Clinical Trial: Blue Light Photodynamic Therapy Treatment for Distal and Lateral Subungual Toenail Onychomycosis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Blue Light Photodynamic Therapy Treatment for Distal and Lateral Subungual Toenail Onychomycosis
Brief Summary: This research study will evaluate the safety and efficacy of using blue light photodynamic therapy (PDT) for treating toenail fungal infections.
Detailed Summary: This research study will evaluate the safety and efficacy of using blue light photodynamic therapy (PDT) for treating toenail fungal infections.
Sponsor: University of Alabama at Birmingham
Current Primary Outcome:
- Number of subjects diagnosed with presence of subungual culture after 3rd treatment session [ Time Frame: 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 [ Time Frame: 3 weeks after baseline ]Based on visual assessment of photographs: presence or absence of fungal infection
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: University of Alabama at Birmingham
Dates:
Date Received: October 16, 2015
Date Started: September 2015
Date Completion: September 2018
Last Updated: January 17, 2017
Last Verified: January 2017