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To evaluate drug safety and efficacy in patients treated with Nowarta110 and to determine therapeutic activity against Plantar Warts
Plantar Warts occur on the soles (plantar surface of feet) and can be severely debilitating for patients even for normal walking. The severity and magnitude of the warts can vary, but they are the cause of much pain and discomfort for all age groups. Nowarta 110 has been evaluated for the therapy of plantar warts caused by the HPV virus, (HPV infection). Clinical experience in a totals of 124 patients receiving Nowarta 110 for 5 weeks treatment in multiple clinics overseas has demonstrated the potential of Nowarta110 with absolutely no side effect.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| Nowarta110 3 drops | Experimental | Nowarta110 3 drops administration |
|
| Nowarta110 6 drops | Experimental | Nowarta110 6 drops administration |
|
| Nowarta110 10 drops | Experimental | Nowarta110 10 drops administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nowarta110 | Drug | Nowarta110 contains fig extract as the main drug substance, and colloidal silver is used as a medium for penetration of fig extract into the wart lesion. Liquid for topical administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Lesion Assessment | Lesion (plantar wart) size measured in millimeters. Measurement of the longest dimension was recorded. Observed data | 6 weeks |
| Incidence of Zero Lesion Measurement | Percent of participants with lesion measurement either equal to 0 or greater than 0 | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Iraj E Kiani | Chairman | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nowarta Biopharma Inc | Huntington Beach | California | 92648 | United States |
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Random assignment was stratified by the size of the plantar wart:
If the lesion size was less than 1 cm2, 3 drops were applied once weekly for 5 weeks If the lesion size was between 1 cm2 and 2 cm2, 6 drops were applied once weekly for 5 weeks If the lesion size was larger than 2 cm2, 10 drops were applied once weekly for 5 weeks
Recruited at a single center
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matching Placebo |
| FG001 | Norwarta110 3 Drops | Nowarta110 3 drops administered topically |
| FG002 | Nowarta110 6 Drops | Nowarta110 6 drops administered topically |
| FG003 | Nowarta110 10 Drops | Nowarta110 10 drops administered topically |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matching Placebo |
| BG001 | Nowarta110 | All combined Nowarta110 doses |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Lesion Assessment | Lesion (plantar wart) size measured in millimeters. Measurement of the longest dimension was recorded. Observed data | Intent-to-treat | Posted | Mean | Standard Deviation | millimeters | 6 weeks |
|
|
6 weeks
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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 | Placebo | Matching Placebo |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Burning/stinging | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peggy Hagerty | Norwarta | 267-240-4010 | hagertymws@comcast.net |
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| Placebo | Drug | Matching placebo liquid for topic administration. |
|
|
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
|
| Primary | Incidence of Zero Lesion Measurement | Percent of participants with lesion measurement either equal to 0 or greater than 0 | ITT | Posted | Number | percentage of participants | 6 weeks |
|
|
|
| 0 |
| 26 |
| 9 |
| 26 |
| EG001 | Nowarta110 | All combined Nowarta110 doses | 0 | 28 | 1 | 28 |
| Dryness | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Edema | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pain | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment | Pain on treated area |
|
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