CTRI/2025/07/090024招募中不适用
A comparative randomized pilot study for the evaluation of two cosmetic products in patients with radiation dermatitis
NAOS LES LABORATOIRES1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年7月21日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- grade 2 over the period of radiotherapy sessions as well as after their termination.
研究概览
简要总结
This randomized double blind clinical study aims to evaluate the efficacy and safety of two test creams CiCr20 tester 1 and 2 in preventing or managing early stage radiodermatitis grade 1 or non oozing grade 2 in 120 breast cancer patients undergoing external radiotherapy Over a 28 day period participants will apply the assigned product and undergo assessments at Day 0 14 and 28 with parameters such as skin condition radiodermatitis severity scar evolution quality of life and product tolerance measured through clinical evaluation self-assessment and instrumental tools The study excludes patients with severe dermatitis bilateral cancer ongoing use of conflicting treatments or other interfering conditions
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Subjects with a recently emerging radiodermatitis grade 1 or non oozing grade 2 according to CTCAE V5.0 and the investigator Subjects who have started the radiotherapy sessions minimum 7 days before the inclusion of the study average time according to radiotherapist to clinically observe radiodermatitis Subjects with a recently emerging radiodermatitis with minimum of 4 cm2 first record of appearance within 5 days prior to inclusion Subjects undergoing radiotherapy as part of a treatment for breast cancer Subjects undergoing external radiotherapy alone and for the first time patients under concomitant immunotherapy are accepted Subjects undergoing external radiotherapy for whom at least 2 weeks of radiotherapy sessions remain Female subjects aged 18 to 65 years old both inclusive Subjects with Phototype III to VI Subjects under external radiotherapy after conservative surgery or mastectomy Note Subjects who have undergone Mastectomy will be included because of the majority cases However considering the study rationale in each test group 10 subjects at least 7 subjects should be included with conservative surgery Subjects who started external radiotherapy at least 1 month after the end of chemotherapy treatment Subjects under standard fractionated radiotherapy regimens only external Subjects having been informed having signed a voluntarily informed and written consent.
排除标准
- •Subjects with a radiodermatitis grade 1 or non oozing grade 2 according to CTCAE V5.0 and to the investigator having appeared more than 5 days prior to inclusion or grade 2 3 or 4 radiodermatitis according to CTCAE V5.0 Subjects with an oozing grade 2 3 or 4 radiodermatitis according to CTCAE V5.0 Subjects requiring the use of dressing for radiodermatitis Subjects requiring a brachytherapy Women with bilateral breast cancer Women with cup size greater than or equal to D or with any macerative area Pregnant or lactating women Women of childbearing age who do not use an effective contraception Effective contraception methods typically include hormonal contraceptives intrauterine devices IUDs sterilization or strict abstinence among others Smoking subjects more than 4 cigarettes per day Subjects under oral anti inflammatory treatment Subjects who are taking photosensitizing drugs such as cyclins Subjects under local treatment or using another cosmetic product rather than the one advocated in the study Subject with known hypersensitivity to any of the ingredients of test products Subjects having a history of allergic contact dermatitis or irritation to any of the components of the study products Subjects with another skin pathology that may interfere with the evaluation of a radiodermatitis at the investigators discretion Subjects suffering from uncontrolled diabetes auto immune or micro vascular diseases Subjects with sun exposure of the studied area during the study period Subjects participating in another clinical study during the duration of the study Subjects having a strongly altered general condition and or non autonomous subject using ECOG scale less than or equal to 2 Subjects who cannot understand or sign the consent form or complete study paperwork due to language barriers or mental challenges Subjects in the impossibility of submitting to the medical follow up of the study Subjects deprived of liberty by administrative or judicial decision or under guardianship Any emergence of the above cited non inclusion criteria except emergence of non oozing grade 2 radiodermatitis not concerned observed during the study duration as per investigators judgement.
结局指标
主要结局
grade 2 over the period of radiotherapy sessions as well as after their termination.
时间窗: Day 0 | Day 14 | Day 28
The primary objective of the study is to evaluate and compare the cutaneous tolerance of each test
时间窗: Day 0 | Day 14 | Day 28
product in two groups of subjects presenting recently emerging radiodermatitis grade 1 or non oozing
时间窗: Day 0 | Day 14 | Day 28
次要结局
- To check evolution of post surgery scars before and after product usage(subjective appreciation of product)
研究者
Dr Manoj Kumar Sharma
Action cancer hospital
研究点 (1)
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