NCT05472636

Brief Summary

INTRODUCTION: Granuloma annulare is a non-infectious, granulomatous disease that can affect children and adults. Although there are many studies examining adult patients, there are limited studies examining pediatric granuloma annulare cases. It is aimed to examine the demographic, clinical, and pathological features of pediatric granuloma annulare cases in this study. MATERIALS and METHODS: This study was performed retrospectively in a single-center, tertiary dermatology hospital. Forty-one patients, under the age of 18 who were admitted to the dermatology outpatient clinic between 2008-2021 and diagnosed with granuloma annulare were scanned from the hospital database and patient photograph archive. Demographic characteristics, and clinical and histopathological features were evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

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

Study Start

First participant enrolled

March 11, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2022

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 15, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 25, 2022

Completed
Last Updated

July 25, 2022

Status Verified

July 1, 2022

Enrollment Period

2 months

First QC Date

July 15, 2022

Last Update Submit

July 21, 2022

Conditions

Granuloma Annulare

Keywords

Granuloma AnnularePediatric DermatologyPediatric Granuloma Annulare

Outcome Measures

Primary Outcomes (12)

  • Evaluation of the genders of the pediatric patients with granuloma annulare

    male, female

    day 0

  • Evaluation of the ages of the pediatric patients with granuloma annulare

    age (year)

    day 0

  • Evaluation of the concomitant diseases of the pediatric patients with granuloma annulare

    the concomitant diseases of the participants

    day 0

  • Evaluation of the lesion localization of the pediatric patients with granuloma annulare

    head and neck, upper extremity, lower extremity, trunk

    day 0

  • Evaluation of the lesion duration of the pediatric patients with granuloma annulare

    the time interval in between appearance of the lesion and diagnosis (month)

    day 0

  • Evaluation of the lesion type of the pediatric patients with granuloma annulare

    papule, pustule, plaque, nodule

    day 0

  • Evaluation of the mean size of the lesion

    diameter (cm)

    day 0

  • Evaluation of the clinical involvement

    localized, generalized

    day 0

  • Histopathological evaluation of the infiltration type of the pediatric patients with granuloma annulare

    neutrophilic, lymphocytic, lymphohistiocytic, eosinophil, mixed infiltrations

    day 0

  • Histopathological evaluation of the infiltration pattern of the pediatric patients with granuloma annulare

    Interstitial, palisadic

    day 0

  • Evaluation of epidermal findings

    regular/irregular, hyperkeratosis, acanthosis

    day 0

  • Evaluation of depth of infiltrate

    superficial, medium, deep

    day 0

Study Arms (1)

Patients

Patients under the age of 18 who were admitted to the dermatology outpatient clinic between 2008-2021 and diagnosed with granuloma annulare

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients under the age of 18 who were admitted to the dermatology outpatient clinic between 2008-2021 and diagnosed with granuloma annulare

You may qualify if:

  • Being under 18 years old
  • Having granuloma annulare
  • Applying to the Istanbul Training and Research Hospital, Dermatology Outpatient Clinic between 2008-2021
  • Consenting to participate in the study

You may not qualify if:

  • Being over 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Training and Research Hospital

Istanbul, 34098, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Granuloma Annulare

Condition Hierarchy (Ancestors)

Necrobiotic DisordersCollagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesGranulomaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

July 15, 2022

First Posted

July 25, 2022

Study Start

March 11, 2022

Primary Completion

May 11, 2022

Study Completion

June 1, 2022

Last Updated

July 25, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)