- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03105505
The Efficacy of Permethrin 5%, Fusidic Acid 1% and Synthomycine 5% for Demodex - Blepharitis
The Efficacy Of Lyclear (Permethrin 5%) Vs Fusidic Acid1% and Synthomycine 5% for Demodex -Blepharitis Treatment, Prospective-Randomized Trial.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Ashqelon, Israel, 78278
- Barzilai Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Facial skin application once a night for 3 months.
|
Active Comparator: Synthomycine 5%,
Contains chloramphenicol 5%.
|
Eye ointment, eyelids and eyelashes application (chloramphenicol), once a night for 3 months.
|
Active Comparator: Fusidic Acid 1%
Contains 1% w/w fusidic acid anhydrous (as the hemihydrates) and 0.011% w/w.
|
viscous eye drops application once a night for 3 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decrease in demodex infestation in group A (permethrin 5%).
Time Frame: 2 months
|
significant decrease in demodex infestation in comparison to group B and C.
|
2 months
|
Improvement in symptoms and complaints in group A.
Time Frame: 2 months
|
OSDI Questionnaires that describe the severity of the ocular surface disease condition are filled in each visit.
|
2 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 003-16-BRZ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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