NCT04377841

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 13, 2020

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2020

Completed
Last Updated

May 6, 2020

Status Verified

April 1, 2020

Enrollment Period

8 months

First QC Date

May 4, 2020

Last Update Submit

May 4, 2020

Conditions

Demodex InfestationRosaceaBlepharitisMeibomian Gland DysfunctionPityriasis Folliculorum

Keywords

DemodexFacial DemodicosisOcular DemodicosisDirect Microscopic ExaminationRosaceaBlepharitisMeibomian Gland DysfunctionPityriasis Folliculorum

Outcome Measures

Primary Outcomes (1)

  • Quantitative tests of facial and ocular demodicosis

    Association between the results of direct microscopic examination and cilia epilation test

    On initial evaluation

Secondary Outcomes (2)

  • Clinical features and quantitative tests of facial demodicosis

    On initial evaluation

  • Clinical features and quantitative tests of ocular demodicosis

    On initial evaluation

Study Arms (2)

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.

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.

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patient with a diagnosis of facial demodicosis or ocular demodicosis.
  • A. Facial demodicosis defined as both 1 and 2:
  • 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.
  • B. Ocular demodicosis defined as both 3 and 4:
  • 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.

You may not qualify if:

  • Usage of oral Ivermectin, topical Ivermectin or topical tea tree oil in the past 1 month.
  • Patient who cannot tolerate direct microscopic examination or cilia epilation test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100229, Taiwan

RECRUITING

Related Publications (3)

  • 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.

    PMID: 24471456BACKGROUND

  • 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.

    PMID: 20199545BACKGROUND

  • 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.

    PMID: 16123406BACKGROUND

MeSH Terms

Conditions

RosaceaBlepharitisMeibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesEyelid DiseasesEye Diseases

Study Officials

  • Chia-Yu Chu, M.D., Ph.D.

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chang-Ming Huang, M.D.

CONTACT

886-972652516b98401078@ntu.edu.tw

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2020

First Posted

May 6, 2020

Study Start

April 13, 2020

Primary Completion

December 14, 2020

Study Completion

December 14, 2020

Last Updated

May 6, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)