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

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ClinicalTrials.gov Identifier: NCT02933879
Recruitment Status : Completed
First Posted : October 14, 2016
Results First Posted : December 20, 2018
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA

Study Description
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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

Condition or disease Intervention/treatment Phase
Onychomycosis Drug: NVXT topical Drug: Placebo (Vehicle) Topical Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 184 participants
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
Actual Study Start Date : March 21, 2016
Actual Primary Completion Date : March 6, 2018
Actual Study Completion Date : June 21, 2018
Arms and Interventions
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Arm Intervention/treatment
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 (Vehicle) Topical
two 8-week treatment periods separated by a 32-week rest period (Treatment Group C),
 Drug: Placebo (Vehicle) Topical
Placebo (Vehicle) Topical
Other Name: placebo


Outcome Measures
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Primary Outcome Measures :
  1. Number 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

  2. Number of Patients in Each Treatment Group With a Complete Therapeutic Cure [ Time Frame: Day 141 ]
    Complete therapeutic cure is defined as both complete clinical and mycological cure of the target toenail


Secondary Outcome Measures :
  1. Number 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

  2. Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure [ Time Frame: Day 141 ]
    Almost complete therapeutic cure is defined as both mycological and satisfactory clinical cure of the target toenail

  3. Number 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.

  4. Number of Patients in Each Treatment Group With a Mycological Cure [ Time Frame: Day 141 ]
    Mycological cure is defined as a negative KOH test and a negative fungal culture.

  5. Number of Patients in Each Treatment Group With a Complete Clinical Cure [ Time Frame: day 365 ]
    Complete clinical cure is defined as 0% nail involvement.

  6. Number of Patients in Each Treatment Group With a Complete Clinical Cure [ Time Frame: Day 281 ]
    Complete clinical cure is defined as 0% nail involvement.

  7. Number of Patients in Each Treatment Group With a Complete Clinical Cure [ Time Frame: Day 141 ]
    Complete clinical cure is defined as 0% nail involvement.

  8. Number 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.

  9. Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure [ Time Frame: Day 281 ]
    Satisfactory clinical cure is defined as <5% of the target toenail involvement.

  10. Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure [ Time Frame: Day 141 ]
    Satisfactory clinical cure is defined as <5% of the target toenail involvement.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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


Locations
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United States, Pennsylvania
Novum Pharmaceutical Research Services (Novum)
Pittsburgh, Pennsylvania, United States, 15219
Sponsors and Collaborators
Taro Pharmaceuticals USA
Investigators
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Study Chair: Novum Pharmaceutical Research Services http://www.novumprs.com/contact
  Study Documents (Full-Text)

Documents provided by Taro Pharmaceuticals USA:
Statistical Analysis Plan  [PDF] March 21, 2018
Study Protocol  [PDF] July 19, 2016

More Information
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Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT02933879    
Other Study ID Numbers: NVXT 1404
First Posted: October 14, 2016    Key Record Dates
Results First Posted: December 20, 2018
Last Update Posted: December 20, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
 Infection
Mycoses
Nail Diseases
Skin Diseases