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

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

Detailed Description
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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

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

Conditions
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Papillomavirus Infections, Warts, Condylomata Acuminata, Epidermodysplasia Verruciformis

Intervention / Treatment
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* Other: PURELL VF481
* Other: Placebo Solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PURELL Left Hand/ Placebo Right Hand<br>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<br>* 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<br>* Other names: PURELL VF481 alcohol based hand gel;Other: Placebo Solution<br>* 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<br>|
| Placebo Comparator: Placebo Solution Left Hand/ PURELL Right hand<br>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<br>* 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<br>* Other names: PURELL VF481 alcohol based hand gel;Other: Placebo Solution<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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