NCT04224597

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 8, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

2 months

First QC Date

January 8, 2020

Last Update Submit

January 23, 2020

Conditions

EnthesitisAcne VulgarisUltrasonography

Keywords

enthesitisacne vulgarisGuess

Outcome Measures

Primary Outcomes (2)

  • patellar tendon thicknesses of patients with acne vulgaris and healthy controls

    3 months

  • Ashilles tendon thicknesses of patients with acne vulgaris and healthy controls

    3 months

Study Arms (2)

Patients with acne vulgaris

patients with acne vulgaris aged between 18-25 year

Diagnostic Test: ultrasonography

Healthy controls

healthy controls aged between 18-25 year

Diagnostic Test: ultrasonography

Interventions

ultrasonographyDIAGNOSTIC_TEST

all participants will be determined by ultrasonography.

Healthy controlsPatients with acne vulgaris

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients with acne vulgaris and healthy controls aged between 18-25

You may not qualify if:

  • Participants with rheumatic and neurologic disease, history of trauma ,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dilek Eker Büyükşireci

Çorum, Central Anatolia, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Dilek E Büyükşireci

CONTACT

+905439196253dilekeker55@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist doctor

Study Record Dates

First Submitted

January 8, 2020

First Posted

January 13, 2020

Study Start

February 1, 2020

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)