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Status unknownNCT04377841Updated May 6, 2020

Facial Demodicosis and Ocular Demodicosis

An observational study in Demodex Infestation, Rosacea and Blepharitis, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2020-05-06.

Sponsored by National Taiwan University Hospital · Observational

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
20 Years and older
Sex
All
01

Study 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 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:

  1. 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.
  2. 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.

02

Conditions studied

  • 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
03

In context

Rosacea

233 studies on the registry are indexed under Rosacea; 23 are open to participants now.

This study's planned enrollment of 120 is below the median of 265 across 23 observational studies indexed under Rosacea.

Browse Rosacea studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Browse National Taiwan University Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients aged 20 years or older and with a diagnosis of either facial demodicosis or ocular demodicosis.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patient with a diagnosis of facial demodicosis or ocular demodicosis.

A. Facial demodicosis defined as both 1 and 2:

  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.

    B. Ocular demodicosis defined as both 3 and 4:

  3. 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.
  4. Demodex infestation detected by cilia epilation test ≥ 1 mite/eyelid.

Exclusion criteria

Exclusion Criteria:

  1. Usage of oral Ivermectin, topical Ivermectin or topical tea tree oil in the past 1 month.
  2. Patient who cannot tolerate direct microscopic examination or cilia epilation test.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Quantitative tests of facial and ocular demodicosis

    Association between the results of direct microscopic examination and cilia epilation test

    Time frame: On initial evaluation

Secondary outcomes

  1. Clinical features and quantitative tests of facial demodicosis

    Association between the clinical features and the result of direct microscopic examination

    Time frame: On initial evaluation

  2. Clinical features and quantitative tests of ocular demodicosis

    Association between the clinical features and the result of cilia epilation

    Time frame: On initial evaluation

07

Study locations

1 of 1 sites recruiting
  • National Taiwan University Hospital
    Taipei, 100229, Taiwan
    Recruiting
08

References and documents

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 24471456 ↗
  • Askin 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 20199545 ↗
  • Gao 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2020 (actual). Primary completion is estimated for Dec 2020, 8 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 4, 2020
First posted
May 6, 2020
StartActual
Apr 13, 2020
Primary completionEst.
Dec 14, 2020
CompletionEst.
Dec 14, 2020
Last update
May 6, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04377841
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
May 6, 2020
Start date
Apr 13, 2020
Primary completion
Dec 14, 2020 (estimated)
Completion
Dec 14, 2020 (estimated)
Last update
May 6, 2020

Study contacts

Chang-Ming Huang, M.D.
Contact
b98401078@ntu.edu.tw
886-972652516
Chia-Yu Chu, M.D., Ph.D.
principal investigator · National Taiwan University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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