This research study will evaluate the safety and efficacy of using blue light photodynamic therapy (PDT) for treating toenail fungal infections.
This research study will evaluate the safety and efficacy of using blue light photodynamic therapy (PDT) for treating toenail fungal infections.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Photosensitizing
Dermatology at the Whitaker Clinic
Birmingham, Alabama, United States
Number of subjects diagnosed with presence of subungual culture after 3rd treatment session
Based on presence of fungal infection from culture assessment
Time frame: 3 weeks after baseline
Number of subjects with clinical cure based on photographs after the 3rd treatment session
Based on visual assessment of photographs: presence or absence of fungal infection
Time frame: 3 weeks after baseline
Compare rates of mycological and clinical cure after three treatments between two groups with different ALA incubation times
Time frame: 3 weeks after baseline
Evaluate the durability of treatment outcomes with subungual culture and photographs at 24 weeks
Time frame: 24 weeks after first treatment
Evaluate tolerability to treatment using a Visual Analog Scale (VAS) pain scale questionnaire at each treatment visit
Time frame: 1 week after baseline
Evaluate tolerability to treatment using a Visual Analog Scale (VAS) pain scale questionnaire at each treatment visit
Time frame: 2 weeks after baseline
Evaluate tolerability to treatment using a Visual Analog Scale (VAS) pain scale questionnaire at each treatment visit
Time frame: 3 weeks after baseline
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