Pulsed Dye Laser Treatment of Onychomycosis

Onychomycosis Clinical Trial

Official title:

Pulsed Dye Laser Treatment of Onychomycosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01915355
• Other study ID #: IRB 13D.230
• Status: Completed
• Phase: N/A
• First received: July 29, 2013
• Last updated: August 17, 2016
• Start date: July 2013
• Est. completion date: July 2015

Study information

• Verified date: August 2016
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: July 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Onychomycosis

Intervention

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

Locations

Country	Name	City	State
United States	Jefferson Dermatology Associates	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Nail Clearance	After 3 laser treatments, the subject should experience clinical clearance.	approximately 12 weeks	No