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Safety and Efficacy of Next Science Gel on Toenail Fungus

Primary Purpose

Onychomycosis of Toenail

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Next Science Treatment Gel
Sponsored by
Next Science TM
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Onychomycosis of Toenail focused on measuring DSO, toenail, onychomycosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Doctors Research NetworkRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Next Science

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Complete Cure at Week 48
Complete cure rate at week 48 defined as 0% clinical involvement, negative potassium hydroxide examination and negative culture of the target hallux nail
Complete Cure at Week 52
Complete cure rate at week 52 defined as 0% clinical involvement, negative mycology, and negative potassium hydroxide examination of the target hallux nail at week 52
Almost Complete Cure at Week 48
Almost complete cure rate at week 48 defined as less than 10% clinical involvement, negative potassium hydroxide examination, and negative culture of the target hallux nail at week 48
Almost Complete Cure at Week 52
Almost complete cure rate at week 52 defined as less than 10% clinical involvement, negative potassium hydroxide examination, and negative culture of the target hallux nail at Week 52
Time to Complete Cure
Measured across all observation points
Time to Almost Complete Cure
Measured across all observation points
Percent Change in Area of Nail Involvement
Calculated as a ratio of clear to involved measured across all observation points
Growth of Clear Nail
Change in area of clear nail growth measured across all observation points
Mycological Cure Rate
Changes in mycological cure rates (Changes in the proportion of subjects who achieved mycological cure, defined as negative culture and potassium hydroxide examination) measured across all observation points
Dermatopyhyte Identification and Characterization
Changes in the types of dermatophytes dermatophytes across all observation points
Overall Fungal Species
Change types of overall fungal species across all observation points

Full Information

First Posted
July 30, 2019
Last Updated
July 31, 2019
Sponsor
Next Science TM
Collaborators
Doctors Research Network, Tissue Analytics, NTS Ventures
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1. Study Identification

Unique Protocol Identification Number
NCT04042857
Brief Title
Safety and Efficacy of Next Science Gel on Toenail Fungus
Official Title
Safety and Efficacy of Next Science Wound Gel in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO): An Open-Label Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 26, 2019 (Actual)
Primary Completion Date
October 1, 2020 (Anticipated)
Study Completion Date
October 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Next Science TM
Collaborators
Doctors Research Network, Tissue Analytics, NTS Ventures

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Patients will apply Next Science Wound Gel daily to each study treatment hallux nail for 48 weeks once approved for participation. Analysis will be attained via potassium hydroxide examination (KOH test), nail culture, PCR analysis, and photographic imaging. Subjects may have both hallux nails sampled at screening for culture and KOH testing if both hallux nails appear to meet the criteria for study inclusion. Only subjects with both a positive culture and KOH examination will start study treatment. Subjects may have repeat KOH and culture testing both performed if the first screening test results in at least one of the tests being negative. At investigator's discretion, other affected toenails besides the study target hallux nail may be treated but will not be included for analysis. Patients will come for in-clinic visits at screening, baseline/randomization visit/week 0, week 4, week 8, week 12, week 24, week 36, week 48, and week 52. If subjects achieve complete cure (as defined by mycological cure and 0% nail involvement) prior to Week 48, patients will be encouraged to continue in the trial with active treatment for the full protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis of Toenail
Keywords
DSO, toenail, onychomycosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Next Science
Arm Type
Experimental
Arm Description
Patients will apply Next Science treatment to the study target hallux nail for 48 weeks daily.
Intervention Type
Device
Intervention Name(s)
Next Science Treatment Gel
Intervention Description
Next Science Treatment Gel will be applied after nail surface nail-filing and/or debridement.
Primary Outcome Measure Information:
Title
Mycological Cure at 48 Weeks
Description
Mycological cure rate at week 48 as defined by negative potassium hydroxide examination and negative culture of the target hallux nail
Time Frame
Baseline to 48 Weeks
Title
Clinical Efficacy at 48 Weeks
Description
Clinical efficacy rate at week 48 as defined by less than 10% clinical involvement of the target hallux nail
Time Frame
Baseline to 48 Weeks
Secondary Outcome Measure Information:
Title
Complete Cure at Week 48
Description
Complete cure rate at week 48 defined as 0% clinical involvement, negative potassium hydroxide examination and negative culture of the target hallux nail
Time Frame
Baseline to 48 Weeks
Title
Complete Cure at Week 52
Description
Complete cure rate at week 52 defined as 0% clinical involvement, negative mycology, and negative potassium hydroxide examination of the target hallux nail at week 52
Time Frame
Baseline to 52 Weeks
Title
Almost Complete Cure at Week 48
Description
Almost complete cure rate at week 48 defined as less than 10% clinical involvement, negative potassium hydroxide examination, and negative culture of the target hallux nail at week 48
Time Frame
Baseline to 48 Weeks
Title
Almost Complete Cure at Week 52
Description
Almost complete cure rate at week 52 defined as less than 10% clinical involvement, negative potassium hydroxide examination, and negative culture of the target hallux nail at Week 52
Time Frame
Baseline to Week 52
Title
Time to Complete Cure
Description
Measured across all observation points
Time Frame
Baseline to 52 Weeks
Title
Time to Almost Complete Cure
Description
Measured across all observation points
Time Frame
Baseline to 52 Weeks
Title
Percent Change in Area of Nail Involvement
Description
Calculated as a ratio of clear to involved measured across all observation points
Time Frame
Baseline to 52 Weeks
Title
Growth of Clear Nail
Description
Change in area of clear nail growth measured across all observation points
Time Frame
Baseline to 52 Weeks
Title
Mycological Cure Rate
Description
Changes in mycological cure rates (Changes in the proportion of subjects who achieved mycological cure, defined as negative culture and potassium hydroxide examination) measured across all observation points
Time Frame
Baseline to 52 Weeks
Title
Dermatopyhyte Identification and Characterization
Description
Changes in the types of dermatophytes dermatophytes across all observation points
Time Frame
Baseline to 52 Weeks
Title
Overall Fungal Species
Description
Change types of overall fungal species across all observation points
Time Frame
Baseline to 52 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dianne Porral
Phone
8555642762
Email
dporral@nextscience.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria S Surprenant, DPM
Organizational Affiliation
Doctors Research Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Doctors Research Network
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nara Clinical Research Network
Phone
305-662-1444
Email
nneiva@miamifoot.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety and Efficacy of Next Science Gel on Toenail Fungus

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