Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05877313
Status:
COMPLETED
Last Update Posted:
2024-04-17
First Post:
2023-05-06
Brief Title:
Nitric Oxide Releasing Solution NORS For The Treatment Of Human PapillomavirusHPV Verrucae Plantaris Plantar Warts
Sponsor:
Sanotize Research and Development corp
Organization:
Sanotize Research and Development corp
Study Overview
Official Title:
Phase 2a Multicenter Randomized Double-Blinded Placebo-Controlled Clinical Trial To Evaluate The Safety And Efficacy Of Topical Nitric Oxide Releasing Solution For The Treatment Of Human Papillomavirus Verrucae Plantaris
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A phase 2a multicenter randomized double-blinded placebo-controlled clinical trial to evaluate the safety and efficacy of topical nitric oxide releasing solution NORS for the treatment of human papillomavirus HPV caused verrucae plantaris plantar warts Participants will be treated over a 21 day period with a final evaluation on Day 35 They will be separated into 3 treatment groups placebo 1x and 2x dose Participants will be evaluated for change in wart size wart clearance and HPV genotype
Detailed Description:
This is a multicenter randomized double-blinded placebo-controlled phase 2a clinical trial to evaluate the safety and efficacy of NORS in adolescent and adult volunteers as a treatment for verrucae plantaris plantar warts Participants aged 12 or older with plantar warts on the bottom of the foot feet will be enrolled into one of 3 cohorts in a ratio of 111 NORS1X 3 dosesweek NORS 2X 3 dosesweek placebo vehicle 3 dosesweek for 3 weeks
Participants with or without underlying medical conditions unless exclusionary seeking treatment at the site for plantar warts will be eligible Eligible recruited participants will have three or more currently active plantar warts on the bottom of their footfeet Participants who are currently pursuing other forms of treatment eg over-the-counter wart removers a treatment recommended by their physician or are waiting for a current treatment will be excluded from the study
After enrollment and randomization participants will self-administer study treatment--defined as either blinded study NORS footbath treatment or placebo vehicle sterile water footbath treatment--three times a week for three weeks Study treatment will be delivered via a single footbath filled with 500 mL of NORS solution Placebo treatment will be delivered via a single footbath filled with 500 mL of vehicle solution Each treatment will be a 15-minute soaking time per foot If both feet are affected the participant will receive the same treatment on both feet Thirty 30 participants will be enrolled with 10 participants per treatment The study duration is five weeks which includes ScreeningBaseline Day 0 3 weeks 21 days of Treatment and 14 days of Follow-Up Lesions will be scored at enrollment Day 0 and subsequently at follow-up visits Day 7 Day 14 Day 21 Day 28 and Day 35
The primary endpoint is to evaluate the efficacy of NORS to provide lesion clearance by photographic lesion length measurement Day 35 Photographs and counting of warts will be performed at each visit Wart length and clearance evaluation will be recorded at each site visit to Day 35 Lesion clearance is defined as a length of 0 mm After each wart assessment at site visits warts may be debrided as necessary per the investigators evaluation and standard of care Secondary endpoints will assess lesions for the mean reduction in dimensions as measured by the change in longest length size from baseline observed at Days 7 14 21 28 and 35 lesion clearance by Physician Wart Assessment PWA0 and pain reduction using an 11- point Pain Numeric Rating Scale NRS 0 to 10 An exploratory endpoint will evaluate the distribution of HPV genotypes determined by swabbing the overlaying skin of the wart from participants at baseline Participants will additionally have their vitals tracked and skin visually assessed for inflammation at baseline Day 0 and follow-up visits Day 35 Adverse events will also be tracked as a measure of safety The discontinuation rate for tolerance unless for a lack of perceived efficacy will also be tracked
Participants will have six on-site visits Screening and randomization will be completed on Day 0 followed by a three-week 21-day treatment period until Day 21 A site visit will occur on Day 7 Day 14 and at the end-of-treatment EOT site visit on Day 21 The treatment period will be followed by a 14-day follow-up period with a visit on Day 28 and an end-of-study EOS visit on Day 35 During the entire study the participant will be instructed to keep a daily journal of observations to report to the site investigator at their visits ie when they observed each lesions clearance new occurrences of lesions or recurrence of the same lesions
During the visits on Days 7 14 21 28 and 35 Follow-Up the investigatorstudy staff will review and assess information about lesion clearance pain other outcomes andor adverse events At the screeningbaselinerandomization visit and at the EOT visit the patients medical history including priorconcomitant illness medication adverse event physical examination and vital signs assessment will be conductedrecorded Urine pregnancy tests will be conducted in women of childbearing potential at the screening visit and at EOT visitearly termination visit
Data collection and monitoring will be performed remotely and on-site Screening and enrollment will take place on-site with consenting procedure performed in-person on-site Participants will receive study treatment directly from the site No laboratory bloodwork assessments will be performed
Participants with or without underlying medical conditions unless exclusionary seeking treatment at the site for plantar warts will be eligible Eligible recruited participants will have three or more currently active plantar warts on the bottom of their footfeet Participants who are currently pursuing other forms of treatment eg over-the-counter wart removers a treatment recommended by their physician or are waiting for a current treatment will be excluded from the study
After enrollment and randomization participants will self-administer study treatment--defined as either blinded study NORS footbath treatment or placebo vehicle sterile water footbath treatment--three times a week for three weeks Study treatment will be delivered via a single footbath filled with 500 mL of NORS solution Placebo treatment will be delivered via a single footbath filled with 500 mL of vehicle solution Each treatment will be a 15-minute soaking time per foot If both feet are affected the participant will receive the same treatment on both feet Thirty 30 participants will be enrolled with 10 participants per treatment The study duration is five weeks which includes ScreeningBaseline Day 0 3 weeks 21 days of Treatment and 14 days of Follow-Up Lesions will be scored at enrollment Day 0 and subsequently at follow-up visits Day 7 Day 14 Day 21 Day 28 and Day 35
The primary endpoint is to evaluate the efficacy of NORS to provide lesion clearance by photographic lesion length measurement Day 35 Photographs and counting of warts will be performed at each visit Wart length and clearance evaluation will be recorded at each site visit to Day 35 Lesion clearance is defined as a length of 0 mm After each wart assessment at site visits warts may be debrided as necessary per the investigators evaluation and standard of care Secondary endpoints will assess lesions for the mean reduction in dimensions as measured by the change in longest length size from baseline observed at Days 7 14 21 28 and 35 lesion clearance by Physician Wart Assessment PWA0 and pain reduction using an 11- point Pain Numeric Rating Scale NRS 0 to 10 An exploratory endpoint will evaluate the distribution of HPV genotypes determined by swabbing the overlaying skin of the wart from participants at baseline Participants will additionally have their vitals tracked and skin visually assessed for inflammation at baseline Day 0 and follow-up visits Day 35 Adverse events will also be tracked as a measure of safety The discontinuation rate for tolerance unless for a lack of perceived efficacy will also be tracked
Participants will have six on-site visits Screening and randomization will be completed on Day 0 followed by a three-week 21-day treatment period until Day 21 A site visit will occur on Day 7 Day 14 and at the end-of-treatment EOT site visit on Day 21 The treatment period will be followed by a 14-day follow-up period with a visit on Day 28 and an end-of-study EOS visit on Day 35 During the entire study the participant will be instructed to keep a daily journal of observations to report to the site investigator at their visits ie when they observed each lesions clearance new occurrences of lesions or recurrence of the same lesions
During the visits on Days 7 14 21 28 and 35 Follow-Up the investigatorstudy staff will review and assess information about lesion clearance pain other outcomes andor adverse events At the screeningbaselinerandomization visit and at the EOT visit the patients medical history including priorconcomitant illness medication adverse event physical examination and vital signs assessment will be conductedrecorded Urine pregnancy tests will be conducted in women of childbearing potential at the screening visit and at EOT visitearly termination visit
Data collection and monitoring will be performed remotely and on-site Screening and enrollment will take place on-site with consenting procedure performed in-person on-site Participants will receive study treatment directly from the site No laboratory bloodwork assessments will be performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None