetus to potentially dangerous agent with unknown risk
- •For male patients with female partners of childbearing potential, agreement to use adequate contraception while you are participating in the study and 1 month after applying your last dose
排除标准
- •Pregnancy or breast-feeding
- •History of congestive heart failure or other findings of ventricular dysfunction
- •History of current evidence of malabsorption or liver disease
- •Current immunosuppression or taking immunosuppressive drugs
- •Taking oral itraconazole
- •Taking any medication known to affect hedgehog (HH) signaling pathway
- •The subject has used topical or systemic therapies that might interfere with the evaluation of the study medication during the study; specifically these include the topical use to the study tumors of: glucocorticoids (ii) retinoids (e.g., etretinate, isotretinoin, tazarotene, tretinoin, adapalene) systemically or topically (iii) alpha-hydroxy acids (e.g., glycolic acid, lactic acid) to more than 5% of the skin during the six months prior to study entry (iv) 5-fluorouracil or imiquimod; also - treatment with systemic chemotherapy or agents known to be inhibitors of HH signaling within 60 days to starting study medication
研究组 & 干预措施
Treatment (itraconazole and placebo)
Patients apply itraconazole topically BID and placebo topically BID for 12 weeks.
干预措施: Placebo (Other)
Treatment (itraconazole and placebo)
Patients apply itraconazole topically BID and placebo topically BID for 12 weeks.
干预措施: Itraconazole (Drug)
结局指标
主要结局
Percentage change of GLi levels in treated vs untreated tumors
时间窗: Up to 1 month
will be assessed as relative GLi1 mRNA expression
次要结局
- Change in BCC tumor size(At baseline, 1, 4, and 12 weeks)
研究者
Jean Yuh Tang
Associate Professor of Dermatology
Stanford University