NCT04218877

Brief Summary

This study evaluates the influence of different triggers on atopic dermatitis manifestation in children under 3 years old.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 6, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

March 10, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2020

Completed
Last Updated

February 2, 2022

Status Verified

February 1, 2022

Enrollment Period

9 months

First QC Date

December 30, 2019

Last Update Submit

February 1, 2022

Conditions

Atopic Dermatitis

Keywords

atopic dermatitis

Outcome Measures

Primary Outcomes (1)

  • Trigger's factors for atopic dermatitis

    Vitamins during pregnancy; probiotics during pregnancy; school for future parents; vaginal birth; cesarian section; "golden hour" after delivery; antibiotics for mother and child right away after delivery; vaccination; breastfeeding; time after delivery for discharging hospital; using herbs for child's bathing; cosmetics for child; mother's diet after delivery; air's moisture; newborn's acne; pets; in what age child taste egg, cow's milk, fish, wheat, peanut, seafood; breastfeeding durations; infant formula in first year. All this factor will be aggregated as "yes" and "no"

    3 years

Study Arms (3)

Children with atopic dermatitis

Children 1-3 years old with atopic dermatitis

Children without atopic dermatitis

Children with genetic predisposition

Children with genetic predisposition to atopic dermatitis, but without manifestations

Eligibility Criteria

Age1 Year - 3 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients A Medclinic

You may qualify if:

  • children 1-3 age without rash, without atopic dermatitis
  • children 1-3 age with recurrent atopic dermatitis

You may not qualify if:

  • children 1-3 age with non-specific rush
  • children age 1-2 with atopic dermatitis without rush during previous year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amedclinic

Moscow, 129626, Russia

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
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2019

First Posted

January 6, 2020

Study Start

March 10, 2020

Primary Completion

December 10, 2020

Study Completion

December 10, 2020

Last Updated

February 2, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)