Blue Light Photodynamic Therapy Treatment for Distal and Lateral Subungual Toenail Onychomycosis

The University of Alabama at Birmingham

Status: Completed

Conditions: Toenail Onychomycosis; Distal and Lateral Subungual Toenail Onychomycosis

Treatments: Procedure: Aminolevulinic Acid (ALA)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03022903

F150128007

Details and patient eligibility

About

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

Full description

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

Enrollment: 2 patients

Sex: Female

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Photodynamic Therapy (PDT)

Other group

Description:

PDT with ALA (photosensitizer) for 3 hours

Treatment:

Procedure: Aminolevulinic Acid (ALA)