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

Onychomycosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02445495
• Other study ID #: PDA288
• Status: Completed
• Phase: N/A
• First received: April 30, 2015
• Last updated: May 12, 2015
• Start date: November 2013
• Est. completion date: November 2014

Study information

• Verified date: April 2015
• Source: Pacific Dermaesthetics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Onychomycosis

Intervention

Device:
• GenesisPlus 1064 nm Nd:YAG laser
Genesis Plus 1064 nm Nd: YAG laser to treat onychomycosis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Jason K Rivers, MD, FRCPC, FAAD	Cutera Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in % of infected toenail involvement	onychomycosis involvement	change from baseline up to 6 months	No