OnychomycosisPhase 2NCT02022215
Efficacy and Safety Study of ME1111 in Patients With Onychomycosis
A Phase 2 study testing ME1111 Solution, Low strength and ME1111 Solution, High strength in people with Onychomycosis, run by Meiji Seika Pharma Co., Ltd. at 31 sites in United States.
Trial summary
The purpose of the study is to determine the safety and efficacy of high and low strength of ME1111 solutions compared to the vehicle in the treatment of onychomycosis of the toenail. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- ME1111 Solution, Low strength and ME1111 Solution, High strength
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 304 participants
- Where
- 31 sitesUnited States
- Study dates
- 19 Dec 2013to 1 Mar 2016
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild to moderate distal lateral subungual onychomycosis
- A positive potassium hydroxide (KOH) microscopy
- A positive fungal culture for a dermatophyte
- Good general health
Who cannot join
- Uncontrolled diabetes
- Onychomycosis of the fingernails
- Prior use of antifungal drugs (Failure to complete the specified washout period)
- History of HIV, Hepatitis B or Hepatitis C
- Diagnosis of psoriasis or history of psoriasis
- Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
- Pregnancy/lactation
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Study site
Albuquerque, New Mexico
Study site
Ann Arbor, Michigan
Study site
Austin, Texas
Study site
Baltimore, Maryland
Study site
Birmingham, Alabama
Study site
Boise, Idaho
Study site
Cincinnati, Ohio
Study site
Clinton Township, Michigan
Study site
College Station, Texas
Study site
Dallas, Texas
Study site
Denver, Colorado
Study site
Encinitas, California
Study site
Evansville, Indiana
Study site
Fridley, Minnesota
Study site
Knoxville, Tennessee
Study site
Lynchburg, Virginia
Study site
Miami, Florida
Study site
Miramar, Florida
Study site
Mt. Pleasant, South Carolina
Study site
Nashville, Tennessee
Study site
New York, New York
Study site
Newnan, Georgia
Study site
Norfolk, Virginia
Study site
Portland, Oregon
Study site
Rochester, New York
Study site
Salt Lake City, Utah
Study site
San Antonio, Texas
Study site
San Diego, California
Study site
San Francisco, California
Study site
Santa Rosa, California
Study site
Spokane, Washington
About this study
Official title: A Phase 2 Randomized, Double-Blind, Vehicle-Controlled, Dose-Ranging Study to Investigate the Efficacy and Safety of ME1111 in Patients With Mild to Moderate Onychomycosis
The purpose of the study is to determine the safety and efficacy of high and low strength of ME1111 solutions compared to the vehicle in the treatment of onychomycosis of the toenail.
- Conditions
- Onychomycosis
- Being tested
- ME1111 Solution, Low strength, ME1111 Solution, High strength, Matching Vehicle Solution
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ME1111 Solution, Low strengthDrug
ME1111 Solution, Low strength, applied once daily for 48 weeks
ME1111 Solution, High strengthDrug
ME1111 Solution, High strength, applied once daily for 48 weeks
Matching Vehicle SolutionDrug
Matching Vehicle Solution, applied once daily for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| ME1111 Solution, Low strength | Experimental | Not described Receives: Drug: ME1111 Solution, Low strength |
| ME1111 Solution, High strength | Experimental | Not described Receives: Drug: ME1111 Solution, High strength |
| Matching Vehicle Solution | Placebo comparator | Not described Receives: Drug: Matching Vehicle Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete cure rate at Week 52
complete cure :clear (zero %) clinical involvement of the target great toenail and mycologic cure.
Measured: Week 52
Secondary outcomes (3)
Complete or almost complete cure rate at Week 52
complete or almost complete cure:5 % or less clinical involvement of the target great toenail and mycologic cure.
Measured: Week 52
Number of Adverse events
Measured: Up to Week 48, Week 52, EOS
Local Tolerability Assessments
Local Tolerability Assessments:Burning/Stinging, Pruritus, Dryness, Scaling, Erythema, General Irritation, Induration/Edema, Oozing/crusting.
Measured: Up to Week 48, Week 52, EOS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study start19 Dec 2013
- Primary completion28 Oct 2015
- Study completion1 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OnychomycosisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meiji Seika Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Meiji Study Director, Study director, Meiji Seika Pharma Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02022215
- Sponsor's protocol ID
- ME1111-2
- Status last verified
- Mar 2024
- First submitted
- 15 Dec 2013
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Double-Blind, Vehicle-Controlled, Dose-Ranging Study to Investigate the Efficacy and Safety of ME1111 in Patients With Mild to Moderate Onychomycosis
- ClinicalTrials.gov ID
- NCT02022215
- Acronym / sponsor ID
- ME1111-2
- Conditions
- Onychomycosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Meiji Seika Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Dec 2013 (actual)
- Primary completion
- 28 Oct 2015 (actual)
- Study completion
- 1 Mar 2016 (actual)
- First posted
- 27 Dec 2013 (estimated)
- 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 purpose of the study is to determine the safety and efficacy of high and low strength of ME1111 solutions compared to the vehicle in the treatment of onychomycosis of the toenail.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ME1111 Solution, Low strength | Experimental | Drug: ME1111 Solution, Low strength |
| ME1111 Solution, High strength | Experimental | Drug: ME1111 Solution, High strength |
| Matching Vehicle Solution | Placebo comparator | Drug: Matching Vehicle Solution |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Mild to moderate distal lateral subungual onychomycosis
- A positive potassium hydroxide (KOH) microscopy
- A positive fungal culture for a dermatophyte
- Good general health
Key exclusion criteria (7 listed)
- Uncontrolled diabetes
- Onychomycosis of the fingernails
- Prior use of antifungal drugs (Failure to complete the specified washout period)
- History of HIV, Hepatitis B or Hepatitis C
- Diagnosis of psoriasis or history of psoriasis
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 |
|---|---|---|
| ME1111 Solution, Low strengthME1111 Solution, Low strength, applied once daily for 48 weeks | Drug | ME1111 Solution, Low strength |
| ME1111 Solution, High strengthME1111 Solution, High strength, applied once daily for 48 weeks | Drug | ME1111 Solution, High strength |
| Matching Vehicle SolutionMatching Vehicle Solution, applied once daily for 48 weeks | Drug | Matching Vehicle Solution |
Primary outcome
Complete cure rate at Week 52
Time frame: Week 52
complete cure :clear (zero %) clinical involvement of the target great toenail and mycologic cure.
3 secondary outcomes
Complete or almost complete cure rate at Week 52
Time frame: Week 52
Number of Adverse events
Time frame: Up to Week 48, Week 52, EOS
Local Tolerability Assessments
Time frame: Up to Week 48, Week 52, EOS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
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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.
Meiji Study Director study director
Meiji Seika Pharma Co., Ltd.
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ME1111 Solution, Low strength and ME1111 Solution, High strength in people with Onychomycosis, run by Meiji Seika Pharma Co., Ltd. at 31 sites in United States.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Complete cure rate at Week 52 (time frame: Week 52). 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 18 Mar 2024.