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Status unknownNCT03105505Updated Jan 30, 2018

The Efficacy of Permethrin 5%, Fusidic Acid 1% and Synthomycine 5% for Demodex - Blepharitis

A Phase 4 interventional study of Permethrin 5% and Synthomycine 5% in Inflammation of the Eyelids, sponsored by Barzilai Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-30.

Sponsored by Barzilai Medical Center · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The study aims to investigate the effect of Permethrin 5% treatment on Signs and symptoms of Demodex-blepharitis in comparison to Synthomycine 5% and Fucithalmic (fusidic acid 1%) .

Read the detailed description

3 arms study. 75 patient total, 25 patients in each group.

Group A (study group) patients will apply facially Permethrin 5% every night for 3 months.

Group B patients will apply on the eyelids Fusidic acid 1% every night for 3 months.

Group C patients will apply on the eyelids Synthomycine 5% every night for 3 months

Follow up Evaluation will be made after one week, one month, two months, three months, 4 months and half a year.

02

Conditions studied

  • Inflammation of the Eyelids
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult (Age ≥18Y) individuals clinically diagnosed with Demodex- blepharitis.

Exclusion criteria

Exclusion Criteria:

  • Known sensitivity to all study medications or components. Pregnant women and individuals deemed unfit to provide informed consent. Systemic steroid use.
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
75 participants (estimated)

Study arms

  • Active comparator
    Permethrin 5%

    Contains permethrin 5% w/w (equivalent to 50 mg/g), formaldehyde solution 0.278% w/w and butylated hydroxytoluene (E321) 0.02% w/w.

    Drug: Permethrin 5%

  • Active comparator
    Synthomycine 5%,

    Contains chloramphenicol 5%.

    Drug: Synthomycine 5%

  • Active comparator
    Fusidic Acid 1%

    Contains 1% w/w fusidic acid anhydrous (as the hemihydrates) and 0.011% w/w.

    Drug: Fusidic Acid 1% M/R Eye Drops

Interventions

  • DrugPermethrin 5%

    Facial skin application once a night for 3 months.

  • DrugSynthomycine 5%

    Eye ointment, eyelids and eyelashes application (chloramphenicol), once a night for 3 months.

  • DrugFusidic Acid 1% M/R Eye Drops

    viscous eye drops application once a night for 3 months.

05

What researchers measure

Primary outcomes

  1. Decrease in demodex infestation in group A (permethrin 5%).

    significant decrease in demodex infestation in comparison to group B and C.

    Time frame: 2 months

  2. Improvement in symptoms and complaints in group A.

    OSDI Questionnaires that describe the severity of the ocular surface disease condition are filled in each visit.

    Time frame: 2 months

06

Study locations

1 site
  • Barzilai Medical Center
    Ashqelon, 78278, Israel
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03105505
Lead sponsor
Barzilai Medical Center
Responsible party
Igor Kaiserman (Prof Igor Kaiserman, Barzilai Medical Center) — Principal investigator
First posted
Apr 10, 2017
Start date
Apr 28, 2017
Primary completion
Sep 2018 (estimated)
Completion
Sep 2018 (estimated)
Last update
Jan 30, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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