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

Primary Purpose

Onychomycosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NVXT topical
Placebo (Vehicle) Topical
Sponsored by
Taro Pharmaceuticals USA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Onychomycosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Novum Pharmaceutical Research Services (Novum)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NVXT topical

Placebo (Vehicle) Topical

Arm 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),

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

Outcomes

Primary Outcome Measures

Number of Patients in Each Treatment Group With a Complete Therapeutic Cure
Complete therapeutic cure is defined as both complete clinical and mycological cure of the target toenail
Number of Patients in Each Treatment Group With a Complete Therapeutic Cure
Complete therapeutic cure is defined as both complete clinical and mycological cure of the target toenail

Secondary Outcome Measures

Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure
Almost complete therapeutic cure is defined as both mycological and satisfactory clinical cure of the target toenail
Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure
Almost complete therapeutic cure is defined as both mycological and satisfactory clinical cure of the target toenail
Number of Patients in Each Treatment Group With a Mycological Cure
Mycological cure is defined as a negative KOH test and a negative fungal culture.
Number of Patients in Each Treatment Group With a Mycological Cure
Mycological cure is defined as a negative KOH test and a negative fungal culture.
Number of Patients in Each Treatment Group With a Complete Clinical Cure
Complete clinical cure is defined as 0% nail involvement.
Number of Patients in Each Treatment Group With a Complete Clinical Cure
Complete clinical cure is defined as 0% nail involvement.
Number of Patients in Each Treatment Group With a Complete Clinical Cure
Complete clinical cure is defined as 0% nail involvement.
Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure
Satisfactory clinical cure is defined as <5% of the target toenail involvement.
Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure
Satisfactory clinical cure is defined as <5% of the target toenail involvement.
Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure
Satisfactory clinical cure is defined as <5% of the target toenail involvement.

Full Information

First Posted
October 12, 2016
Last Updated
December 18, 2018
Sponsor
Taro Pharmaceuticals USA
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1. Study Identification

Unique Protocol Identification Number
NCT02933879
Brief Title
Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi-Site Phase 2b Clinical Study
Official Title
A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi- Site Phase 2b Clinical Study to Assess the Efficacy, Safety and Tolerability Patients With Mild to Moderate Onychomycosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
March 21, 2016 (Actual)
Primary Completion Date
March 6, 2018 (Actual)
Study Completion Date
June 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taro Pharmaceuticals USA

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
184 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NVXT topical
Arm Type
Experimental
Arm 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),
Arm Title
Placebo (Vehicle) Topical
Arm Type
Placebo Comparator
Arm Description
two 8-week treatment periods separated by a 32-week rest period (Treatment Group C),
Intervention Type
Drug
Intervention Name(s)
NVXT topical
Other Intervention Name(s)
Active
Intervention Description
topical treatment
Intervention Type
Drug
Intervention Name(s)
Placebo (Vehicle) Topical
Other Intervention Name(s)
placebo
Intervention Description
Placebo (Vehicle) Topical
Primary Outcome Measure Information:
Title
Number of Patients in Each Treatment Group With a Complete Therapeutic Cure
Description
Complete therapeutic cure is defined as both complete clinical and mycological cure of the target toenail
Time Frame
Day 365
Title
Number of Patients in Each Treatment Group With a Complete Therapeutic Cure
Description
Complete therapeutic cure is defined as both complete clinical and mycological cure of the target toenail
Time Frame
Day 141
Secondary Outcome Measure Information:
Title
Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure
Description
Almost complete therapeutic cure is defined as both mycological and satisfactory clinical cure of the target toenail
Time Frame
Day 365
Title
Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure
Description
Almost complete therapeutic cure is defined as both mycological and satisfactory clinical cure of the target toenail
Time Frame
Day 141
Title
Number of Patients in Each Treatment Group With a Mycological Cure
Description
Mycological cure is defined as a negative KOH test and a negative fungal culture.
Time Frame
day 365
Title
Number of Patients in Each Treatment Group With a Mycological Cure
Description
Mycological cure is defined as a negative KOH test and a negative fungal culture.
Time Frame
Day 141
Title
Number of Patients in Each Treatment Group With a Complete Clinical Cure
Description
Complete clinical cure is defined as 0% nail involvement.
Time Frame
day 365
Title
Number of Patients in Each Treatment Group With a Complete Clinical Cure
Description
Complete clinical cure is defined as 0% nail involvement.
Time Frame
Day 281
Title
Number of Patients in Each Treatment Group With a Complete Clinical Cure
Description
Complete clinical cure is defined as 0% nail involvement.
Time Frame
Day 141
Title
Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure
Description
Satisfactory clinical cure is defined as <5% of the target toenail involvement.
Time Frame
day 365
Title
Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure
Description
Satisfactory clinical cure is defined as <5% of the target toenail involvement.
Time Frame
Day 281
Title
Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure
Description
Satisfactory clinical cure is defined as <5% of the target toenail involvement.
Time Frame
Day 141

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novum Pharmaceutical Research Services
Organizational Affiliation
http://www.novumprs.com/contact
Official's Role
Study Chair
Facility Information:
Facility Name
Novum Pharmaceutical Research Services (Novum)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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