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

• Sponsor: Akron General Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00973856
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arms: 2
• Duration (Months): 28
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The objective is to conduct a pilot study to determine the effectiveness of PURELL VF481 to treat warts located on the hands.

Condition or Disease	Intervention/Treatment	Phase
Papillomavirus Infections; Warts; Condylomata Acuminata; Epidermodysplasia Verruciformis	Other: PURELL VF481; Other: Placebo Solution	N/A

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

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Effectiveness of an Alcohol Based Hand Gel for the Reduction of Warts on the Hands
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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; 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 Names: PURELL VF481 alcohol based hand gel ; Other: Placebo 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
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; 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 Names: PURELL VF481 alcohol based hand gel ; Other: Placebo 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

Outcome Measures

Primary Outcome Measures

1. Difference in % Reduction in Wart Size Between Product A and Product B at Each Timepoint [Baseline, 4, 8, and 12 weeks, change at 12 weeks reported]

   Data is not available due to study closure and data destruction

Secondary Outcome Measures

1. Change in Size of Warts Treated by Each Product at Each Time Point. [Baseline, 4, 8 and 12 weeks, change at 12 weeks reported]

   Data is not available due to study closure and data destruction

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: 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:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Akron Dermatology	Akron	Ohio	United States	44307

Sponsors and Collaborators

• Akron General Medical Center

Investigators

• Principal Investigator: Eliot Mostow, M.D>, Akron General Medical Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Akron General Medical Center

Publications

None provided.

• Responsible Party: Akron General Medical Center
• ClinicalTrials.gov Identifier: NCT00973856
• Other Study ID Numbers: 09025
• First Posted: Sep 9, 2009
• Last Update Posted: Jan 27, 2021
• Last Verified: Jan 1, 2021

• Additional relevant MeSH terms: Warts; Papillomavirus Infections; Epidermodysplasia Verruciformis

Study Results

Participant Flow

Pre-assignment Detail	There were no pre-assignment details. Once consented, pts were enrolled into both study arms.

Arm/Group Title	PURELL VF481 Left Hand/ Placebo Right Hand	Placebo Solution Left Hand/ PURELL VF481 Right Hand
Arm/Group Description	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 PURELL 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	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 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 Comparator: 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
Period Title: Overall Study
STARTED	3	2
COMPLETED	3	2
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	PURELL VF481 Left Hand/ Placebo Right Hand	Placebo Solution Left Hand/ PURELL VF481 Right Hand	Total
Arm/Group Description	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 PURELL 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	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 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 Comparator: 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	Total of all reporting groups
Overall Participants	3	2	5
Overall warts	5	5	10
Age (warts) [Count of Units]
<=18 years	0	0	0
Between 18 and 65 years	5	5	10
>=65 years	0	0	0
Sex/Gender, Customized (warts) [Count of Units]
Sex/Gender unspecified	5	5	10
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	5 166.7%	5 250%	10 200%

Outcome Measures

1. Primary Outcome

Title	Difference in % Reduction in Wart Size Between Product A and Product B at Each Timepoint
Description	Data is not available due to study closure and data destruction
Time Frame	Baseline, 4, 8, and 12 weeks, change at 12 weeks reported

Outcome Measure Data

Analysis Population Description

Data is not available due to study closure and data destruction

Arm/Group Title	Purell VF481
Arm/Group Description	Active Ingredient: 70% ethanol
Measure Participants	0
Measure wart reduction %	0

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	2 years
Adverse Event Reporting Description	Same definition
Arm/Group Title	Purell VF481		Placebo
Arm/Group Description	Active Ingredient: 70% ethanol		15% alcohol formulation that aesthetically resembles VF481
All Cause Mortality
	Purell VF481		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/5 (0%)
Serious Adverse Events
	Purell VF481		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/5 (0%)
Other (Not Including Serious) Adverse Events
	Purell VF481		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/5 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.