Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05877313 |
| Other study ID # |
HPV-Warts-01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
August 2, 2023 |
| Est. completion date |
April 12, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Sanotize Research and Development corp. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 1:1:1
(NORS1X, 3 doses/week; NORS 2X, 3 doses/week; placebo vehicle, 3 doses/week 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 foot/feet.
Participants who are currently pursuing other forms of treatment (e.g., 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 Screening/Baseline (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 (PWA=0); 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, i.e., when they observed each lesion's 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 investigator/study staff
will review and assess information about lesion clearance, pain, other outcomes, and/or
adverse events. At the screening/baseline/randomization visit and at the EOT visit, the
patient's medical history (including prior/concomitant illness, medication, adverse event),
physical examination, and vital signs assessment will be conducted/recorded. Urine pregnancy
tests will be conducted in women of childbearing potential at the screening visit and at EOT
visit/early 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.
