WartsPhase 4NCT01712295
17% Salicylate Versus 17% Salicylate-Ethyl Pyruvate for Plantar Foot Warts
A Phase 4 study testing 17% Salicylate with ethyl pyruvate and Salicylates in people with Warts, run by Grossman, Michael, D.P.M. at 1 site in United States.
Trial summary
Plantar warts on the sole of the foot are among the most common warts seen in podiatry clinics. Some patients are readily cured by simple standard of care treatments that include wart debridement (trimming or excision) and application of 17% salicylate (commercially known as Compound W)or by other treatments that may… Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Warts
- What is being tested?
- 17% Salicylate with ethyl pyruvate and Salicylates
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Mar 2014
- Phase
- Phase 4
- 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- evidence of skin plantar wart(s)
Who cannot join
- iodine allergy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Main Line Foot and Ankle Center
Ardmore, Pennsylvania, 19003
Michael R Grossman, DPM, 610-645-6314, michaelrgrossman@hotmail.com
Michael R Grossman, DPM
About this study
Official title: New Formulation of Salicylate to Improve Treatment of Common Skin Warts
Plantar warts on the sole of the foot are among the most common warts seen in podiatry clinics. Some patients are readily cured by simple standard of care treatments that include wart debridement (trimming or excision) and application of 17% salicylate (commercially known as Compound W)or by other treatments that may be painful and affect mobility. No treatment is consistently effective and most patients fail treatment multiple times.
Ethyl pyruvate (EP)is a common food additive noted to be 'generally regarded as safe' that may improve the activity of salicylate in wart treatment by improving the ability to penetrate and/or persist in the skin. The use of 17% salicylate with the addition of EP may improve cures of common foot plantar warts in subjects who also be receiving other standard-of-care treatment.
- Conditions
- Warts
- Being tested
- 17% Salicylate with ethyl pyruvate, Salicylates
- Keywords
- Warts, salicylic acid, ethyl pyruvate
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
17% Salicylate with ethyl pyruvateDrug
Also called Compound W
SalicylatesDrug
| Study group | Role | What they receive |
|---|---|---|
| 17% Salicylate with Ethyl Pyruvate | Experimental | Subjects with plantar wart(s) will apply the product to warts twice a day for up to 16 weeks. Receives: Drug: 17% Salicylate with ethyl pyruvate |
| 17% salicylate | Active comparator | subjects will apply 17% salicylate (standard of care treatment) to plantar skin wart(s) twice a day for up to 16 weeks Receives: Drug: Salicylates |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if salicylate with ethyl pyruvate (SA-EP) eliminates plantar warts more quickly than salicylate (SA) alone.
Subjects' wart(s) are treated with SA or SA-EP every two weeks for up to 16 weeks.
Measured: 16 weeks
Secondary outcomes (1)
To determine if salicylate with ethyl pyruvate (SA-EP) in treatment of plantar warts causes adverse events other than those known to occur with SA (salicylate)alone.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2012 (estimated)
- Study startNov 2011
- Primary completionDec 2013 (estimated)
- Study completionMar 2014 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grossman, Michael, D.P.M.
- Collaborators
- Main Line Health
- Responsible party
- Sponsor
- Investigators
- Michael R Grossman, DPM, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01712295
- Sponsor's protocol ID
- R12-3128
- Status last verified
- Oct 2012
- First submitted
- 19 Oct 2012
- Last updated
- 23 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Formulation of Salicylate to Improve Treatment of Common Skin Warts
- ClinicalTrials.gov ID
- NCT01712295
- Acronym / sponsor ID
- R12-3128
- Conditions
- Warts
- Keywords
- Warts, salicylic acid, ethyl pyruvate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Grossman, Michael, D.P.M.
- Collaborators
- Main Line Health
- Study start
- Nov 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 23 Oct 2012 (estimated)
- 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.
Plantar warts on the sole of the foot are among the most common warts seen in podiatry clinics. Some patients are readily cured by simple standard of care treatments that include wart debridement (trimming or excision) and application of 17% salicylate (commercially known as Compound W)or by other treatments that may be painful and affect mobility. No treatment is consistently effective and most patients fail treatment multiple times.
Ethyl pyruvate (EP)is a common food additive noted to be 'generally regarded as safe' that may improve the activity of salicylate in wart treatment by improving the ability to penetrate and/or persist in the skin. The use of 17% salicylate with the addition of EP may improve cures of common foot plantar warts in subjects who also be receiving other standard-of-care treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 17% Salicylate with Ethyl Pyruvate | Experimental | Drug: 17% Salicylate with ethyl pyruvateSubjects with plantar wart(s) will apply the product to warts twice a day for up to 16 weeks. |
| 17% salicylate | Active comparator | Drug: Salicylatessubjects will apply 17% salicylate (standard of care treatment) to plantar skin wart(s) twice a day for up to 16 weeks |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- evidence of skin plantar wart(s)
Key exclusion criteria (1 listed)
- iodine allergy
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 |
|---|---|---|
| 17% Salicylate with ethyl pyruvateAlso: Compound W | Drug | 17% Salicylate with Ethyl Pyruvate |
| Salicylates | Drug | 17% salicylate |
Primary outcome
To determine if salicylate with ethyl pyruvate (SA-EP) eliminates plantar warts more quickly than salicylate (SA) alone.
Time frame: 16 weeks
Subjects' wart(s) are treated with SA or SA-EP every two weeks for up to 16 weeks.
1 secondary outcome
To determine if salicylate with ethyl pyruvate (SA-EP) in treatment of plantar warts causes adverse events other than those known to occur with SA (salicylate)alone.
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2012.
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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.
Michael R Grossman, DPM principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 17% Salicylate with ethyl pyruvate and Salicylates in people with Warts, run by Grossman, Michael, D.P.M. at 1 site 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 1 inclusion and 1 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 23 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Michael Grossman, DPM (610-645-6314, michaelrgrossman@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine if salicylate with ethyl pyruvate (SA-EP) eliminates plantar warts more quickly than salicylate (SA) alone. (time frame: 16 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 23 Oct 2012.