Atopic Dermatitis (AD)NCT07194408
In-Use Tolerance Study Under Dermatological and Pediatric Controls of Sunscreen in Children With Atopic Dermatitis
An observational study of Atopic Dermatitis (AD) and SCORAD Index (15-25), run by Pierre Fabre Dermo Cosmetique at 1 site in Mauritius.
Trial summary
Atopic dermatitis is a chronic skin condition requiring sun protection, yet research on sunscreen effectiveness and skin tolerance in Atopic Dermatitis is limited. This study evaluates a broad-spectrum SPF50+ sunscreen on 22 children with Atopic Dermatitis, assessing skin tolerance through dermatologic and pediatric… Read more about this study
- Who is it for?
- Ages 3 to 11 years
- Conditions the study is for
- Atopic Dermatitis (AD), SCORAD Index (15-25)
- What is being tested?
- Sunscreen RV4620A RP2552
- How many people
- 22 participants
- Where
- 1 siteMauritius
- Study dates
- 12 Dec 2023to 16 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 3 to 11 years
- All sexes
- No healthy volunteers
- Child
Study population: Subjects will be recruited from the investigation centre's panel. They will be selected on the basis of inclusion and non-inclusion criteria specific to the study and on their ability to comply with the constraints required by the protocol. They will be definitely included in the study after a specific interview and a clinical examination.
Who may be able to join
- Criteria related to the population:
- phototype: I to IV;
- face and body skin type: all skin types;
- subjects must be registered with health social security or health social insurance (if required by national regulations);
- subjects' parent(s)/ legal representatives having signed their written Informed Consent form for their participation in the study and a photograph authorization;
- subjects' parent(s)/ legal representatives certifying the truth of the personal information declared to the Investigator;
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- Health Status: Considered a "healthy subject" by the Investigators (excluding SCORAD considerations).
- Criteria Related to Atopic Dermatitis:
- Subject must present atopic dermatitis according to the U.K Working Party's Diagnostic Criteria for Atopic Dermatitis, with mild atopic dermatitis indicated by a SCORAD score of 15 to 25 (inclusive), determined by a dermatologist and a pediatrician together.
- Non-Inclusion Criteria:
- Criteria Related to Population:
- Subjects who have participated in another clinical trial within the week before the inclusion visit, or for a longer period if deemed necessary by the Investigator.
- Subjects currently participating or planning to participate in another clinical trial during the study, either in the same or a different investigation center.
- Criteria Related to Subject's Health:
- Subjects experiencing a flare of atopic dermatitis.
- Subjects with dermatological conditions that may interfere with study data or are considered hazardous by the Investigator (e.g., pityriasis versicolor, severe pigmentation disorders such as vitiligo, melasma, multiple lentigines, numerous or large congenital nevi).
- Subjects with a personal medical history that may interfere with study data or is incompatible with study requirements (except if required by the Sponsor, e.g., atopic dermatitis).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Atopic dermatitis is a chronic skin condition requiring sun protection, yet research on sunscreen effectiveness and skin tolerance in Atopic Dermatitis is limited. This study evaluates a broad-spectrum SPF50+ sunscreen on 22 children with Atopic Dermatitis, assessing skin tolerance through dermatologic and pediatric controls.
Read the detailed description
Atopic dermatitis is a chronic skin condition that necessitates sun protection, yet there is limited research on the effectiveness of sunscreens and skin tolerance in Atopic Dermatitis.
Objectives: This study aims to evaluate the tolerance of a broad-spectrum SPF50+ sunscreen in children with Atopic Dermatitis, monitored through dermatological and pediatric assessments.
Methods: This study is conducted on 22 children with Atopic Dermatitis confirmed using the SCORAD index (15-25).
The protocol includes 2 visits and assessments as follow:
- Visit 1: Inclusion (Day 1) - Before and immediately after application (10 to 30 minutes), the investigator conducts a clinical evaluation of the dermatological tolerance of the investigational product. SCORAD evaluation by the dermatologist and pediatrician together is performed on Day 1.
- Home Application Period: Day 1 to Day 22 - Continued application of the sunscreen at home in real conditions of use
- Visit 3: End of Study (Day 22) -The investigators conduct a clinical evaluation of the dermatological tolerance of the investigational product. In addition, a questionnaire is used to evaluate global and perceived efficacy of the sunscreen.
- Conditions
- Atopic Dermatitis (AD), SCORAD Index (15-25)
- Being tested
- Sunscreen RV4620A RP2552
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunscreen RV4620A RP2552Other
Dermo-cosmetic product, Broadspectrum Sunscreen RV4620A RP2552, very high protection product.
Instructions for product use given to the subjects: Apply before and during sun exposure, at least twice daily. During sun exposure, applications must be renewed as often as necessary, in particular after swimming, perspiring, towelling, in order to ensure a good protection. On days of bad weather, apply the product in the morning and at the beginning of the afternoon.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Children intended to use Sunscreen RV4620A RP2552 product Receives: Other: Sunscreen RV4620A RP2552 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global tolerance assessment by the investigator
Global tolerance is assessed on the "tolerance population" which includes all the subjects who applied at least once investigational product.
This assessment allows for attribution of one of the 5 levels : excellent, very good, good, moderate, bad.
Measured: At the end of the study, after Last Patient Out, (after Day 22)
Secondary outcomes (1)
Evaluation Global Acceptability of the Sunscreen RV4620A - RP2552
The subjects' parent(s)/ legal representatives give their global appreciation about the product with positive and negative feedback. According to the items, the subjects' parent(s)/ legal representatives have to answer opened questions and a question using a scale from 0 to 10.
Measured: Visit 3 (Day 22)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start12 Dec 2023
- Primary completion16 Feb 2024
- Study completion16 Feb 2024
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194408
- Sponsor's protocol ID
- RV4620A20230438
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 26 Sep 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 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-Use Tolerance Study Under Dermatological and Pediatric Controls of Sunscreen in Children With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07194408
- Acronym / sponsor ID
- RV4620A20230438
- Conditions
- Atopic Dermatitis (AD), SCORAD Index (15-25)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 16 Feb 2024 (actual)
- Study completion
- 16 Feb 2024 (actual)
- First posted
- 26 Sep 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.
Atopic dermatitis is a chronic skin condition requiring sun protection, yet research on sunscreen effectiveness and skin tolerance in Atopic Dermatitis is limited. This study evaluates a broad-spectrum SPF50+ sunscreen on 22 children with Atopic Dermatitis, assessing skin tolerance through dermatologic and pediatric controls.
Detailed description
Atopic dermatitis is a chronic skin condition that necessitates sun protection, yet there is limited research on the effectiveness of sunscreens and skin tolerance in Atopic Dermatitis.
Objectives: This study aims to evaluate the tolerance of a broad-spectrum SPF50+ sunscreen in children with Atopic Dermatitis, monitored through dermatological and pediatric assessments.
Methods: This study is conducted on 22 children with Atopic Dermatitis confirmed using the SCORAD index (15-25).
The protocol includes 2 visits and assessments as follow:
- Visit 1: Inclusion (Day 1) - Before and immediately after application (10 to 30 minutes), the investigator conducts a clinical evaluation of the dermatological tolerance of the investigational product. SCORAD evaluation by the dermatologist and pediatrician together is performed on Day 1.
- Home Application Period: Day 1 to Day 22 - Continued application of the sunscreen at home in real conditions of use
- Visit 3: End of Study (Day 22) -The investigators conduct a clinical evaluation of the dermatological tolerance of the investigational product. In addition, a questionnaire is used to evaluate global and perceived efficacy of the sunscreen.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test group | – | Other: Sunscreen RV4620A RP2552Children intended to use Sunscreen RV4620A RP2552 product |
Who may qualify
- Ages
- 3 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Subjects will be recruited from the investigation centre's panel. They will be selected on the basis of inclusion and non-inclusion criteria specific to the study and on their ability to comply with the constraints required by the protocol. They will be definitely included in the study after a specific interview and a clinical examination.
Key inclusion criteria (17 listed)
- phototype: I to IV;
- face and body skin type: all skin types;
- subjects must be registered with health social security or health social insurance (if required by national regulations);
- subjects' parent(s)/ legal representatives having signed their written Informed Consent form for their participation in the study and a photograph authorization;
- subjects' parent(s)/ legal representatives certifying the truth of the personal information declared to the Investigator;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Sunscreen RV4620A RP2552Dermo-cosmetic product, Broadspectrum Sunscreen RV4620A RP2552, very high protection product. Instructions for product use given to the subjects: Apply before and during sun exposure, at least twice daily. During sun exposure, applications must be renewed as often as necessary, in particular after swimming, perspiring, towelling, in order to ensure a good protection. On days of bad weather, apply the product in the morning and at the beginning of the afternoon. | Other | Test group |
Primary outcome
Global tolerance assessment by the investigator
Time frame: At the end of the study, after Last Patient Out, (after Day 22)
Global tolerance is assessed on the "tolerance population" which includes all the subjects who applied at least once investigational product. This assessment allows for attribution of one of the 5 levels : excellent, very good, good, moderate, bad.
1 secondary outcome
Evaluation Global Acceptability of the Sunscreen RV4620A - RP2552
Time frame: Visit 3 (Day 22)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis (AD) and SCORAD Index (15-25), run by Pierre Fabre Dermo Cosmetique at 1 site in Mauritius.
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 17 inclusion and 0 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: finished, as of the sponsor's last update on 26 Sep 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 Mauritius. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global tolerance assessment by the investigator (time frame: At the end of the study, after Last Patient Out, (after Day 22)). 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 26 Sep 2025.