Treatment of Demodex Blepharitis With Ivermectin Gel 0.1% Plus Metronidazole 1% (NCT02236403) | Clinical Trial Compass
CompletedPhase 3
Treatment of Demodex Blepharitis With Ivermectin Gel 0.1% Plus Metronidazole 1%
Colombia60 participantsStarted 2014-10
Plain-language summary
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
Who can participate
Age range18 Years – 80 Years
SexALL
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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