NCT03076918已完成不适用
A Phase II Study Evaluating the Non-inferiority of the Device FLEXITHERALIGHT Compared to the Conventional Photodynamic Therapy (PDT)
University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2014年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Treated lesion response rate
研究概览
简要总结
This study compares the efficacy and tolerance of a new device (FLEXITHERALIGHT) for photodynamic therapy in the treatment of keratosis actinic in comparison of classical PDT with Aktilite®.
详细描述
The study is an intraindividual comparison of two methods. The number of subjects to be enrolled is 47 patients. All participants will receive both two treatments in a single visit : a first period of 2.5 hours of illumination with FLEXITHERALIGHT device followed by a continuous red light Spectrum (between 7 and 10 minutes) with Aktilite® after an appropriate incubation of methyl aminolevulinate).
Patients will complete a pain assessment scale after receiving both treatments, then, 3 follow up visits will be scheduled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •Clinical diagnosis of minimum 10 previously untreated not pigmented, non-hyperkeratotic AK lesions of Grade I and II of the forehead and/or scalp (according to Olsen et Al. JAAD 1991, cf. REF 31) where other therapies are unacceptable or considered medically less appropriate with a symmetrical repartition on both side of the forehead and/or scalp. The diagnosis of AK will be determined upon clinical evaluation (i.e. visual inspection and palpation) by the investigator.
- •Symmetrical areas in terms of number and severity of lesions. The axis of symmetry between the two areas will be defined by the investigator according to the distribution of lesions.
- •The two areas to be treated should not be coalescing. A minimum distance of 10mm is required between the lesions located on the 2 symmetrical areas. A minimum distance of 2 mm is required between the lesions on the same side.
- •Minimum 5 lesions with similar dimensions at both symmetrical areas will be treated. If the number of lesions is >7, only 7 lesions on each side will be considered.
排除标准
- •Patients with porphyria.
- •Patients immunosuppressed for idiopathic, disease specific or therapeutic reasons.
- •Use of topical corticosteroids to lesional areas within 2 weeks before PDT.
- •Patients receiving local treatment (including cryotherapy and curettage, any - Patients receiving topical treatment (including imiquimod, 5-FU and diclofenac, Picato) in face / scalp area within the last 3 months.
- •Use of topical retinoids or alpha-hydroxy acids, urea or systemic retinoids, chemotherapy or immunotherapy within 4 weeks of PDT.
- •Pigmented AK lesion(s).
- •Known allergy to Metvixia, a similar PDT compound or excipients of the cream including arachis oil, or to peanut or soya.
- •Participation in other clinical studies either currently or within the last 30 days.
- •Female subjects must be of either:
- •Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or, Childbearing potential, provided there is a confirmed negative urine pregnancy test prior to study treatment, to rule out pregnancy.
- •Any condition which may be associated with a risk of poor protocol compliance.
- •Patients currently receiving regular ultraviolet radiation therapy
研究组 & 干预措施
Conventional PDT
Active Comparator
Aktilite® Galderma
干预措施: Aktilite® Galderma (Device)
FLEXITHERALIGHT PDT
Experimental
Light Emitting Textile Device
干预措施: FLEXITHERALIGHT PDT (Device)
结局指标
主要结局
Treated lesion response rate
时间窗: up to month 6
Each treatment area will be counted, graded with Clinical grade of AK, mapped and photographed
次要结局
- Fluorescence measure of the PpIX(Baseline, after 3 hours of incubation, in case of treatment interruption, immediately after the treatment, and at 15 and 30 minutes after the end of the treatment.)
- Rate of patients with at least 75% of reduction of the lesions(Months 3 and Months 6)
- Visual Analog scale of pain(Day 1 and D ay 7.)
- Dermatology Life Quality Index (DLQI)(At Day 7, Months 3 and Months 6)
- Scale for clinical assessment of the subject's skin aspect(Months 3 and Months 6)
- Irradiance measure in mW/cm2 for each AK(during Aktilite® treatment at Day 1)
- Satisfaction Questionnaire(At Day 7, Months 3 and Months 6)
研究者
研究点 (1)
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