Safety and Efficacy of Next Science Gel on Toenail Fungus

Safety and Efficacy of Next Science Wound Gel in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO): An Open-Label Pilot Study

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.

Study Overview

• Status: Unknown
• Conditions: Onychomycosis of Toenail
• Intervention / Treatment: Device: Next Science Treatment Gel

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: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dianne Porral; Phone Number: 8555642762; Email: dporral@nextscience.com

Study Locations

• United States
  • Florida
    • South Miami, Florida, United States, 33143
      • Recruiting
      • Doctors Research Network
      • Contact: Nara Clinical Research Network; Phone Number: 305-662-1444; Email: nneiva@miamifoot.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline to 48 Weeks
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	Baseline to 52 Weeks
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	Baseline to 48 Weeks
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	Baseline to Week 52
Time to Complete Cure	Measured across all observation points	Baseline to 52 Weeks
Time to Almost Complete Cure	Measured across all observation points	Baseline to 52 Weeks
Percent Change in Area of Nail Involvement	Calculated as a ratio of clear to involved measured across all observation points	Baseline to 52 Weeks
Growth of Clear Nail	Change in area of clear nail growth measured across all observation points	Baseline to 52 Weeks
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	Baseline to 52 Weeks
Dermatopyhyte Identification and Characterization	Changes in the types of dermatophytes dermatophytes across all observation points	Baseline to 52 Weeks
Overall Fungal Species	Change types of overall fungal species across all observation points	Baseline to 52 Weeks

Collaborators and Investigators

• Sponsor: Next Science TM
• Collaborators: Doctors Research Network; Tissue Analytics; NTS Ventures
• Investigators: Principal Investigator: Maria S Surprenant, DPM, Doctors Research Network

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 26, 2019
• Primary Completion (ANTICIPATED): October 1, 2020
• Study Completion (ANTICIPATED): October 1, 2021

Study Registration Dates

• First Submitted: July 30, 2019
• First Submitted That Met QC Criteria: July 31, 2019
• First Posted (ACTUAL): August 2, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 2, 2019
• Last Update Submitted That Met QC Criteria: July 31, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: onychomycosis; DSO; toenail
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Tinea; Dermatomycoses; Nail Diseases; Onychomycosis
• Other Study ID Numbers: CSP-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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