Treatment of Demodex Blepharitis With Ivermectin Gel 0.1% Plus Metronidazole 1%
Study Details
Study Description
Brief 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ivermectin 0.1% Metronidazole 1% 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%
Other Names:
|
| Placebo Comparator: Control 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
Volunteers with no signs of blepharitis and with eyelashes with no demodex. Symptoms and signs will be compared with experimental group
|
Outcome Measures
Primary Outcome Measures
- Erradication of Demodex mites [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 Outcome Measures
- Change in lid margin rednes and bulbar conjunctival hyperemia categorized from 0 (none) to 3 (severe) according to the next score [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
Eligibility Criteria
Criteria
Inclusion Criteria:
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• Patients with symptomatic Demodex blepharitis for duration of at least 3 months.
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Age range: 18 yeras and older.
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Both genders and all ethnic groups comparable with the local community.
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Able to understand and willing to sign a written informed consent
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Able and willing to cooperate with the investigational plan.
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Able and willing to complete all mandatory follow-up visits.
Exclusion Criteria:
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• Patients who are currently engaged in another clinical trial, unwilling or unable to give consent, to accept randomization, or to return for scheduled visits.
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Children under 18.
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Pregnant women or expecting to be pregnant during the study.
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Systemic immune deficient conditions such as AIDS or under systemic immunosuppressant.
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Concomitant use of ophthalmic topical medications (excluding non-preserved tear substitutes).
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Concomitant use of systemic antibiotics or steroids.
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Contact lens wear
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Active ocular infection or allergy
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Unable to close eyes or uncontrolled blinking Previous allergic reaction to metronidazole and / or ivermectin
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital de Engativa | Bogotá | Colombia |
Sponsors and Collaborators
- Universidad Nacional de Colombia
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- demodex0.1