Recruiting
NA
INTERVENTIONAL
NCT05575882
Anti-relapse Efficacy and Tolerance Assessment of a Cosmetic Cream for Very Dry, Irritated to Atopic Sensitive Skin.
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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).
Detailed Description
This is a prospective, double blind, multicentric and comparative study including 5 visits (on D0 which corresponds to inclusion visit, D30, D60, D90, and D120). It will take place from June 2024 to June 2025 in Argentina (CIREC LATAM, Buenos Aires) and India (CIDP, New Dheli). This study will include 100 patients (50 in India and 50 in Argentina) who will be followed up for 120 days (± 3 days).
Interventions
Name:
Skin hydration
Type:
OTHER
Description:
Skin hydration outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.
Name:
Barrier function measurement
Type:
OTHER
Description:
TEWL measurement outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.
Name:
Potential of hydrogen measurement (pH)
Type:
OTHER
Description:
pH measurement outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.
Name:
Clinical evaluation of atopic dermatitis
Type:
OTHER
Description:
EASI score on each visit. Non invasive technique.
Name:
Quality of life assessment
Type:
OTHER
Description:
Cardiff questionnaires to assess quality of life of subjects and their family members.
Name:
Assessment of the effect on itching and sleep disturbances
Type:
OTHER
Description:
Visual analogue scale from 0 to 10
Name:
Assessment of the tolerance of the study product or placebo
Type:
OTHER
Description:
By collection of Adverse Events (AEs) on daily log and electronic Case Report Form (eCRF).
Primary Outcomes
Measure:
Change of acute flares of eczema in patients with chronic atopic dermatitis (AD)
TimeFrame:
4 months
Description:
Clinical evaluation by dermatologist on each visit and daily log statements by the parents.
Trial Information
NCT ID
NCT05575882
Status
Recruiting
Study Type
INTERVENTIONAL
Phases
NA
Sponsor
NAOS Argentina S.A.
Last Updated
December 15, 2025