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

A Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Parallel Group Study of the Safety and Efficacy of NAB001 in the Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenails for 52 Wks

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01208168

Enrollment

468

Registered

2010-09-23

Start date

2010-09-30

Completion date

2012-07-31

Last updated

2013-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Onychomycosis

Keywords

toenail fungus, onychomycosis, nail infection

Brief summary

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.

Interventions

DRUGNAB001

nail lacquer, once daily, 52 weeks

DRUGVehicle alone

nail lacquer, once daily, 52 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Complete cure rate at Week 56. Complete cure defined as clinically clear nail and mycological cure.	Week 56 after 52 weeks of treatment

Secondary

Measure	Time frame
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).	Week 56

Countries

Dominican Republic, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026