Comparative Analysis of Filmed Sequences for the Assessment of Discomfort in Atopic Dermatitis of Infants Under 6 Months of Age (PRURINEO)
Primary Purpose
Atopic Dermatitis
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Filmed consultation with a dermatologist
Sponsored by
About this trial
This is an interventional other trial for Atopic Dermatitis
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
Sites / Locations
- CHRU de Brest
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Atopic Dermatitis patients
Healthy patients
Arm Description
Filmed consultation with a dermatologist. Laterality and tactile sensitivity test.
Filmed consultation with a dermatologist. Laterality and tactile sensitivity test.
Outcomes
Primary Outcome Measures
Frequency of occurrence of each behaviors
The frequency of occurrence of each behaviors will be identify.
Percentage of time passed to express each behavior
The percentage of time passed to express each behavior will be noted.
Secondary Outcome Measures
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
Tactile sensitivity test
Von frey filaments will be applied on the patients skin to estimate the reaction threshold to a subtle tactile stimuli.
Laterality test
An object will be presented to the patient and the dermatologist will note the hand used by the patient to take it.
Full Information
NCT ID
NCT03684343
First Posted
September 11, 2018
Last Updated
January 20, 2023
Sponsor
University Hospital, Brest
1. Study Identification
Unique Protocol Identification Number
NCT03684343
Brief Title
Comparative Analysis of Filmed Sequences for the Assessment of Discomfort in Atopic Dermatitis of Infants Under 6 Months of Age
Acronym
PRURINEO
Official Title
Comparative Analysis of Filmed Sequences for the Assessment of Discomfort in Atopic Dermatitis of Infants Under 6 Months of Age
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
inclusion difficulties
Study Start Date
January 13, 2020 (Actual)
Primary Completion Date
October 15, 2021 (Actual)
Study Completion Date
October 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atopic Dermatitis patients
Arm Type
Other
Arm Description
Filmed consultation with a dermatologist. Laterality and tactile sensitivity test.
Arm Title
Healthy patients
Arm Type
Other
Arm Description
Filmed consultation with a dermatologist. Laterality and tactile sensitivity test.
Intervention Type
Other
Intervention Name(s)
Filmed consultation with a dermatologist
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency of occurrence of each behaviors
Description
The frequency of occurrence of each behaviors will be identify.
Time Frame
Day 0
Title
Percentage of time passed to express each behavior
Description
The percentage of time passed to express each behavior will be noted.
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
SCORin Atopic Dermatitis
Description
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
Time Frame
Day 0
Title
Tactile sensitivity test
Description
Von frey filaments will be applied on the patients skin to estimate the reaction threshold to a subtle tactile stimuli.
Time Frame
Day 0
Title
Laterality test
Description
An object will be presented to the patient and the dermatologist will note the hand used by the patient to take it.
Time Frame
Day 0
10. Eligibility
Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
CHRU de Brest
City
Brest
ZIP/Postal Code
29200
Country
France
12. IPD Sharing Statement
Learn more about this trial
Comparative Analysis of Filmed Sequences for the Assessment of Discomfort in Atopic Dermatitis of Infants Under 6 Months of Age
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