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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01498393
First received: December 20, 2011
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Fungal Nail Infection
 Other: treatment
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled Study of the 1320 nm Nd:YAG Laser for Improving the Appearance of Onychomycosis

Resource links provided by NLM:

MedlinePlus related topics: Molds
U.S. FDA Resources

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • improving fungal nail infection [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    fungal nail


Enrollment: 10
Study Start Date: December 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: treatment
1320 nm Nd:YAG Laser for Improving the Appearance of Onychomycosis
 Other: treatment
CoolTouch CT3 Plus™ laser with the CoolBreeze Zoom handpiece

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01498393

Locations
United States, California
Beckman Laser Institute
Irvine, California, United States, 92612
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Kristen Kelly, MD Beckman Laser Institute, UCI
  More Information

No publications provided

Responsible Party: University of California, Irvine
ClinicalTrials.gov Identifier: NCT01498393     History of Changes
Other Study ID Numbers: NIH/LAMMP
Study First Received: December 20, 2011
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
fungal nail

Additional relevant MeSH terms:
Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
 Infection
Mycoses
Nail Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013