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Anti-relapse Efficacy and Tolerance Assessment of a Cosmetic Cream for Very Dry, Irritated to Atopic Sensitive Skin.
Sponsor: NAOS Argentina S.A.
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).
Official title: Anti-relapse Efficacy and Tolerance Assessment of a Cosmetic Cream Intended for Very Dry, Irritated to Atopic Sensitive Skin
Key Details
Gender
All
Age Range
6 Months - 15 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2022-11-03
Completion Date
2025-11
Last Updated
2025-03-25
Healthy Volunteers
No
Conditions
Interventions
Skin hydration
Skin hydration outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.
Barrier function measurement
TEWL measurement outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.
Potential of hydrogen measurement (pH)
pH measurement outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.
Clinical evaluation of atopic dermatitis
EASI score on each visit. Non invasive technique.
Quality of life assessment
Cardiff questionnaires to assess quality of life of subjects and their family members.
Assessment of the effect on itching and sleep disturbances
Visual analogue scale from 0 to 10
Assessment of the tolerance of the study product or placebo
By collection of Adverse Events (AEs) on daily log and electronic Case Report Form (eCRF).
Locations (3)
Cirec Latam
Ciudad Autónoma de Buenos Aire, Ciudad Autónoma de Buenos Aire, Argentina
CIDP
New Delhi, India
KK Women's & Children's Hospital
Singapore, Singapore, Singapore