Facial Demodicosis and Ocular Demodicosis

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT04377841
Collaborator
(none)
120
1
8
14.9

Study Details

Study Description

Brief 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.

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
120 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Clinical Correlation Between Facial Demodicosis and Ocular Demodicosis
Actual Study Start Date :
Apr 13, 2020
Anticipated Primary Completion Date :
Dec 14, 2020
Anticipated Study Completion Date :
Dec 14, 2020

Arms and Interventions

Arm Intervention/Treatment
Facial Demodicosis

Clinical presentation of facial skin matches any of the followings: Pityriasis folliculorum. Papulopustular lesion. Rosacea. Demodex infestation detected by direct microscopic examination ≥ 5 mites/cm2.

Ocular Demodicosis

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.

Outcome Measures

Primary Outcome Measures

  1. Quantitative tests of facial and ocular demodicosis [On initial evaluation]

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

Secondary Outcome Measures

  1. Clinical features and quantitative tests of facial demodicosis [On initial evaluation]

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

  2. Clinical features and quantitative tests of ocular demodicosis [On initial evaluation]

    Association between the clinical features and the result of cilia epilation

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

  2. Pityriasis folliculorum.

  3. Papulopustular lesion.

  4. Rosacea.

  5. Demodex infestation detected by direct microscopic examination ≥ 5 mites/cm2.

B. Ocular demodicosis defined as both 3 and 4:
  1. Clinical presentation of ocular region matches any of the followings:

  2. Chronic blepharitis.

  3. Eyelash abnormalities: trichiasis, distichiasis, madarosis.

  4. Meibomian gland dysfunction.

  5. Recurrent chalazion.

  6. Ocular rosacea.

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

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Taiwan University Hospital Taipei Taiwan 100229

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

  • Principal Investigator: Chia-Yu Chu, M.D., Ph.D., National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT04377841
Other Study ID Numbers:
  • 201912024RIND
First Posted:
May 6, 2020
Last Update Posted:
May 6, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National Taiwan University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 6, 2020