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

Primary Purpose

Inflammation of the Eyelids

Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Permethrin 5%
Synthomycine 5%
Fusidic Acid 1% M/R Eye Drops
Sponsored by
Barzilai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammation of the Eyelids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Barzilai Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Permethrin 5%

Synthomycine 5%,

Fusidic Acid 1%

Arm 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.

Contains chloramphenicol 5%.

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

Outcomes

Primary Outcome Measures

Decrease in demodex infestation in group A (permethrin 5%).
significant decrease in demodex infestation in comparison to group B and C.
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.

Secondary Outcome Measures

Full Information

First Posted
March 28, 2017
Last Updated
January 29, 2018
Sponsor
Barzilai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03105505
Brief Title
The Efficacy of Permethrin 5%, Fusidic Acid 1% and Synthomycine 5% for Demodex - Blepharitis
Official Title
The Efficacy Of Lyclear (Permethrin 5%) Vs Fusidic Acid1% and Synthomycine 5% for Demodex -Blepharitis Treatment, Prospective-Randomized Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 28, 2017 (Actual)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barzilai Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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%) .
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation of the Eyelids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Permethrin 5%
Arm Type
Active Comparator
Arm 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.
Arm Title
Synthomycine 5%,
Arm Type
Active Comparator
Arm Description
Contains chloramphenicol 5%.
Arm Title
Fusidic Acid 1%
Arm Type
Active Comparator
Arm Description
Contains 1% w/w fusidic acid anhydrous (as the hemihydrates) and 0.011% w/w.
Intervention Type
Drug
Intervention Name(s)
Permethrin 5%
Intervention Description
Facial skin application once a night for 3 months.
Intervention Type
Drug
Intervention Name(s)
Synthomycine 5%
Intervention Description
Eye ointment, eyelids and eyelashes application (chloramphenicol), once a night for 3 months.
Intervention Type
Drug
Intervention Name(s)
Fusidic Acid 1% M/R Eye Drops
Intervention Description
viscous eye drops application once a night for 3 months.
Primary Outcome Measure Information:
Title
Decrease in demodex infestation in group A (permethrin 5%).
Description
significant decrease in demodex infestation in comparison to group B and C.
Time Frame
2 months
Title
Improvement in symptoms and complaints in group A.
Description
OSDI Questionnaires that describe the severity of the ocular surface disease condition are filled in each visit.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Barzilai Medical Center
City
Ashqelon
ZIP/Postal Code
78278
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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