OnychomycosisPhase 2NCT00385502
A Trial of the Safety and Efficacy of EcoNail™ in the Treatment of Fungus Infections of the Great Toenail
A Phase 2 study testing EcoNail™ (econazole 5%/SEPA® 18% nail lacquer) in people with Onychomycosis, run by Abeona Therapeutics, Inc at 3 sites in United States.
Trial summary
Approximately 40 qualified subjects with mild-to-moderate great toenail fungus infection will be treated for 48 weeks with lacquer application to at least one affected great toenail. All subjects will receive treatment with EcoNail™ lacquer. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- EcoNail™ (econazole 5%/SEPA® 18% nail lacquer)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2006to Jun 2008
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are men and women greater than or equal to 18 years of age and less than or equal to 65 years of age.
- Female subjects who are post-menopausal (amenorrheic for at least 1 year), surgically sterile, have a partner with a vasectomy, or routinely using an acceptable means of contraception (acceptable methods may include hormonal contraceptives, intrauterine device, spermicide and barrier, abstinence and partner/spouse sterility).
- Subjects who have mycologically confirmed distal subungual onychomycosis of at least one or both great toenails ("target toenails"), defined as a positive result by office-based KOH preparation (± Chlorazol B) and by laboratory culture demonstrating one of more of the following organisms: T. rubrum, T. mentagrophytes, T. tonsurans and/or E. floccosum
- Subjects who have target toenail showing 20-65% (+/- 2%) involvement as judged by the clinical investigator.
- Subjects who have target toenail showing great than or equal to 3 mm distal involvement as judged by the clinical investigator.
- Subjects who have target toenail showing great than or equal to 2 mm proximal clear nail at the cuticle.
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- Subjects must agree not to apply other nail polish or related products to the affected nails for the duration of the study.
- Subjects must refrain from filing, clipping, or otherwise disturbing the treated nail(s) for the duration of the study [NOTE: Clinic personnel will debride the affected nails during monthly visits. Subjects should not engage in these activities at home during the course of the study.]
- Subjects must have the ability to understand the nature of the study and any hazards of participating in it and the willingness to communicate satisfactorily with the investigator and staff and to participate in, and comply with the requirements of the entire study.
- Subjects must be able to read and sign the study Informed Consent form and comply with the requirements outlined in the informed consent form.
Who cannot join
- Subjects with < 20% or > 65% (+/- 2%) involvement of the target toenail.
- Subjects with great than or equal to 4 mm thickness of the target toenail.
- Subjects with totally dystrophic great toe.
- Subjects with great toenails which show white superficial or proximal subungual onychomycosis, or a "spike" of onychomycosis extending to the cuticle.
- Subjects whose nail cultures grow Candida species as the only pathogen.
- Subjects who have reported treatment with a topical anti-fungal agent for onychomycosis during the four weeks prior to screening for this study.
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- Subjects who have been treated with a systemic anti-fungal agent during the three months prior to screening for this study.
- Subjects with any other nail abnormality or dermatological condition, including (but not limited to) psoriasis and lichen planus, that could prevent obtaining a normal-appearing toenail if complete cure was achieved or could otherwise interfere with required study assessments.
- Subjects with a history of organ transplantation, Human Immunodeficiency Virus (HIV) seropositivity or other historical or clinical evidence of an immunocompromised state.
- Subjects with a history of uncontrolled insulin-dependent diabetes mellitus.
- Subjects with a history of diabetic peripheral neuropathy.
- Subjects with a history of clinically significant lower extremity peripheral occlusive vascular disease.
- Subjects with a presence of plantar (moccasin) tinea pedis.
- Subjects with a history of hypersensitivity or allergic reactions on the skin or nails, including reactions to nail polish and/or nail polish remover.
- Subjects known to have an allergy to econazole, ethanol, Eudragit, or SEPA.
- Female subjects who are pregnant or lactating.
- Subjects with clinically relevant abnormal history, physical findings, or laboratory values at the screening assessment that could interfere with the objectives or the safety of the volunteer.
- Subjects who have a condition or abnormality that in the investigator's opinion may interfere with the assessments, conduct of the study, may affect the subject's safety, or is otherwise unsuitable for enrollment.
- Subjects who are currently participating or, within the previous 30 days, have participated in another investigational drug study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
New York, New York, 10032
Study site
Portland, Oregon, 97210
Study site
Tucson, Arizona, 85741
About this study
Official title: A Phase II Trial of the Safety, Local Tolerability, and Efficacy of EcoNail™ (Econazole 5%/SEPA® 18% Nail Lacquer) in Onychomycosis of the Great Toenail
Approximately 40 qualified subjects with mild-to-moderate great toenail fungus infection will be treated for 48 weeks with lacquer application to at least one affected great toenail. All subjects will receive treatment with EcoNail™ lacquer.
Read the detailed description
This study will use a multi-center, open-label study design in subjects with onychomycosis of at least one great toenail to assess the safety, local tolerability, and efficacy of chronic daily ungual application of EcoNail™. Forty (40) evaluable subjects will apply study drug daily to at least one affected great toenail for 48 weeks. The subjects must comply with all inclusion and exclusion criteria.
- Conditions
- Onychomycosis
- Being tested
- EcoNail™ (econazole 5%/SEPA® 18% nail lacquer)
- Keywords
- toenail, fungus, onychomycosis, antifungal, anti-fungal, nail
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EcoNail™ (econazole 5%/SEPA® 18% nail lacquer)Drug
Also called econazole, SEPA
nail lacquer applied daily for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| EcoNail™ | Experimental | econazole 5%/SEPA® 18% nail lacquer Receives: Drug: EcoNail™ (econazole 5%/SEPA® 18% nail lacquer) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine effectiveness of EcoNail™ lacquer, as determined by effects on nail mycology and appearance, when applied daily for 48 weeks to diseased great toenails in subjects with onychomycosis.
Measured: Week 48
Secondary outcomes (1)
Evaluate the safety and local tolerability of EcoNail™ lacquer under the same circumstances.
Measured: Week 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2006 (estimated)
- Study startSep 2006
- Primary completionJun 2008
- Study completionJun 2008
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abeona Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael H. Silverman, MD, Study director, Biostrategics Consulting, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00385502
- Sponsor's protocol ID
- MCHM EC-200
- Status last verified
- Sep 2020
- First submitted
- 5 Oct 2006
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of the Safety, Local Tolerability, and Efficacy of EcoNail™ (Econazole 5%/SEPA® 18% Nail Lacquer) in Onychomycosis of the Great Toenail
- ClinicalTrials.gov ID
- NCT00385502
- Acronym / sponsor ID
- MCHM EC-200
- Conditions
- Onychomycosis
- Keywords
- toenail, fungus, onychomycosis, antifungal, anti-fungal, nail
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Abeona Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2006 (actual)
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 9 Oct 2006 (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.
Approximately 40 qualified subjects with mild-to-moderate great toenail fungus infection will be treated for 48 weeks with lacquer application to at least one affected great toenail. All subjects will receive treatment with EcoNail™ lacquer.
Detailed description
This study will use a multi-center, open-label study design in subjects with onychomycosis of at least one great toenail to assess the safety, local tolerability, and efficacy of chronic daily ungual application of EcoNail™. Forty (40) evaluable subjects will apply study drug daily to at least one affected great toenail for 48 weeks. The subjects must comply with all inclusion and exclusion criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EcoNail™ | Experimental | Drug: EcoNail™ (econazole 5%/SEPA® 18% nail lacquer)econazole 5%/SEPA® 18% nail lacquer |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects who are men and women greater than or equal to 18 years of age and less than or equal to 65 years of age.
- Female subjects who are post-menopausal (amenorrheic for at least 1 year), surgically sterile, have a partner with a vasectomy, or routinely using an acceptable means of contraception (acceptable methods may include hormonal contraceptives, intrauterine device, spermicide and barrier, abstinence and partner/spouse sterility).
- Subjects who have mycologically confirmed distal subungual onychomycosis of at least one or both great toenails ("target toenails"), defined as a positive result by office-based KOH preparation (± Chlorazol B) and by laboratory culture demonstrating one of more of the following organisms: T. rubrum, T. mentagrophytes, T. tonsurans and/or E. floccosum
- Subjects who have target toenail showing 20-65% (+/- 2%) involvement as judged by the clinical investigator.
- Subjects who have target toenail showing great than or equal to 3 mm distal involvement as judged by the clinical investigator.
Key exclusion criteria (19 listed)
- Subjects with < 20% or > 65% (+/- 2%) involvement of the target toenail.
- Subjects with great than or equal to 4 mm thickness of the target toenail.
- Subjects with totally dystrophic great toe.
- Subjects with great toenails which show white superficial or proximal subungual onychomycosis, or a "spike" of onychomycosis extending to the cuticle.
- Subjects whose nail cultures grow Candida species as the only pathogen.
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 |
|---|---|---|
| EcoNail™ (econazole 5%/SEPA® 18% nail lacquer)Also: econazole, SEPAnail lacquer applied daily for 48 weeks | Drug | EcoNail™ |
Primary outcome
Determine effectiveness of EcoNail™ lacquer, as determined by effects on nail mycology and appearance, when applied daily for 48 weeks to diseased great toenails in subjects with onychomycosis.
Time frame: Week 48
1 secondary outcome
Evaluate the safety and local tolerability of EcoNail™ lacquer under the same circumstances.
Time frame: Week 56
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 3 Sep 2020.
- Sponsor's websiteLink provided by the sponsor.
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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.
Michael H. Silverman, MD study director
Biostrategics Consulting, Ltd.
3 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 EcoNail™ (econazole 5%/SEPA® 18% nail lacquer) in people with Onychomycosis, run by Abeona Therapeutics, Inc at 3 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 10 inclusion and 19 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 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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?
Determine effectiveness of EcoNail™ lacquer, as determined by effects on nail mycology and appearance, when applied daily for 48 weeks to diseased great toenails in subjects with onychomycosis. (time frame: Week 48). 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 3 Sep 2020.