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

NCT05877313 | Completed Phase 2

• 1 other identifier: HPV-Warts-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

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.

Conditions

Verruca Plantaris

Keywords

Plantar Warts; Warts; HPV

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of NORS as a treatment for verrucae plantaris as measured by lesion clearance (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

  35 Days

Secondary Outcomes (4)

• To assess the mean reduction in lesion dimensions as measured by the change in size from baseline observed at Day 7, 14, 21, 28 and 35.

  35 days

• To assess by mean changes in size of lesion as measured by area at Days 7, 14, 21, 28 and 35 and lesion clearance (Day 35).

  35 days

• To evaluate (median) time to pain reduction of lesion(s).

  35 days

• To assess the safety and tolerability of NORS.

  35 days

Other Outcomes (3)

• Evaluate the distribution of HPV genotypes.

  Baseline visit only

• Evaluate lesion clearance using an alternative assessment instrument.

  35 days

• Evaluate a dermatologic quality of life instrument.

  35 days

Study Arms (3)

Nitric Oxide Releasing Solution 1X

ACTIVE COMPARATOR

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

Drug: Nitric Oxide

Nitric Oxide Releasing Solution 2X

ACTIVE COMPARATOR

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

Drug: Nitric Oxide

Vehicle Control

PLACEBO COMPARATOR

Foot bath with sterile water delivered 3 times weekly (Mon, Wed, Fri) 500mL sterile water in a foot bath.

Other: Sterile water foot bath

Interventions

Sterile water foot bath OTHER

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

Vehicle Control

Nitric Oxide DRUG

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.

Also known as: Nitric Oxide Releasing Solution (NORS)

Nitric Oxide Releasing Solution 1X; Nitric Oxide Releasing Solution 2X

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 12 years old at the time of consent.
• Three or more plantar warts (single foot, or both feet).
• If female, be surgically sterile or post-menopausal (no menses for at least 12 months), or if of childbearing potential, must be using an acceptable method of contraception such as a combination estrogen/progestin hormonal contraceptive (oral or injected) for at least 1 month prior to Day 1, or such items as an intrauterine device (IUD), intrauterine system (IUS), transdermal hormonal implant, vaginal hormonal ring, or 2 forms of the following: diaphragm, cervical cap, patch, condom, spermicide, or sponge. Total abstinence is permitted. Local requirements will apply if local regulations deviate from the previously listed contraception methods to prevent pregnancy. In addition, females of childbearing potential must agree to continue to use their method of birth control for the duration of the study.
• If male, be surgically sterile, or agree to use appropriate contraception (latex condom with spermicide) when engaging in sexual activity and agree not to donate sperm for the duration of the study.
• Be in good health (i.e., no acute illnesses or hospitalizations within 30 days of the study start, no planned procedures during study participation, and no newly diagnosed chronic illnesses that are not deemed stable by the participant's primary care physician), in the opinion of the Investigator, based on medical history (i.e., absence of any clinically relevant abnormality) during Screening.
• Be able to understand and provide written informed consent.
• Must be willing and able to manage the self-treatment and attend on-site study visits.

You may not qualify if:

• Participants with acute illnesses or hospitalizations within 30 days of the study start, and/or planned procedures during study participation, and/or newly diagnosed chronic illnesses that are not deemed stable by the participant's primary care physician), based on Investigator assessment of medical history during Screening.
• Participants who are currently in another trial for the treatment of warts.
• Participants with any unhealed or newly obtained infection, wound, injury, or lesion on the foot the month prior to Screening.
• Participants who are immunosuppressed, immunodeficient, or are receiving any form of immunosuppression drug.
• Participants with any prior history of neuropathy.
• Participants who are receiving concomitant treatment of plantar warts (involving any form of therapy).
• Females who are breastfeeding, pregnant, or attempting to become pregnant.
• Participants who have conditions that participation is not in their best interest, i.e., hypersensitivity to the product's ingredients.
• Participants with a recent ulcer, tumor, or surgery performed on their foot within the previous month.
• Participants whose participation in the study, in the opinion of the Investigator, have a condition that would interfere with their ability to adhere to the protocol (e.g., participants who are mentally or neurologically disabled and who are considered not fit to participate in the study), interfere with the assessment of the investigational product, or compromise the safety of the participant or the quality of the data.

Sponsors & Collaborators

• Sanotize Research and Development corp.: lead

Study Sites (3)

Achilles Foot Health Centre

Surrey, British Columbia, V3R 1J7, Canada

Location

Spectrum Health

Vancouver, British Columbia, V5Z 2T1, Canada

Location

Pacific Derm

Vancouver, British Columbia, V6H 4E1, Canada

Location

Related Publications (1)

• Schumacher SA, Dugom L, Martins J, Leemhuis J, Teskey SJL, Moore K, Miller CC. Efficacy and safety of a topical nitric oxide-releasing solution (NORS) as a noninvasive treatment for plantar warts (verrucae plantaris). J Dermatolog Treat. 2026 Dec;37(1):2610918. doi: 10.1080/09546634.2025.2610918. Epub 2026 Jan 6.

  PMID: 41493215 DERIVED

MeSH Terms

Conditions

Warts

Interventions

Nitric Oxide

Condition Hierarchy (Ancestors)

Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals

Study Officials

• Keith Moore, PHARMMD

  SaNOtize R&D Corp

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2023
• First Posted: May 26, 2023
• Study Start: August 2, 2023
• Primary Completion: February 1, 2024
• Study Completion: April 12, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)