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