NCT03105505

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%) .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 10, 2017

Completed
18 days until next milestone

Study Start

First participant enrolled

April 28, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

1.3 years

First QC Date

March 28, 2017

Last Update Submit

January 29, 2018

Conditions

Inflammation of the Eyelids

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

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.

Drug: Permethrin 5%

Synthomycine 5%,

ACTIVE COMPARATOR

Contains chloramphenicol 5%.

Drug: Synthomycine 5%

Fusidic Acid 1%

ACTIVE COMPARATOR

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

Drug: Fusidic Acid 1% M/R Eye Drops

Interventions

Permethrin 5%DRUG

Facial skin application once a night for 3 months.

Permethrin 5%
Synthomycine 5%DRUG

Eye ointment, eyelids and eyelashes application (chloramphenicol), once a night for 3 months.

Synthomycine 5%,
Fusidic Acid 1% M/R Eye DropsDRUG

viscous eye drops application once a night for 3 months.

Fusidic Acid 1%

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Adult (Age ≥18Y) individuals clinically diagnosed with Demodex- blepharitis.

You may not qualify if:

  • \- Known sensitivity to all study medications or components. Pregnant women and individuals deemed unfit to provide informed consent. Systemic steroid use.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barzilai Medical Center

Ashkelon, 78278, Israel

Location

MeSH Terms

Interventions

Fusidic Acid

Intervention Hierarchy (Ancestors)

CholestadienolsCholestadienesCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsMembrane LipidsLipids

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof Igor Kaiserman

Study Record Dates

First Submitted

March 28, 2017

First Posted

April 10, 2017

Study Start

April 28, 2017

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

January 30, 2018

Record last verified: 2018-01

Locations

IL(1)