Atopic Dermatitis (AD)DA_CeraVeNCT07204561
CeraVe Effect on Restoring Skin Hydration as Maintenance Regimen in Subjects With Mild to Moderate Atopic Dermatitis
A study testing CeraVe Moisturizing Cream and Galenico in people with Atopic Dermatitis (AD), run by Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse at 1 site in Italy.
Trial summary
This is an open-label, randomised, comparative, prospective, interventional study of a cosmetic product. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Atopic Dermatitis (AD)
- What is being tested?
- CeraVe Moisturizing Cream and Galenico
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteItaly
- Study dates
- 25 Mar 2025to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione PTV - Policlinico Tor Vergata
Roma, RM
Prof.ssa Elena Campione, 0620908446, elena.campione@ptvonline.it
About this study
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
This is an open-label, randomised, comparative, prospective, interventional study of a cosmetic product.
Read the 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)
- Being tested
- CeraVe Moisturizing Cream, Galenico
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeraVe Moisturizing CreamOther
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.
GalenicoOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - CeraVe | Experimental | 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. Receives: Other: CeraVe Moisturizing Cream |
| Arm 2 - Galenico | Active comparator | 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. Receives: Other: Galenico |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in EASI score
Changes in EASI (Eczema Area and Severity Index) score. A clinical assessment of disease severity (EASI) will be conducted at three separate visits: a screening visit on Day -15, and two visits on Days 1 and 42. At the screening visit, subjects will be given a medical corticosteroid topical treatment (mometasone furoate cream) to improve their EASI score by at least 90% between Day -15 and Day 1. Only individuals with an EASI score reduction of at least 90% between Day -15 and Day 1 will be randomised into two groups. EASI score interpretation: 0: clear; 0.1-1: almost clear; 1.1-7: mild; 7.1-21: moderate; 21.1-50: severe; 50.1-72: very severe.
Measured: From enrollment to the end of treatment at 6 weeks
Secondary outcomes (4)
Cosmetic acceptability
The cosmetic acceptability of the emollients is assessed in two groups of participants using specific questionnaires. The 21 questions covered texture, fluidity and penetration of the emollients. Scoring was as follows: 0 = totally agree; 1 = agree; 2 = disagree; 3 = totally disagree.
Measured: From visit 1 to the end of treatment at 6 weeks
Changes in ADCT score
The ADCT (Atopic Dermatitis Control Tool) score is compared between groups. This is a set of six concise questions designed to evaluate the various aspects of atopic dermatitis (AD) control that have been identified as important by patients and clinicians. Each question is scored between 0 and 4 points (0 = none, 4 = very severe). The sum of the points from the answers to the six ADCT questions is the ADCT total score. The ADCT total score will be between 0 and 24.
Measured: From enrollment to the end of treatment at 6 weeks
The number and proportion of subjects who experience a relapse of AD.
The number and proportion of subjects who experience a relapse of atopic dermatitis (AD) in the two groups. If a relapse of AD occurs, the subject should discontinue the application of the CeraVe emollient or the common soft emollient. They 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.
Measured: 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.
We will compare images of visual changes to the skin barrier collected at screening and visits 1 and 42. The images will only refer to areas affected by the disease and will not contain any recognisable features that could identify the subjects.
Measured: From enrollment to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start25 Mar 2025
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A clinical assessment of disease severity (EASI) will be conducted at three separate visits: a screening visit on Day -15, and two visits on Days 1 and 42. At the screening visit, subjects will be given a medical corticosteroid topical treatment (mometasone furoate cream) to improve their EASI score by at least 90% between Day -15 and Day 1. Only individuals with an EASI score reduction of at least 90% between Day -15 and 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.
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204561
- Sponsor's protocol ID
- SID05
- Acronym
- DA_CeraVe
- Status last verified
- Sep 2025
- First submitted
- 9 Jun 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07204561
- Acronym / sponsor ID
- DA_CeraVe / SID05
- Conditions
- Atopic Dermatitis (AD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente TrasmesseUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A clinical assessment of disease severity (EASI) will be conducted at three separate visits: a screening visit on Day -15, and two visits on Days 1 and 42. At the screening visit, subjects will be given a medical corticosteroid topical treatment (mometasone furoate cream) to improve their EASI score by at least 90% between Day -15 and Day 1. Only individuals with an EASI score reduction of at least 90% between Day -15 and 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - CeraVe | Experimental | Other: CeraVe Moisturizing CreamSubjects 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. |
| Arm 2 - Galenico | Active comparator | Other: GalenicoSubjects 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CeraVe Moisturizing CreamDuring 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 | Arm 1 - CeraVe |
| GalenicoDuring 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. | Other | Arm 2 - Galenico |
Primary outcome
Changes in EASI score
Time frame: From enrollment to the end of treatment at 6 weeks
Changes in EASI (Eczema Area and Severity Index) score. A clinical assessment of disease severity (EASI) will be conducted at three separate visits: a screening visit on Day -15, and two visits on Days 1 and 42. At the screening visit, subjects will be given a medical corticosteroid topical treatment (mometasone furoate cream) to improve their EASI score by at least 90% between Day -15 and Day 1. Only individuals with an EASI score reduction of at least 90% between Day -15 and Day 1 will be randomised into two groups. EASI score interpretation: 0: clear; 0.1-1: almost clear; 1.1-7: mild; 7.1-21: moderate; 21.1-50: severe; 50.1-72: very severe.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CeraVe Moisturizing Cream and Galenico in people with Atopic Dermatitis (AD), run by Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof.ssa Elena Campione (+39 0620908446, elena.campione@ptvonline.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in EASI score (time frame: From enrollment to the end of treatment at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.