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

NCT ID: NCT03684343

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-13
• Study Completion Date: 2021-10-15

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Atopic Dermatitis patients

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

Group Type: OTHER

Filmed consultation with a dermatologist

Intervention Type: OTHER

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.

Healthy patients

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

Group Type: OTHER

Filmed consultation with a dermatologist

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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 :

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

Exclusion Criteria

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

• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHRU de Brest

Brest, France, France

Countries

France

References

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.

Reference Type: RESULT

PMID: 40199912 (View on PubMed)

Other Identifiers

29BRC17.0205 - PRURINEO

Identifier Type: -

Identifier Source: org_study_id