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

Study Overview
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Brief Summary
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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

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

Conditions
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Chronic Blepharitis

Intervention / Treatment
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* Drug: Ivermectin 0.1% Metronidazole 1%
* Other: None intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ivermectin 0.1% Metronidazole 1%<br>30 patients will receive the treatment and at 15 days a second visit will be done and changes in mite counts will be determinated and correlated with symtoms and signs. | Drug: Ivermectin 0.1% Metronidazole 1%<br> <br> * Other names: 22,23-dihydroavermectin B1a + 22,23-dihydroavermectin B1b;|
| Placebo Comparator: Control<br>30 volunters with no signs of blepharitis and with eyelashes with no demodex .None intervention. Symptoms and signs will be compared with experimental group | Other: None intervention<br>* Volunteers with no signs of blepharitis and with eyelashes with no demodex. Symptoms and signs will be compared with experimental group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erradication of Demodex mites | 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 | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lid margin rednes and bulbar conjunctival hyperemia categorized from 0 (none) to 3 (severe) according to the next score | 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 | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blepharitis , Demodex, Ivermectin, Metronidazole