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

Phase 3

Completed

• Conditions: Chronic Blepharitis
• Interventions: Other: None intervention; Drug: Ivermectin 0.1% Metronidazole 1%

• Registration Number: NCT02236403
• Lead Sponsor: Universidad Nacional de Colombia

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-08
• Study First Submitted QC: 2014-09-08
• Study First Posted: 2014-09-10
• Study Start: 2014-10
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-03
• Last Update Posted: 2021-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	None intervention	30 volunters with no signs of blepharitis and with eyelashes with no demodex .None intervention. Symptoms and signs will be compared with experimental group
Ivermectin 0.1% Metronidazole 1%	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital de Engativa; 🇨🇴 Bogotá, Colombia