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Pulsed Dye Laser Treatment of Onychomycosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Thomas Jefferson University
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01915355
First received: July 29, 2013
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Onychomycosis
Device: Pulsed Dye Laser for the treatment of nail fungus

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pulsed Dye Laser Treatment of Onychomycosis

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Total Nail Clearance [ Time Frame: approximately 12 weeks ] [ Designated as safety issue: No ]
    After 3 laser treatments, the subject should experience clinical clearance.


Estimated Enrollment: 10
Study Start Date: July 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pulsed Dye Laser for fungus treatment
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01915355

Contacts
Contact: Jefferson Dermatology 215-955-6680

Locations
United States, Pennsylvania
Jefferson Dermatology Associates Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Jefferson Dermatology    215-955-6680      
Sub-Investigator: Joya Sahu, MD         
Principal Investigator: Nazanin Saedi, MD         
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Nazanin Saedi, MD Jefferson Dermatology Associates
  More Information

No publications provided

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01915355     History of Changes
Other Study ID Numbers: IRB 13D.230
Study First Received: July 29, 2013
Last Updated: August 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:
onychomycosis
nail
fungus

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

ClinicalTrials.gov processed this record on August 21, 2014