Demodex Density, Immune Response and Oxidative Stress in Rosacea Patients

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: Rosacea
• Intervention / Treatment: Other: Obtaining a blood sample; Device: Reflectance confocal microscopy; Device: Sebumeter; Device: Video dermoscopy

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

Study Locations

• Turkey
  • Org. Abd. Nafiz Gürman
    • Istanbul, Org. Abd. Nafiz Gürman, Turkey, 34098
      • Recruiting
      • Istanbul Training and Research Hospital
      • Contact: Tugba Falay; Phone Number: +905056545501; Email: tugbafalay@hotmail.com
      • Contact: Vefa Aslı Erdemir; Phone Number: +905052685651; Email: vefaasli@hotmail.com
      • 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

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

How is the study designed?

Design Details

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

Number of groups / cohorts

2

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	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	Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
The number of follicle of right cheek and forehead	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	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	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	Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Total oxidant capacity (TOC)	Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Total antioxidant capacity (TAC)	Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Oxidative stress index (OSI)	Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Paraoxonase-1 (PON-1)	Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Aryl esterase (ARES)	Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Myeloperoxidase (MPO)	Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Tumor necrosis factor-alpha (TNF-α)	Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Interleukin-1beta (IL-1β)	Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Matrix metalloproteinase-1 (MMP-1)	Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Matrix metalloproteinase-1 (MMP-9)	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	Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Photoaging severity of face by using RCM and dermoscopy	Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.

Collaborators and Investigators

• 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

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: oxidative stress; demodex; reflectance confocal microscopy
• Additional Relevant MeSH Terms: Skin Diseases; Rosacea
• Other Study ID Numbers: 71306642-050.01.04