Demodex Density, Immune Response and Oxidative Stress in Rosacea Patients

NCT ID: NCT02556827

Last Updated: 2015-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Rosacea

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Obtaining a blood sample

Intervention Type OTHER

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.

Reflectance confocal microscopy

Intervention Type DEVICE

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.

Sebumeter

Intervention Type DEVICE

Sebum rate at forehead and right cheek were evaluated with sebumeter

Video dermoscopy

Intervention Type DEVICE

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.

Obtaining a blood sample

Intervention Type OTHER

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.

Reflectance confocal microscopy

Intervention Type DEVICE

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.

Sebumeter

Intervention Type DEVICE

Sebum rate at forehead and right cheek were evaluated with sebumeter

Video dermoscopy

Intervention Type DEVICE

Dermoscopic photoaging scale were assessed by using video dermoscopy.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type DEVICE

Sebumeter

Sebum rate at forehead and right cheek were evaluated with sebumeter

Intervention Type DEVICE

Video dermoscopy

Dermoscopic photoaging scale were assessed by using video dermoscopy.

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role collaborator

Istanbul Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Tuğba Falay

Resident Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tugba Falay

Role: PRINCIPAL_INVESTIGATOR

Istanbul Training and Research Hospital

Vefa Aslı Erdemir

Role: STUDY_DIRECTOR

Istanbul Training and Research Hospital

Mehmet Salih Gürel

Role: STUDY_DIRECTOR

Istanbul Training and Research Hospital

Abdurrahim Kocyigit

Role: STUDY_DIRECTOR

Bezmialem Vakif University

Duygu Erdil

Role: STUDY_CHAIR

Istanbul Training and Research Hospital

Eray Metin Güler

Role: STUDY_CHAIR

Bezmialem Vakif University

Locations

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Istanbul Training and Research Hospital

Istanbul, Org. Abd. Nafiz Gürman, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Tugba Falay

Role: CONTACT

+905056545501

Vefa Aslı Erdemir

Role: CONTACT

+905052685651

Facility Contacts

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Tugba Falay

Role: primary

+905056545501

Vefa Aslı Erdemir

Role: backup

+905052685651

Other Identifiers

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71306642-050.01.04

Identifier Type: -

Identifier Source: org_study_id

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