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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

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.

Condition or disease Intervention/treatment Phase
Onychomycosis of Toenail Device: Next Science Treatment Gel Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 26, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2021

Arm Intervention/treatment
Experimental: Next Science
Patients will apply Next Science treatment to the study target hallux nail for 48 weeks daily.
Device: Next Science Treatment Gel
Next Science Treatment Gel will be applied after nail surface nail-filing and/or debridement.




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. Time to Complete Cure [ Time Frame: Baseline to 52 Weeks ]
    Measured across all observation points

  6. Time to Almost Complete Cure [ Time Frame: Baseline to 52 Weeks ]
    Measured across all observation points

  7. 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

  8. Growth of Clear Nail [ Time Frame: Baseline to 52 Weeks ]
    Change in area of clear nail growth measured across all observation points

  9. 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

  10. Dermatopyhyte Identification and Characterization [ Time Frame: Baseline to 52 Weeks ]
    Changes in the types of dermatophytes dermatophytes across all observation points

  11. Overall Fungal Species [ Time Frame: Baseline to 52 Weeks ]
    Change types of overall fungal species across all observation points



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04042857


Contacts
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Contact: Dianne Porral 8555642762 dporral@nextscience.com

Locations
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United States, Florida
Doctors Research Network Recruiting
South Miami, Florida, United States, 33143
Contact: Nara Clinical Research Network    305-662-1444    nneiva@miamifoot.com   
Sponsors and Collaborators
Next Science TM
Doctors Research Network
Tissue Analytics
NTS Ventures
Investigators
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Principal Investigator: Maria S Surprenant, DPM Doctors Research Network

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Responsible Party: Next Science TM
ClinicalTrials.gov Identifier: NCT04042857     History of Changes
Other Study ID Numbers: CSP-010
First Posted: August 2, 2019    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Next Science TM:
DSO
toenail
onychomycosis
Additional relevant MeSH terms:
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Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases