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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

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

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

NCT ID

NCT03105505

First Posted

March 28, 2017

Last Updated

January 29, 2018

Sponsor

Barzilai Medical Center

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

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

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

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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