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

Inflammation of the Eyelids Clinical Trial

Official title:

The Efficacy Of Lyclear (Permethrin 5%) Vs Fusidic Acid1% and Synthomycine 5% for Demodex -Blepharitis Treatment, Prospective-Randomized Trial.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03105505
• Other study ID #: 003-16-BRZ
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: March 28, 2017
• Last updated: January 29, 2018
• Start date: April 28, 2017
• Est. completion date: September 2018

Study information

• Verified date: January 2018
• Source: Barzilai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%) .

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 75
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blepharitis
• Inflammation
• Inflammation of the Eyelids

Intervention

Drug:
• Permethrin 5%
Facial skin application once a night for 3 months.
• Synthomycine 5%
Eye ointment, eyelids and eyelashes application (chloramphenicol), once a night for 3 months.
• Fusidic Acid 1% M/R Eye Drops
viscous eye drops application once a night for 3 months.

Locations

Country	Name	City	State
Israel	Barzilai Medical Center	Ashqelon

Sponsors (1)

Lead Sponsor	Collaborator
Barzilai Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in demodex infestation in group A (permethrin 5%).	significant decrease in demodex infestation in comparison to group B and C.	2 months
Primary	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