NCT03076892已完成不适用
A Phase II Study Evaluating the Non-inferiority and Better Tolerability of the Device PHOS-ISTOS Compared to the Conventional Photodynamic Therapy (PDT)
University Hospital, Lille4 个研究点 分布在 2 个国家目标入组 47 人开始时间: 2016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
- 47
- 试验地点
- 4
- 主要终点
- Treated lesion response rate
研究概览
简要总结
This study aims to compare the efficacy and tolerance of a new photodynamic therapy device (PHOS-ISTOS) with the conventional PDT device (Aktilite®) for the treatment of actinic keratosis of the scalp
详细描述
The study is an intraindividual comparison of two methods. The number of subjects to be enrolled is 47. Patients will receive both treatments in a single visit: A first period of 2.5 hours of illumination with Phos-Istos device followed by a continuous red light spectrum (between 7 and 10 minutes) with Aktilite® after an appropriate incubation of MAL (methyl aminolevulinate). Patients will complete a pain assessment scale after receiving both treatments. 3 follow-up visits will be then 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.
- •No treatment for the AKs in the previous 30 days.
- •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 10 mm 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-electrocoagulation, any PDT treatment) in face / scalp area within the last 30 days.
- •Patients receiving topical treatment (including imiquimod, 5-FU and diclofenac, Picato) in face / scalp area within the last 30 days.in
- •Use of topical retinoids or alpha-hydroxy acids, systemic retinoids, chemotherapy or immunotherapy within 30 days of PDT.
- •Pigmented AK lesion(s).
- •Known allergy to Metvixia/Metvix, 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 or blood analysis 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)
PHOS ISTOS PDT
Experimental
Light Emitting textile device
干预措施: PHOS ISTOS 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
- Visual analog scale of pain(at Day 1 and Day 7)
- Satisfaction autoquestionnaire(at Day 7, Month 3 and Month 6)
- Scale for clinical assessment of the subject's skin aspect(at Month 3 and Month 6)
- Rate of patients with at least 75% of reduction of the lesions(at Month 3 and Month 6)
- Dermatology Life Quality Index (DLQI )(at day 1 , Day 7, Month 3 and Month 6)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
不适用
Evaluating the Device FLEXITHERALIGHT Compared to the Conventional Photodynamic TherapyKeratosis, ActinicNCT03076918University Hospital, Lille29
招募中
1 期
Phase I/II study of photodynamic therapy (PDT) using talaporfin sodium and diode laser for local failure after chemoradiotherapy (CRT) or radiotherapy (RT) for patients with esophageal cancerEsophageal cancerJPRN-UMIN000003970Kyoto University28
招募中
2 期
Phase II study of photodynamic therapy (PDT) for malignant meningiomamalignant/atypical meningiomaJPRN-UMIN000031156Kobe University Hospital35
已完成
不适用
Evaluation of Effectiveness of Photodynamic Therapy with Low-level Diode Laser in Nonsurgical Treatment of Peri-implantitisperi-implantitis or inflamatory condition around dental implant.IRCT2017030932749N2Vice chancellor for research,isfahan University of Medical Sciences40
Unknown
不适用
Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Small Genital WartsGenital WartsNCT03948321Shanghai Dermatology Hospital20