RecruitingNot ApplicableNCT05575882

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


Sponsor

NAOS Argentina S.A.

Enrollment

100 participants

Start Date

Nov 3, 2022

Study Type

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

Min Age: 6 MonthsMax Age: 15 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Assessment of the effect on itching and sleep disturbances, Assessment of the tolerance of the study product or placebo, and others for people with atopic dermatitis and eczema, atopic. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 6 Months to 15 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERSkin hydration

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

OTHERBarrier function measurement

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

OTHERPotential of hydrogen measurement (pH)

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

OTHERClinical evaluation of atopic dermatitis

EASI score on each visit. Non invasive technique.

OTHERQuality of life assessment

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

OTHERAssessment of the effect on itching and sleep disturbances

Visual analogue scale from 0 to 10

OTHERAssessment 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

View Full Details on ClinicalTrials.gov

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NCT05575882


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