Plantar WartPhase 2/3NCT02151630
Pyruvic Acid Versus Salicylic Acid Preparation in Treatment of Plantar Warts
A Phase 2/3 study testing Pyruvic acid and Salicylic Acid in people with Plantar Wart, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
Plantar warts can be bothersome and painful requiring treatment. The investigators will compare the efficacy of pyruvic acid and salicylic acid in treating multiple plantar warts. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Plantar Wart
- What is being tested?
- Pyruvic acid and Salicylic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- May 2014to Sep 2014
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- aged 12 years and above
- multiple warts (at least 2)
Who cannot join
- mosaic warts
- already under any treatment for warts
- pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Skin Diseases and Leishmaniasis Research Center
Isfahan, Isfahan
Fatima Assaf, M.D., 0098 913 0965384, dr.assafsaid@gmail.com
Fatima Assaf, M.D.
About this study
Official title: Comparison of 70% Pyruvic Acid Solution and Duofilm Solution in Treatment of Plantar Wart
Plantar warts can be bothersome and painful requiring treatment. The investigators will compare the efficacy of pyruvic acid and salicylic acid in treating multiple plantar warts. Patients with multiple plantar warts will be randomized to receive either pyruvic acid 70% or compound salicylic acid solution (salicylic acid 16.7%, lactic acid 16.7%, and collodion 100%) applying topically twice a day for 4 weeks. Patients will be visited every 2 weeks for one month after starting treatment and then every one month for up to 3 months. The number and size of warts will be evaluated.
- Conditions
- Plantar Wart
- Being tested
- Pyruvic acid, Salicylic Acid
- Keywords
- wart, verruca vulgaris, topical therapy, pyruvic acid, salicylic acid
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyruvic acidDrug
Salicylic AcidDrug
| Study group | Role | What they receive |
|---|---|---|
| Pyruvic acid | Active comparator | Patients will receive pyruvic acid solution 70% prepared by solving of pyruvic acid in water/ethanol solution. Patients will be advised to apply the solution twice daily for a period of four weeks. Application of petrolatum to the surrounding normal skin protects against the corrosive effect of the concentrated acid. Receives: Drug: Pyruvic acid |
| Salicylic acid | Active comparator | Patients will receive a combination of salicylic acid 16.7%, lactic acid 16.7%, and collodion 100%. Patients will be advised to apply the solution twice daily for a period of four weeks. Application of petrolatum to the surrounding normal skin protects against the corrosive effect of the concentrated acid. Receives: Drug: Salicylic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wart number
Patients will be visited every two weeks for one month and then every month for up to 3 months by a dermatologist. On each visit, warts will be inspected to determine the number of warts. Any wart totally non-detectable by inspection and touch will be considered as healed.
Measured: From before to 3 months after
Wart size
Patients will be visited every two weeks for one month and then every month for up to 3 months by a dermatologist. On each visit, warts will be inspected to determine the size of warts. The size of the warts will be calculated as the mean size of all the warts.
Measured: From before to 3 months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startMay 2014
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plantar WartStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatima Assaf, Isfahan University of Medical Sciences
- Investigators
- Fatima Assaf, M.D., Principal investigator, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151630
- Sponsor's protocol ID
- 393219
- Status last verified
- May 2014
- First submitted
- 28 May 2014
- Last updated
- 30 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kwok CS, Holland R, Gibbs S. Efficacy of topical treatments for cutaneous warts: a meta-analysis and pooled analysis of randomized controlled trials. Br J Dermatol. 2011 Aug;165(2):233-46. doi: 10.1111/j.1365-2133.2011.10218.x. Epub 2011 May 26.
PubMed 21219294
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 70% Pyruvic Acid Solution and Duofilm Solution in Treatment of Plantar Wart
- ClinicalTrials.gov ID
- NCT02151630
- Acronym / sponsor ID
- 393219
- Conditions
- Plantar Wart
- Keywords
- wart, verruca vulgaris, topical therapy, pyruvic acid, salicylic acid
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 30 May 2014 (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 can be bothersome and painful requiring treatment. The investigators will compare the efficacy of pyruvic acid and salicylic acid in treating multiple plantar warts. Patients with multiple plantar warts will be randomized to receive either pyruvic acid 70% or compound salicylic acid solution (salicylic acid 16.7%, lactic acid 16.7%, and collodion 100%) applying topically twice a day for 4 weeks. Patients will be visited every 2 weeks for one month after starting treatment and then every one month for up to 3 months. The number and size of warts will be evaluated.
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 |
|---|---|---|
| Pyruvic acid | Active comparator | Drug: Pyruvic acidPatients will receive pyruvic acid solution 70% prepared by solving of pyruvic acid in water/ethanol solution. Patients will be advised to apply the solution twice daily for a period of four weeks. Application of petrolatum to the surrounding normal skin protects against the corrosive effect of the concentrated acid. |
| Salicylic acid | Active comparator | Drug: Salicylic AcidPatients will receive a combination of salicylic acid 16.7%, lactic acid 16.7%, and collodion 100%. Patients will be advised to apply the solution twice daily for a period of four weeks. Application of petrolatum to the surrounding normal skin protects against the corrosive effect of the concentrated acid. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- aged 12 years and above
- multiple warts (at least 2)
Key exclusion criteria (3 listed)
- mosaic warts
- already under any treatment for warts
- pregnant or lactating women
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 |
|---|---|---|
| Pyruvic acid | Drug | Pyruvic acid |
| Salicylic Acid | Drug | Salicylic acid |
Primary outcome
Wart number
Time frame: From before to 3 months after
Patients will be visited every two weeks for one month and then every month for up to 3 months by a dermatologist. On each visit, warts will be inspected to determine the number of warts. Any wart totally non-detectable by inspection and touch will be considered as healed.
Wart size
Time frame: From before to 3 months after
Patients will be visited every two weeks for one month and then every month for up to 3 months by a dermatologist. On each visit, warts will be inspected to determine the size of warts. The size of the warts will be calculated as the mean size of all the warts.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2014.
- Background: PubMed 21219294Kwok CS, Holland R, Gibbs S. Efficacy of topical treatments for cutaneous warts: a meta-analysis and pooled analysis of randomized controlled trials. Br J Dermatol. 2011 Aug;165(2):233-46. doi: 10.1111/j.1365-2133.2011.10218.x. Epub 2011 May 26.
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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.
Fatima Assaf, M.D. principal investigator
Isfahan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pyruvic acid and Salicylic Acid in people with Plantar Wart, run by Isfahan University of Medical Sciences at 1 site in Iran.
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 2 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 30 May 2014. 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 Iran. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Fatima Assaf, M.D. (0098 913 0965384, dr.assafsaid@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wart number (time frame: From before to 3 months after). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02151630, which also lists 1 linked publication.
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 30 May 2014.