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

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanotize Research and Development corp.
• Treatments: Nitric Oxide

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.