Toenail Onychomycosis, Distal and Lateral Subungual Toenail Onychomycosis
Conditions
Brief summary
This research study will evaluate the safety and efficacy of using blue light photodynamic therapy (PDT) for treating toenail fungal infections.
Detailed description
This research study will evaluate the safety and efficacy of using blue light photodynamic therapy (PDT) for treating toenail fungal infections.
Interventions
PROCEDUREAminolevulinic Acid (ALA)
Photosensitizing
Sponsors
DUSA Pharmaceuticals, Inc.
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects diagnosed with presence of subungual culture after 3rd treatment session | 3 weeks after baseline | Based on presence of fungal infection from culture assessment |
| Number of subjects with clinical cure based on photographs after the 3rd treatment session | 3 weeks after baseline | Based on visual assessment of photographs: presence or absence of fungal infection |
Secondary
| Measure | Time frame |
|---|---|
| Compare rates of mycological and clinical cure after three treatments between two groups with different ALA incubation times | 3 weeks after baseline |
| Evaluate the durability of treatment outcomes with subungual culture and photographs at 24 weeks | 24 weeks after first treatment |
| Evaluate tolerability to treatment using a Visual Analog Scale (VAS) pain scale questionnaire at each treatment visit | 1 week after baseline |
Countries
United States
Outcome results
None listed