Demodex Density, Immune Response and Oxidative Stress in Rosacea Patients

NCT02556827 | Unknown

• 1 other identifier: 71306642-050.01.04
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Rosacea

Keywords

demodex; oxidative stress; reflectance confocal microscopy

Outcome Measures

Primary Outcomes (1)

• Severity of rosacea

  Rosacea patients who refer to criteria will be evaluated throughout 4 months.

Secondary Outcomes (15)

• 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.

Other Outcomes (2)

• 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.

Study Arms (2)

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; Device: Reflectance confocal microscopy; Device: Sebumeter; Device: 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; Device: Video dermoscopy

Interventions

Obtaining a blood sample 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.

H, Rosacea patients; K, Healthy volunteers

Reflectance confocal microscopy 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.

H, Rosacea patients; K, Healthy volunteers

Sebumeter DEVICE

Sebum rate at forehead and right cheek were evaluated with sebumeter

H, Rosacea patients; K, Healthy volunteers

Video dermoscopy DEVICE

Dermoscopic photoaging scale were assessed by using video dermoscopy.

H, Rosacea patients; K, Healthy volunteers

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Istanbul Training and Research Hospital: lead
• Bezmialem Vakif University: collaborator

Study Sites (1)

Istanbul Training and Research Hospital

Istanbul, Org. Abd. Nafiz Gürman, 34098, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Tugba Falay

  Istanbul Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

• Duygu Erdil

  Istanbul Training and Research Hospital

  STUDY CHAIR

• Eray Metin Güler

  Bezmialem Vakif University

  STUDY CHAIR

Central Study Contacts

Tugba Falay

CONTACT

+905056545501; tugbafalay@hotmail.com

Vefa Aslı Erdemir

CONTACT

+905052685651; vefaasli@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor

Study Record Dates

• First Submitted: September 21, 2015
• First Posted: September 22, 2015
• Study Start: July 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 23, 2015

Record last verified: 2015-09

Locations

TU (1)