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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%) .
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Permethrin 5% | Active Comparator | Contains permethrin 5% w/w (equivalent to 50 mg/g), formaldehyde solution 0.278% w/w and butylated hydroxytoluene (E321) 0.02% w/w. |
|
| Synthomycine 5%, | Active Comparator | Contains chloramphenicol 5%. |
|
| Fusidic Acid 1% | Active Comparator | Contains 1% w/w fusidic acid anhydrous (as the hemihydrates) and 0.011% w/w. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Permethrin 5% | Drug | Facial skin application once a night for 3 months. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in demodex infestation in group A (permethrin 5%). | significant decrease in demodex infestation in comparison to group B and C. | 2 months |
| 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. | 2 months |
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barzilai Medical Center | Ashkelon | 78278 | Israel |
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| ID | Term |
|---|---|
| D005672 | Fusidic Acid |
| ID | Term |
|---|---|
| D002775 | Cholestadienols |
| D002774 | Cholestadienes |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
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| Synthomycine 5% |
| Drug |
Eye ointment, eyelids and eyelashes application (chloramphenicol), once a night for 3 months. |
|
| Fusidic Acid 1% M/R Eye Drops | Drug | viscous eye drops application once a night for 3 months. |
|
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |