MedTrace Logo

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

NCT05575882 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-03-25

No results posted yet for this study

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).

Conditions

Interventions

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).

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.

Sponsors & Collaborators

  • NAOS Argentina S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-03
Primary Completion
2025-10-31
Completion
2025-11-30

Countries

  • Argentina
  • India
  • Singapore

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05575882 on ClinicalTrials.gov