Early Feasibility Study to Evaluate the Efficacy of the RenewalNail™ Plasma Treatment System in P… (NCT03216200) | Clinical Trial Compass
CompletedNot Applicable
Early Feasibility Study to Evaluate the Efficacy of the RenewalNail™ Plasma Treatment System in Patients With Onychomycosis (Fungal Nail)
United States5 participantsStarted 2017-07-07
Plain-language summary
A 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.
Who can participate
Age range21 Years – 75 Years
SexALL
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Inclusion Criteria:
* Subjects who are between 21 to 75 years (inclusive) of age;
* 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 big toe nail 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 during the week of treatment (from Study Visits 1 through 3);
* 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), diaphragm or cervical cap with spermicide, medically prescribed intrauterine device, oral or systemic hormonal contraceptive, surgical sterilization (e.g., hysterectomy or tubal ligation);
* Women of childbearin…
What they're measuring
1
Mycological Cure
Timeframe: 2 cultures taken a week apart within 2 weeks after the first treatment