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Purpose

This research study will evaluate the safety and efficacy of using blue light photodynamic therapy (PDT) for treating toenail fungal infections.

Conditions

Eligibility

Eligible Ages
Between 19 Years and 70 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients older than 19 and younger than 70 years - Give written informed consent prior to any study procedures being conducted, and candidates will authorize the release and use of protected health information (PHI) - Diagnosed with distal lateral subungual onychomycosis (DLSO) of the great toe with both positive potassium hydroxide (KOH) and positive culture growth of Trichophyton rubrum - No topical treatment for DLSO in the preceding 2 weeks and no oral treatment for DLSO (itraconazole or terbinafine) in the preceding 8 weeks - At lease 20% of target great toe nail affected

Exclusion Criteria

  • Unable to comply with the protocol (as defined y the investigator; i.e. drug or alcohol abuse or history of noncompliance) - Patients with active nail disease that would confound evaluation of DLSO, such as psoriasis - Patients with greater than 6 toenails affected - Over 90% of target great toe affected - Evidence of fingernail fungal infection - Patients with recurrent serious infections or have been hospitalized in the preceding 6 months for infection - Patients with known history of HIV or hepatitis B or C infection - Patients with severe, progressive, or uncontrolled with renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurologic disease - Any subject who, in the opinion of the investigator, will be uncooperative or unable to comply with study procedures

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Photodynamic Therapy (PDT) 		PDT with ALA (photosensitizer) for 3 hours
  • Procedure: Aminolevulinic Acid (ALA)
    Photosensitizing
    Other names:
    • ALA is a topical drug used in the administration of PDT.

More Details

Status
Completed
Sponsor
University of Alabama at Birmingham

Study Contact

Detailed Description

This research study will evaluate the safety and efficacy of using blue light photodynamic therapy (PDT) for treating toenail fungal infections.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.