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Nitric Oxide Releasing Solution
Nitric Oxide Releasing Solution (NORS) for Plantar Warts
Phase 2
Waitlist Available
Research Sponsored by Sanotize Research and Development corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 35 days
Awards & highlights
Study Summary
This trial will test a topical treatment for plantar warts caused by HPV. Participants will receive the treatment for 21 days and be evaluated at the end.
Who is the study for?
This trial is for individuals aged 12 and older with three or more plantar warts. Participants must be in good health, not have been hospitalized recently, and agree to use contraception if applicable. Pregnant women, those trying to conceive, or with recent foot injuries are excluded.Check my eligibility
What is being tested?
The study tests a topical nitric oxide releasing solution (NORS) against placebo over 21 days to treat plantar warts caused by HPV. It's randomized and double-blinded; participants won't know if they're getting NORS at one of two doses or a placebo.See study design
What are the potential side effects?
Potential side effects may include local skin reactions at the application site such as redness, irritation, or discomfort due to the active ingredient or other components of the treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 35 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~35 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To evaluate the efficacy of NORS as a treatment for verrucae plantaris as measured by lesion clearance (Day 35).
Secondary outcome measures
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).
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.
To assess the safety and tolerability of NORS.
+1 moreOther outcome measures
Evaluate a dermatologic quality of life instrument.
Evaluate lesion clearance using an alternative assessment instrument.
Evaluate the distribution of HPV genotypes.
Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: Nitric Oxide Releasing Solution 1XActive Control1 Intervention
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
Group II: Nitric Oxide Releasing Solution 2XActive Control1 Intervention
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
Group III: Vehicle ControlPlacebo Group1 Intervention
Foot bath with sterile water delivered 3 times weekly (Mon, Wed, Fri)
500mL sterile water in a foot bath.
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Who is running the clinical trial?
Sanotize Research and Development corp.Lead Sponsor
8 Previous Clinical Trials
2,130 Total Patients Enrolled
Keith Moore, PHARMMDStudy DirectorSaNOtize R&D Corp
1 Previous Clinical Trials
10 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You recently had surgery or a wound on your foot within the past month.You have three or more warts on the bottom of your foot or feet.You are taking medications or have a condition that weakens your immune system.You have experienced nerve problems in the past.You are currently receiving treatment for plantar warts.
Research Study Groups:
This trial has the following groups:- Group 1: Nitric Oxide Releasing Solution 1X
- Group 2: Nitric Oxide Releasing Solution 2X
- Group 3: Vehicle Control
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the experiment currently open to recruitment?
"According to clinicaltrials.gov, enrollment for this trial is currently closed as of May 24th 2023-- it was originally posted on June 1st 2023. Nevertheless, there are still other active trials recruiting patients at present time."
Answered by AI
Are there any dangers associated with utilizing Nitric Oxide Releasing Solution 1X?
"Nitric Oxide Releasing Solution 1X was judged to be a level 2 in terms of safety, based on the Phase 2 trial data currently available. As such, there is some evidence that it is safe but no proof of efficacy yet."
Answered by AI
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