- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01498393
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
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Irvine, California, United States, 92612
- Beckman Laser Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Laser treatment
Laser treatment to Improve the Appearance of Onychomycosis
|
Laser treatment to Improve the Appearance of Onychomycosis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improving the Appearance of fungal nail
Time Frame: 6 months
|
Laser treatment to Improve the Appearance of Onychomycosis
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20118536
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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