Randomized, Comparative Study to Evaluate the Effects of Cosmetic Balm on Xerosis and Associated Signs and Symptoms, Induced by Systemic Anticancer Treatments in Subjects Receiving Targeted Educational Action Compared to a Control Group

Fecha de inicio: 19 de febrero de 2019

Inclusion Criteria: 1. Criteria related to the population: * Subject having signed his/her written informed consent for his/her participation in the study * Subject affiliated to a social security system or health insurance, or is a beneficiary * Subject with phototype I, II, III, IV according to the Fitzpatrick scale * For woman of childbearing potential: use of an effective method of contraception, as assessed by the investigator for at least 4 weeks before inclusion in the study and using it during the whole duration of the study 2. Criteria related to diseases and general health: * Subject having a grade ≥ 2 of dry skin on NCI-CTCAE scale in 3 grades, assessed on the entire body * Subject having an intensity of dry skin ≥ 3, according a 5-points scale, on the target area * Subject having a general state of clinical and/or physical health adequate(s) to carry out the study according to the investigator's opinion, and presenting a total score ≤ 1 according to the "performance status" scale of WHO (World Health Organization) in 5-points 3. Criteria related to treatments: * On-going systemic anticancer treatment, whatever the dosage and whatever the duration of treatment Exclusion Criteria: 1. Criteria related to the population: * For woman of childbearing potential: pregnant or breastfeeding or planning to be pregnant during the study * Subject unable to understand the information given including study procedures (for linguistic or psychiatric reasons) and to give his/her consent in writing * Subject who, in the judgement of the investigator, is not likely to be compliant during the study * Subject who has forfeited his/her freedom by administrative or legal award or is under guardianship * Subject is in a position likely to represent a conflict of interest and/or is a family member of any people involved in the conduct of the study (secretary, nurse, technician,…), of the investigational site * Subject who is currently participating, who plans to participate or who has participated within the previous weeks in another clinical study liable to interfere with the study assessments according to the investigator's assessment * Subject unable to write required information in a subject diary 2. Criteria related to diseases and general health * Subject having a grade= 3 of pruritus on NCI-CTCAE scale in 3 grades, assessed on the entire body * Subject presenting infectious (viral, bacterial, fungal) or inflammatory complications, on the entire body * Subject with a history of atopic or contact dermatitis * Subject presenting any other dermatological condition the day of the visit (atopic or contact dermatitis, chronic xerosis, ..), liable to interfere with the study assessments, according to the investigator's opinion * Subject with history of allergy or intolerance to any of the study products ingredients 3. Criteria related to treatments and cosmetic products * Radiotherapy in progress or planned during the study * Application of dermocorticoïdes during 5 consecutive days within the 10 days previous the visit * Any other topical or systemic treatment previously used or on-going (other than systemic anticancer treatment and antihistaminic) liable to interfere with the study assessments or incompatible with the study procedures, according to the investigator's opinion * Application of any other topical treatment or topical cosmetic product (except hygiene product), liable to interfere with the study assessments, according to the investigator's opinion, on the entire body, the day of the visit