NCT05575882

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: NAOS Argentina S.A. · Industry
• Sex: All
• Age: 6 Months – 15 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Atopic Dermatitis
• Eczema, Atopic

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2022-11-03
• Primary completion: 2025-10-01
• Completion: 2025-11-01
• First posted: 2022-10-12
• Last updated: 2025-03-25

Locations

3 sites across 3 countries: Argentina, India, Singapore