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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PURELL Left Hand/ Placebo Right Hand | Experimental | One product will be assigned to each hand to minimize treatment confusion for the participants. PURELL VF481 Left Hand/ Placebo Right Hand |
|
| Placebo Solution Left Hand/ PURELL Right hand | Placebo Comparator | One (1) product will be assigned to each hand to minimize treatment confusion for the participants PURELL VF481 Right Hand/ Placebo Left Hand 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PURELL VF481 | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 4, 8, and 12 weeks, change at 12 weeks reported |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Size of Warts Treated by Each Product at Each Time Point. | Data is not available due to study closure and data destruction | Baseline, 4, 8 and 12 weeks, change at 12 weeks reported |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eliot Mostow, M.D> | Cleveland Clinic Akron General | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akron Dermatology | Akron | Ohio | 44307 | United States |
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| Label | URL |
|---|---|
| Akron General Medical Center | View source |
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There were no pre-assignment details. Once consented, pts were enrolled into both study arms.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Units |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Data is not available due to study closure and data destruction | Posted | Baseline, 4, 8, and 12 weeks, change at 12 weeks reported | wart reduction % | wart reduction % |
|
|
2 years
Same definition
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Purell VF481 | Active Ingredient: 70% ethanol | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eliot Mostow, MD | Cleveland Clinic Akron General | emostow@akronderm.com |
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| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D014860 | Warts |
| D003218 | Condylomata Acuminata |
| D004819 | Epidermodysplasia Verruciformis |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| Placebo Solution | Other | 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 |
|
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| warts |
|
| warts |
| warts |
|
|
| Sex/Gender, Customized | Count of Units | warts | warts |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
|
| Region of Enrollment | Number | participants | warts |
|
|
| wart reduction % |
|
| 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 | Data is not available due to study closure and data destruction | Posted | Baseline, 4, 8 and 12 weeks, change at 12 weeks reported |
|
|
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Placebo | 15% alcohol formulation that aesthetically resembles VF481 | 0 | 5 | 0 | 5 | 0 | 5 |
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| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017193 | Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |