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

NCT ID: NCT02445495

Last Updated: 2015-05-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-11-30

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.

Conditions

Onychomycosis

Study Design

• Study Time Perspective: RETROSPECTIVE

Interventions

GenesisPlus 1064 nm Nd:YAG laser

Genesis Plus 1064 nm Nd: YAG laser to treat onychomycosis

Intervention Type: DEVICE

Other Intervention Names

Cutera®

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cutera Inc.

INDUSTRY

Sponsor Role: collaborator

Jason K Rivers, MD, FRCPC, FAAD

OTHER

Sponsor Role: lead

Responsible Party

Jason K Rivers, MD, FRCPC, FAAD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

PDA288

Identifier Type: -

Identifier Source: org_study_id