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Device

Nail Genesis DLSO Product for Fungal Nail Infection

N/A
Recruiting
Research Sponsored by Nail Genesis LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject is male or female, and 18 to 65 years of age, inclusive.
Subject must be physically able to reach toes to clean, trim, and apply product to the target toenail.
Must not have
Subject has any disease/condition that might cause toenail abnormalities or interfere with evaluation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 48
Awards & highlights

Study Summary

This trial will evaluate safety and effectiveness of a product to treat infected toenails in 338 adult males and non-pregnant, non-lactating females. Subjects will use product or a vehicle once daily for 48 weeks and be evaluated at Week 52.

Who is the study for?
This trial is for adults aged 18-65 with a fungal infection in at least one great toenail, but without severe underlying conditions like diabetes or immune deficiencies. Participants must not be pregnant or nursing and should agree to use contraception. They must have stopped any other nail treatments for specific periods before the trial.Check my eligibility
What is being tested?
The study tests Nail Genesis DLSO Product against a non-medicated version (vehicle) to treat toenail fungus. It's randomized, meaning people are put into two groups by chance, with more receiving the actual product than the vehicle, and it's double-blind so neither participants nor researchers know who gets which treatment.See study design
What are the potential side effects?
Potential side effects aren't specified here, but generally topical treatments can cause local reactions such as redness, itching, or irritation at the site of application.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are between the ages of 18 and 65, and identify as either male or female.
Select...
You must possess the physical capability to bend and reach your toes in order to effectively groom, cut, and apply product to the desired toe nails.
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You are willing and able to return for further study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
You have a medical condition that could affect the health of your toenails or make it difficult to assess them accurately.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effectiveness - Complete Cure
Safety - Adverse Events
Secondary outcome measures
Almost complete cure
Mycological Cure

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Nail Genesis DLSO ProductExperimental Treatment1 Intervention
Nail Genesis DLSO Product, poly(urea-urethane) in carrier solvents, applied topically, once daily, to target toenail.
Group II: VehiclePlacebo Group1 Intervention
poly(urea-urethane) in carrier solvents, applied topically, once daily, to target toenail.

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Nail Genesis LLCLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility open to join this trial?

"In order to be eligible for this medical trial, candidates must have a fungal nail infection and fall between 18-65 years old. Approximately 338 patients are being enrolled in the study."

Answered by AI

Are there a number of US-based medical centers conducting this trial?

"The trial is presently taking place at 10 different locations with Montclair, Sacramento and San Bernardino being some of the more prominent sites. To reduce time spent travelling, it could be beneficial to select a local site if you are considering participating in this medical study."

Answered by AI

Does the eligibility criteria for this experiment encompass those aged fifty and above?

"This medical study is only available to those who are between 18 and 65 years old. However, there are separate clinical trials that provide treatments for both youths under the age of 18 and seniors over 65."

Answered by AI

Is this study recruiting any new participants?

"Clinicaltrials.gov indicates that this medical trial, which was initially posted on October 1st 2023, is not presently enlisting patients. However, 8 other trials are currently enrolling volunteers for clinical studies."

Answered by AI

Who else is applying?

What site did they apply to?
Doctors Research Network
Minnesota Clinical Study Center
DermResearch
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

These fungal toe nails have become an issue for me.
PatientReceived 1 prior treatment

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. Doctors Research Network: < 48 hours
Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Evaluation of the Effectiveness of Nail Genesis DLSO Product for Onychomycosis
2023. "Evaluation of the Effectiveness of Nail Genesis DLSO Product for Onychomycosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06074315.
~180 spots leftby Jan 2025
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