CompletedNCT00973856Updated Jan 31, 2023Results posted

Evaluation of the Effectiveness of an Alcohol Based Hand Gel for the Reduction of Warts on the Hands

An interventional study of PURELL VF481 and Placebo Solution in Papillomavirus Infections, Warts and Condylomata Acuminata, sponsored by Cleveland Clinic Akron General. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-01-31.

Sponsored by Cleveland Clinic Akron General · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 5
Allocation: Non-randomized
Ages: 18 Years to 75 Years
Sex: All

Study summary

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

Conditions studied

Papillomavirus Infections
Warts
Condylomata Acuminata
Epidermodysplasia Verruciformis

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In context

Warts

180 studies on the registry are indexed under Warts; 28 are open to participants now.

This study's enrollment of 5 is below the median of 70 across 159 interventional studies indexed under Warts.

Browse Warts studies →

Lead sponsor

Cleveland Clinic Akron General is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 5 participants (actual)

Study arms

Experimental
PURELL Left Hand/ Placebo Right Hand
One product will be assigned to each hand to minimize treatment confusion for the participants. PURELL VF481 Left Hand/ Placebo Right Hand
Other: PURELL VF481 · Other: Placebo Solution
Placebo comparator
Placebo Solution Left Hand/ PURELL Right hand
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
Other: PURELL VF481 · Other: Placebo Solution

Interventions

OtherPURELL VF481
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
Also known as: PURELL VF481 alcohol based hand gel
OtherPlacebo Solution
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

What researchers measure

Primary outcomes

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
Time frame: Baseline, 4, 8, and 12 weeks, change at 12 weeks reported

Secondary outcomes

Change in Size of Warts Treated by Each Product at Each Time Point.
Data is not available due to study closure and data destruction
Time frame: Baseline, 4, 8 and 12 weeks, change at 12 weeks reported

Results

Posted Jul 2, 2019

Participant flow

Participant flow — Overall Study
Milestone	PURELL VF481 Left Hand/ Placebo Right Hand	Placebo Solution Left Hand/ PURELL VF481 Right Hand
Started	3	2
Completed	3	2
Not completed	0	0

Outcome measures

PrimaryDifference 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

Time frame:: Baseline, 4, 8, and 12 weeks, change at 12 weeks reported

No measurements were reported for this outcome.

SecondaryChange in Size of Warts Treated by Each Product at Each Time Point.

Data is not available due to study closure and data destruction

Time frame:: Baseline, 4, 8 and 12 weeks, change at 12 weeks reported

No measurements were reported for this outcome.

Adverse events

Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Purell VF481	0/5 (0%)	0/5 (0%)	0/5 (0%)
Placebo	0/5 (0%)	0/5 (0%)	0/5 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(warts)	PURELL VF481 Left Hand/ Placebo Right Hand	Placebo Solution Left Hand/ PURELL VF481 Right Hand	Total
<=18 years	0	0	0
Between 18 and 65 years	5	5	10
>=65 years	0	0	0

Sex/Gender, Customized
Sex/Gender, Customized(warts)	PURELL VF481 Left Hand/ Placebo Right Hand	Placebo Solution Left Hand/ PURELL VF481 Right Hand	Total
Sex/Gender unspecified	5	5	10

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	PURELL VF481 Left Hand/ Placebo Right Hand	Placebo Solution Left Hand/ PURELL VF481 Right Hand	Total
Count of participants	—	—	0

Region of Enrollment
Region of Enrollment(participants)	PURELL VF481 Left Hand/ Placebo Right Hand	Placebo Solution Left Hand/ PURELL VF481 Right Hand	Total
United States	5	5	10

Study locations

1 site

Akron Dermatology
Akron, Ohio 44307, United States

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00973856
Lead sponsor: Cleveland Clinic Akron General
Responsible party: Sponsor
First posted: Sep 9, 2009
Start date: Sep 2009
Primary completion: Dec 2011
Completion: Jan 2012
Results posted: Jul 2, 2019
Last update: Jan 31, 2023

Study contacts

Eliot Mostow, M.D>

principal investigator · Cleveland Clinic Akron General

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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