CeraVe to restore skin hydration as maintenance for 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
This trial will test whether using CeraVe moisturizing cream as a maintenance treatment keeps skin hydrated in adults with mild-to-moderate atopic dermatitis after steroid-induced clearance.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse Academic / other |
| Locations | 1 site (Roma, RM) |
| Trial ID | NCT07204561 on ClinicalTrials.gov |
What this trial studies
This is an open-label, randomized, comparative, prospective interventional trial comparing CeraVe moisturizing cream to a standard pharmacy-prepared emollient as a maintenance regimen. Adult participants with mild-to-moderate atopic dermatitis (EASI 1-21) who achieve at least a 90% EASI reduction after topical steroid treatment will be randomized to one of the two emollients and given a basic detergent for washing. The primary outcome is restoration of skin barrier hydration, with secondary endpoints including cosmetic acceptability and differences in ADCT scores. Participants will discontinue if they experience a documented relapse of atopic dermatitis.
Who should consider this trial
Good fit: Adults (18+) with clinically confirmed mild-to-moderate atopic dermatitis who achieve ≥90% EASI reduction after steroid treatment and can give informed consent are eligible for randomization.
Not a fit: Patients using systemic AD therapies, those with other dermatologic conditions that confound assessment, or those who do not reach the required EASI improvement are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, patients may get improved skin hydration and potentially longer maintenance of disease control using a widely available moisturizer.
How similar studies have performed: Regular emollient maintenance is a well-established approach with evidence of benefit, but direct randomized comparisons of CeraVe versus a pharmacy-made emollient are limited.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Roma, RM
- Fondazione PTV - Policlinico Tor Vergata — Roma, Rm, Italy (Recruiting)
Study contacts
- Study coordinator: Prof.ssa Elena Campione
- Email: elena.campione@ptvonline.it
- Phone: +39 0620908446
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.