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

A Randomized, Placebo-Controlled Study of the 1320 nm Nd:YAG Laser for Improving the Appearance of Onychomycosis

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01498393

Enrollment

Registered

2011-12-23

Start date

2011-12-31

Completion date

2012-12-31

Last updated

2022-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fungal Nail Infection

Keywords

fungal nail

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.

Interventions

DEVICELaser treatment

Laser treatment to Improve the Appearance of Onychomycosis

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Improving the Appearance of fungal nail	6 months	Laser treatment to Improve the Appearance of Onychomycosis

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026