Facial Demodicosis and Ocular Demodicosis

Clinical Correlation Between Facial Demodicosis and Ocular Demodicosis

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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100229
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Chang-Ming Huang, M.D.; Phone Number: 886-972652516; Email: b98401078@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative tests of facial and ocular demodicosis	Association between the results of direct microscopic examination and cilia epilation test	On initial evaluation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical features and quantitative tests of facial demodicosis	Association between the clinical features and the result of direct microscopic examination	On initial evaluation
Clinical features and quantitative tests of ocular demodicosis	Association between the clinical features and the result of cilia epilation	On initial evaluation

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2020
• Primary Completion (Anticipated): December 14, 2020
• Study Completion (Anticipated): December 14, 2020

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 6, 2020

Study Record Updates

• Last Update Posted (Actual): May 6, 2020
• Last Update Submitted That Met QC Criteria: May 4, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Rosacea; Demodex; Meibomian Gland Dysfunction; Blepharitis; Facial Demodicosis; Ocular Demodicosis; Direct Microscopic Examination; Pityriasis Folliculorum
• Additional Relevant MeSH Terms: Skin Diseases; Eye Diseases; Skin Diseases, Papulosquamous; Eyelid Diseases; Rosacea; Meibomian Gland Dysfunction; Blepharitis; Pityriasis
• Other Study ID Numbers: 201912024RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No