NCT07204561

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

Analysis of the CeraVe Emollient Effect on Restoring the Hydration of the Skin Barrier as Maintenance Regimen in Subjects With Mild to Moderate Atopic Dermatitis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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 In this case, they will be withdrawn from the study.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

Interventions

Type	Name	Description
OTHER	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.
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.

Timeline

• Start date: 2025-03-25
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2025-10-02
• Last updated: 2025-10-02

Locations

1 site across 1 country: Italy