- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00385502
A Trial of the Safety and Efficacy of EcoNail™ in the Treatment of Fungus Infections of the Great Toenail
September 1, 2020 updated by: Abeona Therapeutics, Inc
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Tucson, Arizona, United States, 85741
-
-
New York
-
New York, New York, United States, 10032
-
-
Oregon
-
Portland, Oregon, United States, 97210
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EcoNail™
econazole 5%/SEPA® 18% nail lacquer
|
nail lacquer applied daily for 48 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Week 48
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluate the safety and local tolerability of EcoNail™ lacquer under the same circumstances.
Time Frame: Week 56
|
Week 56
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Michael H. Silverman, MD, Biostrategics Consulting, Ltd.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2006
Primary Completion (Actual)
June 1, 2008
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
October 5, 2006
First Submitted That Met QC Criteria
October 5, 2006
First Posted (Estimate)
October 9, 2006
Study Record Updates
Last Update Posted (Actual)
September 3, 2020
Last Update Submitted That Met QC Criteria
September 1, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Infections
- Bacterial Infections and Mycoses
- Skin Diseases, Infectious
- Mycoses
- Tinea
- Dermatomycoses
- Nail Diseases
- Onychomycosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- 14-alpha Demethylase Inhibitors
- Econazole
Other Study ID Numbers
- MCHM EC-200
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Onychomycosis
-
Vésale HospitalJanssen-Cilag Ltd.CompletedPrevalence of Onychomycosis | Diabetic Neuropathic Patients | Diagnostic of Onychomycosis | Patients Clinically Suspected of Onychomycosis | Reliability of the Diagnosis of OnychomycosisBelgium
-
University of Alabama at BirminghamDUSA Pharmaceuticals, Inc.CompletedToenail Onychomycosis | Distal and Lateral Subungual Toenail OnychomycosisUnited States
-
DeviceFarm, Inc.Symbio, LLC; Center for Dermatology Clinical Research, Inc.CompletedOnychomycosis Due to Trichophyton Rubrum | Onychomycosis Due to Trichophyton MentagrophytesUnited States
-
Janssen Korea, Ltd., KoreaCompleted
-
Cairo UniversityRecruiting
-
Mediprobe Research Inc.Emblation LimitedRecruiting
-
Oystershell NVCompletedOnychomycosis of ToenailTunisia
-
Erchonia CorporationWithdrawnOnychomycosis of ToenailUnited States
-
William N HandelmanUnknown
-
DeviceFarm, Inc.CompletedOnychomycosis | Onychomycosis of ToenailUnited States