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

Barzilai Medical Center

Status and phase: Unknown; Phase 4

Conditions: Inflammation of the Eyelids

Treatments: Drug: Permethrin 5%; Drug: Fusidic Acid 1% M/R Eye Drops; Drug: Synthomycine 5%

Study type: Interventional

Funder types: Other

Identifiers

NCT03105505

003-16-BRZ

Details and patient eligibility

About

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%) .

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

Permethrin 5%

Active Comparator group

Description:

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

Treatment:

Drug: Permethrin 5%

Synthomycine 5%,

Active Comparator group

Description:

Contains chloramphenicol 5%.

Treatment:

Drug: Synthomycine 5%

Fusidic Acid 1%

Active Comparator group

Description:

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

Treatment:

Drug: Fusidic Acid 1% M/R Eye Drops