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Clinical Trials in Italy / NCT07204561
Recruiting Not applicable

CeraVe Effect on Restoring Skin Hydration as Maintenance Regimen in Subjects With Mild to Moderate Atopic Dermatitis

NCT07204561 · tracked via the Priya Life Science Italy tracker
Sponsor
Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse
Phase
Not applicable
Started
2025-03-25
Last updated
2025-10-02

Condition(s) studied

Atopic Dermatitis (AD)

Investigational drug(s) / intervention(s)

CeraVe Moisturizing CreamGalenico

CeraVe Moisturizing Cream: During 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: During 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.

Study summary

This is an open-label, randomised, comparative, prospective, interventional study of a cosmetic product.

Eligibility

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
Inclusion criteria: Subjects with clinically confirmed mild-to-moderate atopic dermatitis (AD), as defined by an Eczema Area and Severity Index (EASI) score of 1-21, whose lesions will clear after treatment with a steroid and who will experience at least a 90% reduction in their EASI score. \- Participants of any gender, aged 18 years or over, from any phototype or ethnic group. Participants must be willing and able to give informed consent to participate in the study. Exclusion criteria: * 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).

Primary outcome measure(s)

  • Changes in EASI score — From enrollment to the end of treatment at 6 weeks
    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.

Trial sites (1)

FacilityCityRegionStatus
Fondazione PTV - Policlinico Tor Vergata Roma RM Recruiting

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National Register of Moderate and Severe Adult Atopic Dermatitis Recruiting
Retrospective and Prospective Observational Study in Patients With Advanced Basal Cell Carcinoma Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07204561 on ClinicalTrials.gov ↗ ← All trials in Italy