NCT04042857

Brief Summary

This is a 52 week, 20-patient open-label pilot study on the safety and efficacy of Next Science Wound gel in the treatment of mild to moderate Distal Subungual Onychomycosis.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 26, 2019

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 2, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

August 2, 2019

Status Verified

July 1, 2019

Enrollment Period

1.2 years

First QC Date

July 30, 2019

Last Update Submit

July 31, 2019

Conditions

Onychomycosis of Toenail

Keywords

DSOtoenailonychomycosis

Outcome Measures

Primary Outcomes (2)

  • Mycological Cure at 48 Weeks

    Mycological cure rate at week 48 as defined by negative potassium hydroxide examination and negative culture of the target hallux nail

    Baseline to 48 Weeks

  • Clinical Efficacy at 48 Weeks

    Clinical efficacy rate at week 48 as defined by less than 10% clinical involvement of the target hallux nail

    Baseline to 48 Weeks

Secondary Outcomes (11)

  • Complete Cure at Week 48

    Baseline to 48 Weeks

  • Complete Cure at Week 52

    Baseline to 52 Weeks

  • Almost Complete Cure at Week 48

    Baseline to 48 Weeks

  • Almost Complete Cure at Week 52

    Baseline to Week 52

  • Time to Complete Cure

    Baseline to 52 Weeks

  • +6 more secondary outcomes

Study Arms (1)

Next Science

EXPERIMENTAL

Patients will apply Next Science treatment to the study target hallux nail for 48 weeks daily.

Device: Next Science Treatment Gel

Interventions

Next Science Treatment GelDEVICE

Next Science Treatment Gel will be applied after nail surface nail-filing and/or debridement.

Next Science

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 18 years old and above
  • Established and active diagnosis of distal subungual onychomycosis of at least one hallux nail affecting 20-75% of the hallux nail
  • Positive culture for dermatophytes and positive potassium hydroxide examination
  • Provide signed and dated informed consent
  • Willing to comply with all study procedures and available for the duration of the study

You may not qualify if:

  • Known allergic reaction to the study products
  • Unable to provide signed and dated informed consent form
  • Unable or unwilling to comply with all study procedures and/or unavailable for duration of the study
  • Thickness of mycotic nail is greater than 3mm
  • Less than 2mm of clear nail at the proximal aspect
  • History of rheumatoid arthritis
  • Subject with any other disease or condition other than DSO that would affect nail appearance or interfere with image analysis
  • Unwilling or unable to limit use of nail polish for duration of study
  • Known history of PVD, immune system concerns, or ongoing chemotherapy
  • Severe moccasin tinea pedis
  • Prior systemic antifungal drugs 6 months before study start date
  • Prior topical therapy for toenail fungus 2 months before study start date
  • Any diseases or circumstances in which the patient should not participate in the study in the opinion of the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Doctors Research Network

South Miami, Florida, 33143, United States

RECRUITING

MeSH Terms

Conditions

Onychomycosis

Condition Hierarchy (Ancestors)

TineaDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousNail DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Maria S Surprenant, DPM

    Doctors Research Network

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dianne Porral

CONTACT

8555642762dporral@nextscience.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2019

First Posted

August 2, 2019

Study Start

July 26, 2019

Primary Completion

October 1, 2020

Study Completion

October 1, 2021

Last Updated

August 2, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)