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

A Single Centre Retrospective Chart Review Study to Assess the Efficacy of the GenesisPlus 1064 nm Nd:YAG Laser in the Treatment of Onychomycosis

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.

Study Overview

• Status: Completed
• Conditions: Onychomycosis
• Intervention / Treatment: Device: GenesisPlus 1064 nm Nd:YAG laser

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 Type: Observational
• Enrollment (Actual): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

100 participants at primary clinic

Description

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 Plan

How is the study designed?

Design Details

• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in % of infected toenail involvement	onychomycosis involvement	change from baseline up to 6 months

Collaborators and Investigators

• Sponsor: Jason K Rivers, MD, FRCPC, FAAD
• Collaborators: Cutera Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: April 30, 2015
• First Submitted That Met QC Criteria: May 12, 2015
• First Posted (Estimate): May 15, 2015

Study Record Updates

• Last Update Posted (Estimate): May 15, 2015
• Last Update Submitted That Met QC Criteria: May 12, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Tinea; Dermatomycoses; Nail Diseases; Onychomycosis
• Other Study ID Numbers: PDA288