Facial Demodicosis and Ocular Demodicosis

• Conditions: Meibomian Gland Dysfunction; Blepharitis; Demodex Infestation; Rosacea; Pityriasis Folliculorum

• Registration Number: NCT04377841
• Lead Sponsor: National Taiwan University Hospital

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 Timeline

• Status Verified: 2020-04
• Study Start: 2020-04-13
• Study First Submitted: 2020-05-04
• Study First Submitted QC: 2020-05-04
• Last Update Submitted: 2020-05-04
• Study First Posted: 2020-05-06
• Last Update Posted: 2020-05-06
• Primary Completion: 2020-12-14
• Study Completion: 2020-12-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Clinical features and quantitative tests of ocular demodicosis	On initial evaluation	Association between the clinical features and the result of cilia epilation
Clinical features and quantitative tests of facial demodicosis	On initial evaluation	Association between the clinical features and the result of direct microscopic examination

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan