EUCTR2019-002545-38-DK进行中（未招募）1 期
Biodistribution of ablative fractional laser-assisted topical delivery of Vismodegib in basal cell carcinomas.
Bispebjerg Hospital, Department of Dermatology0 个研究点目标入组 34 人开始时间: 2019年6月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 34
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients above 18 years of age
- •Clinically and histologically verified nodular BCC with diameter =8 mm at baseline.
- •Signed informed consent.
- •Female subjects of childbearing potential1 must be confirmed not pregnant by a negative pregnancy test prior to study treatment and must use a safe contraceptive method for 24 months after study participation.
- •Patients with multiple BCC or locally advanced BCC in continuous oral vismodegib treatment (150 mg per day) for at least 14 days.
- •Male subjects with female partners of childbearing potential must use condom until 2 months after study participation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •Concomittant treatment with itraconazole, ketoconazole or imiquimod.
- •Concomittant chemotherapeutic treatment.
- •Infiltrative BCC or basosquamous carcinoma.
- •Pregnant or lactating women.
- •Allergies to vismodegib.
- •Patients with a tendency to form keloids.
- •Other skin diseases or tattoos in the treatment area.
研究者
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