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Safety and Efficacy of Next Science Gel on Toenail Fungus

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ClinicalTrials.gov Identifier: NCT04042857
Recruitment Status : Recruiting
First Posted : August 2, 2019
Last Update Posted : August 2, 2019
Sponsor:
Collaborators:
Doctors Research Network
Tissue Analytics
NTS Ventures
Information provided by (Responsible Party):
Next Science TM

Tracking Information
First Submitted Date  ICMJE July 30, 2019
First Posted Date  ICMJE August 2, 2019
Last Update Posted Date August 2, 2019
Actual Study Start Date  ICMJE July 26, 2019
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2019)
  • Mycological Cure at 48 Weeks [ Time Frame: Baseline to 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 [ Time Frame: Baseline to 48 Weeks ]
    Clinical efficacy rate at week 48 as defined by less than 10% clinical involvement of the target hallux nail
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2019)
  • Complete Cure at Week 48 [ Time Frame: Baseline to 48 Weeks ]
    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 [ Time Frame: Baseline to 52 Weeks ]
    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 [ Time Frame: Baseline to 48 Weeks ]
    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 [ Time Frame: Baseline to 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 [ Time Frame: Baseline to 52 Weeks ]
    Measured across all observation points
  • Time to Almost Complete Cure [ Time Frame: Baseline to 52 Weeks ]
    Measured across all observation points
  • Percent Change in Area of Nail Involvement [ Time Frame: Baseline to 52 Weeks ]
    Calculated as a ratio of clear to involved measured across all observation points
  • Growth of Clear Nail [ Time Frame: Baseline to 52 Weeks ]
    Change in area of clear nail growth measured across all observation points
  • Mycological Cure Rate [ Time Frame: Baseline to 52 Weeks ]
    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 [ Time Frame: Baseline to 52 Weeks ]
    Changes in the types of dermatophytes dermatophytes across all observation points
  • Overall Fungal Species [ Time Frame: Baseline to 52 Weeks ]
    Change types of overall fungal species across all observation points
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Next Science Gel on Toenail Fungus
Official Title  ICMJE Safety and Efficacy of Next Science Wound Gel in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO): An Open-Label Pilot Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Onychomycosis of Toenail
Intervention  ICMJE Device: Next Science Treatment Gel
Next Science Treatment Gel will be applied after nail surface nail-filing and/or debridement.
Study Arms  ICMJE Experimental: Next Science
Patients will apply Next Science treatment to the study target hallux nail for 48 weeks daily.
Intervention: Device: Next Science Treatment Gel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 31, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2021
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dianne Porral 8555642762 dporral@nextscience.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04042857
Other Study ID Numbers  ICMJE CSP-010
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Next Science TM
Study Sponsor  ICMJE Next Science TM
Collaborators  ICMJE
  • Doctors Research Network
  • Tissue Analytics
  • NTS Ventures
Investigators  ICMJE
Principal Investigator: Maria S Surprenant, DPM Doctors Research Network
PRS Account Next Science TM
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP