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

Last updated: September 24, 2025
Sponsor: Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dermatitis, Atopic

Treatment

CeraVe Moisturizing Cream

Galenico

Clinical Study ID

NCT07204561
SID05
  • Ages 18-99
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion criteria:

  • Age <18 years. Participants who are unwilling or unable to give informed consent toparticipate in the study.

  • Receiving any systemic treatment for atopic dermatitis (AD), includingcorticosteroids, cyclosporine, any approved biologics or JAK inhibitors.

  • Any dermatological disorder which, in the investigator's opinion, may interfere withthe accurate evaluation of the subject's skin characteristics (except AD).

Study Design

Total Participants: 98
Treatment Group(s): 2
Primary Treatment: CeraVe Moisturizing Cream
Phase:
Study Start date:
March 25, 2025
Estimated Completion Date:
July 31, 2026

Study 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.

Connect with a study center

  • Fondazione PTV - Policlinico Tor Vergata

    Roma 8957247, RM
    Italy

    Active - Recruiting

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