Chart Review of the Efficacy of the GenesisPlus 1064 nm Nd:YAG Laser in the Treatment of Onychomycosis

Completed

• Conditions: Onychomycosis

• Registration Number: NCT02445495
• Lead Sponsor: Jason K Rivers, MD, FRCPC, FAAD

Brief Summary

The purpose of this study is to determine if toenail onychomycosis can be reduced by means of exposure to laser energy from the Cutera® GenesisPlus 1064 Nd:YAG laser system.

Detailed Description

This is a retrospective, open-label, single-centre study for the collection of clinical data on the efficacy and safety of the Cutera® GenesisPlus 1064 nm Nd:YAG laser for the treatment of nail fungus (onychomycosis). Safety and efficacy of treatment with the GenesisPlus laser will be evaluated by (1) assessment of subject's great toenail photographs at baseline and after two treatments with GenesisPlus Laser utilizing planimetry measurement of infected vs. clear nail area in target toenail photographs, (2) by clinical and subjective review of acute and follow up adverse events that may have resulted from laser treatment of the target toenails.

Study Timeline

• Study Start: 2013-11
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2015-04
• Study First Submitted: 2015-04-30
• Study First Submitted QC: 2015-05-12
• Last Update Submitted: 2015-05-12
• Study First Posted: 2015-05-15
• Last Update Posted: 2015-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in % of infected toenail involvement	change from baseline up to 6 months	onychomycosis involvement