OnychomycosisPhase 2NCT02933879

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

A Phase 2 study testing NVXT topical in people with Onychomycosis, run by Sun Pharmaceutical Industries, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Onychomycosis
What is being tested?: NVXT topical
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 184 participants
Where: 1 siteUnited States
Study dates: 21 Mar 2016to 21 Jun 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Novum Pharmaceutical Research Services (Novum)
Pittsburgh, Pennsylvania, 15219

Other trials in United States

About this study

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

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.

Conditions: Onychomycosis
Being tested: NVXT topical, Placebo (Vehicle) Topical
Medical subject headings: Onychomycosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NVXT topicalDrug
Also called Active
topical treatment
Placebo (Vehicle) TopicalDrug
Also called placebo
Placebo (Vehicle) Topical

Study groups in NCT02933879
Study group	Role	What they receive
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), Receives: Drug: NVXT topical
Placebo (Vehicle) Topical	Placebo comparator	two 8-week treatment periods separated by a 32-week rest period (Treatment Group C), Receives: Drug: Placebo (Vehicle) Topical

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: Day 141

Secondary outcomes (10)

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
Measured: Day 365
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
Measured: Day 141
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.
Measured: day 365
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.
Measured: Day 141
Number of Patients in Each Treatment Group With a Complete Clinical Cure
Complete clinical cure is defined as 0% nail involvement.
Measured: day 365
Number of Patients in Each Treatment Group With a Complete Clinical Cure
Complete clinical cure is defined as 0% nail involvement.
Measured: Day 281
Number of Patients in Each Treatment Group With a Complete Clinical Cure
Complete clinical cure is defined as 0% nail involvement.
Measured: Day 141
Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure
Satisfactory clinical cure is defined as <5% of the target toenail involvement.
Measured: day 365
Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure
Satisfactory clinical cure is defined as <5% of the target toenail involvement.
Measured: Day 281
Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure
Satisfactory clinical cure is defined as <5% of the target toenail involvement.
Measured: Day 141

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Mar 201621 Jun 2018

First posted14 Oct 2016 (estimated)
Study start21 Mar 2016
Primary completion6 Mar 2018
Study completion21 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for OnychomycosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 184 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02933879
Sponsor's protocol ID: NVXT 1404
Status last verified: Dec 2018
First submitted: 12 Oct 2016
Last updated: 20 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Onychomycosis trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02933879
Acronym / sponsor ID: NVXT 1404
Conditions: Onychomycosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 184 participants (actual)
Lead sponsor: Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
Study start: 21 Mar 2016 (actual)
Primary completion: 6 Mar 2018 (actual)
Study completion: 21 Jun 2018 (actual)
First posted: 14 Oct 2016 (estimated)
Results: Posted 20 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
NVXT topical	Experimental	Drug: NVXT topicaldaily 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),
Placebo (Vehicle) Topical	Placebo comparator	Drug: Placebo (Vehicle) Topicaltwo 8-week treatment periods separated by a 32-week rest period (Treatment Group C),

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NVXT topicalAlso: Activetopical treatment	Drug	NVXT topical
Placebo (Vehicle) TopicalAlso: placeboPlacebo (Vehicle) Topical	Drug	Placebo (Vehicle) Topical

Primary outcome

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
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

10 secondary outcomes

Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure
Time frame: Day 365
Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure
Time frame: Day 141
Number of Patients in Each Treatment Group With a Mycological Cure
Time frame: day 365
Number of Patients in Each Treatment Group With a Mycological Cure
Time frame: Day 141
Number of Patients in Each Treatment Group With a Complete Clinical Cure
Time frame: day 365
Number of Patients in Each Treatment Group With a Complete Clinical Cure
Time frame: Day 281
Number of Patients in Each Treatment Group With a Complete Clinical Cure
Time frame: Day 141
Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure
Time frame: day 365
Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure
Time frame: Day 281
Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure
Time frame: Day 141

Results and safety

Results posted to the registry on 20 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NVXT Topical Treatment Group A	64	48
NVXT Topical Treatment Group B	62	48
Placebo (Vehicle) Topical Treatment Group C	58	41

Primary outcome: Number of Patients in Each Treatment Group With a Complete Therapeutic Cure

Time frame: Day 365. Count of participants. Unit: Participants

Measure	NVXT Topical Treatment Group A n = 52	NVXT Topical Treatment Group B n = 48	Placebo (Vehicle) Topical Treatment Group C n = 43
Value	1	0	1

NVXT Topical Treatment Group B vs Placebo (Vehicle) Topical Treatment Group C: p = 0.4615, Z-test, 2 sided

Population analysed: 1 Subject from Group B and 1 Subject from Group C were excluded from Efficacy Analysis because they did not have positive mycological culture screenings. Also, 12 subjects from Group A, 13 from Group B, and 14 from Group C were excluded because they had no efficacy data for the relevant analysis.

Primary outcome: Number of Patients in Each Treatment Group With a Complete Therapeutic Cure

Time frame: Day 141. Count of participants. Unit: Participants

Measure	NVXT Topical Treatment Group A+B n = 107	Placebo (Vehicle) Topical Treatment Group C n = 49
Value	0	1

Population analysed: Groups A and B were combined to compare against Group C to determine statistically significant difference when combining both groups that received test treatment in the first 56 Days vs only placebo. 19 subjects from Group A+B and 9 from Group C were excluded because they had no efficacy data or they lacked positive mycological cultures.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year, 1 month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NVXT Topical Treatment Group A	0 of 64 (0%)	19 of 64 (29.7%)	0 of 64
NVXT Topical Treatment Group B	0 of 62 (0%)	14 of 62 (22.6%)	0 of 62
Placebo (Vehicle) Topical Treatment Group C	1 of 58 (1.7%)	13 of 58 (22.4%)	0 of 58

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Active, not recruitingPhase 1
Photodynamic Therapy For Onychomycosis
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Recruiting
URGO MICKAEL Filmogel, Topical Treatment of Onychomycosis
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Active, not recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novum Pharmaceutical Research Services study chair

http://www.novumprs.com/contact

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NVXT topical in people with Onychomycosis, run by Sun Pharmaceutical Industries, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients in Each Treatment Group With a Complete Therapeutic Cure (time frame: Day 365). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02933879.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2018.