Evaluation of the Effectiveness of Nail Genesis DLSO Product for Onychomycosis
Public ClinicalTrials.gov record NCT06074315. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT06074315
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 338 participants
Conditions and interventions
Interventions
Device
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2023
- Primary completion
- Dec 31, 2024
- Completion
- Dec 31, 2024
- Last update posted
- Dec 7, 2023
2023 – 2025
United States locations
- U.S. sites
- 10
- U.S. states
- 7
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Trials Institute of Northwest Arkansas | Fayetteville | Arkansas | 72703 | Recruiting |
| Catalina Research Institute, LLC | Montclair | California | 91763 | Recruiting |
| Northern California Research | Sacramento | California | 95821 | Recruiting |
| Metro Clinical Trials | San Bernardino | California | 92404 | Recruiting |
| Doctors Research Network | South Miami | Florida | 33143 | Recruiting |
| Minnesota Clinical Study Center | New Brighton | Minnesota | 55112 | Not yet recruiting |
| Rochester Clinical Research, LLC | Rochester | New York | 14609 | Recruiting |
| DermResearch | Austin | Texas | 78759 | Recruiting |
| West Houston Clinical Research Service | Houston | Texas | 77055 | Recruiting |
| The Education & Research Foundation, Inc. | Lynchburg | Virginia | 24501 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06074315, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 7, 2023 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06074315 live on ClinicalTrials.gov.