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

Universidad Nacional de Colombia

Status and phase: Completed; Phase 3

Conditions: Chronic Blepharitis

Treatments: Drug: Ivermectin 0.1% Metronidazole 1%; Other: None intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02236403

demodex0.1

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Ivermectin 0.1% Metronidazole 1%

Experimental group

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.

Treatment:

Drug: Ivermectin 0.1% Metronidazole 1%

Control

Placebo Comparator group

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

Treatment:

Other: None intervention