Pulsed Dye Laser Treatment of Onychomycosis

Not Applicable

Completed

• Conditions: Onychomycosis

• Registration Number: NCT01915355
• Lead Sponsor: Thomas Jefferson University

Brief Summary

The purpose of this research is to investigate the use of the Candela V-beam Pulsed Dye Laser for the treatment of onychomycosis, or nail fungus.

Hypothesis: Complete nail clearance will occur in approximately half of patients after 3 laser treatments.

Detailed Description

10 patients will participate nationally. The investigators hope to enroll all 10 patients at Jefferson. Involvement in the study will last about 8-12 weeks for the subject. The entire study will take about 12 months to complete.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-29
• Study First Submitted QC: 2013-07-31
• Study First Posted: 2013-08-02
• Primary Completion: 2014-12
• Study Completion: 2015-07
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-17
• Last Update Posted: 2016-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Ages 18-65 years old
• Diagnosis of onychomycosis based on positive fungal culture for dermatophyte and positive PAS from toenail clipping

Exclusion Criteria

• HIV/immunosuppression
• Candidal toenail infection
• Prior PO antifungal therapy within last 6 months
• Personal history of psoriasis, lichen planus, or significant photosensitivity disorder
• Any serious generalized medical condition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Total Nail Clearance	approximately 12 weeks	After 3 laser treatments, the subject should experience clinical clearance.

Trial Locations

Locations (1)

Jefferson Dermatology Associates; 🇺🇸 Philadelphia, Pennsylvania, United States