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CompletedNCT02933879Updated Dec 20, 2018Results posted

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

A Phase 2 interventional study of NVXT topical and Placebo (Vehicle) Topical in Onychomycosis, sponsored by Sun Pharmaceutical Industries, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-20.

Sponsored by Sun Pharmaceutical Industries, Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Mar 2016, registered Oct 2016).
Phase
Phase 2
Study type
Interventional
Enrollment
184
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Onychomycosis

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03

In context

Onychomycosis

153 studies on the registry are indexed under Onychomycosis; 14 are open to participants now.

This study's enrollment of 184 is above the median of 60 across 138 interventional studies indexed under Onychomycosis.

Browse Onychomycosis studies →

Lead sponsor

Sun Pharmaceutical Industries, Inc. is the lead sponsor of 9 studies on the registry; 3 are open to participants now.

Browse Sun Pharmaceutical Industries Limited studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Females who are pregnant, lactating or likely to become pregnant during the study.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
184 participants (actual)

Study arms

  • 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

  • Placebo comparator
    Placebo (Vehicle) Topical

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

    Drug: Placebo (Vehicle) Topical

Interventions

  • DrugNVXT topical

    topical treatment

    Also known as: Active

  • DrugPlacebo (Vehicle) Topical

    Placebo (Vehicle) Topical

    Also known as: placebo

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Day 365

  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

    Time frame: Day 141

Secondary outcomes

  1. 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

    Time frame: Day 365

  2. 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

    Time frame: Day 141

  3. 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.

    Time frame: day 365

  4. 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.

    Time frame: Day 141

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

    Complete clinical cure is defined as 0% nail involvement.

    Time frame: day 365

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

    Complete clinical cure is defined as 0% nail involvement.

    Time frame: Day 281

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

    Complete clinical cure is defined as 0% nail involvement.

    Time frame: Day 141

  8. Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure

    Satisfactory clinical cure is defined as \<5% of the target toenail involvement.

    Time frame: day 365

  9. Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure

    Satisfactory clinical cure is defined as \<5% of the target toenail involvement.

    Time frame: Day 281

  10. Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure

    Satisfactory clinical cure is defined as \<5% of the target toenail involvement.

    Time frame: Day 141

07

Results

Posted Dec 20, 2018

Participant flow

Participant flow — Overall Study
MilestoneNVXT Topical Treatment Group ANVXT Topical Treatment Group BPlacebo (Vehicle) Topical Treatment Group C
Started646258
Completed484841
Not completed161417

Outcome measures

PrimaryNumber 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

Time frame:
Day 365
Reported as:
Count of participants · Participants
Number of Patients in Each Treatment Group With a Complete Therapeutic Cure
ParticipantsNVXT Topical Treatment Group ANVXT Topical Treatment Group BPlacebo (Vehicle) Topical Treatment Group C
Number of Patients in Each Treatment Group With a Complete Therapeutic Cure101
Statistical analysis
  • NVXT Topical Treatment Group B vs Placebo (Vehicle) Topical Treatment Group C · Z-test, 2 sided · p = 0.4615
PrimaryNumber 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

Time frame:
Day 141
Reported as:
Count of participants · Participants
Number of Patients in Each Treatment Group With a Complete Therapeutic Cure
ParticipantsNVXT Topical Treatment Group A+BPlacebo (Vehicle) Topical Treatment Group C
Number of Patients in Each Treatment Group With a Complete Therapeutic Cure01
SecondaryNumber 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

Time frame:
Day 365
Reported as:
Count of participants · Participants
Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure
ParticipantsNVXT Topical Treatment Group ANVXT Topical Treatment Group BPlacebo (Vehicle) Topical Treatment Group C
Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure224
Statistical analysis
  • NVXT Topical Treatment Group B vs Placebo (Vehicle) Topical Treatment Group C · Z-test, 2 sided · p = 0.0404
  • NVXT Topical Treatment Group A vs Placebo (Vehicle) Topical Treatment Group C · Z-test, 2 sided · p = 0.2106
SecondaryNumber 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

Time frame:
Day 141
Reported as:
Count of participants · Participants
Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure
ParticipantsNVXT Topical Treatment Group A+BPlacebo (Vehicle) Topical Treatment Group C
Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure11
SecondaryNumber of Patients in Each Treatment Group With a Mycological Cure

Mycological cure is defined as a negative KOH test and a negative fungal culture.

Time frame:
day 365
Reported as:
Count of participants · Participants
Number of Patients in Each Treatment Group With a Mycological Cure
ParticipantsNVXT Topical Treatment Group ANVXT Topical Treatment Group BPlacebo (Vehicle) Topical Treatment Group C
Number of Patients in Each Treatment Group With a Mycological Cure71312
Statistical analysis
  • NVXT Topical Treatment Group B vs Placebo (Vehicle) Topical Treatment Group C · Z-test, 2 sided · p = 1.0000
SecondaryNumber of Patients in Each Treatment Group With a Mycological Cure

Mycological cure is defined as a negative KOH test and a negative fungal culture.

Time frame:
Day 141
Reported as:
Count of participants · Participants
Number of Patients in Each Treatment Group With a Mycological Cure
ParticipantsNVXT Topical Treatment Group A+BPlacebo (Vehicle) Topical Treatment Group C
Number of Patients in Each Treatment Group With a Mycological Cure3010
SecondaryNumber of Patients in Each Treatment Group With a Complete Clinical Cure

Complete clinical cure is defined as 0% nail involvement.

Time frame:
day 365
Reported as:
Count of participants · Participants
Number of Patients in Each Treatment Group With a Complete Clinical Cure
ParticipantsNVXT Topical Treatment Group ANVXT Topical Treatment Group BPlacebo (Vehicle) Topical Treatment Group C
Number of Patients in Each Treatment Group With a Complete Clinical Cure111
Statistical analysis
  • NVXT Topical Treatment Group B vs Placebo (Vehicle) Topical Treatment Group C · Z-test, 2 sided · p = 1.0000
SecondaryNumber of Patients in Each Treatment Group With a Complete Clinical Cure

Complete clinical cure is defined as 0% nail involvement.

Time frame:
Day 281
Reported as:
Count of participants · Participants
Number of Patients in Each Treatment Group With a Complete Clinical Cure
ParticipantsNVXT Topical Treatment Group A+BPlacebo (Vehicle) Topical Treatment Group C
Number of Patients in Each Treatment Group With a Complete Clinical Cure00
SecondaryNumber of Patients in Each Treatment Group With a Complete Clinical Cure

Complete clinical cure is defined as 0% nail involvement.

Time frame:
Day 141
Reported as:
Count of participants · Participants
Number of Patients in Each Treatment Group With a Complete Clinical Cure
ParticipantsNVXT Topical Treatment Group A+BPlacebo (Vehicle) Topical Treatment Group C
Number of Patients in Each Treatment Group With a Complete Clinical Cure01
SecondaryNumber of Patients in Each Treatment Group With a Satisfactory Clinical Cure

Satisfactory clinical cure is defined as \<5% of the target toenail involvement.

Time frame:
day 365
Reported as:
Count of participants · Participants
Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure
ParticipantsNVXT Topical Treatment Group ANVXT Topical Treatment Group BPlacebo (Vehicle) Topical Treatment Group C
Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure725
Statistical analysis
  • NVXT Topical Treatment Group B vs Placebo (Vehicle) Topical Treatment Group C · Z-test, 2 sided · p = 0.2467
SecondaryNumber of Patients in Each Treatment Group With a Satisfactory Clinical Cure

Satisfactory clinical cure is defined as \<5% of the target toenail involvement.

Time frame:
Day 281
Reported as:
Count of participants · Participants
Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure
ParticipantsNVXT Topical Treatment Group A+BPlacebo (Vehicle) Topical Treatment Group C
Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure21
SecondaryNumber of Patients in Each Treatment Group With a Satisfactory Clinical Cure

Satisfactory clinical cure is defined as \<5% of the target toenail involvement.

Time frame:
Day 141
Reported as:
Count of participants · Participants
Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure
ParticipantsNVXT Topical Treatment Group A+BPlacebo (Vehicle) Topical Treatment Group C
Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure22

Adverse events

Collected over 1 year, 1 month. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
NVXT Topical Treatment Group A0/64 (0%)0/64 (0%)19/64 (29.7%)
NVXT Topical Treatment Group B0/62 (0%)0/62 (0%)14/62 (22.6%)
Placebo (Vehicle) Topical Treatment Group C0/58 (0%)1/58 (1.7%)13/58 (22.4%)
Most frequent serious events
Most frequent serious events
EventNVXT Topical Treatment Group ANVXT Topical Treatment Group BPlacebo (Vehicle) Topical Treatment Group C
Idiopathic pulmonary fibrosisRespiratory, thoracic and mediastinal disorders0/640/621/58
Most frequent other events
Showing 10 of 50
Most frequent other events
EventNVXT Topical Treatment Group ANVXT Topical Treatment Group BPlacebo (Vehicle) Topical Treatment Group C
NasopharyngitisInfections and infestations5/640/622/58
Gamma-glutamyltransferase increasedInvestigations0/640/624/58
Upper respiratory tract infectionInfections and infestations3/644/621/58
Back painMusculoskeletal and connective tissue disorders4/641/620/58
Aspartate aminotransferase increasedInvestigations0/640/623/58
Eosinophil count increasedInvestigations0/642/621/58
HeadacheNervous system disorders2/642/620/58
CoughRespiratory, thoracic and mediastinal disorders0/642/621/58
Seasonal allergyImmune system disorders2/640/620/58
ContusionInjury, poisoning and procedural complications2/640/620/58

Baseline characteristics

Age, Continuous
Age, Continuous(years)NVXT Topical Treatment Group ANVXT Topical Treatment Group BPlacebo (Vehicle) Topical Treatment Group CTotal
Mean51.6 ± 15.053.1 ± 14.750.8 ± 12.651.8 ± 14.2
Sex: Female, Male
Sex: Female, Male(Participants)NVXT Topical Treatment Group ANVXT Topical Treatment Group BPlacebo (Vehicle) Topical Treatment Group CTotal
Female21172159
Male434537125
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)NVXT Topical Treatment Group ANVXT Topical Treatment Group BPlacebo (Vehicle) Topical Treatment Group CTotal
Hispanic or Latino413839118
Not Hispanic or Latino23241966
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)NVXT Topical Treatment Group ANVXT Topical Treatment Group BPlacebo (Vehicle) Topical Treatment Group CTotal
American Indian or Alaska Native0000
Asian0000
Native Hawaiian or Other Pacific Islander0000
Black or African American127827
White525550157
More than one race0000
Unknown or Not Reported0000
08

Study locations

1 site
  • Novum Pharmaceutical Research Services (Novum)
    Pittsburgh, Pennsylvania 15219, United States
09

References and documents

Study documents

  • Statistical analysis plan · Mar 21, 2018
  • Study protocol · Jul 19, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02933879
Lead sponsor
Sun Pharmaceutical Industries, Inc.
Responsible party
Sponsor
First posted
Oct 14, 2016
Start date
Mar 21, 2016
Primary completion
Mar 6, 2018
Completion
Jun 21, 2018
Results posted
Dec 20, 2018
Last update
Dec 20, 2018

Study contacts

Novum Pharmaceutical Research Services
study chair · http://www.novumprs.com/contact

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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