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

NCT02445495 | Completed

• 1 other identifier: PDA288
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Onychomycosis

Outcome Measures

Primary Outcomes (1)

• change in % of infected toenail involvement

  onychomycosis involvement

  change from baseline up to 6 months

Interventions

GenesisPlus 1064 nm Nd:YAG laser DEVICE

Genesis Plus 1064 nm Nd: YAG laser to treat onychomycosis

Also known as: Cutera®

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

100 participants at primary clinic

You may qualify if:

• Male or Female subjects, age 18 to 80 years (inclusive).
• Subject with a clinical diagnosis of onychomycosis of one or both great toenails at baseline.
• Subject with a positive potassium hydroxide (KOH) stain and/or fungal culture.
• Subject has baseline and post treatment digital photographs of target great toenails.
• Subjects provided informed consent for treatment of nails with the Cutera GenesisPlus laser system.

You may not qualify if:

• 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.
• Subjects have had a history or clinical diagnosis of moccasin type tinea pedis, lichen planus, psoriasis or bacterial nail infection.
• Subjects had a history or clinical diagnosis of coexisting disorders that may potentially demonstrate nail manifestations.
• Systemic antifungal medication within six (6) months prior to or following Cutera® GenesisPlus laser treatment.
• Subjects who have had a history or clinical diagnosis of repetitive nail trauma prior to treatment.
• 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.
• Subjects who were pregnant or breastfeeding.

Sponsors & Collaborators

• Jason K Rivers, MD, FRCPC, FAAD: lead
• Cutera Inc.: collaborator

MeSH Terms

Conditions

Onychomycosis

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 30, 2015
• First Posted: May 15, 2015
• Study Start: November 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: May 15, 2015

Record last verified: 2015-04