This is an open-label, randomised, comparative, prospective, interventional study of a cosmetic product.
None
Age <18 years. Participants who are unwilling or unable to give informed consent to participate in the study.
Receiving any systemic treatment for atopic dermatitis (AD), including corticosteroids, cyclosporine, any approved biologics or JAK inhibitors.
Any dermatological disorder which, in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin characteristics (except AD).
Parallel
CeraVe Moisturizing Cream
Other interventionDuring the 42-day maintenance phase, subjects must apply the CeraVe emollient twice a day after washing with the basic detergent as part of their normal hygiene routine.
Galenico
Other interventionDuring the 42-day maintenance phase, subjects must apply the emollient twice a day after washing with the basic detergent as part of their normal hygiene routine.
Changes in EASI score
Changes in EASI (Eczema Area and Severity Index) score. A clinical assessment of disease severity (EASI) will be conducted at three separate visits: a screening visit on Day -15, and two visits on Days 1 and 42. At the screening visit, subjects will be given a medical corticosteroid topical treatment (mometasone furoate cream) to improve their EASI score by at least 90% between Day -15 and Day 1. Only individuals with an EASI score reduction of at least 90% between Day -15 and Day 1 will be randomised into two groups. EASI score interpretation: 0: clear; 0.1-1: almost clear; 1.1-7: mild; 7.1-21: moderate; 21.1-50: severe; 50.1-72: very severe.
Cosmetic acceptability
The cosmetic acceptability of the emollients is assessed in two groups of participants using specific questionnaires. The 21 questions covered texture, fluidity and penetration of the emollients. Scoring was as follows: 0 = totally agree; 1 = agree; 2 = disagree; 3 = totally disagree.
Changes in ADCT score
The ADCT (Atopic Dermatitis Control Tool) score is compared between groups. This is a set of six concise questions designed to evaluate the various aspects of atopic dermatitis (AD) control that have been identified as important by patients and clinicians. Each question is scored between 0 and 4 points (0 = none, 4 = very severe). The sum of the points from the answers to the six ADCT questions is the ADCT total score. The ADCT total score will be between 0 and 24.
The number and proportion of subjects who experience a relapse of AD.
The number and proportion of subjects who experience a relapse of atopic dermatitis (AD) in the two groups. If a relapse of AD occurs, the subject should discontinue the application of the CeraVe emollient or the common soft emollient. They should be examined by a physician and treated according to the severity of the AD. In this case, they will be withdrawn from the study.
Changes in the visual appearance of the skin barrier over time, as observed by comparing images collected during the three scheduled study visits.
We will compare images of visual changes to the skin barrier collected at screening and visits 1 and 42. The images will only refer to areas affected by the disease and will not contain any recognisable features that could identify the subjects.
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