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

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

Status: Enrolling

Conditions: Atopic Dermatitis (AD)

Treatments: Other: Galenico; Other: CeraVe Moisturizing Cream

Study type: Interventional

Funder types: Other

Identifiers

NCT07204561

SID05

Details and patient eligibility

About

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

Full 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 In this case, they will be withdrawn from the study.

Enrollment: 98 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

Arm 1 - CeraVe

Experimental group

Description:

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.

Treatment:

Other: CeraVe Moisturizing Cream

Arm 2 - Galenico

Active Comparator group

Description:

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.

Treatment:

Other: Galenico