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

Primary Purpose

Papillomavirus Infections, Warts, Condylomata Acuminata

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PURELL VF481
Placebo Solution
Sponsored by
Cleveland Clinic Akron General
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Papillomavirus Infections

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Akron Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PURELL Left Hand/ Placebo Right Hand

Placebo Solution Left Hand/ PURELL Right hand

Arm Description

One product will be assigned to each hand to minimize treatment confusion for the participants. PURELL VF481 Left Hand/ Placebo 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Size of Warts Treated by Each Product at Each Time Point.
Data is not available due to study closure and data destruction

Full Information

First Posted
September 8, 2009
Last Updated
January 3, 2023
Sponsor
Cleveland Clinic Akron General
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1. Study Identification

Unique Protocol Identification Number
NCT00973856
Brief Title
Evaluation of the Effectiveness of an Alcohol Based Hand Gel for the Reduction of Warts on the Hands
Official Title
Evaluation of the Effectiveness of an Alcohol Based Hand Gel for the Reduction of Warts on the Hands
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cleveland Clinic Akron General

4. Oversight

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papillomavirus Infections, Warts, Condylomata Acuminata, Epidermodysplasia Verruciformis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PURELL Left Hand/ Placebo Right Hand
Arm Type
Experimental
Arm Description
One product will be assigned to each hand to minimize treatment confusion for the participants. PURELL VF481 Left Hand/ Placebo Right Hand
Arm Title
Placebo Solution Left Hand/ PURELL Right hand
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
PURELL VF481
Other Intervention Name(s)
PURELL VF481 alcohol based hand gel
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Placebo Solution
Intervention Description
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
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eliot Mostow, M.D>
Organizational Affiliation
Cleveland Clinic Akron General
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akron Dermatology
City
Akron
State/Province
Ohio
ZIP/Postal Code
44307
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.akrongeneral.org
Description
Akron General Medical Center

Learn more about this trial

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

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