Demodex Density, Immune Response and Oxidative Stress in Rosacea Patients

September 22, 2015 updated by: Tuğba Falay, Istanbul Training and Research Hospital

Investigation of Relation Between Demodex Density With Immune Response and Oxidative Stress in Rosacea Patients

Aim of study is to determine reactive oxygen products and antioxidant capacity with rosacea patients; to measure metalloproteinase level and inflammatory markers of immune response and investigate their corelation with demodex infestation and also investigate the role of photoaging and sebum secretion in rosacea.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Rosacea is a common and chronic inflammatory disease characterized by facial erythema, papule, pustule and telangiectasia. Ultraviolet, Demodex mite, oxidative stress and antioxidant system disorders are emphasized in increased inflammation seen in rosacea.

The aim of our study was to evaluate the status of oxidative stress, matrix metalloproteinase (MMP) and inflammatory markers in systemic circulation, their relationship with demodex density and investigate the role of photoaging and sebum secretion in rosacea.

Forty patients with rosacea and age, gender and skin phenotype matched 40 healthy volunteers were enrolled in the study. Reflectance confocal microscopy (RCM) was used to calculate facial demodex density. The number of demodex, follicle, the number of mite per follicle, the number of infested follicle and the number of mite per infested follicle were calculated with RCM.

Photoaging severity and facial sebum levels were also assessed. Total oxidant capacity (TOC), total antioxidant capacity (TAC), oxidative stress index (OSI), paraoxonase-1 (PON-1), aryl esterase (ARES), myeloperoxidase (MPO), tumor necrosis factor-alpha (TNF-α), interleukin-1beta (IL-1β), matrix metalloproteinase-1 (MMP-1) and matrix metalloproteinase-9 (MMP-9) levels in venous blood were measured.

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Org. Abd. Nafiz Gürman
      • Istanbul, Org. Abd. Nafiz Gürman, Turkey, 34098
        • Recruiting
        • Istanbul Training and Research Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tugba Falay
        • Principal Investigator:
          • Vefa Aslı Erdemir
        • Sub-Investigator:
          • Mehmet Salih Gürel
        • Sub-Investigator:
          • Abdurrahim Kocyigit
        • Sub-Investigator:
          • Duygu Erdil
        • Sub-Investigator:
          • Eray Metin Güler

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Rosacea patients who are between the ages of 18-70, who having no systemic illness and who were not smoking and who were not using any topical and systemic treatment for a month attended to the study. As a control group it was planned that healthy volunteers who were compatible in terms of age, sex and skin phenotype, who were not smoking, with no systemic illness to be taken.

Description

Inclusion Criteria:

  • Between the ages of 18-70
  • No systemic illness
  • No other inflammatory dermatoses except for rosacea
  • No smoking
  • Not using any topical, systemic treatment and sunblock at least a month for rosacea or other condition

Exclusion Criteria:

  • Systemic illness
  • Other inflammatory dermatoses except for rosacea
  • Smoking
  • Using any topical, systemic treatment and sunblock for rosacea or other condition
  • Type 4 rosacea patient (only ocular involvement)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
H, Rosacea patients

Rosacea patients who were between the ages of 18-70, having no systemic illness and who were not smoking.

Obtaining a blood sample; TOC, TAC, OSI, PON-1, ARES, MPO, TNF-α, IL-1β, MMP-1 and MMP-9 levels in venous blood were measured Reflectance confocal microscopy; 1mm2-sized 10 images were taken from right cheek and forehead; the number of demodex, follicle, the number of mite per follicle, the number of infested follicle and the number of mite per infested follicle were calculated with RCM. And photoaging severity were also assessed by using RCM. Sebum rate at forehead and right cheek were evaluated with sebumeter. Dermoscopic photoaging scale were assessed by using video dermoscopy.
Other: Obtaining a blood sample
Total oxidant capacity (TOC), total antioxidant capacity (TAC), oxidative stress index (OSI), paraoxonase-1 (PON-1), aryl esterase (ARES), myeloperoxidase (MPO), tumor necrosis factor-alpha (TNF-α), interleukin-1beta (IL-1β), matrix metalloproteinase-1 (MMP-1) and matrix metalloproteinase-9 (MMP-9) levels in venous blood were measured.
Device: Reflectance confocal microscopy
1mm2-sized 10 images were taken from right cheek and forehead; the number of demodex, follicle, the number of mite per follicle, the number of infested follicle and the number of mite per infested follicle were calculated with RCM. And photoaging severity were also assessed by using RCM.
Device: Sebumeter
Sebum rate at forehead and right cheek were evaluated with sebumeter
Device: Video dermoscopy
Dermoscopic photoaging scale were assessed by using video dermoscopy.
K, Healthy volunteers

Healthy volunteers who were compatible in terms of age, sex and skin phenotype, having no systemic illness and who were not smoking.

Obtaining a blood sample; TOC, TAC, OSI, PON-1, ARES, MPO, TNF-α, IL-1β, MMP-1 and MMP-9 levels in venous blood were measured Reflectance confocal microscopy; 1mm2-sized 10 images were taken from right cheek and forehead; the number of demodex, follicle, the number of mite per follicle, the number of infested follicle and the number of mite per infested follicle were calculated with RCM. And photoaging severity were also assessed by using RCM. Sebum rate at forehead and right cheek were evaluated with sebumeter. Dermoscopic photoaging scale were assessed by using video dermoscopy.
Other: Obtaining a blood sample
Total oxidant capacity (TOC), total antioxidant capacity (TAC), oxidative stress index (OSI), paraoxonase-1 (PON-1), aryl esterase (ARES), myeloperoxidase (MPO), tumor necrosis factor-alpha (TNF-α), interleukin-1beta (IL-1β), matrix metalloproteinase-1 (MMP-1) and matrix metalloproteinase-9 (MMP-9) levels in venous blood were measured.
Device: Reflectance confocal microscopy
1mm2-sized 10 images were taken from right cheek and forehead; the number of demodex, follicle, the number of mite per follicle, the number of infested follicle and the number of mite per infested follicle were calculated with RCM. And photoaging severity were also assessed by using RCM.
Device: Sebumeter
Sebum rate at forehead and right cheek were evaluated with sebumeter
Device: Video dermoscopy
Dermoscopic photoaging scale were assessed by using video dermoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Severity of rosacea
Time Frame: Rosacea patients who refer to criteria will be evaluated throughout 4 months.
Rosacea patients who refer to criteria will be evaluated throughout 4 months.

Secondary Outcome Measures

Outcome Measure
Time Frame
The number of demodex of right cheek and forehead
Time Frame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
The number of follicle of right cheek and forehead
Time Frame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
The number of mite per follicle of right cheek and forehead
Time Frame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
The number of infested follicle of right cheek and forehead
Time Frame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
The number of mite per infested follicle of right cheek and forehead
Time Frame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Total oxidant capacity (TOC)
Time Frame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Total antioxidant capacity (TAC)
Time Frame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Oxidative stress index (OSI)
Time Frame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Paraoxonase-1 (PON-1)
Time Frame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Aryl esterase (ARES)
Time Frame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Myeloperoxidase (MPO)
Time Frame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Tumor necrosis factor-alpha (TNF-α)
Time Frame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Interleukin-1beta (IL-1β)
Time Frame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Matrix metalloproteinase-1 (MMP-1)
Time Frame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Matrix metalloproteinase-1 (MMP-9)
Time Frame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.

Other Outcome Measures

Outcome Measure
Time Frame
Sebum levels of right cheek and forehead
Time Frame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Photoaging severity of face by using RCM and dermoscopy
Time Frame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Training and Research Hospital

Collaborators

Bezmialem Vakif University

Investigators

  • Principal Investigator: Tugba Falay, Istanbul Training and Research Hospital
  • Study Director: Vefa Aslı Erdemir, Istanbul Training and Research Hospital
  • Study Director: Mehmet Salih Gürel, Istanbul Training and Research Hospital
  • Study Director: Abdurrahim Kocyigit, Bezmialem Vakif University
  • Study Chair: Duygu Erdil, Istanbul Training and Research Hospital
  • Study Chair: Eray Metin Güler, Bezmialem Vakif University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

November 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

September 21, 2015

First Submitted That Met QC Criteria

September 21, 2015

First Posted (Estimate)

September 22, 2015

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 71306642-050.01.04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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