Safety & Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails

Phase 3TerminatedNCT01208168

Promius Pharma, LLC468 enrolled

Overview

The objectives of this study are to assess the safety of NAB001 for topical treatment of mild to moderate distal onychomycosis of the toenails over 52 weeks and to compare the efficacy of NAB001 to vehicle alone at the end of the study (Week 56) after treating for 52 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

468

Conditions

Onychomycosis

Interventions

NAB001DRUG

nail lacquer, once daily, 52 weeks

Vehicle aloneDRUG

nail lacquer, once daily, 52 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * mild to moderate fungal infection of the toenail as assessed by study doctor * koh positive \& dermatophyte culture positive at Visit 1 * good general health as assessed by the study doctor Exclusion Criteria: * severe fungal toenail infection * prior use of antifungal drugs (wash-out allowed, duration varies on class) * significant confounding conditions as assessed by study doctor * pregnancy/lactation * must forego nail salon procedures during study for at least \~60 weeks

Locations (24)

Unnamed facility

Phoenix, Arkansas, United States

Outcomes

Primary Outcomes

Complete cure rate at Week 56. Complete cure defined as clinically clear nail and mycological cure.

Time frame: Week 56 after 52 weeks of treatment

Secondary Outcomes

Proportion of subjects with effective treatment at week 56. Effective treatment defined as mycological cure and an IGA of 0 or 1 (Clear or almost clear).

Time frame: Week 56

Data from ClinicalTrials.gov

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