NCT06551363

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2019

Completed
5.2 years until next milestone

First Posted

Study publicly available on registry

August 13, 2024

Completed
Last Updated

August 13, 2024

Status Verified

February 1, 2018

Enrollment Period

2 months

First QC Date

June 21, 2019

Last Update Submit

August 12, 2024

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitisinfantEtology

Outcome Measures

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.

    6 month

Secondary Outcomes (1)

  • Frequency of behaviors according to the severity of atopic dermatitis

    6 month

Eligibility Criteria

Age0 Months - 1 Year
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2019

First Posted

August 13, 2024

Study Start

March 1, 2018

Primary Completion

April 26, 2018

Study Completion

April 26, 2018

Last Updated

August 13, 2024

Record last verified: 2018-02

Locations

FR(1)