Facial Demodicosis and Ocular Demodicosis

NCT ID: NCT04377841

Last Updated: 2020-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-13

Study Completion Date

2020-12-14

Brief Summary

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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

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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.

Conditions

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Demodex Infestation Rosacea Blepharitis Meibomian Gland Dysfunction Pityriasis Folliculorum

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chia-Yu Chu, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chang-Ming Huang, M.D.

Role: CONTACT

886-972652516

Facility Contacts

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Chang-Ming Huang, M.D.

Role: primary

886-972652516

References

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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.

Reference Type BACKGROUND
PMID: 24471456 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20199545 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16123406 (View on PubMed)

Other Identifiers

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201912024RIND

Identifier Type: -

Identifier Source: org_study_id

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