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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

December 20, 2011
January 15, 2013
December 2011
December 2012   (final data collection date for primary outcome measure)
improving fungal nail infection [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
fungal nail
Same as current
Complete list of historical versions of study NCT01498393 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

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.
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Fungal Nail Infection
Other: treatment
CoolTouch CT3 Plus™ laser with the CoolBreeze Zoom handpiece
No Intervention: treatment
1320 nm Nd:YAG Laser for Improving the Appearance of Onychomycosis
Intervention: Other: treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01498393
NIH/LAMMP
Yes
University of California, Irvine
University of California, Irvine
Not Provided
Principal Investigator: Kristen Kelly, MD Beckman Laser Institute, UCI
University of California, Irvine
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP