Clinical Trial: A Phase I/II Double-blind Safety and Efficacy Evaluation of Nowarta110 in Patients With Plantar Warts
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase I/II, Two- Staged Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Nowarta110 in Patients With Plantar Warts and Clinical Recovery Successfully Completed
Brief Summary:
To evaluate drug safety and efficacy in patients treated with Nowarta110 and to determine therapeutic activity against Plantar Warts
- Clinical Tolerance
- Clinical Recovery
- Evaluate Safety
Detailed Summary: Plantar Warts occur on the soles (plantar surface of feet) and can be severely debilitating for patients even for normal walking. The severity and magnitude of the warts can vary, but they are the cause of much pain and discomfort for all age groups. Nowarta 110 has been evaluated for the therapy of plantar warts caused by the HPV virus, (HPV infection). Clinical experience in a totals of 124 patients receiving Nowarta 110 for 5 weeks treatment in multiple clinics overseas has demonstrated the potential of Nowarta110 with absolutely no side effect.
Sponsor: Nowarta Biopharma Inc
Current Primary Outcome:
- Lesion Assessment [ Time Frame: 6 weeks ]Lesion (plantar wart) size measured in millimeters. Measurement of the longest dimension was recorded. Observed data
- Incidence of Zero Lesion Measurement [ Time Frame: 6 weeks ]Percent of participants with lesion measurement either equal to 0 or greater than 0
Original Primary Outcome: Local adverse event and site reaction [ Time Frame: 7 days ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Nowarta Biopharma Inc
Dates:
Date Received: January 10, 2015
Date Started: February 2015
Date Completion:
Last Updated: October 6, 2016
Last Verified: October 2016
