Papillomavirus InfectionsNCT00973856
Evaluation of the Effectiveness of an Alcohol Based Hand Gel for the Reduction of Warts on the Hands
A study testing PURELL VF481 in people with Papillomavirus Infections and Warts, run by Cleveland Clinic Akron General at 1 site in United States.
Trial summary
The objective is to conduct a pilot study to determine the effectiveness of PURELL VF481 to treat warts located on the hands. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Papillomavirus Infections, Warts, Condylomata Acuminata
- What is being tested?
- PURELL VF481
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jan 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with 2+ warts being seen at a Dermatologist's office
- 2 or more warts on the hands that are located at least 1 cm apart or on separate fingers
- Warts must have been present for at least 2 months
- Wart size must be between 2 mm-15 mm in diameter
- Participants must be in good general health
- Participants must be able to speak and read in English.
- Participant must be able to read and sign participant instruction sheet, and informed consent and authorization.
- Subjects must be able to understand and execute the instructions presented in pictorial form.
Who cannot join
- Pregnancy (Patients will be asked to verify using criteria of contraception, menstrual cycle, and pregnancy test, if necessary).
- Treatment of warts with other methods such as salicylic acid, etc., in the past 14 days.
- Known allergies to common topical antimicrobials or the individual ingredients in either test product.
- Participation in a clinical study in the past 7 days or participation in another clinical study
- Unwillingness to perform requirements of the study
- Any medical condition that should preclude participation in the study, at the discretion of the physician
- Missed ≥ 6 of the treatments in a 4 week study period
Trial locations and contacts
1 site in 1 country.
About this study
The objective is to conduct a pilot study to determine the effectiveness of PURELL VF481 to treat warts located on the hands.
Read the detailed description
- At least 5, but not more than 20 participants will be enrolled in the study.
- Each wart is randomly assigned a test product prior to the start of the study
- Warts are equally distributed between products so that an equal number of warts treated on each person. One (1) product will be assigned to each hand to minimize treatment confusion for the participants
- The test product will be applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage.
- Subjects will log date and time of application and anything notable (such as changes in wart appearance or missed dose) in a log book.
- Measurement of wart (longest diameter) and photos taken at each visit by trained office medical assistants, LPNs, PA-C or MD.
- Time points for office visitation: Baseline (0 weeks), 4 weeks, 8 weeks, 12 weeks
- Being tested
- PURELL VF481, Placebo Solution
- Medical subject headings
- Papillomavirus Infections, Warts, Condylomata Acuminata, Epidermodysplasia Verruciformis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PURELL VF481Other
Also called PURELL VF481 alcohol based hand gel
One (1) pump of test product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed
Placebo SolutionOther
One (1) pump of product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed
| Study group | Role | What they receive |
|---|---|---|
| PURELL Left Hand/ Placebo Right Hand | Experimental | One product will be assigned to each hand to minimize treatment confusion for the participants.
PURELL VF481 Left Hand/ Placebo Right Hand Receives: Other: PURELL VF481; Other: Placebo Solution |
| Placebo Solution Left Hand/ PURELL Right hand | Placebo comparator | One (1) product will be assigned to each hand to minimize treatment confusion for the participants PURELL VF481 Right Hand/ Placebo Left Hand
One (1) pump of test product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed Receives: Other: PURELL VF481; Other: Placebo Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in % Reduction in Wart Size Between Product A and Product B at Each Timepoint
Data is not available due to study closure and data destruction
Measured: Baseline, 4, 8, and 12 weeks, change at 12 weeks reported
Secondary outcomes (1)
Change in Size of Warts Treated by Each Product at Each Time Point.
Data is not available due to study closure and data destruction
Measured: Baseline, 4, 8 and 12 weeks, change at 12 weeks reported
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Papillomavirus InfectionsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cleveland Clinic Akron General
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eliot Mostow, M.D>, Principal investigator, Cleveland Clinic Akron General
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00973856
- Sponsor's protocol ID
- 09025
- Status last verified
- Jan 2023
- First submitted
- 8 Sep 2009
- Last updated
- 31 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of an Alcohol Based Hand Gel for the Reduction of Warts on the Hands
- ClinicalTrials.gov ID
- NCT00973856
- Acronym / sponsor ID
- 09025
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Cleveland Clinic Akron GeneralUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 9 Sep 2009 (estimated)
- Results
- Posted 2 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective is to conduct a pilot study to determine the effectiveness of PURELL VF481 to treat warts located on the hands.
Detailed description
- At least 5, but not more than 20 participants will be enrolled in the study.
- Each wart is randomly assigned a test product prior to the start of the study
- Warts are equally distributed between products so that an equal number of warts treated on each person. One (1) product will be assigned to each hand to minimize treatment confusion for the participants
- The test product will be applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage.
- Subjects will log date and time of application and anything notable (such as changes in wart appearance or missed dose) in a log book.
- Measurement of wart (longest diameter) and photos taken at each visit by trained office medical assistants, LPNs, PA-C or MD.
- Time points for office visitation: Baseline (0 weeks), 4 weeks, 8 weeks, 12 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PURELL Left Hand/ Placebo Right Hand | Experimental | Other: PURELL VF481, Other: Placebo SolutionOne product will be assigned to each hand to minimize treatment confusion for the participants. PURELL VF481 Left Hand/ Placebo Right Hand |
| Placebo Solution Left Hand/ PURELL Right hand | Placebo comparator | Other: PURELL VF481, Other: Placebo SolutionOne (1) product will be assigned to each hand to minimize treatment confusion for the participants PURELL VF481 Right Hand/ Placebo Left Hand One (1) pump of test product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with 2+ warts being seen at a Dermatologist's office
- 2 or more warts on the hands that are located at least 1 cm apart or on separate fingers
- Warts must have been present for at least 2 months
- Wart size must be between 2 mm-15 mm in diameter
- Participants must be in good general health
Key exclusion criteria (7 listed)
- Pregnancy (Patients will be asked to verify using criteria of contraception, menstrual cycle, and pregnancy test, if necessary).
- Treatment of warts with other methods such as salicylic acid, etc., in the past 14 days.
- Known allergies to common topical antimicrobials or the individual ingredients in either test product.
- Participation in a clinical study in the past 7 days or participation in another clinical study
- Unwillingness to perform requirements of the study
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 |
|---|---|---|
| PURELL VF481Also: PURELL VF481 alcohol based hand gelOne (1) pump of test product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed | Other | PURELL Left Hand/ Placebo Right Hand, Placebo Solution Left Hand/ PURELL Right hand |
| Placebo SolutionOne (1) pump of product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed | Other | PURELL Left Hand/ Placebo Right Hand, Placebo Solution Left Hand/ PURELL Right hand |
Primary outcome
Difference in % Reduction in Wart Size Between Product A and Product B at Each Timepoint
Time frame: Baseline, 4, 8, and 12 weeks, change at 12 weeks reported
Data is not available due to study closure and data destruction
1 secondary outcome
Change in Size of Warts Treated by Each Product at Each Time Point.
Time frame: Baseline, 4, 8 and 12 weeks, change at 12 weeks reported
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Akron General Medical CenterLink provided by the sponsor.
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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.
Eliot Mostow, M.D> principal investigator
Cleveland Clinic Akron General
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PURELL VF481 in people with Papillomavirus Infections and Warts, run by Cleveland Clinic Akron General 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 8 inclusion and 7 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: finished, as of the sponsor's last update on 31 Jan 2023. 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. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Difference in % Reduction in Wart Size Between Product A and Product B at Each Timepoint (time frame: Baseline, 4, 8, and 12 weeks, change at 12 weeks reported). 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 31 Jan 2023.