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

NCT ID: NCT07204561

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-25
• Study Completion Date: 2026-07-31

Brief Summary

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

Detailed Description

Atopic dermatitis is a common chronic inflammatory skin condition that affects individuals with specific alterations to the epidermal barrier. It is also characterised by defective ceramide production. Emollients play an important role in managing atopic dermatitis, including during the maintenance phase following topical cortisone therapy. However, the effect of CeraVe emollient cream on restoring skin barrier hydration has yet to be investigated.

The primary objective is to evaluate the effect of the CeraVe emollient on restoring skin barrier hydration as a maintenance regimen in subjects with mild to moderate atopic dermatitis. The secondary objectives are to evaluate and compare the cosmetic acceptability of CeraVe with that of a commonly used emollient produced in a licensed pharmacy laboratory, and to assess the differences in ADCT (Atopic Dermatitis Control Tool) scores between groups.

Subjects with mild-to-moderate atopic dermatitis (AD), as defined by an EASI score of 1-21, will be enrolled in the study. Only individuals with an EASI score reduction of at least 90% between screening (Day -15) and Visit 1 (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.

If the participant experiences a relapse of atopic dermatitis (AD), as reported in their diary and in the eCRF, they should discontinue the application of CeraVe Emollient or a common soft emollient. The subject 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 In this case, they will be withdrawn from the study.

Conditions

Atopic Dermatitis (AD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1 - CeraVe

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.

Group Type: EXPERIMENTAL

CeraVe Moisturizing Cream

Intervention Type: 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 2 - Galenico

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.

Group Type: ACTIVE_COMPARATOR

Galenico

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fondazione PTV - Policlinico Tor Vergata

Roma, RM, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Prof.ssa Elena Campione

Role: CONTACT

elena.campione@ptvonline.it

+39 0620908446

Facility Contacts

Prof.ssa Elena Campione

Role: primary

elena.campione@ptvonline.it

0620908446

Other Identifiers

SID05

Identifier Type: -

Identifier Source: org_study_id