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

NARecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

November 3, 2022

Primary Completion Date

October 31, 2025

Study Completion Date

November 30, 2025

Conditions
Atopic DermatitisEczema, Atopic
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).

Trial Locations (3)

1426

NOT_YET_RECRUITING

Cirec Latam, Ciudad Autónoma de Buenos Aire

110005

RECRUITING

CIDP, New Delhi

179939

SUSPENDED

KK Women's & Children's Hospital, Singapore

All Listed Sponsors
lead

NAOS Argentina S.A.

INDUSTRY