Distal Lateral Subungual OnychomycosisNCT06074315
Evaluation of the Effectiveness of Nail Genesis DLSO Product for Onychomycosis
A study testing Nail Genesis DLSO Product in people with Distal Lateral Subungual Onychomycosis and Onychomycosis, run by Nail Genesis LLC at 10 sites in United States.
Trial summary
This is a Pre-IDE, prospective, multicenter, randomized, parallel-group, double-blind, vehicle- controlled study to evaluate safety and effectiveness of Nail Genesis DLSO Product for the treatment of DLSO compared with vehicle in infected great toenails in a total of 338 males and non-pregnant, non-lactating, females… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Distal Lateral Subungual Onychomycosis, Onychomycosis
- What is being tested?
- Nail Genesis DLSO Product
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 338 participants
- Where
- 10 sitesUnited States
- Study dates
- 1 Oct 2023to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is male or female, and 18 to 65 years of age, inclusive.
- Subject has nail fungal infection of at least one great toenail (per visual assessment, positive KOH preparation, and positive dermatophyte culture).
- Subject has target toenail showing 20-50% involvement without matrix (lunula) involvement.
- Subject has 3 mm of unaffected nail (from proximal nail fold) on target toenail.
- Subject has target toenail thickness of 3 mm or less.
- Subject must be physically able to reach toes to clean, trim, and apply product to the target toenail.
Show all 10Show fewer
- Subject is willing and available to return for study follow up.
- Subject or legal representative is able to understand and provide signed consent for participating in the study.
- Female subject of childbearing potential has negative urine pregnancy test.
- Females must be post-menopausal or must agree to use approved contraceptives (actions, de- vices or medications to prevent or reduce the likelihood of pregnancy) throughout the study (abstinence is NOT an accepted form of contraception).
Who cannot join
- Subject has known hypersensitivity or allergy to the product materials.
- Subject has negative KOH preparation or dermatophyte culture.
- Subject has dermatophytoma on target toenail.
- Subject is enrolled in another investigational drug, device, or product protocol that would interfere with this study.
- Subject is using other topical or pharmaceutical treatments for any nail conditions; a wash-out period of at least four weeks after discontinuation of a topical product or 12 months after discontinuation of an oral product or light-based therapy for treatment of nail fungus is required.
- Subject has history of immunosuppression and/or clinical signs indicative of possible immunosuppression.
Show all 12Show fewer
- Subject with possible chronic disease, including: diabetes, psoriasis, immune deficiency (HIV), severe foot injury, chronic vascular disease, or in which delayed treatment (approved treatment) of DLSO for one year could present a significant health concern.
- Subject has presence of toenail infection other than dermatophytes on target toenail.
- Subject has any disease/condition that might cause toenail abnormalities or interfere with evaluation.
- Subject has had previous toenail surgery on target toenail.
- Subject is a pregnant or nursing female.
- Subject is an Investigator, Nail Genesis' personnel, or Nail Genesis' Scientific Advisory Board (SAB) members, or their immediate family.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
DermResearch
Austin, Texas, 78759
Sasha Thompson, 512-349-9889, regulatorydri@vial.com
Janet Dubois, MD
- Recruiting
Clinical Trials Institute of Northwest Arkansas
Fayetteville, Arkansas, 72703
Hillary Walker, 479-544-3483, hwalker@ctinwa.com
Tim Dugan, 501-655-6138, tdugan@ctinwa.com
- Recruiting
West Houston Clinical Research Service
Houston, Texas, 77055
Braulio Suarez, MD, 281-738-2642, bsuarez@whcrs.com
Oscar De Valle, MD
- Recruiting
The Education & Research Foundation, Inc.
Lynchburg, Virginia, 24501
Bridgett Tweedy, 434-847-8400, btweedy@educationandresearch.com
Sue Foster, 434-857-8400, sfoster@educationandresearch.com
- Recruiting
Catalina Research Institute, LLC
Montclair, California, 91763
Araselly Romero, 909-590-8409 ext. 237, aromero@catalinari.com
Claudia Ramirez, 9095906306, cramirez@catalinari.com
- Not yet recruiting
Minnesota Clinical Study Center
New Brighton, Minnesota, 55112
Jenjira Skrei, 763-571-4200, jskrei@associatedskincare.com
Steven Kempers, MD
- Recruiting
Rochester Clinical Research, LLC
Rochester, New York, 14609
Devon Taylor, 585-288-0890, regulatory@rcrclinical.com
Amanda Reed, 585-288-0890, regulatory@rcrclinical.com
- Recruiting
Northern California Research
Sacramento, California, 95821
Laurie Johnson, 916-484-0500, ljohnson@norcare.net
Douglas Young, MD
- Recruiting
Metro Clinical Trials
San Bernardino, California, 92404
Araselly Romero, 909-590-8409, aromero@catalinari.com
Claudia Ramirez, 9095906306, cramirez@catalinari.com
- Recruiting
Doctors Research Network
South Miami, Florida, 33143
Patria Divison, 305-665-3017, pdivison@drnmiami.com
Maria Surprenant, MD
About this study
This is a Pre-IDE, prospective, multicenter, randomized, parallel-group, double-blind, vehicle- controlled study to evaluate safety and effectiveness of Nail Genesis DLSO Product for the treatment of DLSO compared with vehicle in infected great toenails in a total of 338 males and non-pregnant, non-lactating, females between 18 and 65 years of age (inclusive). Subjects will be randomized in a 2:1 ratio to receive either Nail Genesis DLSO Product or vehicle.
Subject eligibility will be determined during a Screening assessment. Subjects will complete a 4week washout period after discontinuation of a topical product or a 12-month washout period after discontinuation of an oral product or light-based therapy prior to randomization. Eligible subjects will be randomized in a 2:1 ratio to receive Nail Genesis DLSO Product or vehicle, respectively. During the 52-week trial, study medication will be administered once daily to the target toenail for 48 weeks.
A subject will be considered to have completed the study when he or she has completed the study assessments at Week 52. The 52-week visit is for follow-up safety assessments.
- Being tested
- Nail Genesis DLSO Product, Nail Genesis DLSO Product (vehicle only)
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nail Genesis DLSO ProductDevice
Nail fungus is difficult to treat with topical drugs because of the thickness of the nails (Murdan, 2002). Nail Genesis DLSO Product does not contain a drug or antifungal agent and so is not designed to have a direct action on the microorganism, but instead will act by changing the conditions that allow growth of the fungus (i.e., keeping the nail plate and underlying nail bed dry and inhibiting secondary infection).
Nail Genesis DLSO Product (vehicle only)Device
The Nail Genesis DLSO product poly-urethane vehicle
| Study group | Role | What they receive |
|---|---|---|
| Nail Genesis DLSO Product | Experimental | Nail Genesis DLSO Product, poly(urea-urethane) in carrier solvents, applied topically, once daily, to target toenail. Receives: Device: Nail Genesis DLSO Product |
| Vehicle | Placebo comparator | poly(urea-urethane) in carrier solvents, applied topically, once daily, to target toenail. Receives: Device: Nail Genesis DLSO Product (vehicle only) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness - Complete Cure
Proportion of subjects with Complete Cure (0% involvement of the target toenail in addition to Mycologic Cure (defined as both negative KOH stain and negative dermatophyte culture).
Measured: Week 48
Safety - Adverse Events
Proportion of subjects with treatment-emergent AEs of Nail Genesis DLSO Product compared with vehicle control)
Measured: Week 48
Secondary outcomes (2)
Almost complete cure
Proportion of subjects achieving almost Complete Cure (< 10% clinical involvement of the target toenail) in addition to Mycologic Cure.
Measured: Week 48
Mycological Cure
Proportion of subjects achieving Mycologic Cure of the target toenail at Week 48
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Oct 2023
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Lateral Subungual OnychomycosisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, multicenter, randomized, parallel-group, double-blind, vehicle- controlled study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 338 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nail Genesis LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074315
- Sponsor's protocol ID
- CT002-02
- Status last verified
- Dec 2023
- First submitted
- 2 Oct 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Nail Genesis DLSO Product for Onychomycosis
- ClinicalTrials.gov ID
- NCT06074315
- Acronym / sponsor ID
- CT002-02
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 338 participants (estimated)
- Lead sponsor
- Nail Genesis LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 10 Oct 2023 (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 Pre-IDE, prospective, multicenter, randomized, parallel-group, double-blind, vehicle- controlled study to evaluate safety and effectiveness of Nail Genesis DLSO Product for the treatment of DLSO compared with vehicle in infected great toenails in a total of 338 males and non-pregnant, non-lactating, females between 18 and 65 years of age (inclusive). Subjects will be randomized in a 2:1 ratio to receive either Nail Genesis DLSO Product or vehicle.
Subject eligibility will be determined during a Screening assessment. Subjects will complete a 4week washout period after discontinuation of a topical product or a 12-month washout period after discontinuation of an oral product or light-based therapy prior to randomization. Eligible subjects will be randomized in a 2:1 ratio to receive Nail Genesis DLSO Product or vehicle, respectively. During the 52-week trial, study medication will be administered once daily to the target toenail for 48 weeks.
A subject will be considered to have completed the study when he or she has completed the study assessments at Week 52. The 52-week visit is for follow-up safety assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- prospective, multicenter, randomized, parallel-group, double-blind, vehicle- controlled study
| Arm | Type | Receives |
|---|---|---|
| Nail Genesis DLSO Product | Experimental | Device: Nail Genesis DLSO ProductNail Genesis DLSO Product, poly(urea-urethane) in carrier solvents, applied topically, once daily, to target toenail. |
| Vehicle | Placebo comparator | Device: Nail Genesis DLSO Product (vehicle only)poly(urea-urethane) in carrier solvents, applied topically, once daily, to target toenail. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject is male or female, and 18 to 65 years of age, inclusive.
- Subject has nail fungal infection of at least one great toenail (per visual assessment, positive KOH preparation, and positive dermatophyte culture).
- Subject has target toenail showing 20-50% involvement without matrix (lunula) involvement.
- Subject has 3 mm of unaffected nail (from proximal nail fold) on target toenail.
- Subject has target toenail thickness of 3 mm or less.
Key exclusion criteria (12 listed)
- Subject has known hypersensitivity or allergy to the product materials.
- Subject has negative KOH preparation or dermatophyte culture.
- Subject has dermatophytoma on target toenail.
- Subject is enrolled in another investigational drug, device, or product protocol that would interfere with this study.
- Subject is using other topical or pharmaceutical treatments for any nail conditions; a wash-out period of at least four weeks after discontinuation of a topical product or 12 months after discontinuation of an oral product or light-based therapy for treatment of nail fungus is required.
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 |
|---|---|---|
| Nail Genesis DLSO ProductNail fungus is difficult to treat with topical drugs because of the thickness of the nails (Murdan, 2002). Nail Genesis DLSO Product does not contain a drug or antifungal agent and so is not designed to have a direct action on the microorganism, but instead will act by changing the conditions that allow growth of the fungus (i.e., keeping the nail plate and underlying nail bed dry and inhibiting secondary infection). | Device | Nail Genesis DLSO Product |
| Nail Genesis DLSO Product (vehicle only)The Nail Genesis DLSO product poly-urethane vehicle | Device | Vehicle |
Primary outcome
Effectiveness - Complete Cure
Time frame: Week 48
Proportion of subjects with Complete Cure (0% involvement of the target toenail in addition to Mycologic Cure (defined as both negative KOH stain and negative dermatophyte culture).
Safety - Adverse Events
Time frame: Week 48
Proportion of subjects with treatment-emergent AEs of Nail Genesis DLSO Product compared with vehicle control)
2 secondary outcomes
Almost complete cure
Time frame: Week 48
Mycological Cure
Time frame: Week 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Individual participant dataSharing planned: Undecided
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. This study is not recruiting at the moment.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nail Genesis DLSO Product in people with Distal Lateral Subungual Onychomycosis and Onychomycosis, run by Nail Genesis LLC at 10 sites 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 10 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brittany Ishmael (719 321 0876, brittany.ishmael@brightps.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness - Complete Cure (time frame: Week 48). 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 8 Dec 2023.