Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:05 PM
Ignite Modification Date:
2025-12-24 @ 2:05 PM
NCT ID:
NCT02445495
Eligibility Criteria:
Inclusion Criteria:
1. Male or Female subjects, age 18 to 80 years (inclusive).
2. Subject with a clinical diagnosis of onychomycosis of one or both great toenails at baseline.
3. Subject with a positive potassium hydroxide (KOH) stain and/or fungal culture.
4. Subject has baseline and post treatment digital photographs of target great toenails.
5. Subjects provided informed consent for treatment of nails with the Cutera GenesisPlus laser system.
Exclusion Criteria:
1. Subjects have received laser treatment of the infected great toenail(s) with a non-Cutera® laser system within twelve (12) months prior to Cutera® GenesisPlus laser treatment.
2. Subjects have had a history or clinical diagnosis of moccasin type tinea pedis, lichen planus, psoriasis or bacterial nail infection.
3. Subjects had a history or clinical diagnosis of coexisting disorders that may potentially demonstrate nail manifestations.
4. Systemic antifungal medication within six (6) months prior to or following Cutera® GenesisPlus laser treatment.
5. Subjects who have had a history or clinical diagnosis of repetitive nail trauma prior to treatment.
6. Subjects who have participated in any clinical research study within thirty (30) days prior to or within 210 days following final Cutera® GenesisPlus laser treatment.
7. Subjects who were pregnant or breastfeeding.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02445495
Study Brief:
Protocol Section:
NCT02445495