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RECRUITING
NCT05575882
NA

Anti-relapse Efficacy and Tolerance Assessment of a Cosmetic Cream for Very Dry, Irritated to Atopic Sensitive Skin.

Sponsor: NAOS Argentina S.A.

View on ClinicalTrials.gov

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

Interventions

OTHER

Skin hydration

Skin hydration outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.

OTHER

Barrier function measurement

TEWL measurement outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.

OTHER

Potential of hydrogen measurement (pH)

pH measurement outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.

OTHER

Clinical evaluation of atopic dermatitis

EASI score on each visit. Non invasive technique.

OTHER

Quality of life assessment

Cardiff questionnaires to assess quality of life of subjects and their family members.

OTHER

Assessment of the effect on itching and sleep disturbances

Visual analogue scale from 0 to 10

OTHER

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