Insight Research
Quatre Bornes, Mauritius, 72218
NCT Number: NCT07194421
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 :
* Visit 1: Inclusion (Day 1) * Visit 2: Intermediate Visit (Day 8) * Visit 3: End of Study (Day 22)
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Notify Me18 year–45 year
All sexes
Observational
Quatre Bornes, Mauritius, 72218
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Criteria Related to Skin Condition:
Non-Inclusion Criteria:
Criteria Related to Population:
Criteria Related to Subject's Health:
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.
Time frame: At the end of the study, after Last Patient Out, (after Day 22)
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.
Time frame: Visit 3 (Day 22)
The subjects answer a 10-questions questionnaire about user satisfaction, texture, and overall experience with the product, providing insights into its appeal and usability.
Time frame: Visit 1 (Day 1, before investigational product application) and Visit 3 (Day 22)
The subjects answer a questionnaire regarding the irritative factors
Time frame: Visit 1 (Day 1, before investigational product application) and Visit 3 (Day 22)
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.
Time frame: Visit 1 (Day 1, before investigational product application) and Visit 3 (Day 22)
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.
Time frame: Visit 1 (Day 1, before investigational product application) and Visit 3 (Day 22)
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
Pierre Fabre Dermo Cosmetique
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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