Granuloma AnnulareNCT05472636
Evaluation of 41 Cases of Pediatric Granuloma Annulare
An observational study of Granuloma Annulare, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Granuloma Annulare
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Mar 2022to 1 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients under the age of 18 who were admitted to the dermatology outpatient clinic between 2008-2021 and diagnosed with granuloma annulare
Who may be able to join
- 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
Who cannot join
- -Being over 18 years old
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Training and Research Hospital
Istanbul, 34098
About this study
Official title: Clinical and Histopathological Evaluation of 41 Cases of Pediatric Granuloma Annulare
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.
Read the detailed description
Granuloma annulare; is a non-infectious, granulomatous skin reaction with potential triggers that can affect the adult and pediatric age group. Diabetes mellitus, hyperlipidemia, and malignancy have been described in association with adult granuloma annulare cases. While there are studies on the clinical, pathological features and associated diseases in patients with adult granuloma annulare, a limited number of studies have been conducted on pediatric granuloma annulare patients. Therefore, clinical and histopathological evaluation of pediatric granuloma annulare cases was planned in our study.
This study was performed retrospectively in a single-center tertiary dermatology hospital. 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. Cases with uncertain diagnosis were not included in the study. Cases with dermatological findings recorded in detail and/or diagnosed histopathologically were included in the study. Demographic features, lesion localization, lesion characteristics (size, elementary lesion, color), involvement (localized/generalized), histopathological features, concomitant diseases, differential diagnoses in cases with histopathology, regression time and recommended treatments were recorded.
- Conditions
- Granuloma Annulare
- Keywords
- Granuloma Annulare, Pediatric Dermatology, Pediatric Granuloma Annulare
- Medical subject headings
- Granuloma Annulare
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients under the age of 18 who were admitted to the dermatology outpatient clinic between 2008-2021 and diagnosed with granuloma annulare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the genders of the pediatric patients with granuloma annulare
male, female
Measured: day 0
Evaluation of the ages of the pediatric patients with granuloma annulare
age (year)
Measured: day 0
Evaluation of the concomitant diseases of the pediatric patients with granuloma annulare
the concomitant diseases of the participants
Measured: day 0
Evaluation of the lesion localization of the pediatric patients with granuloma annulare
head and neck, upper extremity, lower extremity, trunk
Measured: 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)
Measured: day 0
Evaluation of the lesion type of the pediatric patients with granuloma annulare
papule, pustule, plaque, nodule
Measured: day 0
Evaluation of the mean size of the lesion
diameter (cm)
Measured: day 0
Evaluation of the clinical involvement
localized, generalized
Measured: day 0
Histopathological evaluation of the infiltration type of the pediatric patients with granuloma annulare
neutrophilic, lymphocytic, lymphohistiocytic, eosinophil, mixed infiltrations
Measured: day 0
Histopathological evaluation of the infiltration pattern of the pediatric patients with granuloma annulare
Interstitial, palisadic
Measured: day 0
Evaluation of epidermal findings
regular/irregular, hyperkeratosis, acanthosis
Measured: day 0
Evaluation of depth of infiltrate
superficial, medium, deep
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start11 Mar 2022
- Primary completion11 May 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Granuloma AnnulareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ayse Esra Koku Aksu, Istanbul Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472636
- Sponsor's protocol ID
- 97
- Status last verified
- Jul 2022
- First submitted
- 15 Jul 2022
- Last updated
- 25 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Histopathological Evaluation of 41 Cases of Pediatric Granuloma Annulare
- ClinicalTrials.gov ID
- NCT05472636
- Acronym / sponsor ID
- 97
- Conditions
- Granuloma Annulare
- Keywords
- Granuloma Annulare, Pediatric Dermatology, Pediatric Granuloma Annulare
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 11 May 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Granuloma annulare; is a non-infectious, granulomatous skin reaction with potential triggers that can affect the adult and pediatric age group. Diabetes mellitus, hyperlipidemia, and malignancy have been described in association with adult granuloma annulare cases. While there are studies on the clinical, pathological features and associated diseases in patients with adult granuloma annulare, a limited number of studies have been conducted on pediatric granuloma annulare patients. Therefore, clinical and histopathological evaluation of pediatric granuloma annulare cases was planned in our study.
This study was performed retrospectively in a single-center tertiary dermatology hospital. 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. Cases with uncertain diagnosis were not included in the study. Cases with dermatological findings recorded in detail and/or diagnosed histopathologically were included in the study. Demographic features, lesion localization, lesion characteristics (size, elementary lesion, color), involvement (localized/generalized), histopathological features, concomitant diseases, differential diagnoses in cases with histopathology, regression time and recommended treatments were recorded.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Patients under the age of 18 who were admitted to the dermatology outpatient clinic between 2008-2021 and diagnosed with granuloma annulare |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients under the age of 18 who were admitted to the dermatology outpatient clinic between 2008-2021 and diagnosed with granuloma annulare
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- -Being over 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of the genders of the pediatric patients with granuloma annulare
Time frame: day 0
male, female
Evaluation of the ages of the pediatric patients with granuloma annulare
Time frame: day 0
age (year)
Evaluation of the concomitant diseases of the pediatric patients with granuloma annulare
Time frame: day 0
the concomitant diseases of the participants
Evaluation of the lesion localization of the pediatric patients with granuloma annulare
Time frame: day 0
head and neck, upper extremity, lower extremity, trunk
Evaluation of the lesion duration of the pediatric patients with granuloma annulare
Time frame: day 0
the time interval in between appearance of the lesion and diagnosis (month)
Evaluation of the lesion type of the pediatric patients with granuloma annulare
Time frame: day 0
papule, pustule, plaque, nodule
Evaluation of the mean size of the lesion
Time frame: day 0
diameter (cm)
Evaluation of the clinical involvement
Time frame: day 0
localized, generalized
Histopathological evaluation of the infiltration type of the pediatric patients with granuloma annulare
Time frame: day 0
neutrophilic, lymphocytic, lymphohistiocytic, eosinophil, mixed infiltrations
Histopathological evaluation of the infiltration pattern of the pediatric patients with granuloma annulare
Time frame: day 0
Interstitial, palisadic
Evaluation of epidermal findings
Time frame: day 0
regular/irregular, hyperkeratosis, acanthosis
Evaluation of depth of infiltrate
Time frame: day 0
superficial, medium, deep
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Granuloma Annulare, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the genders of the pediatric patients with granuloma annulare (time frame: day 0). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2022.