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

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.

Study Overview

• Status: Terminated
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Other: Filmed consultation with a dermatologist

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • France
    • Brest, France, France, 29200
      • CHRU de Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 months (Child)
• Accepts Healthy Volunteers: Yes

Description

Atopic dermatitis patients :

Inclusion Criteria:

• Young infant Under 6 month
• Patient with AD (SCORAD between 25 and 50 for moderate AD and > 50 for severe AD)
• Informed consent of the patient's parents

Healthy patients :

Inclusion Criteria:

• Young infant under 6 month
• Free of any pathology
• Informed consent of the patient's parents

Exclusion Criteria (for every patients) :

• Acute intercurrent disease
• Severe malformation
• Underage parents or parent unable to give their consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Atopic Dermatitis patients; Filmed consultation with a dermatologist. Laterality and tactile sensitivity test.	Other: Filmed consultation with a dermatologist; Patient will be seen by a dermatologist for a consultation which will be filmed. During the consult, a laterality test and a tactile sensitivity test will be performed. After the consult, videos will be analysed by scientists to identify the frequency of occurrence of each behavior and the percentage of time passed to express each behavior.
Other: Healthy patients; Filmed consultation with a dermatologist. Laterality and tactile sensitivity test.	Other: Filmed consultation with a dermatologist; Patient will be seen by a dermatologist for a consultation which will be filmed. During the consult, a laterality test and a tactile sensitivity test will be performed. After the consult, videos will be analysed by scientists to identify the frequency of occurrence of each behavior and the percentage of time passed to express each behavior.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of occurrence of each behaviors	The frequency of occurrence of each behaviors will be identify.	Day 0
Percentage of time passed to express each behavior	The percentage of time passed to express each behavior will be noted.	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SCORin Atopic Dermatitis	SCORAD is a severity score used for atopic dermatitis. Only patients with AD will performed this test. SCORAD<25 : mild AD; 25<SCORAD<50 : moderate AD and SCORAD >50 : severe AD	Day 0
Tactile sensitivity test	Von frey filaments will be applied on the patients skin to estimate the reaction threshold to a subtle tactile stimuli.	Day 0
Laterality test	An object will be presented to the patient and the dermatologist will note the hand used by the patient to take it.	Day 0

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Publications and helpful links

General Publications

• Boyard A, Cosnard C, Simon D, Le Pors C, Abasq-Thomas C, Grandgeorge M, Misery L, Henry S, Roue JM. Evidences for gestures associated with pruritus in very young infants: a pilot study. Sci Rep. 2025 Apr 8;15(1):11943. doi: 10.1038/s41598-025-93412-8.

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2020
• Primary Completion (Actual): October 15, 2021
• Study Completion (Actual): October 15, 2021

Study Registration Dates

• First Submitted: September 11, 2018
• First Submitted That Met QC Criteria: September 24, 2018
• First Posted (Actual): September 25, 2018

Study Record Updates

• Last Update Posted (Estimated): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic
• Other Study ID Numbers: 29BRC17.0205 - PRURINEO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No