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

NCT ID: NCT03105505

Last Updated: 2018-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-28

Study Completion Date

2018-09-30

Brief Summary

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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%) .

Detailed Description

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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.

Conditions

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Inflammation of the Eyelids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Permethrin 5%

Intervention Type DRUG

Facial skin application once a night for 3 months.

Synthomycine 5%,

Contains chloramphenicol 5%.

Group Type ACTIVE_COMPARATOR

Synthomycine 5%

Intervention Type DRUG

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

Fusidic Acid 1%

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

Group Type ACTIVE_COMPARATOR

Fusidic Acid 1% M/R Eye Drops

Intervention Type DRUG

viscous eye drops application once a night for 3 months.

Interventions

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Permethrin 5%

Facial skin application once a night for 3 months.

Intervention Type DRUG

Synthomycine 5%

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

Intervention Type DRUG

Fusidic Acid 1% M/R Eye Drops

viscous eye drops application once a night for 3 months.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- Known sensitivity to all study medications or components. Pregnant women and individuals deemed unfit to provide informed consent. Systemic steroid use.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Barzilai Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Igor Kaiserman

Prof Igor Kaiserman

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Barzilai Medical Center

Ashkelon, , Israel

Site Status

Countries

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Israel

Other Identifiers

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003-16-BRZ

Identifier Type: -

Identifier Source: org_study_id

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