Clinical trial NCT04377841: Facial Demodicosis and Ocular Demodicosis
Official title: Clinical Correlation Between Facial Demodicosis and Ocular Demodicosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Demodex Infestation
Rosacea
Blepharitis
Meibomian Gland Dysfunction
Pityriasis Folliculorum
Keywords: Demodex
Facial Demodicosis
Ocular Demodicosis
Direct Microscopic Examination
Rosacea
Blepharitis
Meibomian Gland Dysfunction
Pityriasis Folliculorum
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 20 years or older and with a diagnosis of either facial demodicosis or ocular demodicosis.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quantitative tests of facial and ocular demodicosis
timeFrame: On initial evaluation
Secondary outcomes:
measure: Clinical features and quantitative tests of facial demodicosis
timeFrame: On initial evaluation
measure: Clinical features and quantitative tests of ocular demodicosis
timeFrame: On initial evaluation
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chia-Yu Chu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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. doi: 10.1167/iovs.05-0275.