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OpenTrials
Completed

NCT Number: NCT02236403

Treatment of Demodex Blepharitis With Ivermectin Gel 0.1% Plus Metronidazole 1%

Blepharitis is a endemic inflammatory disease caused mainly by Demodex folliculorum and Demodex Brevis, This mites are often associated with anaerobic bacteria that produces a skin inflammation, so a intervention that reduces the number of mites and bacteria would be desirable. Ivermectin a macrolid compound have demonstrated activity against scabies and lice in humans and in animals and a single application have show a good response in lice eradication.

In this study , investigators will determinate the security and effectiveness of this compound in the eradication of mites

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Key information

Conditions

Chronic Blepharitis Blepharitis Eye Diseases Eyelid Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital de Engativa

Bogotá, Colombia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Patients with symptomatic Demodex blepharitis for duration of at least 3 months.
  • Age range: 18 yeras and older.
  • Both genders and all ethnic groups comparable with the local community.
  • Able to understand and willing to sign a written informed consent
  • Able and willing to cooperate with the investigational plan.
  • Able and willing to complete all mandatory follow-up visits.

Exclusion criteria

  • • Patients who are currently engaged in another clinical trial, unwilling or unable to give consent, to accept randomization, or to return for scheduled visits.
  • Children under 18.
  • Pregnant women or expecting to be pregnant during the study.
  • Systemic immune deficient conditions such as AIDS or under systemic immunosuppressant.
  • Concomitant use of ophthalmic topical medications (excluding non-preserved tear substitutes).
  • Concomitant use of systemic antibiotics or steroids.
  • Contact lens wear
  • Active ocular infection or allergy
  • Unable to close eyes or uncontrolled blinking Previous allergic reaction to metronidazole and / or ivermectin

Treatment and study plan

Ivermectin 0.1% Metronidazole 1%

Drug

Other names: 22,23-dihydroavermectin B1a + 22,23-dihydroavermectin B1b

None intervention

Other

Volunteers with no signs of blepharitis and with eyelashes with no demodex. Symptoms and signs will be compared with experimental group

Primary outcomes

  1. Erradication of Demodex mites

    Time frame: 2 months

    Reduction in mites count after treatment compared to baseline data. If mites are not observed in the last visit a complete eradication will be considered. Patients with one or more mites will be considered as a incomplete eradication

Secondary outcomes

  1. Change in lid margin rednes and bulbar conjunctival hyperemia categorized from 0 (none) to 3 (severe) according to the next score

    Time frame: 2 months

    Change in lid margin rednes and bulbar conjunctival hyperemia categorized from 0 (none) to 3 (severe) according to the next score

    • None (0) = normal
    • Mild (1) = Slight localized injection
    • Moderate (2) = pink color
    • Severe (3) = dark redness

Sponsors and collaborators

Lead sponsor

Universidad Nacional de Colombia

Other

Registry information

Official study title

Diagnosis of Demodex Blapharitis and Treatment With Ivermectin Gel 0.1%/ Metronidazole 1%

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 10, 2014
Registry last updated
May 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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