NCT03684343

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 25, 2018

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 13, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2021

Completed
Last Updated

December 12, 2025

Status Verified

January 1, 2023

Enrollment Period

1.8 years

First QC Date

September 11, 2018

Last Update Submit

December 5, 2025

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • SCORin Atopic Dermatitis

    Day 0

  • Tactile sensitivity test

    Day 0

  • Laterality test

    Day 0

Study Arms (2)

Atopic Dermatitis patients

OTHER

Filmed consultation with a dermatologist. Laterality and tactile sensitivity test.

Other: Filmed consultation with a dermatologist

Healthy patients

OTHER

Filmed consultation with a dermatologist. Laterality and tactile sensitivity test.

Other: Filmed consultation with a dermatologist

Interventions

Filmed consultation with a dermatologistOTHER

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.

Atopic Dermatitis patientsHealthy patients

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, France, 29200, France

Location

Related Publications (1)

  • 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.

    PMID: 40199912RESULT

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2018

First Posted

September 25, 2018

Study Start

January 13, 2020

Primary Completion

October 15, 2021

Study Completion

October 15, 2021

Last Updated

December 12, 2025

Record last verified: 2023-01

Locations

FR(1)