Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-28 @ 2:23 AM
Study NCT ID:
NCT00973856
Status:
COMPLETED
Last Update Posted:
2023-01-31
First Post:
2009-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Effectiveness of an Alcohol Based Hand Gel for the Reduction of Warts on the Hands
Sponsor:
Cleveland Clinic Akron General
Organization:
Study Overview
Official Title:
Evaluation of the Effectiveness of an Alcohol Based Hand Gel for the Reduction of Warts on the Hands
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective is to conduct a pilot study to determine the effectiveness of PURELL VF481 to treat warts located on the hands.
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
* 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: