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Foot bath with nitric oxide releasing solution (NORS) at 1X dosage delivered 3 times weekly (Mon, Wed, Fri).

500mL NORS in a footbath @ 4110 ppm\*min

Foot bath with nitric oxide releasing solution (NORS) at 2X dosage delivered 3 times weekly (Mon, Wed, Fri).

500mL NORS in a footbath @ 12190 ppm\*min

Foot bath with sterile water delivered 3 times weekly (Mon, Wed, Fri)

500mL sterile water in a foot bath.

Participants will use the same foot bath and sterile water used in the treatment arm minus the active ingredients.

Sterile water foot bath

Participants will use a foot bath filled with 500mL of NORS for 15 min. The solution's two components are mixed 1:1 to 500mL in the foot bath immediately before treatment. The solution contains NO at 68.9ppm\*hrs and 203.2ppm\*hrs for 1X and 2X solutions respectively, and it acts as a virucidal agent. Instructions for storage, handling, and use will be provided to site staff and participants.

Keith Moore, PHARMMD

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.

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.

Nitric Oxide Releasing Solution (NORS) For The Treatment Of Human Papillomavirus(HPV) Verrucae Plantaris (Plantar Warts)

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

HPV genotypes will be determined by swabbing the overlaying skin of the warts from participants at baseline. Analysis will be performed using a multiplex PCR reaction.

Lesion clearance will be evaluated by the Physician Wart Assessment tool (PWA=0 on Day 35).

Dermatology Life Quality Index (DLQI) (questions score change from baseline at Day 35)

The efficacy of NORS as measured by the clearance of the wart(s) defined by a photographic lesion measurement of zero (0) length and as compared to a placebo treatment

Reduction in lesion (plantar wart) size measured in millimeters with each NORS dose as compared to reduction with placebo treatment. Measurement of the longest dimension will be recorded and the mean reduction in dimensions as measured by the change in size from baseline observed at Day 7, 14, 21, 28 and 35.

Changes in the size (area) of lesion from baseline will be measured on each visit.

Number of participants who experience reduced pain in their lesions and the time to reduction. This will be scored on an 11-point Pain Numeric Rating Scale (NRS; 0 to 10). Lesions will be scored at enrollment, daily by participants, and subsequently on follow up visits (Day 7, 14, 21, 28 and 35).

Number of participants who find the NORS treatment tolerable.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Nitric Oxide Releasing Solution (NORS) For The Treatment Of Human Papillomavirus(HPV) Verrucae Plantaris (Plantar Warts)	NCT05877313	Verruca Plantar...	Sterile water f... Nitric Oxide	12 Years -	Sanotize Research and Development corp.
Nitric Oxide Releasing Solution (NORS) For The Treatment Of Human Papillomavirus(HPV) Verrucae Plantaris (Plantar Warts)	NCT05877313	Verruca Plantar...	Sterile water f... Nitric Oxide	12 Years -	Sanotize Research and Development corp.

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