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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Children intended to use Sunscreen RV4620A RP2552 product |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunscreen RV4620A RP2552 | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the end of the study, after Last Patient Out, (after Day 22) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Visit 3 (Day 22) |
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Inclusion Criteria:
Criteria related to the population:
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:
Criteria Related to Subject's Health:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Insight Research | Quatre Bornes | Mauritius | 72218 | Mauritius |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |