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Completed

NCT Number: NCT02933879

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

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

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Key information

Conditions

Onychomycosis Bacterial Infections and Mycoses Dermatomycoses Infections Mycoses Nail Diseases Skin Diseases Skin Diseases, Infectious Skin and Connective Tissue Diseases Tinea

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novum Pharmaceutical Research Services (Novum)

Pittsburgh, Pennsylvania, 15219, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NVXT topical

Drug

topical treatment

Other names: Active

Placebo (Vehicle) Topical

Drug

Placebo (Vehicle) Topical

Other names: placebo

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 14, 2016
Registry last updated
Dec 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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