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

Study Overview
=================
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.

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

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Other: Filmed consultation with a dermatologist


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Maximum Age: 6 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Atopic Dermatitis patients<br>Filmed consultation with a dermatologist. Laterality and tactile sensitivity test. | Other: Filmed consultation with a dermatologist<br>* 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.<br>|
| Other: Healthy patients<br>Filmed consultation with a dermatologist. Laterality and tactile sensitivity test. | Other: Filmed consultation with a dermatologist<br>* 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.<br>|

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 |