Early Feasibility Study to Evaluate the Efficacy and Safety of the RenewalNail™ Plasma Treatment System in Patients With Mild to Moderate Onychomycosis (Fungal Nail)

NCT03072550 | Completed Results FDA Device

• 1 other identifier: DFCR-0002
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

Brief Summary

Early feasibility study to determine if a three-treatment protocol with the RenewalNail™ plasma treatment system over a week will result in mycological cure and/or clear nail growth on the treated hallux toe.

Conditions

Onychomycosis Due to Trichophyton Rubrum; Onychomycosis Due to Trichophyton Mentagrophytes

Keywords

fungal nail; toenail fungus

Outcome Measures

Primary Outcomes (1)

• Mycological Cure

  mycological cure defined as two consecutive negative cultures per FDA guideline

  2 cultures taken a week apart within 2 weeks after the first treatment

Study Arms (1)

Multi-center open label

EXPERIMENTAL

Thirty Subjects with 20-75% Distal Subungual Onychomycosis (mild to moderate DSO) infection of their big toe (hallux) nail infected by the dermatophytes Trichophyton (T.) rubrum or T. mentagrophytes will be enrolled. All Subjects will receive three 45-minute plasma treatments performed over a week.

Device: RenewalNail™ Plasma Treatment System

Interventions

RenewalNail™ Plasma Treatment System DEVICE

application of cold atmospheric plasma to a fungal infected toenail

Also known as: cold atmospheric plasma treatment

Multi-center open label

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who are between 21 to 75 years (inclusive) of age;
• Subjects male or female and of any race;
• Subjects who are in good general health and free from any clinically significant disease that might interfere with the study evaluations.
• Subjects with established clinical diagnosis of distal subungual onychomycosis;
• Subjects with at least one or both big toe nails involved with 20-75% infection;
• Subjects with both positive KOH and culture for onychomycosis dermatophytes in screening of nail samples;
• Subjects whose infection is confirmed to be caused by T. rubrum or T. mentagrophytes;
• Subjects who are willing and able to refrain from employing other (non-study) treatments (traditional or alternative) for his or her toenail onychomycosis throughout study participation;
• Subjects who are willing and able to refrain from the use of nail cosmetics such as clear and/or colored nail lacquers throughout study participation;
• Subjects who are willing and able to give written informed consent and able to adhere to procedures and visit schedules;
• Women of childbearing potential who are currently sexually active must agree to use a medically accepted method of contraception while receiving protocol specified treatment. Methods include condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device, oral or systemic hormonal contraceptive (plus an additional reliable barrier method), surgical sterilization (e.g., hysterectomy or tubal ligation);
• Women of childbearing potential who are not currently sexually active must agree to use a medically accepted method of contraception should they become sexually active while participating in the study;
• Women of childbearing potential must have a negative pregnancy test prior to start of study.

You may not qualify if:

• Subjects with presence of dermatophytoma (defined as demarcated and localized thick masses) of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail;
• Subjects with onychomycosis infection involving lunula of the affected toenail(s) or spikes of disease extending to nail matrix in the affected big toenail(s);
• Subjects with conditions other than distal subungual onychomycosis known to cause abnormal nail appearance such as psoriasis, severe moccasin-type tinea pedis requiring treatment, symptomatic interdigital tinea pedis, lichen planus, or other abnormalities that could result in a clinically abnormal nail;
• Subjects whose foot is too large (larger than US men's size 13) or too small (smaller than US women's size 3) to properly fit into the plasma treatment device;
• Subjects with a history of multiple repeated failures with previous therapies for onychomycosis;
• Subjects whose affected big toenails cannot become normal in the opinion of the investigator;
• Subjects with abnormality of the affected big toenail(s) that could prevent a normal appearing nail if clearing of infection is achieved;
• Subjects with trauma to the affected big toenail(s) as identified by the study doctor;
• Subjects who received topical antifungal treatment of the nails within 2 weeks before study initiation;
• Subjects who received systemic antifungal treatment within 3 months before study initiation;
• Subjects with dementia or psychic condition that might interfere with the ability to understand the study and thus give written informed consent;
• Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding treatment;
• Subjects who are unwilling or unable to refrain from employing other (non-study) treatments (traditional and alternative) for their toenail onychomycosis throughout study participation;
• Subjects who are unwilling or unable to refrain from the use of nail cosmetics such as clear and/or colored nail lacquers until the end of study participation;
• Subjects who are immunocompromised (e.g. adrenal insufficiency, diabetes mellitus, febrile neutropenia, and the human immunodeficiency virus infected);

Sponsors & Collaborators

• DeviceFarm, Inc.: lead
• Symbio, LLC: collaborator
• Center for Dermatology Clinical Research, Inc.: collaborator

Study Sites (2)

Center for Dermatology Clinical Research, Inc.

Fremont, California, 94538, United States

Location

Center For Clinical Research Inc.

San Francisco, California, 94115, United States

Location

Results Point of Contact

• Title: Jeffrey N Roe
• Organization: DeviceFarm

jeffnroe1@devicefarmtech.com

925-895-1584

Study Officials

• Jeffrey N Roe, PhD

  DeviceFarm, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: multi-center open-label study

Study Record Dates

• First Submitted: March 2, 2017
• First Posted: March 7, 2017
• Study Start: March 1, 2017
• Primary Completion: April 1, 2018
• Study Completion: June 30, 2018
• Last Updated: September 16, 2019
• Results First Posted: August 29, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)