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

January 3, 2023 updated by: Akron General Medical Center
The objective is to conduct a pilot study to determine the effectiveness of PURELL VF481 to treat warts located on the hands.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Akron, Ohio, United States, 44307
        • Akron Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 4, 8, and 12 weeks, change at 12 weeks reported

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Data is not available due to study closure and data destruction
Baseline, 4, 8 and 12 weeks, change at 12 weeks reported

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akron General Medical Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

September 8, 2009

First Submitted That Met QC Criteria

September 8, 2009

First Posted (ESTIMATE)

September 9, 2009

Study Record Updates

Last Update Posted (ACTUAL)

January 31, 2023

Last Update Submitted That Met QC Criteria

January 3, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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