EUCTR2012-004111-32-DE进行中（未招募）1 期
Prospective, open-label, multicentre study on the incidence of Squamous Cell Carcinoma and Actinic Keratoses in solid organ transplant recipients treated with per protocol, cyclic field application of MAL-PDT versus lesion adapted cryotherapy
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
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 who are able to understand and provide written informed consent to participate in the clinical trial (signed informed consent) according to ICH-GCP
- •Male or nonpregnant, nonlactating female
- •immunosuppressed kidney- (including simultaneous kidney/pancreas-), liver-, lung- and heart-transplanted patients
- •Multiple mild to moderate AK (> 5 AK) distributed over 3 target areas on the face and/or scalp (each 8x18cm2)
- •at least one previous invasive SCC within one of the target areas during the last 12 months before enrolment (Day 1)
- •Patient under stable/unchanged immunosuppressive regimen within the 6 preceding months. For patients under mTOR inhibitors, the previous SCC must have occurred while the patients were receiving a stable mTOR inhibitor therapy for at least 6 months.
- •Negative urine pregnancy test (the detection limit of human Choriongonadotropine (hCG) must be below 25U/ml)
- •Patients willing to comply with the study protocol
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Patient with active invasive SCC in the target areas
- •Active AK grade III (Ohlsen et al.) or evidence of Bowen’s Disease (BD) in at least one target area
- •Known or suspected allergy or hypersensitivity to any of the trial ingredients such as methyl aminolevulinate, glyceryl monostearate, cetostearyl alcohol, poloxyl 40 stearate, methyl parahydroxy benzoate (E218), propyl parahydroxybenzoate (E216), disodium edetate, glycerol, white soft paraffin, cholesterol, isopropyl myristate, arachis oil (peanut oil), almond oil, oleyl alcohol and purified water
- •Patients with a porphyria
- •Patients with a morphoeic basal cell carcinoma within 5cm of any target area
- •Dermatological disease or condition that might be exacerbated by MAL(Metvix®)-PDT or cryotherapy treatment or may impair trial assessments
- •Evidence of unstable or uncontrolled clinically significant medical condition
- •Known or supposed systemic malignant tumor
- •Systemic chemotherapy within the last 1 year prior to randomisation
- •Current or previous (= 6 months) intake of retinoids or any other systemic treatment for AK or interferon-treatment
- •active topical treatment (excluding surgery) against non-melanoma skin cancer (NMSC) in at least one target area within the last 12 weeks prior to enrolment (Day 1)
- •Planned major change in the immunosuppression
- •Patients participating in a clinical trial within the last 4 weeks prior to randomisation
- •Female patients with childbearing potential without adequate contraception (oral contraceptive or intrauterine device during the study period and one month thereafter)
- •Patients who are detained or held under guard by arrangement of the law or authorities
研究者
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