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
Data Collection
Pruritus+3
+ Signs and Symptoms
+ Skin Diseases
Other
Utilizing specific methods not covered by standard models in order to address unique research questions.Summary
Study start date: February 19, 2019
Actual date on which the first participant was enrolled.Systemic anticancer treatments, whether they are conventional molecules or more current molecules such as targeted therapies, are responsible for numerous dermatological adverse effects, notably xerosis, the repercussions of which may lead to a decrease in compliance, dose reductions or even a complete cessation of cancer treatment. To date, the management of these adverse effects is not performed routinely and published efficacy data on secondary side effects are missing. The purpose of this comparative study is to evaluate the clinical efficacy of the RV4429A balm combined with a targeted educational action, on the improvement of induced xerosis on the one hand and on the improvement of the signs and symptoms associated with this induced xerosis. on the other hand ; based on clinical, biometrological and biological criteria. The objective is to provide data on this product in this symptomatology. Xerosis and the associated dermatological signs / symptoms will be assessed individually as well as through overall scores, as measured by both the investigator and the patient as clinical expression is often poorly correlated with psychic and functional impact. Quality of life, cosmetic acceptability and targeted educational action and tolerance will also be assessed. The improvement of the quality of life of the patients, the reduction of the undesirable effects induced could thus guarantee the observance of the patients vis-à-vis the anticancer treatments. The study area is the whole body. A target area will be chosen and will be located on one of the upper limbs (outside the hands) or on the trunk (outside a hairy area). The target area is defined as the xerosis area representative of the the most severe xerotic state, according to the investigator's opinion. The dermatologist who will evaluate the participant should be, as far as possible, the same throughout the study. A second period will be carried out by the participants of the control group who will enter in the targeted educational action phase of in their turn. The study includes 2 visits for the informed group and 3 visits for the control group: * V1 (J1) - Inclusion (common to both groups) * V2 (J21 ± 2J or J28 ± 2J) - End of study (informed group) - Intermediate (control group) * V3 (J42 ± 2J or J56 ± 2J) - End of study (control group) The dates of the visits 2 and 3 will be adapted to the frequency of the visits of administration of the anticancer treatment. The maximum duration of participation for a participant may be 23 days or 44 days or it may be 30 days or 58 days from the inclusion visit to the end-of-study visit, depending on the group and depending the timeframe between cancer treatment visits. All subjects in the control group will enter onto the informed group after three weeks or one month (depending on the timeframe between cancer treatment visits), regardless of their condition (presence or absence of on-going xerosis).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.29 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 4 locations
Centre Hospitalier de Carcassonne
Carcassonne, FranceCentre Hospitalier de Tarbes
Tarbes, FranceInstitut Universitaire du Cancer Toulouse- Oncopole
Toulouse, France