Clinical trial NCT02556827: Demodex Density, Immune Response and Oxidative Stress in Rosacea Patients
Official title: Investigation of Relation Between Demodex Density With Immune Response and Oxidative Stress in Rosacea Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rosacea
Keywords: demodex
oxidative stress
reflectance confocal microscopy
Lead sponsor: Istanbul Training and Research Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Bezmialem Vakif University
First posted: 2015-09-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Severity of rosacea
timeFrame: Rosacea patients who refer to criteria will be evaluated throughout 4 months.
Secondary outcomes:
measure: The number of demodex of right cheek and forehead
timeFrame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
measure: The number of follicle of right cheek and forehead
timeFrame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
measure: The number of mite per follicle of right cheek and forehead
timeFrame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
measure: The number of infested follicle of right cheek and forehead
timeFrame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
measure: The number of mite per infested follicle of right cheek and forehead
timeFrame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
measure: Total oxidant capacity (TOC)
timeFrame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
measure: Total antioxidant capacity (TAC)
timeFrame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
measure: Oxidative stress index (OSI)
timeFrame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
measure: Paraoxonase-1 (PON-1)
timeFrame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
measure: Aryl esterase (ARES)
timeFrame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
measure: Myeloperoxidase (MPO)
timeFrame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
measure: Tumor necrosis factor-alpha (TNF-α)
timeFrame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
measure: Interleukin-1beta (IL-1β)
timeFrame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
measure: Matrix metalloproteinase-1 (MMP-1)
timeFrame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
measure: Matrix metalloproteinase-1 (MMP-9)
timeFrame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Other outcomes:
measure: Sebum levels of right cheek and forehead
timeFrame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
measure: Photoaging severity of face by using RCM and dermoscopy
timeFrame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Training and Research Hospital
state: Org. Abd. Nafiz Gürman
Study officials:
affiliation: Istanbul Training and Research Hospital
name: Tugba Falay
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul Training and Research Hospital
name: Vefa Aslı Erdemir
role: STUDY_DIRECTOR
affiliation: Istanbul Training and Research Hospital
name: Mehmet Salih Gürel
role: STUDY_DIRECTOR
affiliation: Bezmialem Vakif University
name: Abdurrahim Kocyigit
role: STUDY_DIRECTOR
affiliation: Istanbul Training and Research Hospital
name: Duygu Erdil
role: STUDY_CHAIR
affiliation: Bezmialem Vakif University
name: Eray Metin Güler
role: STUDY_CHAIR
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