Safety and Efficacy of Next Science Gel on Toenail Fungus

Onychomycosis of Toenail Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04042857
• Other study ID #: CSP-010
• Status: Recruiting
• Phase: N/A
• Start date: July 26, 2019
• Est. completion date: October 1, 2021

Study information

• Verified date: July 2019
• Source: Next Science TM
• Contact: Dianne Porral
• Phone: 8555642762
• Email: dporral[@]nextscience.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Onychomycosis
• Onychomycosis of Toenail

Intervention

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

Locations

Country	Name	City	State
United States	Doctors Research Network	South Miami	Florida

Sponsors (4)

Lead Sponsor	Collaborator
Next Science TM	Doctors Research Network, NTS Ventures, Tissue Analytics

Country where clinical trial is conducted

United States, 

Outcome

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