EnthesitisNCT04224597
Evaluation of the Presence of Enthesitis in Patients With Acne Vulgaris
An observational study of Enthesitis and Acne Vulgaris, run by Erol Olcok Corum Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Acne vulgaris is an inflammatory disease of the pilosebaceous unit, affecting about 85% of the young population. In the studies p. acne is a potent stimulator of the release of IFN-gamma (IFN-)) and IL-17 from CD4 + T cells, and the presence of IL-17 + cells in the perifollicular infiltrate has been shown in biopsies… Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Enthesitis, Acne Vulgaris, Ultrasonography
- What is being tested?
- ultrasonography
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2020to 1 Apr 2020
- 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 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients with acne vulgaris and healthy controls aged between 18-25
Who may be able to join
- Patients with acne vulgaris and healthy controls aged between 18-25
Who cannot join
- Participants with rheumatic and neurologic disease, history of trauma ,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dilek Eker Büyükşireci
Çorum, Central Anatolia
About this study
Acne vulgaris is an inflammatory disease of the pilosebaceous unit, affecting about 85% of the young population. In the studies p. acne is a potent stimulator of the release of IFN-gamma (IFN-)) and IL-17 from CD4 + T cells, and the presence of IL-17 + cells in the perifollicular infiltrate has been shown in biopsies of inflammatory acne lesions. Therefore, acne is thought to be a Th17-related disease (1).
This study was aimed to evaluate the presence of enthesitis in patients with acne vulgaris.
Read the detailed description
Patients with acne vulgaris and healthy controls aged between 18-25 who admitted to Hitit University Erol Olcok Education and Research Hostpital Dermatology policlinic will be icluded. Patients with rheumatic, neurological diseases, history of trauma and previous fractures will be excluded from the study. After all the participants were evaluated by the dermatologist and demographic data will be recorded, the participants will be examined by the physical medicine and rehabilitation specialist and the short form-36 (sf-36), hospital anxiety and depression scale will be completed. Bilateral lower extremity tendon thicknesses and the presence of erosion, bursitis, etc. will be evaluated according to the criteria of Guess (Glasgow Ultrasound Enthesitis Scoring System) and Guess score will be determined for all participants. A total of 48 participants, 24 patients with acne vulgaris and 24 healthy controls, will be included in the study (2).
- Conditions
- Enthesitis, Acne Vulgaris, Ultrasonography
- Being tested
- ultrasonography
- Keywords
- enthesitis, acne vulgaris, Guess
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonographyDiagnostic test
all participants will be determined by ultrasonography.
| Study group | Role | What they receive |
|---|---|---|
| Patients with acne vulgaris | patients with acne vulgaris aged between 18-25 year Receives: Diagnostic Test: ultrasonography | |
| Healthy controls | healthy controls aged between 18-25 year Receives: Diagnostic Test: ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
patellar tendon thicknesses of patients with acne vulgaris and healthy controls
Measured: 3 months
Ashilles tendon thicknesses of patients with acne vulgaris and healthy controls
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start1 Feb 2020 (estimated)
- Primary completion1 Apr 2020 (estimated)
- Study completion1 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EnthesitisStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erol Olcok Corum Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Eker Büyükşireci, Erol Olcok Corum Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04224597
- Sponsor's protocol ID
- Hitit University
- Status last verified
- Jan 2020
- First submitted
- 8 Jan 2020
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- 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 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Presence of Enthesitis in Patients With Acne Vulgaris
- ClinicalTrials.gov ID
- NCT04224597
- Acronym / sponsor ID
- Hitit University
- Conditions
- Enthesitis, Acne Vulgaris, Ultrasonography
- Keywords
- enthesitis, acne vulgaris, Guess
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Erol Olcok Corum Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 1 Apr 2020 (estimated)
- First posted
- 13 Jan 2020 (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.
Acne vulgaris is an inflammatory disease of the pilosebaceous unit, affecting about 85% of the young population. In the studies p. acne is a potent stimulator of the release of IFN-gamma (IFN-)) and IL-17 from CD4 + T cells, and the presence of IL-17 + cells in the perifollicular infiltrate has been shown in biopsies of inflammatory acne lesions. Therefore, acne is thought to be a Th17-related disease (1).
This study was aimed to evaluate the presence of enthesitis in patients with acne vulgaris.
Detailed description
Patients with acne vulgaris and healthy controls aged between 18-25 who admitted to Hitit University Erol Olcok Education and Research Hostpital Dermatology policlinic will be icluded. Patients with rheumatic, neurological diseases, history of trauma and previous fractures will be excluded from the study. After all the participants were evaluated by the dermatologist and demographic data will be recorded, the participants will be examined by the physical medicine and rehabilitation specialist and the short form-36 (sf-36), hospital anxiety and depression scale will be completed. Bilateral lower extremity tendon thicknesses and the presence of erosion, bursitis, etc. will be evaluated according to the criteria of Guess (Glasgow Ultrasound Enthesitis Scoring System) and Guess score will be determined for all participants. A total of 48 participants, 24 patients with acne vulgaris and 24 healthy controls, will be included in the study (2).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with acne vulgaris | – | Diagnostic Test: ultrasonographypatients with acne vulgaris aged between 18-25 year |
| Healthy controls | – | Diagnostic Test: ultrasonographyhealthy controls aged between 18-25 year |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with acne vulgaris and healthy controls aged between 18-25
Key inclusion criteria (1 listed)
- Patients with acne vulgaris and healthy controls aged between 18-25
Key exclusion criteria (1 listed)
- Participants with rheumatic and neurologic disease, history of trauma ,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasonographyall participants will be determined by ultrasonography. | Diagnostic test | Healthy controls, Patients with acne vulgaris |
Primary outcome
patellar tendon thicknesses of patients with acne vulgaris and healthy controls
Time frame: 3 months
Ashilles tendon thicknesses of patients with acne vulgaris and healthy controls
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: No
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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.
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 Enthesitis and Acne Vulgaris, run by Erol Olcok Corum 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 1 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: status not confirmed, as of the sponsor's last update on 27 Jan 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dilek E Büyükşireci (+905439196253, dilekeker55@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patellar tendon thicknesses of patients with acne vulgaris and healthy controls (time frame: 3 months). The study lists 2 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 27 Jan 2020.