CeraVe Effect on Restoring Skin Hydration as Maintenance Regimen in Subjects With Mild to Moderate Atopic Dermatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CeraVe Moisturizing Cream, Galenico.
- Who it may be relevant to
- Registry conditions: Atopic Dermatitis (AD). Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- 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.
Primary outcome measures
- Changes in EASI score [Time frame: From enrollment to the end of treatment at 6 weeks]
Secondary outcome measures (4)
- Cosmetic acceptability [Time frame: From visit 1 to the end of treatment at 6 weeks]
- Changes in ADCT score [Time frame: From enrollment to the end of treatment at 6 weeks]
- The number and proportion of subjects who experience a relapse of AD. [Time frame: 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. [Time frame: From enrollment to the end of treatment at 6 weeks]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Fondazione PTV - Policlinico Tor Vergata — Roma
Identifiers
NCT: NCT07204561 · SID05