Safety and Efficacy of NVXT Solution in Mild-to-Moderate Fungal Infection of the Toe Nail

Taro Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Onychomycosis

Treatments: Drug: Vehicle of test product; Drug: NVXT Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT02343627

NVXT 1405

Details and patient eligibility

About

This study will examine the safety, tolerability and efficacy of NVXT in a new formulation in patients with mild-to-moderate fungal infection of the toe nail.

Full description

This Phase IIa pilot multiple-dose study will examine the safety, tolerability and efficacy of NVXT in a new formulation in patients with mild-to-moderate fungal infection of the toe nail.

Enrollment: 47 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinically diagnosed onychomycosis
• Presence of dermatophyte fungal infection with no current topical or systemic antifungal therapy
• Clinical diagnosis of mild-to-moderate fungal infection of at least one toe involving 10-50% of the nail area, without involvement of one of the lunular proximal regions
• Positive potassium hydroxide mount preparation
• Positive fungal culture for a dermatophyte

Exclusion criteria

• Nail or anatomical abnormalities of the toe that may interfere with evaluations or dosing compliance

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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47 participants in 2 patient groups, including a placebo group

NVXT Solution

Experimental group

Description:

NVXT Solution once daily for 60 days

Treatment:

Drug: NVXT Solution

Vehicle of test product

Placebo Comparator group

Description:

Vehicle of test product, once daily for 60 days

Treatment:

Drug: Vehicle of test product