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EcoNail

Phase 2

Onychomycosis | Small molecule | Infectious Disease |Abeona Therapeutics Inc.|Trials Updated: Sep 3, 2020

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

EcoNail clinical trials

EcoNail · 1 trial · 1 indication

Phase 2 1
NCT00385502A Trial of the Safety and Efficacy of EcoNail™ in the Treatment of Fungus Infections of the Great ToenailOnychomycosis
COMPLETED40 Analytics
PHASE2COMPLETED
A Trial of the Safety and Efficacy of EcoNail™ in the Treatment of Fungus Infections of the Great Toenail
OnychomycosisUnlock trial analytics

Study Endpoints

Primary Endpoints

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.
Week 48

Secondary Endpoints

Evaluate the safety and local tolerability of EcoNail™ lacquer under the same circumstances.
Week 56
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
EcoNail™EXPERIMENTALeconazole 5%/SEPA® 18% nail lacquer

Interventions

NameTypeDescription
EcoNail™ (econazole 5%/SEPA® 18% nail lacquer)DRUGnail lacquer applied daily for 48 weeks
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites3

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...

Countries:United States
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Frequently asked questions about EcoNail

What is EcoNail used for?

EcoNail is an investigational nail lacquer being developed for the treatment of onychomycosis, a fungal infection of the toenail. It is a small molecule therapy applied topically to the nail. It has been studied in a Phase 2 trial in adults with fungus infections of the great toenail.

Who is developing EcoNail?

EcoNail is being developed by Abeona Therapeutics Inc., which trades on the Nasdaq under the ticker ABEO. The company is the sponsor of the clinical program evaluating the nail lacquer for onychomycosis.

What phase is EcoNail in?

EcoNail is in Phase 2 clinical development. It is an investigational product and has not been approved by the FDA. The Phase 2 trial has been completed, and no active trials are currently listed for this asset.

What clinical trials is EcoNail in?

EcoNail has been evaluated in one completed Phase 2 trial, NCT00385502, titled A Trial of the Safety and Efficacy of EcoNail in the Treatment of Fungus Infections of the Great Toenail. The trial enrolled 40 adults in the United States and studied onychomycosis.