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The trial is taking place at:
W

West Houston Clinical Research Service | Houston, TX

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Evaluation of the Effectiveness of Nail Genesis DLSO Product for Onychomycosis

N

Nail Genesis

Status

Enrolling

Conditions

Distal Lateral Subungual Onychomycosis
Onychomycosis

Treatments

Device: Nail Genesis DLSO Product
Device: Nail Genesis DLSO Product (vehicle only)

Study type

Interventional

Funder types

Industry

Identifiers

NCT06074315
CT002-02

Details and patient eligibility

About

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.

Enrollment

338 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.
  • 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).

Exclusion criteria

  • 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.
  • 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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

338 participants in 2 patient groups, including a placebo group

Nail Genesis DLSO Product
Experimental group
Description:
Nail Genesis DLSO Product, poly(urea-urethane) in carrier solvents, applied topically, once daily, to target toenail.
Treatment:
Device: Nail Genesis DLSO Product
Vehicle
Placebo Comparator group
Description:
poly(urea-urethane) in carrier solvents, applied topically, once daily, to target toenail.
Treatment:
Device: Nail Genesis DLSO Product (vehicle only)

Trial contacts and locations

10

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Central trial contact

Brittany Ishmael

Data sourced from clinicaltrials.gov

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