A unicentric, blind, non-comparative clinical study to evaluate the efficacy of a moisturizer in reducing clinical symptons of atopic dermatites in children through clinical, subjective and instrumental evaluations.
A unicentric, blind, non-comparative clinical study to evaluate the efficacy of a moisturizer in reducing clinical symptons of atopic skin dermatites in children through clinical, subjective and instrumental evaluations. Participants will be divided into 2 groups - (Group 1) Microbiome analysis; and (Group 2) Acceptabily and efficacy Group 1: It will be necessary 13 participants aged between 05 and 12 years old with historical of atopia The participant will remain in the study for 30 days using the product. Visits will be scheduled in D0 and D30. On both visits, samples will be collect to quantify Staphylococcus aureus using qPCR Group 2: It will be necessary 36 participants aged between 05 and 12 years old with historical of atopia The participant will remain in the study for 60 days using the product. Visits will be scheduled in D0, D7, D30 and D60. Instrumental evaluations: It will be evaluate on each visit: Skin hidration using Corneometer - D0, D7, D30, D60 Transepidermic water loss using TEWL - D0, D7, D30, D60 Skin barrier restoration using Confocal Microscopy - D0, D30, D60 Participants will respond to a subjective assessment using a questionnaire to capture possible feelings of discomfort during the study e subjective efficiency. A dermatologist will be available to monitor the participants throughout the study and respond a assessment of clinical efficiency.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
49
Moisturizer containing saccharide isomerate and niacinamide
Medcin Instituto da Pele
Osasco, São Paulo, Brazil
Acceptability in real conditions of use by questionnaire
Confirm in real conditions of use, the absence of risk and irritation and capture feelings of discomfort in the population studied (0 meaning no risk).
Time frame: Day 60
Change of qPCR quantification of Staphylococcus aureus
Evaluate the change in the skin microbiota by quantification of qPCR of Staphylococcus aureus in the skin before (D0) and after 30 (D30) days of continuous use of the product.
Time frame: Change from Baseline (Day 0) and day 30
Clinical Evaluation through dermatological questionnaire
Evaluate the efficacy in reducing the signs of atopic dermatitis through dermatological clinical evaluation after 60 days of continuous use of the product
Time frame: Day 60
Increase of skin hidration using instrumental evaluation - Corneometer
Evaluate the moisturizing efficacy immediately (D0) after application of the investigational product and after 7 (D7), 30 (D30) and 60 (D60) days of continuous use, through the Corneometer equipment®
Time frame: Day 0, 7, 30 and 60
Evaluation of recovery of skin barrier through instrumental method - TEWL
Evaluate the efficacy in the recovery of the skin barrier after 7 (D7), 30 (D30) and 60 (D60) days of continuous use of the product through the Tewameter equipment®
Time frame: Day 7, 30 and 60
Strengthening of the skin barrier
Evaluate the strengthening of the skin barrier in D0 and after 30 (D30) and 60 (D60) days of continuous use of the product by confocal reflectance microscopy
Time frame: Day 0, 30 and 60
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Subjective efficacy from the participants
Evaluate the perceived efficacy of the product from the participant's point of view through a subjective questionnaire immediately after the first application (Timed) and after 7 (D7), 30 (D30) and 60 (D60) days of continuous use of the product
Time frame: Day 0, 7, 30 and 60
Improvement of Quality of Life
Evaluate the improvement of the quality of life of the atopic dermatitis carrier through a questionnaire on quality of life in D0 and after 30 and 60 days of continuous use of the product
Time frame: Day 0, 7, 30 and 60