Health Condition 1: L589- Radiodermatitis, unspecified
Conditions
Interventions
Intervention1: Cream CiCr2.0 tester 1: Cosmetic cream with the composition of Aqua Water Eau Caprylic Capric Triglyceride Glycerin Polyglyceryl3 Polyricinoleate Brassica Campestris Rapeseed Seed Oil B
Sponsors
NAOS LES LABORATOIRES
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to evaluate and compare the cutaneous tolerance of each test product in two groups of subjects presenting recently emerging radiodermatitis grade 1 or non oozing grade 2 over the period of radiotherapy sessions as well as after their termination.Timepoint: Day 0 Day 14 Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| To check evolution of post surgery scars before and after product usage subjective appreciation of productTimepoint: Day 0 Day 14 Day 28 | — |
Countries
India
Contacts
Public ContactMs Deepika Arora
Action cancer hospital
Outcome results
None listed