Clinical trial NCT00973856: Evaluation of the Effectiveness of an Alcohol Based Hand Gel for the Reduction of Warts on the Hands
Official title: Evaluation of the Effectiveness of an Alcohol Based Hand Gel for the Reduction of Warts on the Hands
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Papillomavirus Infections
Warts
Condylomata Acuminata
Epidermodysplasia Verruciformis
Lead sponsor: Cleveland Clinic Akron General
Sponsor class: OTHER
First posted: 2009-09-09
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Difference in % Reduction in Wart Size Between Product A and Product B at Each Timepoint
timeFrame: Baseline, 4, 8, and 12 weeks, change at 12 weeks reported
Secondary outcomes:
measure: Change in Size of Warts Treated by Each Product at Each Time Point.
timeFrame: Baseline, 4, 8 and 12 weeks, change at 12 weeks reported
Other outcomes:
Locations:
city: Akron
country: United States
facility: Akron Dermatology
state: Ohio
Study officials:
affiliation: Cleveland Clinic Akron General
name: Eliot Mostow, M.D>
role: PRINCIPAL_INVESTIGATOR
References: