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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03684343
Acronym
PRURINEO
Enrollment
48
Registered
2018-09-25
Start date
2020-01-13
Completion date
2021-10-15
Last updated
2025-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

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.

Interventions

OTHERFilmed 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.

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Frequency of occurrence of each behaviorsDay 0The frequency of occurrence of each behaviors will be identify.
Percentage of time passed to express each behaviorDay 0The percentage of time passed to express each behavior will be noted.

Secondary

MeasureTime frameDescription
SCORin Atopic DermatitisDay 0SCORAD 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
Tactile sensitivity testDay 0Von frey filaments will be applied on the patients skin to estimate the reaction threshold to a subtle tactile stimuli.
Laterality testDay 0An object will be presented to the patient and the dermatologist will note the hand used by the patient to take it.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026