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

Atopic Dermatitis Clinical Trial

— PRURINEO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03684343
• Other study ID #: 29BRC17.0205 - PRURINEO
• Status: Terminated
• Phase: N/A
• Start date: January 13, 2020
• Est. completion date: October 15, 2021

Study information

• Verified date: January 2023
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: October 15, 2021
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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.

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of occurrence of each behaviors	The frequency of occurrence of each behaviors will be identify.	Day 0
Primary	Percentage of time passed to express each behavior	The percentage of time passed to express each behavior will be noted.	Day 0
Secondary	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	Day 0
Secondary	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
Secondary	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