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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject is a male or non-pregnant female, 18 to 65 years of age
Females must be post-menopausal, surgically sterile, or use an effective method of birth control. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at Visit 1/Baseline
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 22, 43, 64, 85, 106, and 134
Awards & highlights
Study Summary
This trial tests a new patch to treat verruca vulgaris, comparing two strengths to a control patch, to see if it's safe and effective.
Who is the study for?
This trial is for adults aged 18-65 with 1 to 8 common warts. Participants must be in good health, not pregnant, and willing to follow the study plan including telehealth visits. They can't have used certain wart treatments recently or be on immunosuppressive therapy, and they shouldn't have a history of significant eye inflammation or active cancer (except non-melanoma skin cancer).Check my eligibility
What is being tested?
The trial tests two doses of VDMN-21 Patch against a placebo patch to see if they're safe and effective for treating common warts. Participants will receive repeated treatment sessions with one of these patches.See study design
What are the potential side effects?
While specific side effects are not listed here, participants may experience reactions at the site where the patch is applied such as redness, itching, or irritation. Systemic side effects could occur depending on how the body absorbs ingredients from the patch.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old and not pregnant.
Select...
I am a woman who cannot become pregnant or am using birth control and have a negative pregnancy test.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 22, 43, 64, 85, 106, and 134
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 22, 43, 64, 85, 106, and 134
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of subjects with complete clinical resolution of the Target Lesion at end of treatment period
Other outcome measures
Proportion of subjects with complete clinical resolution of Target Lesion by visit
Proportion of subjects with complete clinical resolution of all the Non-Target Lesion(s) by visit
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment Group B (High Dose)Experimental Treatment1 Intervention
High does patch will be applied adjacent to the target wart and remain in place for 5 minutes then removed. There may be up to 6 treatments (approximately 1 per month).
Group II: Treatment Group A (Low Dose)Experimental Treatment1 Intervention
Low does patch will be applied adjacent to the target wart and remain in place for 5 minutes then removed. There may be up to 6 treatments (approximately 1 per month).
Group III: Treatment Group C (Vehicle)Placebo Group1 Intervention
Vehicle patch will be applied adjacent to the target wart and remain in place for 5 minutes then removed. There may be up to 6 treatments (approximately 1 per month).
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Who is running the clinical trial?
Veradermics, Inc.Lead Sponsor
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had specific treatments on my lesion for set periods before the study.I have had serious eye inflammation, like uveitis.I am in good health and have no conditions that would risk my safety in the study.I am between 18 and 65 years old and not pregnant.I am not currently being treated for any cancer except nonmelanoma skin cancer.I've had 3 or more treatments for my specific cancer area without it getting better.I have received an HPV vaccine in the last 24 weeks.I have taken or will take zinc or cimetidine within 30 days before joining the study or during it.I have a significant autoimmune condition or am immunocompromised, but I can use certain corticosteroids.I haven't taken any immune-weakening drugs like steroids or chemotherapy in the last 4 weeks.I have between 1 and 8 common warts.I am a woman who cannot become pregnant or am using birth control and have a negative pregnancy test.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Group A (Low Dose)
- Group 2: Treatment Group B (High Dose)
- Group 3: Treatment Group C (Vehicle)
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.
Does the selection criteria for this research encompass adults aged 25 and above?
"To apply for this medical trial, participants must be within the 18-65 years old age bracket."
Answered by AI
Is it possible to be included in this medical trial?
"To be eligible for participation in this clinical trial, individuals must display warts and fall within the age range of 18 to 65 years old. The research team is aiming to recruit 150 participants."
Answered by AI
Are there multiple locales running this experiment in the same state?
"Currently, 6 different clinical sites are enrolling participants in this trial. Among them are Anderson's Site 01, Greenville's Site 06 and Arlington's Site 03. Other cities involved include 3 other locations."
Answered by AI
Has the Low Dose Treatment Group A obtained regulatory approval from the FDA?
"Our experts have determined that Treatment Group A (Low Dose) is likely safe, rating it a 2 out of 3 due to the lack of data regarding efficacy despite the presence of studies on safety."
Answered by AI
How many participants are actively engaged in this clinical experiment?
"Veradermics, Inc. is the sponsor for this trial and needs 150 eligible participants to complete it successfully; Anderson, South carolina (Site 01) and Greenville, Texas (Site 06) are two of their many operating locations."
Answered by AI
Does the study have any slots available for new participants?
"Indeed, the clinicaltrials.gov website attests that this trial is currently enrolling volunteers: 150 individuals from six sites need to be recruited for study participation. The initial posting date was February 28th 2023 with a recent update on March 22nd of the same year."
Answered by AI
Who else is applying?
What site did they apply to?
Site 05
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I have attempted to treat warts for the past several years, but they have kept coming back.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
what is the time committment?
PatientReceived no prior treatments
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