Condylomata Acuminata, Epidermodysplasia Verruciformis, Papillomavirus Infections, Warts
Conditions
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
Interventions
OTHERPURELL 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
OTHERPlacebo Solution
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
Sponsors
Cleveland Clinic Akron General
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in % Reduction in Wart Size Between Product A and Product B at Each Timepoint | Baseline, 4, 8, and 12 weeks, change at 12 weeks reported | Data is not available due to study closure and data destruction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Size of Warts Treated by Each Product at Each Time Point. | Baseline, 4, 8 and 12 weeks, change at 12 weeks reported | Data is not available due to study closure and data destruction |
Countries
United States
Participant flow
Pre-assignment details
There were no pre-assignment details. Once consented, pts were enrolled into both study arms.
Participants by arm
| Arm | Count |
|---|---|
| PURELL VF481 Left Hand/ Placebo Right Hand 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
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 | 3 |
| PURELL VF481 Left Hand/ Placebo Right Hand 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
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 | 5 |
| Placebo Solution Left Hand/ PURELL VF481 Right Hand 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
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
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 | 2 |
| Placebo Solution Left Hand/ PURELL VF481 Right Hand 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
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
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 | 5 |
| Total | 15 |
Baseline characteristics
| Characteristic | PURELL VF481 Left Hand/ Placebo Right Hand | Placebo Solution Left Hand/ PURELL VF481 Right Hand | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 warts | 0 warts | 0 warts |
| Age, Categorical >=65 years | 0 warts | 0 warts | 0 warts |
| Age, Categorical Between 18 and 65 years | 5 warts | 5 warts | 10 warts |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 5 participants | 5 participants | 10 participants |
| Sex/Gender, Customized Sex/Gender unspecified | 5 warts | 5 warts | 10 warts |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
Primary
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
Time frame: Baseline, 4, 8, and 12 weeks, change at 12 weeks reported
Population: Data is not available due to study closure and data destruction
Secondary
Change in Size of Warts Treated by Each Product at Each Time Point.
Data is not available due to study closure and data destruction
Time frame: Baseline, 4, 8 and 12 weeks, change at 12 weeks reported
Population: Data is not available due to study closure and data destruction