NCT03684343: PRURINEO

Comparative Analysis of Filmed Sequences for the Assessment of Discomfort in Atopic Dermatitis of Infants Under 6 Months of Age

Terminated NA Last updated 12 December 2025

What this trial tests

NA trial testing Filmed consultation with a dermatologist in Atopic Dermatitis in 48 participants. Terminated before completion.

Timeline

13 January 2020

Primary endpoint
15 October 2021

15 October 2021

Quick facts

Lead sponsor	University Hospital, Brest
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	48
Start date	13 January 2020
Primary completion	15 October 2021
Estimated completion	15 October 2021
Sites	1 location across France

Drugs / interventions tested

• Filmed consultation with a dermatologist

Conditions studied

• Atopic Dermatitis — all drugs for Atopic Dermatitis →

Sponsor

University Hospital, Brest

Who can join

Under 6 Months, any sex, with Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Atopic dermatitis (AD) is an frequent chronic and itchy inflammatory dermatitis which concern about 20% of pediatric population with a revelation usually toward 3-6 months of live. However, there are very few data about the prevalence of pruritus of young infants and about the discomfort linked with it. While the skin and the nervous system of young infants (Under 6 month) are competent in pruritus experiment, the acquisition of conscious and deliberate motor ability allowing specific scratching of the body parts which are affected is possible only from 6 month. Thus, the diagnosis of AD intensity and the assesment of the potential associated discomfort are hard. At the present time, the diagnosis and the assesment of pruritus of children are based on a hetero-assesment via scales which are not applicable for infants under 6 month. The visual scale "Numeric Rating Scale" validated in adult population seems to be the most specific to assess AD severity. In pediatric population, the use of "Eppendorf Itch Questionnaire" and the american version of "Childhood Atopic Dermatitis Impact Scale" are recommended. Alternatives to clinic and subjective scoring of pruritus severity are described via actigraphy. Thus, a strong statistic correlation have been demonstrated between a nocturne measure of motor activity of wrist, as a reflect of the intensity of pruritus, and infra-red video analysis. But, once again, the technic is not adapted to young infants because of the absence of conscious and oriented motor ability and as a result of less organised sleep/wake cycle.

In order to improve young infants' (Under 6 month) care, the analysis of their behaviours with AD seems to be necessary to better identify a discomfort of these patients.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.