NCT01915355

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 2, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

August 19, 2016

Status Verified

August 1, 2016

Enrollment Period

1.4 years

First QC Date

July 29, 2013

Last Update Submit

August 17, 2016

Conditions

Onychomycosis

Keywords

onychomycosisnailfungus

Outcome Measures

Primary Outcomes (1)

  • Total Nail Clearance

    After 3 laser treatments, the subject should experience clinical clearance.

    approximately 12 weeks

Study Arms (1)

Pulsed Dye Laser for fungus treatment

EXPERIMENTAL

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

Interventions

Pulsed Dye Laser for the treatment of nail fungusDEVICE

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.

Pulsed Dye Laser for fungus treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jefferson Dermatology Associates

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Onychomycosis

Interventions

Lasers, Dye

Condition Hierarchy (Ancestors)

TineaDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousNail DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Nazanin Saedi, MD

    Jefferson Dermatology Associates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2013

First Posted

August 2, 2013

Study Start

July 1, 2013

Primary Completion

December 1, 2014

Study Completion

July 1, 2015

Last Updated

August 19, 2016

Record last verified: 2016-08

Locations

US(1)