WartsPhase 2NCT04253912
Topical 2% Povidone-Iodine Gel in Verruca Vulgaris
A Phase 2 study testing VBP-245 in people with Warts, run by Veloce BioPharma LLC at 7 sites in United States.
Trial summary
This is a multi-center, randomized, double-blind, placebo-controlled phase 2 study in subjects 8 years of age and older who present with verruca vulgaris (common warts) and desire treatment. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Warts
- What is being tested?
- VBP-245
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 7 sitesUnited States
- Study dates
- 12 Feb 2020to Apr 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject is able to comprehend and is willing to sign an informed consent/assent for participation in this study.
- Male or female ≥ 8 years old.
- Subject has a clinical diagnosis of verruca vulgaris (common warts).
- Subject has up to 6 warts located on the trunk or extremities
Who cannot join
- Subject has clinically atypical warts on the trunk or extremities.
- Subject is immunocompromised (e.g., due to chemotherapy, systemic steroids, genetic immunodeficiency, transplant status, etc.)
- Subject has periungual, subungual, genital, anal, mosaic, plantar, flat, or filiform wart identified as a wart for study treatment.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Veloce BioPharma Clinical Trial Site
Arlington, Virginia, 22209
Veloce BioPharma Clinical Trial Site
Fort Mill, South Carolina, 29708
Veloce BioPharma Clinical Trial Site
Hunt Valley, Maryland, 21030
Veloce BioPharma Clinical Trial Site
Lynchburg, Virginia, 24501
Veloce BioPharma Clinical Trial Site
Plymouth Meeting, Pennsylvania, 19462
Veloce BioPharma Clinical Trial Site
Sugarloaf, Pennsylvania, 18429
Veloce BioPharma Clinical Trial Site
Upper Saint Clair, Pennsylvania, 15241
About this study
Official title: A Phase 2, Double-Blind, Randomized, Parallel Group, Placebo-Controlled, Study to Evaluate Topical 2% Povidone-Iodine Gel (VBP-245) in Subjects With Verruca Vulgaris
This is a multi-center, randomized, double-blind, placebo-controlled phase 2 study in subjects 8 years of age and older who present with verruca vulgaris (common warts) and desire treatment. Subjects may have up to a total of 6 common warts located on their trunk or extremities that will be treated with study medication and followed throughout the study protocol therapy. All warts will be treated two times per day (BID) for12 weeks. Approximately 90 subjects will be enrolled in this study.
- Conditions
- Warts
- Being tested
- VBP-245, Placebo Gel (no Povidone-Iodine)
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VBP-245Drug
2% Povidone-Iodine Gel
Placebo Gel (no Povidone-Iodine)Drug
Placebo Gel (no Povidone-Iodine)
| Study group | Role | What they receive |
|---|---|---|
| VBP-245 | Experimental | Topical 2% Povidone-Iodine Gel Receives: Drug: VBP-245 |
| Control | Placebo comparator | Placebo Gel (no Povidone-Iodine) Receives: Drug: Placebo Gel (no Povidone-Iodine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in wart diameter (mm)
Measured: 12 weeks
Secondary outcomes (2)
Resolution of wart
Wart diameter = 0 mm
Measured: 12 weeks
Application Site Reaction Adverse Events
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start12 Feb 2020
- Primary completion5 Jan 2021
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WartsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veloce BioPharma LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samuel Barone, MD, Study director, Veloce BioPharma LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253912
- Sponsor's protocol ID
- VBP-245-WART2A
- Status last verified
- Mar 2021
- First submitted
- 31 Jan 2020
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Aggregate data will be shared with study investigators.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-Blind, Randomized, Parallel Group, Placebo-Controlled, Study to Evaluate Topical 2% Povidone-Iodine Gel (VBP-245) in Subjects With Verruca Vulgaris
- ClinicalTrials.gov ID
- NCT04253912
- Acronym / sponsor ID
- VBP-245-WART2A
- Conditions
- Warts
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Veloce BioPharma LLCIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 5 Jan 2021 (actual)
- Study completion
- Apr 2021 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, randomized, double-blind, placebo-controlled phase 2 study in subjects 8 years of age and older who present with verruca vulgaris (common warts) and desire treatment. Subjects may have up to a total of 6 common warts located on their trunk or extremities that will be treated with study medication and followed throughout the study protocol therapy. All warts will be treated two times per day (BID) for12 weeks. Approximately 90 subjects will be enrolled in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VBP-245 | Experimental | Drug: VBP-245Topical 2% Povidone-Iodine Gel |
| Control | Placebo comparator | Drug: Placebo Gel (no Povidone-Iodine)Placebo Gel (no Povidone-Iodine) |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is able to comprehend and is willing to sign an informed consent/assent for participation in this study.
- Male or female ≥ 8 years old.
- Subject has a clinical diagnosis of verruca vulgaris (common warts).
- Subject has up to 6 warts located on the trunk or extremities
Key exclusion criteria (3 listed)
- Subject has clinically atypical warts on the trunk or extremities.
- Subject is immunocompromised (e.g., due to chemotherapy, systemic steroids, genetic immunodeficiency, transplant status, etc.)
- Subject has periungual, subungual, genital, anal, mosaic, plantar, flat, or filiform wart identified as a wart for study treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VBP-2452% Povidone-Iodine Gel | Drug | VBP-245 |
| Placebo Gel (no Povidone-Iodine)Placebo Gel (no Povidone-Iodine) | Drug | Control |
Primary outcome
Decrease in wart diameter (mm)
Time frame: 12 weeks
2 secondary outcomes
Resolution of wart
Time frame: 12 weeks
Application Site Reaction Adverse Events
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Individual participant dataSharing planned: Undecided. Aggregate data will be shared with study investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Barone, MD study director
Veloce BioPharma LLC
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VBP-245 in people with Warts, run by Veloce BioPharma LLC at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in wart diameter (mm) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.