View Clinical Trial (Medical Research Study)
Evaluation of the Effectiveness of an Alcohol Based Hand Gel for the Reduction of Warts on the Hands
| City: |
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Akron |
| State: |
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Ohio |
| Zip Code: |
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44307 |
| Conditions: |
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Papillomavirus Infections - Warts - Condylomata Acuminata - Epidermodysplasia Verruciformis |
| Purpose: |
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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.
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| Study Summary: |
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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 (2, 4, or 6), when possible 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
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| 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
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| NCT ID: |
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NCT00973856 |
| Primary Contact: |
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Principal Investigator
Eliot Mostow, M.D>
Akron General Medical Center
Eliot Mostow, M.D.
Phone: 330-535-7100
Email: emostow@neoucom.edu
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| Backup Contact: |
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Email: terri@akronderm.com
Terri Kimble, PA-C
Phone: 330-535-7100
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| Location Contact: |
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Akron, Ohio 44307
United States
Nairmeen Haller, Ph.D.
Phone: 330-344-6001
Email: nhaller@agmc.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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