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

NCT05877313 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-04-17

No results posted yet for this study

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

Interventions

OTHER

Sterile water foot bath

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

DRUG

Nitric Oxide

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.

Sponsors & Collaborators

  • Sanotize Research and Development corp.

    lead INDUSTRY

Principal Investigators

  • Keith Moore, PHARMMD · SaNOtize R&D Corp

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-02
Primary Completion
2024-02-01
Completion
2024-04-12

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05877313 on ClinicalTrials.gov