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

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

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 DLSO of the great toe with both positive 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 preceeding 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