Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02556827
Other study ID # 71306642-050.01.04
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT05597462 - Impact of DFD-29 on Microbial Flora of Healthy, Adult Human Subjects When Administered Over 16 Weeks Phase 1
Completed NCT02601963 - Safety and Efficacy Study of a Topical Minocycline Foam in Patients With Papulopustular Rosacea Phase 2
Completed NCT02249065 - Mirvaso in Use Study Phase 4
Completed NCT02292797 - Assessment of the Rosacea Prevalence in the General Population N/A
Completed NCT01659853 - Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea Phase 3
Completed NCT01426269 - Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® vs Placebo Phase 4
Completed NCT00991198 - The Role of Topically Dissolved Oxygen (TDO) to Ameliorate Signs of Photodamage Phase 2
Terminated NCT04336163 - Skin Imaging to Inform Laser Treatments N/A
Recruiting NCT04108897 - Analysis of the Microbiome in Rosacea Early Phase 1
Completed NCT03872050 - Deep Phenotyping of Rosacea and Migraine
Active, not recruiting NCT06033352 - Potassium-titanyl Phosphate (KTP) Laser vs KTP Laser and Ivermectin Cream for Facial Rosacea Phase 2
Completed NCT03263273 - Study to Evaluate the Safety and Efficacy of Topical Minocycline Gel in Patients With Papulopustular Rosacea Phase 2
Completed NCT04508660 - CGB-400 for the Reduction of Facial Redness Phase 1
Completed NCT04508205 - CGB-400 for the Reduction of Facial Redness and Bumps and Blemishes Phase 1
Completed NCT05094700 - A Study of a Polymeric Surfactant Technology Cleanser in Sensitive Skin Participants N/A
Active, not recruiting NCT03211585 - EVALUATION OF THE EFFECT OF THE PERFECTA V-BEAM LASER ON ROSACEA N/A
Completed NCT02637232 - Mirvaso® Utilisation and Patient Satisfaction Evaluation (MUSE)
Completed NCT02576847 - Study to Evaluate the Long-term Safety of a Once-Daily Omiganan Topical Gel Phase 3
Completed NCT02576860 - Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle Phase 3
Completed NCT02583009 - A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Rosacea Phase 2