Onychomycosis of ToenailNCT04042857
Safety and Efficacy of Next Science Gel on Toenail Fungus
A study testing Next Science Treatment Gel in people with Onychomycosis of Toenail, run by Next Science TM at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Onychomycosis of Toenail
- What is being tested?
- Next Science Treatment Gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2019to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Doctors Research Network
South Miami, Florida, 33143
Nara Clinical Research Network, 305-662-1444, nneiva@miamifoot.com
About this study
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
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.
Read the 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.
- Conditions
- Onychomycosis of Toenail
- Being tested
- Next Science Treatment Gel
- Keywords
- DSO, toenail, onychomycosis
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Next Science Treatment GelDevice
Next Science Treatment Gel will be applied after nail surface nail-filing and/or debridement.
| Study group | Role | What they receive |
|---|---|---|
| Next Science | Experimental | Patients will apply Next Science treatment to the study target hallux nail for 48 weeks daily. Receives: Device: Next Science Treatment Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline to 48 Weeks
Secondary outcomes (11)
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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline to Week 52
Time to Complete Cure
Measured across all observation points
Measured: Baseline to 52 Weeks
Time to Almost Complete Cure
Measured across all observation points
Measured: Baseline to 52 Weeks
Percent Change in Area of Nail Involvement
Calculated as a ratio of clear to involved measured across all observation points
Measured: Baseline to 52 Weeks
Growth of Clear Nail
Change in area of clear nail growth measured across all observation points
Measured: 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
Measured: Baseline to 52 Weeks
Dermatopyhyte Identification and Characterization
Changes in the types of dermatophytes dermatophytes across all observation points
Measured: Baseline to 52 Weeks
Overall Fungal Species
Change types of overall fungal species across all observation points
Measured: Baseline to 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start26 Jul 2019
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Onychomycosis of ToenailStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Next Science TM
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Doctors Research Network, Tissue Analytics, NTS Ventures
- Responsible party
- Sponsor
- Investigators
- Maria S Surprenant, DPM, Principal investigator, Doctors Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042857
- Sponsor's protocol ID
- CSP-010
- Status last verified
- Jul 2019
- First submitted
- 30 Jul 2019
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04042857
- Acronym / sponsor ID
- CSP-010
- Conditions
- Onychomycosis of Toenail
- Keywords
- DSO, toenail, onychomycosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Next Science TMIndustry (pharma, biotech, devices)
- Collaborators
- Doctors Research Network, Tissue Analytics, NTS Ventures
- Study start
- 26 Jul 2019 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 2 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Next Science | Experimental | Device: Next Science Treatment GelPatients will apply Next Science treatment to the study target hallux nail for 48 weeks daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Next Science Treatment GelNext Science Treatment Gel will be applied after nail surface nail-filing and/or debridement. | Device | Next Science |
Primary outcome
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
11 secondary outcomes
Complete Cure at Week 48
Time frame: Baseline to 48 Weeks
Complete Cure at Week 52
Time frame: Baseline to 52 Weeks
Almost Complete Cure at Week 48
Time frame: Baseline to 48 Weeks
Almost Complete Cure at Week 52
Time frame: Baseline to Week 52
Time to Complete Cure
Time frame: Baseline to 52 Weeks
Time to Almost Complete Cure
Time frame: Baseline to 52 Weeks
Percent Change in Area of Nail Involvement
Time frame: Baseline to 52 Weeks
Growth of Clear Nail
Time frame: Baseline to 52 Weeks
Mycological Cure Rate
Time frame: Baseline to 52 Weeks
Dermatopyhyte Identification and Characterization
Time frame: Baseline to 52 Weeks
Overall Fungal Species
Time frame: Baseline to 52 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Onychomycosis of Toenail
Active, not recruitingPhase 1
Photodynamic Therapy For Onychomycosis
Onychomycosis of Toenail
Recruiting
URGO MICKAEL Filmogel, Topical Treatment of Onychomycosis
Onychomycosis of Toenail
Active, not recruiting
Exploring Different Dose-frequency Home Photodynamic Therapy Protocols Using a Novel Home-targeted LED Device for Onychomycosis
Onychomycosis of Toenails, Onychomycosis of Fingernail
Active, not recruitingPhase 2
Safety, Tolerability and Efficacy of Trichostatin A in Patients With Mild to Severe Onychomycosis
Onychomycosis of Toenail
Not yet recruitingPhase 2
A Phase 2 Study to Assess the Effectiveness of Topical Terbinafine in Participants With Mild to Moderate Onychomycosis of the Toenails
Onychomycosis of Toenail
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria S Surprenant, DPM principal investigator
Doctors Research Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Next Science Treatment Gel in people with Onychomycosis of Toenail, run by Next Science TM at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dianne Porral (8555642762, dporral@nextscience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mycological Cure at 48 Weeks (time frame: Baseline to 48 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019.