1320 nm Nd:YAG Laser for Improving the Appearance of Onychomycosis

Phase 1

Completed

• Conditions: Fungal Nail Infection
• Interventions: Device: Laser treatment

• Registration Number: NCT01498393
• Lead Sponsor: University of California, Irvine

Brief Summary

The purpose of this clinical study is to improve the appearance of onychomycosis and morphology of the nail (fungal infection). The researcher can use a light based therapy to gently heat the toenail infected with fungus to improve the appearance of onychomycosis.

Detailed Description

Toenail fungus (onychomycosis) is a common fungal infection of the nail that affects roughly 10% of Americans. Onychomycosis may be a precursor to many complications like ulcers, or skin infections, which may rarely result in amputation. Current treatment options have relatively limited long-term success and recurrence is common.

The researcher can determine that the laser therapy can heat the nail and destroy and decrease the fungus infecting the nail to improving the appearance of the nail.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-20
• Study First Submitted QC: 2011-12-22
• Study First Posted: 2011-12-23
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-28
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Adult Male/ female has been diagnose with fungal nail infection on both great toenails.

Exclusion Criteria

• Any other toenail disease including, but not limited to psoriasis, lichen planus, pachyonychia congenita, etc. as determined by the investigator.
• Excessively thick or hypertrophic nails.
• Subjects with diabetes.
• Subjects that are pregnant
• Receipt of any topical therapy for onychomycosis (i.e. antifungal) within 2 weeks of enrollment, systemic therapy for onychomycosis (i.e. antifungal) within 3 months of enrollment, or any other procedures done on the test area within 6 months of enrollment.
• Subjects with impaired immune systems including, but not limited to HIV, transplant patients on immunosuppression, etc.
• Current or history of psychiatric disease that would interfere with ability to comply with the study protocol or give informed consent.
• History of alcohol or drug abuse that would interfere with ability to comply with the study protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laser treatment	Laser treatment	Laser treatment to Improve the Appearance of Onychomycosis

Primary Outcome Measures

Name	Time	Method
Improving the Appearance of fungal nail	6 months	Laser treatment to Improve the Appearance of Onychomycosis

Trial Locations

Locations (1)

Beckman Laser Institute; 🇺🇸 Irvine, California, United States