NCT02933879

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2018

Completed
6 months until next milestone

Results Posted

Study results publicly available

December 20, 2018

Completed
Last Updated

December 20, 2018

Status Verified

December 1, 2018

Enrollment Period

2 years

First QC Date

October 12, 2016

Results QC Date

November 12, 2018

Last Update Submit

December 18, 2018

Conditions

Onychomycosis

Outcome Measures

Primary Outcomes (2)

  • 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

    Day 365

  • 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

    Day 141

Secondary Outcomes (10)

  • Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure

    Day 365

  • Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure

    Day 141

  • Number of Patients in Each Treatment Group With a Mycological Cure

    day 365

  • Number of Patients in Each Treatment Group With a Mycological Cure

    Day 141

  • Number of Patients in Each Treatment Group With a Complete Clinical Cure

    day 365

  • +5 more secondary outcomes

Study Arms (2)

NVXT topical

EXPERIMENTAL

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),

Drug: NVXT topical

Placebo (Vehicle) Topical

PLACEBO COMPARATOR

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

Drug: Placebo (Vehicle) Topical

Interventions

NVXT topicalDRUG

topical treatment

Also known as: Active
NVXT topical
Placebo (Vehicle) TopicalDRUG

Placebo (Vehicle) Topical

Also known as: placebo
Placebo (Vehicle) Topical

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novum Pharmaceutical Research Services (Novum)

Pittsburgh, Pennsylvania, 15219, United States

Location

MeSH Terms

Conditions

Onychomycosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

TineaDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousNail DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Natalie Yantovskiy
Organization
Taro Pharmaceuticals U.S.A. Inc
Natalie.Yantovskiy@Taro.com
+1 914-345-9001

Study Officials

  • Novum Pharmaceutical Research Services

    http://www.novumprs.com/contact

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2016

First Posted

October 14, 2016

Study Start

March 21, 2016

Primary Completion

March 6, 2018

Study Completion

June 21, 2018

Last Updated

December 20, 2018

Results First Posted

December 20, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)