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

NCT ID: NCT02236403

Last Updated: 2021-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-01-31

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

Conditions

Chronic Blepharitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ivermectin 0.1% Metronidazole 1%

Intervention Type: DRUG

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

Group Type: PLACEBO_COMPARATOR

None intervention

Intervention Type: OTHER

Volunteers with no signs of blepharitis and with eyelashes with no demodex. Symptoms and signs will be compared with experimental group

Interventions

Ivermectin 0.1% Metronidazole 1%

Intervention Type: DRUG

None intervention

Volunteers with no signs of blepharitis and with eyelashes with no demodex. Symptoms and signs will be compared with experimental group

Intervention Type: OTHER

Other Intervention Names

22,23-dihydroavermectin B1a + 22,23-dihydroavermectin B1b

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Nacional de Colombia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital de Engativa

Bogotá, , Colombia

Countries

Colombia

Other Identifiers

demodex0.1

Identifier Type: -

Identifier Source: org_study_id