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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02236403
Recruitment Status : Completed
First Posted : September 10, 2014
Last Update Posted : May 6, 2021
Sponsor:
Information provided by (Responsible Party):
Universidad Nacional de Colombia

Study Description
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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
Chronic Blepharitis Drug: Ivermectin 0.1% Metronidazole 1% Other: None intervention Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Diagnosis of Demodex Blapharitis and Treatment With Ivermectin Gel 0.1%/ Metronidazole 1%
Study Start Date : October 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 22,23-dihydroavermectin B1a + 22,23-dihydroavermectin B1b
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
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Primary Outcome Measures :
  1. Erradication of Demodex mites [ Time Frame: 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 :
  1. Change in lid margin rednes and bulbar conjunctival hyperemia categorized from 0 (none) to 3 (severe) according to the next score [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02236403


Locations
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Colombia
Hospital de Engativa
Bogotá, Colombia
Sponsors and Collaborators
Universidad Nacional de Colombia
More Information
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Responsible Party: Universidad Nacional de Colombia
ClinicalTrials.gov Identifier: NCT02236403    
Other Study ID Numbers: demodex0.1
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: May 2021
Keywords provided by Universidad Nacional de Colombia:
Blepharitis , Demodex, Ivermectin, Metronidazole
Additional relevant MeSH terms:
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Blepharitis
Eyelid Diseases
Eye Diseases
Metronidazole
Ivermectin
 Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents