Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi-Site Phase 2b Clinical Study

Taro Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Onychomycosis

Treatments: Drug: Placebo (Vehicle) Topical; Drug: NVXT topical

Study type: Interventional

Funder types: Industry

Identifiers

NCT02933879

NVXT 1404

Details and patient eligibility

About

A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi- Site Phase 2b Clinical Study to Assess the Efficacy, Safety and Tolerability of 8-Week Regimens of NVXT topical product in Patients with Mild to Moderate Onychomycosis

Full description

Evaluate safety and tolerability of the two regimens of NVXT (Treatment Groups A and B) in patients with mild to moderate distal subungual onychomycosis of the target toenail.

Enrollment: 184 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of onychomycosis of the target toenail (defined as one of the infected great toenails).

Exclusion criteria

• Females who are pregnant, lactating or likely to become pregnant during the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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184 participants in 2 patient groups, including a placebo group

NVXT topical

Experimental group

Description:

daily dosing for one 8-week treatment period (Treatment Group A) and two 8-week treatment periods separated by a 32-week rest period (Treatment Group B),

Treatment:

Drug: NVXT topical

Placebo (Vehicle) Topical

Placebo Comparator group

Description:

two 8-week treatment periods separated by a 32-week rest period (Treatment Group C),

Treatment:

Drug: Placebo (Vehicle) Topical