A Trial of the Safety and Efficacy of EcoNail™ in the Treatment of Fungus Infections of the Great… (NCT00385502) | Clinical Trial Compass
CompletedPhase 2
A Trial of the Safety and Efficacy of EcoNailâ„¢ in the Treatment of Fungus Infections of the Great Toenail
United States40 participantsStarted 2006-09
Plain-language 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 EcoNailâ„¢ lacquer.
Who can participate
Age range18 Years – 65 Years
SexALL
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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. Su…
What they're measuring
1
Determine effectiveness of EcoNailâ„¢ lacquer, as determined by effects on nail mycology and appearance, when applied daily for 48 weeks to diseased great toenails in subjects with onychomycosis.