We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 21 of 62 for:    Onychomycosis | United States

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

This study is currently recruiting participants.
Verified August 2017 by Taro Pharmaceuticals USA
Sponsor:
ClinicalTrials.gov Identifier:
NCT02933879
First Posted: October 14, 2016
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Taro Pharmaceuticals USA
  Purpose
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

Condition Intervention Phase
Onychomycosis Drug: NVXT topical Drug: Placebo (Vehicle) Topical Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by Taro Pharmaceuticals USA:

Primary Outcome Measures:
  • proportion of patients in each treatment group with a complete therapeutic cure [ Time Frame: day 365 ]
    Complete therapeutic cure is defined as both complete clinical and mycological cure of the target toenail


Secondary Outcome Measures:
  • proportion of patients in each treatment group with a complete or almost complete therapeutic cure [ Time Frame: day 365 ]
    Almost complete therapeutic cure is defined as both mycological and satisfactory clinical cure of the target toenail

  • proportion of patients in each treatment group with a mycological cure [ Time Frame: day 365 ]
    Mycological cure is defined as a negative KOH test and a negative fungal culture.

  • proportion of patients in each treatment group with a complete clinical cure [ Time Frame: day 365 ]
    Complete clinical cure is defined as 0% nail involvement.

  • proportion of patients in each treatment group with a satisfactory clinical cure [ Time Frame: day 365 ]
    Satisfactory clinical cure is defined as <5% of the target toenail involvement.


Estimated Enrollment: 180
Actual Study Start Date: March 21, 2016
Estimated Study Completion Date: March 30, 2018
Estimated Primary Completion Date: February 15, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NVXT topical
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
topical treatment
Other Name: Active
Placebo Comparator: Placebo topical
two 8-week treatment periods separated by a 32-week rest period (Treatment Group C),
Drug: Placebo (Vehicle) Topical
topical treatment
Other Name: placebo

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02933879


Contacts
Contact: Taro Pharmaceutical Inc. 914-345-9001
Contact: Novum Pharmaceutical Research Services gdgongas@novumprs.com

Locations
United States, Pennsylvania
Novum Pharmaceutical Research Services (Novum) Recruiting
Pittsburgh, Pennsylvania, United States, 15219
Contact: Gail Gongas    412-363-3300      
Sponsors and Collaborators
Taro Pharmaceuticals USA
Investigators
Study Chair: Novum Pharmaceutical Research Services http://www.novumprs.com/contact
  More Information

Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT02933879     History of Changes
Other Study ID Numbers: NVXT 1404
First Submitted: October 12, 2016
First Posted: October 14, 2016
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases