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CompletedNCT06551363PRE-PRURINEOUpdated Aug 13, 2024

Atopic Dermatitis Cutaneous Discomfort of the Infant Under the Age of One Year : Analysis of Filmed Sequences (PRE-PRURINEO)

An observational study in Atopic Dermatitis, sponsored by University Hospital, Brest. Completed at 1 site in France. Open to participants aged 0 Months to 1 Year. Per ClinicalTrials.gov, last updated 2024-08-13.

Sponsored by University Hospital, Brest · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
7
Ages
0 Months to 1 Year
Sex
All
01

Study summary

Analysis of filmed sequences for the assessment of discomfort in atopic dermatitis in infants under 1year of age

Read the detailed description

Atopic Dermatitis (AD) is a chronic inflammatory and itchy dermatitis particularly common in childhood since it affects about 20% of the pediatric population, with revelation usually around the age of 3-6 months of life. However, there are very few pediatric population data on the prevalence of pruritus and associated discomfort in infants. Although the skin and the nervous system of the infant (\<6 months) are competent in the experiment of the pruritus, the acquisition of an intentional motricity allowing the targeted scratching of the affected body areas is done only from the age of 6 months, making it difficult to diagnose the intensity of the AD and assess the potential discomfort caused. Currently, the diagnosis and assessment of pruritus in children is based on a hetero-rating through scales, which are not at all applicable for infants under 6 months of age (population concerned by our study).

The visual scale Numeric Rating Scale, validated in adult population seems to be the one that most accurately assesses the severity of pruritus. In pediatric populations, the use of the Eppendorf Itch Questionnaire and the US version of the Childhood Atopic Dermatitis Impact Scale are recommended. Alternatives to the clinical and subjective rating of the severity of pruritus have been described via actigraphy: thus, a strong statistical correlation has been demonstrated between a nocturnal measurement of wrist motor activity as a reflection of the intensity of pruritus, and the analysis of videos filmed in infra-red. But, again, the technique is not suitable for young infants, because of the absence of voluntary motivated motor skills, and because of less organized sleep / wake cycles.

In order to better manage infants less than 1 year old, the analysis of their behavior in case of atopic dermatitis seems necessary to us to better identify a potential discomfort in these patients.

This is an essential preliminary study that will allow us to better define the judgment criteria necessary for the implementation of an observational study comparing infants with atopic dermatitis to healthy infants.

02

Conditions studied

  • Atopic Dermatitis

Keywords

  • Atopic dermatitis
  • infant
  • Etology
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 7 is below the median of 150 across 237 observational studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

University Hospital, Brest is the lead sponsor of 594 studies on the registry; 135 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Months to 1 Year
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Infants with moderate to severe atopic dermatitis less than 1 year old

Inclusion criteria

  • Infants under 1 year old
  • with atopic dermatitis
  • No opposition from at least one of the patient's parents

Exclusion criteria

Exclusion Criteria:

  • Acute intercurrent pathology
  • Severe malformation or genetic abnomalies
  • Parent (s) minor (s) or unfit (s) to give their informed consent
  • Refusal of patients
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
7 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Focal sampling and Scan sampling of the behaviors

    Frequency of behaviors observed by the method of "focal sampling" and "scan sampling". All behavioral responses of the infants will be quantified from the video recordings.

    Time frame: 6 month

Secondary outcomes

  1. Frequency of behaviors according to the severity of atopic dermatitis

    Frequency of focal sampling behaviors according to the severity of atopic dermatitis evaluated using SCORAD score All behavioral responses of the infants will be quantified from the video recordings.

    Time frame: 6 month

07

Study locations

1 site
  • CHRU de Brest
    Brest, 29609, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06551363
Lead sponsor
University Hospital, Brest
Responsible party
Sponsor
First posted
Aug 13, 2024
Start date
Mar 1, 2018
Primary completion
Apr 26, 2018
Completion
Apr 26, 2018
Last update
Aug 13, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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