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This study evaluates a broad-spectrum SPF50+ sunscreen on 42 adults with Atopic Dermatitis, measuring skin tolerance and barrier function.
The study includes several visits as follow :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Adult 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 of the product is assessed on the "tolerance population" which includes all the subjects who applied investigational product at least once. 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 Cosmetic Acceptability of the Sunscreen RV4620A - RP2552 | The subjects answer a 10-questions questionnaire about user satisfaction, texture, and overall experience with the product, providing insights into its appeal and usability. | Visit 3 (Day 22) |
| Evaluation of Irritative Factors with Sunscreen RV4620A - RP2552 |
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Inclusion Criteria:
Criteria Related to Skin Condition:
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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The subjects answer a questionnaire regarding the irritative factors |
| Visit 1 (Day 1, before investigational product application) and Visit 3 (Day 22) |
| Evaluation of Transepidermal Water Loss with Sunscreen RV4620A - RP2552 | Trans Epidermal Water Loss measurements are done with a Tewameter TM 300® by a trained technician in a room with controlled temperature and hygrometry. This measurement aims to assess the effect of the investigational product on transepidermal water loss to determine the product's impact on the skin's barrier function. | Visit 1 (Day 1, before investigational product application) and Visit 3 (Day 22) |
| Assessment of Skin pH with Sunscreen RV4620A - RP2552 | Measurement of the skin pH is done using the COURAGE & KHAZAKA PH 900 PC Skin pH meter fitted with an Ingold electrode. The goal is to determine the product's respect of skin surface pH. | Visit 1 (Day 1, before investigational product application) and Visit 3 (Day 22) |
| Assessment of the Lipidic Index Evolution with Sunscreen RV4620A - RP2552 | The quantity of sebum excreted to the skin surface is quantitatively evaluated with a Sebumeter SM 815 (Courage & Khazaka). The goal is to determine the product's respect of skin's barrier function and seboregulating effect | Visit 1 (Day 1, before investigational product application) and Visit 3 (Day 22) |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |