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Facial Demodicosis and Ocular Demodicosis

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National Taiwan University

Status

Unknown

Conditions

Blepharitis
Pityriasis Folliculorum
Meibomian Gland Dysfunction
Demodex Infestation
Rosacea

Study type

Observational

Funder types

Other

Identifiers

NCT04377841
201912024RIND

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

  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.

Trial design

120 participants in 2 patient groups

Facial Demodicosis
Description:
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
Description:
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.

Trial contacts and locations

1

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Central trial contact

Chang-Ming Huang, M.D.

Data sourced from clinicaltrials.gov

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