Inflammation of the EyelidsPhase 4NCT03105505
The Efficacy of Permethrin 5%, Fusidic Acid 1% and Synthomycine 5% for Demodex - Blepharitis
A Phase 4 study testing Permethrin 5%, Synthomycine 5% and Fusidic Acid 1% M/R Eye Drops in people with Inflammation of the Eyelids, run by Barzilai Medical Center at 1 site in Israel.
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%) . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammation of the Eyelids
- What is being tested?
- Permethrin 5%, Synthomycine 5% and Fusidic Acid 1% M/R Eye Drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteIsrael
- Study dates
- 28 Apr 2017to Sep 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (Age ≥18Y) individuals clinically diagnosed with Demodex- blepharitis.
Who cannot join
- Known sensitivity to all study medications or components. Pregnant women and individuals deemed unfit to provide informed consent. Systemic steroid use.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy Of Lyclear (Permethrin 5%) Vs Fusidic Acid1% and Synthomycine 5% for Demodex -Blepharitis Treatment, Prospective-Randomized Trial.
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%) .
Read the 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.
- Conditions
- Inflammation of the Eyelids
- Being tested
- Permethrin 5%, Synthomycine 5%, Fusidic Acid 1% M/R Eye Drops
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Permethrin 5%Drug
Facial skin application once a night for 3 months.
Synthomycine 5%Drug
Eye ointment, eyelids and eyelashes application (chloramphenicol), once a night for 3 months.
Fusidic Acid 1% M/R Eye DropsDrug
viscous eye drops application once a night for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Permethrin 5% |
| Synthomycine 5%, | Active comparator | Contains chloramphenicol 5%. Receives: Drug: Synthomycine 5% |
| Fusidic Acid 1% | Active comparator | Contains 1% w/w fusidic acid anhydrous (as the hemihydrates) and 0.011% w/w. Receives: Drug: Fusidic Acid 1% M/R Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in demodex infestation in group A (permethrin 5%).
significant decrease in demodex infestation in comparison to group B and C.
Measured: 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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start28 Apr 2017
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammation of the EyelidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barzilai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Igor Kaiserman, Barzilai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105505
- Sponsor's protocol ID
- 003-16-BRZ
- Status last verified
- Jan 2018
- First submitted
- 28 Mar 2017
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy Of Lyclear (Permethrin 5%) Vs Fusidic Acid1% and Synthomycine 5% for Demodex -Blepharitis Treatment, Prospective-Randomized Trial.
- ClinicalTrials.gov ID
- NCT03105505
- Acronym / sponsor ID
- 003-16-BRZ
- Conditions
- Inflammation of the Eyelids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Barzilai Medical CenterUniversity, hospital or other
- Study start
- 28 Apr 2017 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 10 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Permethrin 5% | Active comparator | Drug: 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. |
| Synthomycine 5%, | Active comparator | Drug: Synthomycine 5%Contains chloramphenicol 5%. |
| Fusidic Acid 1% | Active comparator | Drug: Fusidic Acid 1% M/R Eye DropsContains 1% w/w fusidic acid anhydrous (as the hemihydrates) and 0.011% w/w. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult (Age ≥18Y) individuals clinically diagnosed with Demodex- blepharitis.
Key exclusion criteria (1 listed)
- Known sensitivity to all study medications or components. Pregnant women and individuals deemed unfit to provide informed consent. Systemic steroid use.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Permethrin 5%Facial skin application once a night for 3 months. | Drug | Permethrin 5% |
| Synthomycine 5%Eye ointment, eyelids and eyelashes application (chloramphenicol), once a night for 3 months. | Drug | Synthomycine 5%, |
| Fusidic Acid 1% M/R Eye Dropsviscous eye drops application once a night for 3 months. | Drug | Fusidic Acid 1% |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Permethrin 5%, Synthomycine 5% and Fusidic Acid 1% M/R Eye Drops in people with Inflammation of the Eyelids, run by Barzilai Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in demodex infestation in group A (permethrin 5%). (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2018.