Demodex InfestationNCT04377841
Facial Demodicosis and Ocular Demodicosis
An observational study of Demodex Infestation and Rosacea, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To understand the association between facial demodicosis and ocular demodicosis, we plan to enroll patients with facial demodicosis, ocular demodicosis, or both, in order to analyze their clinical presentations, the density of Demodex infestation over facial skin and eyelashes, and possible risk factors of the two… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Demodex Infestation, Rosacea, Blepharitis
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Apr 2020to 14 Dec 2020
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 20 years or older and with a diagnosis of either facial demodicosis or ocular demodicosis.
Who may be able to join
- Patient with a diagnosis of facial demodicosis or ocular demodicosis.
- Facial demodicosis defined as both 1 and 2:
- Clinical presentation of facial skin matches any of the followings:
- Pityriasis folliculorum.
- Papulopustular lesion.
- Rosacea.
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- Demodex infestation detected by direct microscopic examination ≥ 5 mites/cm2.
- Ocular demodicosis defined as both 3 and 4:
- Clinical presentation of ocular region matches any of the followings:
- Chronic blepharitis.
- Eyelash abnormalities: trichiasis, distichiasis, madarosis.
- Meibomian gland dysfunction.
- Recurrent chalazion.
- Ocular rosacea.
- Demodex infestation detected by cilia epilation test ≥ 1 mite/eyelid.
Who cannot join
- Usage of oral Ivermectin, topical Ivermectin or topical tea tree oil in the past 1 month.
- Patient who cannot tolerate direct microscopic examination or cilia epilation test.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100229
Chang-Ming Huang, M.D., 886-972652516, b98401078@ntu.edu.tw
About this study
Official title: Clinical Correlation Between Facial Demodicosis and Ocular Demodicosis
To understand the association between facial demodicosis and ocular demodicosis, we plan to enroll patients with facial demodicosis, ocular demodicosis, or both, in order to analyze their clinical presentations, the density of Demodex infestation over facial skin and eyelashes, and possible risk factors of the two diagnoses.
Read the detailed description
Although facial demodicosis and ocular demodicosis are described in a variety of clinical presentations, the association between the two diagnoses is not clearly identified.
Clinically, we plan to enroll 120 patients with facial demodicosis, ocular demodicosis. We will obtain their basic information, medical history, medication, and lifestyle. We will evaluate their clinical features. We will also perform quantitative tests including direct microscopic examination and cilia epilation test:
- Direct microscopic examination: On glabella and bilateral cheeks, follicular contents in the 1-cm × 1-cm area will be squeezed out. The contents are transferred onto a glass slide, covered with mineral oil and a cover slide, and examined under the microscope.
- Epilation: Four (4) non-adjacent cilia will be pulled from each upper eyelid and examined under the microscope. The total Demodex counts are recorded.
We will analyze the clinical presentations, the density of Demodex infestation, and possible risk factors of the two diagnoses.
- Conditions
- Demodex Infestation, Rosacea, Blepharitis, Meibomian Gland Dysfunction, Pityriasis Folliculorum
- Keywords
- Demodex, Facial Demodicosis, Ocular Demodicosis, Direct Microscopic Examination, Rosacea, Blepharitis, Meibomian Gland Dysfunction, Pityriasis Folliculorum
- Medical subject headings
- Rosacea, Blepharitis, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Facial Demodicosis | 1. Clinical presentation of facial skin matches any of the followings: 1. Pityriasis folliculorum. 2. Papulopustular lesion. 3. Rosacea. 2. Demodex infestation detected by direct microscopic examination ≥ 5 mites/cm2. | |
| Ocular Demodicosis | 1. Clinical presentation of ocular region matches any of the followings: 1. Chronic blepharitis. 2. Eyelash abnormalities: trichiasis, distichiasis, madarosis. 3. Meibomian gland dysfunction. 4. Recurrent chalazion. 5. Ocular rosacea. 2. Demodex infestation detected by cilia epilation test ≥ 1 mite/eyelid. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative tests of facial and ocular demodicosis
Association between the results of direct microscopic examination and cilia epilation test
Measured: On initial evaluation
Secondary outcomes (2)
Clinical features and quantitative tests of facial demodicosis
Association between the clinical features and the result of direct microscopic examination
Measured: On initial evaluation
Clinical features and quantitative tests of ocular demodicosis
Association between the clinical features and the result of cilia epilation
Measured: On initial evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start13 Apr 2020
- Primary completion14 Dec 2020 (estimated)
- Study completion14 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Demodex InfestationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chia-Yu Chu, M.D., Ph.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04377841
- Sponsor's protocol ID
- 201912024RIND
- Status last verified
- Apr 2020
- First submitted
- 4 May 2020
- Last updated
- 6 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen W, Plewig G. Human demodicosis: revisit and a proposed classification. Br J Dermatol. 2014 Jun;170(6):1219-25. doi: 10.1111/bjd.12850.
PubMed 24471456Askin U, Seckin D. Comparison of the two techniques for measurement of the density of Demodex folliculorum: standardized skin surface biopsy and direct microscopic examination. Br J Dermatol. 2010 May;162(5):1124-6. doi: 10.1111/j.1365-2133.2010.09645.x. Epub 2010 Feb 25.
PubMed 20199545Gao YY, Di Pascuale MA, Li W, Liu DT, Baradaran-Rafii A, Elizondo A, Kawakita T, Raju VK, Tseng SC. High prevalence of Demodex in eyelashes with cylindrical dandruff. Invest Ophthalmol Vis Sci. 2005 Sep;46(9):3089-94. doi: 10.1167/iovs.05-0275.
PubMed 16123406
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Correlation Between Facial Demodicosis and Ocular Demodicosis
- ClinicalTrials.gov ID
- NCT04377841
- Acronym / sponsor ID
- 201912024RIND
- Conditions
- Demodex Infestation, Rosacea, Blepharitis, Meibomian Gland Dysfunction, Pityriasis Folliculorum
- Keywords
- Demodex, Facial Demodicosis, Ocular Demodicosis, Direct Microscopic Examination, Rosacea, Blepharitis, Meibomian Gland Dysfunction, Pityriasis Folliculorum
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 13 Apr 2020 (actual)
- Primary completion
- 14 Dec 2020 (estimated)
- Study completion
- 14 Dec 2020 (estimated)
- First posted
- 6 May 2020 (actual)
- 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.
To understand the association between facial demodicosis and ocular demodicosis, we plan to enroll patients with facial demodicosis, ocular demodicosis, or both, in order to analyze their clinical presentations, the density of Demodex infestation over facial skin and eyelashes, and possible risk factors of the two diagnoses.
Detailed description
Although facial demodicosis and ocular demodicosis are described in a variety of clinical presentations, the association between the two diagnoses is not clearly identified.
Clinically, we plan to enroll 120 patients with facial demodicosis, ocular demodicosis. We will obtain their basic information, medical history, medication, and lifestyle. We will evaluate their clinical features. We will also perform quantitative tests including direct microscopic examination and cilia epilation test:
- Direct microscopic examination: On glabella and bilateral cheeks, follicular contents in the 1-cm × 1-cm area will be squeezed out. The contents are transferred onto a glass slide, covered with mineral oil and a cover slide, and examined under the microscope.
- Epilation: Four (4) non-adjacent cilia will be pulled from each upper eyelid and examined under the microscope. The total Demodex counts are recorded.
We will analyze the clinical presentations, the density of Demodex infestation, and possible risk factors of the two diagnoses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Facial Demodicosis | – | –1. Clinical presentation of facial skin matches any of the followings: 1. Pityriasis folliculorum. 2. Papulopustular lesion. 3. Rosacea. 2. Demodex infestation detected by direct microscopic examination ≥ 5 mites/cm2. |
| Ocular Demodicosis | – | –1. Clinical presentation of ocular region matches any of the followings: 1. Chronic blepharitis. 2. Eyelash abnormalities: trichiasis, distichiasis, madarosis. 3. Meibomian gland dysfunction. 4. Recurrent chalazion. 5. Ocular rosacea. 2. Demodex infestation detected by cilia epilation test ≥ 1 mite/eyelid. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 20 years or older and with a diagnosis of either facial demodicosis or ocular demodicosis.
Key inclusion criteria (15 listed)
- Patient with a diagnosis of facial demodicosis or ocular demodicosis.
- Facial demodicosis defined as both 1 and 2:
- Clinical presentation of facial skin matches any of the followings:
- Demodex infestation detected by direct microscopic examination ≥ 5 mites/cm2.
- Clinical presentation of ocular region matches any of the followings:
Key exclusion criteria (2 listed)
- Usage of oral Ivermectin, topical Ivermectin or topical tea tree oil in the past 1 month.
- Patient who cannot tolerate direct microscopic examination or cilia epilation test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quantitative tests of facial and ocular demodicosis
Time frame: On initial evaluation
Association between the results of direct microscopic examination and cilia epilation test
2 secondary outcomes
Clinical features and quantitative tests of facial demodicosis
Time frame: On initial evaluation
Clinical features and quantitative tests of ocular demodicosis
Time frame: On initial evaluation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- Background: PubMed 24471456Chen W, Plewig G. Human demodicosis: revisit and a proposed classification. Br J Dermatol. 2014 Jun;170(6):1219-25. doi: 10.1111/bjd.12850.
- Background: PubMed 20199545Askin U, Seckin D. Comparison of the two techniques for measurement of the density of Demodex folliculorum: standardized skin surface biopsy and direct microscopic examination. Br J Dermatol. 2010 May;162(5):1124-6. doi: 10.1111/j.1365-2133.2010.09645.x. Epub 2010 Feb 25.
- Background: PubMed 16123406Gao YY, Di Pascuale MA, Li W, Liu DT, Baradaran-Rafii A, Elizondo A, Kawakita T, Raju VK, Tseng SC. High prevalence of Demodex in eyelashes with cylindrical dandruff. Invest Ophthalmol Vis Sci. 2005 Sep;46(9):3089-94. doi: 10.1167/iovs.05-0275.
- Individual participant dataSharing planned: No
Related trials for Demodex Infestation
Not yet recruitingObservational study
Demodex Mites in Acne Patients and Herbal Extract Susceptibility
Acne, Demodex Infestation
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.
Chia-Yu Chu, M.D., Ph.D. principal investigator
National Taiwan University 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 Demodex Infestation and Rosacea, run by National Taiwan University Hospital at 1 site in Taiwan.
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 15 inclusion and 2 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 6 May 2020. 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 Taiwan. 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 Chang-Ming Huang, M.D. (886-972652516, b98401078@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative tests of facial and ocular demodicosis (time frame: On initial evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04377841, which also lists 3 linked publications.
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 6 May 2020.