Nitric Oxide Releasing Solution (NORS) For The Treatment Of Human Papillomavirus(HPV) Verrucae Pl… (NCT05877313) | Clinical Trial Compass
CompletedPhase 2
Nitric Oxide Releasing Solution (NORS) For The Treatment Of Human Papillomavirus(HPV) Verrucae Plantaris (Plantar Warts)
Canada20 participantsStarted 2023-08-02
Plain-language 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.
Who can participate
Age range12 Years
SexALL
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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…
What they're measuring
1
To evaluate the efficacy of NORS as a treatment for verrucae plantaris as measured by lesion clearance (Day 35).