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

Fungal Nail Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01498393
• Other study ID #: 20118536
• Status: Completed
• Phase: Phase 1
• Start date: December 2011
• Est. completion date: December 2012

Study information

• Verified date: October 2022
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fungal Nail Infection
• Onychomycosis

Intervention

Device:
• Laser treatment
Laser treatment to Improve the Appearance of Onychomycosis

Locations

Country	Name	City	State
United States	Beckman Laser Institute	Irvine	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	Beckman Laser Institute University of California Irvine

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ortiz AE, Truong S, Serowka K, Kelly KM. A 1,320-nm Nd: YAG laser for improving the appearance of onychomycosis. Dermatol Surg. 2014 Dec;40(12):1356-60. doi: 10.1097/DSS.0000000000000189. — View Citation

Outcome

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

External Links

•   A 1,320-nm Nd: YAG laser for improving the appearance of onychomycosis