Facial Demodicosis and Ocular Demodicosis

Rosacea Clinical Trial

Official title:

Clinical Correlation Between Facial Demodicosis and Ocular Demodicosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04377841
• Other study ID #: 201912024RIND
• Status: Recruiting
• Start date: April 13, 2020
• Est. completion date: December 14, 2020

Study information

• Verified date: April 2020
• Source: National Taiwan University Hospital
• Contact: Chang-Ming Huang, M.D.
• Phone: 886-972652516
• Email: b98401078[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 14, 2020
• Est. primary completion date: December 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blepharitis
• Demodex Infestation
• Meibomian Gland Dysfunction
• Pityriasis Folliculorum
• Rosacea

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

Askin U, Seçkin 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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative tests of facial and ocular demodicosis	Association between the results of direct microscopic examination and cilia epilation test	On initial evaluation
Secondary	Clinical features and quantitative tests of facial demodicosis	Association between the clinical features and the result of direct microscopic examination	On initial evaluation
Secondary	Clinical features and quantitative tests of ocular demodicosis	Association between the clinical features and the result of cilia epilation	On initial evaluation