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

Chronic Blepharitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02236403
• Other study ID #: demodex0.1
• Status: Completed
• Phase: Phase 3
• Start date: October 2014
• Est. completion date: January 2015

Study information

• Verified date: May 2021
• Source: Universidad Nacional de Colombia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Blepharitis
• Chronic Blepharitis

Intervention

Drug:
• Ivermectin 0.1% Metronidazole 1%

Other:
• None intervention
Volunteers with no signs of blepharitis and with eyelashes with no demodex. Symptoms and signs will be compared with experimental group

Locations

Country	Name	City	State
Colombia	Hospital de Engativa	Bogotá

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Nacional de Colombia

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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