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

Information source: Universidad Nacional de Colombia
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Blepharitis

Intervention: Ivermectin 0.1% Metronidazole 1% (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Universidad Nacional de Colombia


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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Primary outcome: Erradication of Demodex mites

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


Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.


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


- Concomitant use of ophthalmic topical medications (excluding non-preserved tear


- 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

Locations and Contacts

Hospital de Engativa, Bogotá, Colombia
Additional Information

Starting date: October 2014
Last updated: February 18, 2015

Page last updated: August 23, 2015

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