Anti-relapse Efficacy and Tolerance Assessment of a Cosmetic Cream for Very Dry, Irritated to Atopic Sensitive Skin.
Anti-relapse Efficacy and Tolerance Assessment of a Cosmetic Cream Intended for Very Dry, Irritated to Atopic Sensitive Skin
NAOS Argentina S.A.
100 participants
Nov 3, 2022
INTERVENTIONAL
Conditions
Summary
Multicentric, double blind, randomized, comparative study with two parallel group: study group vs placebo group. 5 visits: inclusion visit \[day (D) 0\] and 4 follow-up visits (D30, D60, D90, and D120).
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
Skin hydration outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.
TEWL measurement outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.
pH measurement outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.
EASI score on each visit. Non invasive technique.
Cardiff questionnaires to assess quality of life of subjects and their family members.
Visual analogue scale from 0 to 10
By collection of Adverse Events (AEs) on daily log and electronic Case Report Form (eCRF).
Locations(3)
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NCT05575882