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

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ClinicalTrials.gov Identifier: NCT03684343
Recruitment Status : Terminated (inclusion difficulties)
First Posted : September 25, 2018
Last Update Posted : February 1, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Study Description
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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.


Condition or disease Intervention/treatment Phase
Atopic Dermatitis Other: Filmed consultation with a dermatologist Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Comparative Analysis of Filmed Sequences for the Assessment of Discomfort in Atopic Dermatitis of Infants Under 6 Months of Age
Actual Study Start Date : January 13, 2020
Actual Primary Completion Date : October 15, 2021
Actual Study Completion Date : October 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arms and Interventions
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Arm Intervention/treatment
Atopic Dermatitis patients
Filmed consultation with a dermatologist. Laterality and tactile sensitivity test.
 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.
Healthy patients
Filmed consultation with a dermatologist. Laterality and tactile sensitivity test.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of occurrence of each behaviors [ Time Frame: Day 0 ]
    The frequency of occurrence of each behaviors will be identify.

  2. Percentage of time passed to express each behavior [ Time Frame: Day 0 ]
    The percentage of time passed to express each behavior will be noted.


Secondary Outcome Measures :
  1. SCORin Atopic Dermatitis [ Time Frame: Day 0 ]
    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

  2. Tactile sensitivity test [ Time Frame: Day 0 ]
    Von frey filaments will be applied on the patients skin to estimate the reaction threshold to a subtle tactile stimuli.

  3. Laterality test [ Time Frame: Day 0 ]
    An object will be presented to the patient and the dermatologist will note the hand used by the patient to take it.


Eligibility Criteria
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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03684343


Locations
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France
CHRU de Brest
Brest, France, 29200
Sponsors and Collaborators
University Hospital, Brest
More Information
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03684343    
Other Study ID Numbers: 29BRC17.0205 - PRURINEO
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: February 1, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
 Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases