NCT05904509

Brief Summary

The aim of the study is to determine the relationship between insulin resistance and disease duration and severity of atopic dermatitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2022

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

September 1, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

1.1 years

First QC Date

June 6, 2023

Last Update Submit

February 12, 2024

Conditions

Atopic Dermatitis

Keywords

atopic dermatitisinsulin resistance

Outcome Measures

Primary Outcomes (4)

  • HOMA-IR

    Patients' blood test show the result of fasting insulin (microU/L) x fasting glucose (mmol/L)/22.5

    12 months

  • SCORAD index

    Severity scoring of atopic dermatitis is calculated for each patient in the study. 6 intensity items (erythema, edema/papulation, oozing/crusts, excoriations, lichenification, dryness); 2 subjective symptoms(itch, sleeplessness); body surface area are studied. Max score is 103.

    12 months

  • EASI index

    Eczema Area and Severity Index is calculated for each patient in the study. Body surface area, 4 intensity items(erythema, induration, excoriation, lichenification) are studied. Max score is 72.

    12 months

  • Duration of the disease

    The time from the first onset of symptoms of the disease to the present. The relationship between insulin resistance and disease duration is examined

    12 months

Eligibility Criteria

Age2 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Atopic dermatitis patients confirmed by a dermatologist

You may qualify if:

  • Atopic dermatitis patients confirmed by a dermatologist

You may not qualify if:

  • patients younger than 2 years
  • patients older than 80 years
  • Atopic dermatitis patients without HOMA-IR result

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dermatitis, AtopicInsulin Resistance

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2023

First Posted

June 15, 2023

Study Start

September 1, 2022

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

February 13, 2024

Record last verified: 2024-02

Locations

TU(1)