RosaceaNCT02556827
Demodex Density, Immune Response and Oxidative Stress in Rosacea Patients
An observational study of Rosacea, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Rosacea
- What is being tested?
- Obtaining a blood sample, Reflectance confocal microscopy and Sebumeter
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2015to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Training and Research Hospital
Istanbul, Org. Abd. Nafiz Gürman, 34098
Tugba Falay, +905056545501, tugbafalay@hotmail.com
Vefa Aslı Erdemir, +905052685651, vefaasli@hotmail.com
About this study
Official title: Investigation of Relation Between Demodex Density With Immune Response and Oxidative Stress in Rosacea Patients
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.
Read the 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.
- Conditions
- Rosacea
- Being tested
- Obtaining a blood sample, Reflectance confocal microscopy, Sebumeter, Video dermoscopy
- Keywords
- demodex, oxidative stress, reflectance confocal microscopy
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obtaining a blood sampleOther
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.
Reflectance confocal microscopyDevice
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.
SebumeterDevice
Sebum rate at forehead and right cheek were evaluated with sebumeter
Video dermoscopyDevice
Dermoscopic photoaging scale were assessed by using video dermoscopy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Obtaining a blood sample; Device: Reflectance confocal microscopy; Device: Sebumeter; Device: Video dermoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of rosacea
Measured: Rosacea patients who refer to criteria will be evaluated throughout 4 months.
Secondary outcomes (15)
The number of demodex of right cheek and forehead
Measured: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
The number of follicle of right cheek and forehead
Measured: 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
Measured: 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
Measured: 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
Measured: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Total oxidant capacity (TOC)
Measured: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Total antioxidant capacity (TAC)
Measured: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Oxidative stress index (OSI)
Measured: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Paraoxonase-1 (PON-1)
Measured: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Aryl esterase (ARES)
Measured: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Myeloperoxidase (MPO)
Measured: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Tumor necrosis factor-alpha (TNF-α)
Measured: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Interleukin-1beta (IL-1β)
Measured: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Matrix metalloproteinase-1 (MMP-1)
Measured: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Matrix metalloproteinase-1 (MMP-9)
Measured: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study startJul 2015
- Primary completionNov 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RosaceaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Collaborators
- Bezmialem Vakif University
- Responsible party
- Principal investigator, Tuğba Falay, Istanbul Training and Research Hospital
- Investigators
- Tugba Falay, Principal investigator, Istanbul Training and Research HospitalVefa Aslı Erdemir, Study director, Istanbul Training and Research HospitalMehmet Salih Gürel, Study director, Istanbul Training and Research HospitalAbdurrahim Kocyigit, Study director, Bezmialem Vakif UniversityDuygu Erdil, Study chair, Istanbul Training and Research HospitalEray Metin Güler, Study chair, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02556827
- Sponsor's protocol ID
- 71306642-050.01.04
- Status last verified
- Sep 2015
- First submitted
- 21 Sep 2015
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Relation Between Demodex Density With Immune Response and Oxidative Stress in Rosacea Patients
- ClinicalTrials.gov ID
- NCT02556827
- Acronym / sponsor ID
- 71306642-050.01.04
- Conditions
- Rosacea
- Keywords
- demodex, oxidative stress, reflectance confocal microscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Collaborators
- Bezmialem Vakif University
- Study start
- Jul 2015
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 22 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| H, Rosacea patients | – | Other: Obtaining a blood sample, Device: Reflectance confocal microscopy, Device: Sebumeter, Device: Video dermoscopyRosacea 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. |
| K, Healthy volunteers | – | Other: Obtaining a blood sample, Device: Reflectance confocal microscopy, Device: Sebumeter, Device: Video dermoscopyHealthy 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obtaining a blood sampleTotal 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. | Other | H, Rosacea patients, K, Healthy volunteers |
| Reflectance confocal microscopy1mm2-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 | H, Rosacea patients, K, Healthy volunteers |
| SebumeterSebum rate at forehead and right cheek were evaluated with sebumeter | Device | H, Rosacea patients, K, Healthy volunteers |
| Video dermoscopyDermoscopic photoaging scale were assessed by using video dermoscopy. | Device | H, Rosacea patients, K, Healthy volunteers |
Primary outcome
Severity of rosacea
Time frame: Rosacea patients who refer to criteria will be evaluated throughout 4 months.
15 secondary outcomes
The number of demodex of right cheek and forehead
Time frame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
The number of follicle of right cheek and forehead
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Total oxidant capacity (TOC)
Time frame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Total antioxidant capacity (TAC)
Time frame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Oxidative stress index (OSI)
Time frame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Paraoxonase-1 (PON-1)
Time frame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Aryl esterase (ARES)
Time frame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Myeloperoxidase (MPO)
Time frame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Tumor necrosis factor-alpha (TNF-α)
Time frame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Interleukin-1beta (IL-1β)
Time frame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Matrix metalloproteinase-1 (MMP-1)
Time frame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Matrix metalloproteinase-1 (MMP-9)
Time frame: Rosacea patients and healthy volunteers who refer to criteria will be evaluated throughout 4 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tugba Falay principal investigator
Istanbul Training and Research Hospital
Vefa Aslı Erdemir study director
Istanbul Training and Research Hospital
Mehmet Salih Gürel study director
Istanbul Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rosacea, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tugba Falay (+905056545501, tugbafalay@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of rosacea (time frame: Rosacea patients who refer to criteria will be evaluated throughout 4 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2015.