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OpenTrials
Completed

NCT Number: NCT00973856

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

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

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Key information

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PURELL VF481

Other

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

Placebo Solution

Other

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 outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Cleveland Clinic Akron General

Other

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Sep 9, 2009
Registry last updated
Jan 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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