Evaluation of the Effectiveness of an Alcohol Based Hand Gel for the Reduction of Warts on the Hands
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Akron General Medical Center.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Akron General Medical Center
Information provided by:
Akron General Medical Center
ClinicalTrials.gov Identifier:
NCT00973856
First received: September 8, 2009
Last updated: May 24, 2010
Last verified: May 2010
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Purpose
The objective is to conduct a pilot study to determine the effectiveness of PURELL VF481 to treat warts located on the hands.
| Condition | Intervention |
|---|---|
|
Papillomavirus Infections Warts Condylomata Acuminata Epidermodysplasia Verruciformis |
Other: PURELL VF481 Other: Placebo Comparator |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Evaluation of the Effectiveness of an Alcohol Based Hand Gel for the Reduction of Warts on the Hands |
Resource links provided by NLM:
Further study details as provided by Akron General Medical Center:
Primary Outcome Measures:
- Difference in % clearance between Product A and Product B at each timepoint [ Time Frame: 4, 8, and 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in size of warts treated by each product at each time point. [ Time Frame: 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: PURELL VF481
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
|
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 Name: PURELL VF481 alcohol based hand gel
|
|
Placebo Comparator: Placebo Solution
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 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: Placebo Comparator
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
|
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 (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
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00973856
Contacts
| Contact: Eliot Mostow, M.D. | 330-535-7100 | emostow@neoucom.edu |
| Contact: Terri Kimble, PA-C | 330-535-7100 | terri@akronderm.com |
Locations
| United States, Ohio | |
| Akron Dermatology | Recruiting |
| Akron, Ohio, United States, 44307 | |
| Contact: Nairmeen Haller, Ph.D. 330-344-6001 nhaller@agmc.org | |
| Contact: Cheryl Goliath 330-344-1884 cgoliath@agmc.org | |
| Principal Investigator: Eliot Mostow, M.D. | |
Sponsors and Collaborators
Akron General Medical Center
Investigators
| Principal Investigator: | Eliot Mostow, M.D> | Akron General Medical Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Eliot Mostow, M.D., Akron General Medical Center |
| ClinicalTrials.gov Identifier: | NCT00973856 History of Changes |
| Other Study ID Numbers: | 09025 |
| Study First Received: | September 8, 2009 |
| Last Updated: | May 24, 2010 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Warts Condylomata Acuminata Epidermodysplasia Verruciformis Papillomavirus Infections DNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Skin Diseases, Viral Tumor Virus Infections Skin Diseases, Infectious |
Skin Diseases Neoplasms Ethanol Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Central Nervous System Depressants Physiological Effects of Drugs Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013