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

Primary Purpose

Fungal Nail Infection

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Laser treatment
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fungal Nail Infection focused on measuring fungal nail

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Beckman Laser Institute

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Laser treatment

Arm Description

Laser treatment to Improve the Appearance of Onychomycosis

Outcomes

Primary Outcome Measures

Improving the Appearance of fungal nail
Laser treatment to Improve the Appearance of Onychomycosis

Secondary Outcome Measures

Full Information

First Posted
December 20, 2011
Last Updated
October 28, 2022
Sponsor
University of California, Irvine
Collaborators
Beckman Laser Institute University of California Irvine
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1. Study Identification

Unique Protocol Identification Number
NCT01498393
Brief Title
1320 nm Nd:YAG Laser for Improving the Appearance of Onychomycosis
Official Title
A Randomized, Placebo-Controlled Study of the 1320 nm Nd:YAG Laser for Improving the Appearance of Onychomycosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
Collaborators
Beckman Laser Institute University of California Irvine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fungal Nail Infection
Keywords
fungal nail

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser treatment
Arm Type
Other
Arm Description
Laser treatment to Improve the Appearance of Onychomycosis
Intervention Type
Device
Intervention Name(s)
Laser treatment
Intervention Description
Laser treatment to Improve the Appearance of Onychomycosis
Primary Outcome Measure Information:
Title
Improving the Appearance of fungal nail
Description
Laser treatment to Improve the Appearance of Onychomycosis
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristen Kelly, MD
Organizational Affiliation
Beckman Laser Institute, UCI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beckman Laser Institute
City
Irvine
State/Province
California
ZIP/Postal Code
92612
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25357174
Citation
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.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/?term=kristen+kelly
Description
A 1,320-nm Nd: YAG laser for improving the appearance of onychomycosis

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

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