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

NCT07204561 | Recruiting

• 1 other identifier: SID05
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atopic Dermatitis (AD)

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of treatment at 6 weeks

Secondary Outcomes (4)

• Cosmetic acceptability

  From visit 1 to the end of treatment at 6 weeks

• Changes in ADCT score

  From enrollment to the end of treatment at 6 weeks

• The number and proportion of subjects who experience a relapse of AD.

  From enrollment to the end of treatment at 6 weeks

• Changes in the visual appearance of the skin barrier over time, as observed by comparing images collected during the three scheduled study visits.

  From enrollment to the end of treatment at 6 weeks

Study Arms (2)

Arm 1 - CeraVe

EXPERIMENTAL

Subjects who agree to participate in this study and have previously signed a specific informed consent form will enter the maintenance phase with CeraVe emollient following corticosteroid treatment as per clinical practice.

Other: CeraVe Moisturizing Cream

Arm 2 - Galenico

ACTIVE COMPARATOR

Subjects who agree to participate in this study and have previously signed a specific informed consent form will enter the maintenance phase with a common soft emollient after corticosteroid treatment, as per clinical practice.

Other: Galenico

Interventions

CeraVe Moisturizing Cream OTHER

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.

Arm 1 - CeraVe

Galenico OTHER

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.

Arm 2 - Galenico

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse: lead

Study Sites (1)

Fondazione PTV - Policlinico Tor Vergata

Roma, RM, Italy

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Prof.ssa Elena Campione

CONTACT

+39 0620908446; elena.campione@ptvonline.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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. Group 1 will enter the maintenance phase with CeraVe emollient, while group 2 will be treated with a standard emollient. Both groups will be provided with a basic detergent for washing.

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: October 2, 2025
• Study Start: March 25, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

IT (1)