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

Primary Purpose

Chronic Blepharitis

Status
Completed
Phase
Phase 3
Locations
Colombia
Study Type
Interventional
Intervention
Ivermectin 0.1% Metronidazole 1%
None intervention
Sponsored by
Universidad Nacional de Colombia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Blepharitis focused on measuring Blepharitis , Demodex, Ivermectin, Metronidazole

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hospital de Engativa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ivermectin 0.1% Metronidazole 1%

Control

Arm Description

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.

30 volunters with no signs of blepharitis and with eyelashes with no demodex .None intervention. Symptoms and signs will be compared with experimental group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 8, 2014
Last Updated
May 3, 2021
Sponsor
Universidad Nacional de Colombia
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1. Study Identification

Unique Protocol Identification Number
NCT02236403
Brief Title
Treatment of Demodex Blepharitis With Ivermectin Gel 0.1% Plus Metronidazole 1%
Official Title
Diagnosis of Demodex Blapharitis and Treatment With Ivermectin Gel 0.1%/ Metronidazole 1%
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Nacional de Colombia

4. Oversight

Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Blepharitis
Keywords
Blepharitis , Demodex, Ivermectin, Metronidazole

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ivermectin 0.1% Metronidazole 1%
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
30 volunters with no signs of blepharitis and with eyelashes with no demodex .None intervention. Symptoms and signs will be compared with experimental group
Intervention Type
Drug
Intervention Name(s)
Ivermectin 0.1% Metronidazole 1%
Other Intervention Name(s)
22,23-dihydroavermectin B1a + 22,23-dihydroavermectin B1b
Intervention Type
Other
Intervention Name(s)
None intervention
Intervention Description
Volunteers with no signs of blepharitis and with eyelashes with no demodex. Symptoms and signs will be compared with experimental group
Primary Outcome Measure Information:
Title
Erradication of Demodex mites
Description
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
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Change in lid margin rednes and bulbar conjunctival hyperemia categorized from 0 (none) to 3 (severe) according to the next score
Description
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
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Hospital de Engativa
City
Bogotá
Country
Colombia

12. IPD Sharing Statement

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

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