Demodex Density, Immune Response and Oxidative Stress in Rosacea Patients

Sponsor

Istanbul Training and Research Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02556827

Collaborator

Bezmialem Vakif University (Other)

Enrollment

Location

Duration (Months)

15.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Rosacea	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 Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Study Start Date :

Jul 1, 2015

Anticipated Primary Completion Date :

Nov 1, 2015

Anticipated Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	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.

Arm

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

Device: Reflectance confocal microscopy

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.

Outcome Measures

Primary Outcome Measures

Severity of rosacea [Rosacea patients who refer to criteria will be evaluated throughout 4 months.]

Secondary Outcome Measures

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

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul Training and Research Hospital	Istanbul	Org. Abd. Nafiz Gürman	Turkey	34098

Sponsors and Collaborators

Istanbul Training and Research Hospital
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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tuğba Falay, Resident Doctor, Istanbul Training and Research Hospital

ClinicalTrials.gov Identifier:

NCT02556827

Other Study ID Numbers:

71306642-050.01.04

First Posted:

Sep 22, 2015

Last Update Posted:

Sep 23, 2015

Last Verified:

Sep 1, 2015

Keywords provided by Tuğba Falay, Resident Doctor, Istanbul Training and Research Hospital

demodex

oxidative stress

reflectance confocal microscopy

Additional relevant MeSH terms:

Rosacea

Study Results

No Results Posted as of Sep 23, 2015