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
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
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
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Hospital de Engativa, Bogotá, Colombia
Additional Information
Starting date: October 2014
Last updated: February 18, 2015
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