Demodex Density, Immune Response and Oxidative Stress in Rosacea Patients

Rosacea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02556827
• Other study ID #: 71306642-050.01.04
• Status: Recruiting
• Phase: N/A
• First received: September 21, 2015
• Last updated: September 22, 2015
• Start date: July 2015
• Est. completion date: December 2015

Study information

• Verified date: September 2015
• Source: Istanbul Training and Research Hospital
• Contact: Tugba Falay
• Phone: +905056545501
• Email: tugbafalay[@]hotmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Rosacea

Intervention

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-a), interleukin-1beta (IL-1ß), 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.
• Sebumeter
Sebum rate at forehead and right cheek were evaluated with sebumeter
• Video dermoscopy
Dermoscopic photoaging scale were assessed by using video dermoscopy.

Locations

Country	Name	City	State
Turkey	Istanbul Training and Research Hospital	Istanbul	Org. Abd. Nafiz Gürman

Sponsors (2)

Lead Sponsor	Collaborator
Istanbul Training and Research Hospital	Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sebum levels of right cheek and forehead		Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.	No
Other	Photoaging severity of face by using RCM and dermoscopy		Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.	No
Primary	Severity of rosacea		Rosacea patients who refer to criteria will be evaluated throughout 4 months.	No
Secondary	The number of demodex of right cheek and forehead		Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.	No
Secondary	The number of follicle of right cheek and forehead		Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	Total oxidant capacity (TOC)		Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.	No
Secondary	Total antioxidant capacity (TAC)		Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.	No
Secondary	Oxidative stress index (OSI)		Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.	No
Secondary	Paraoxonase-1 (PON-1)		Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.	No
Secondary	Aryl esterase (ARES)		Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.	No
Secondary	Myeloperoxidase (MPO)		Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.	No
Secondary	Tumor necrosis factor-alpha (TNF-a)		Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.	No
Secondary	Interleukin-1beta (IL-1ß)		Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.	No
Secondary	Matrix metalloproteinase-1 (MMP-1)		Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.	No
Secondary	Matrix metalloproteinase-1 (MMP-9)		Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.	No