Plantar Warts
Conditions
Brief summary
To evaluate drug safety and efficacy in patients treated with Nowarta110 and to determine therapeutic activity against Plantar Warts * Clinical Tolerance * Clinical Recovery * Evaluate Safety
Detailed description
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.
Interventions
DRUGNowarta110
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.
DRUGPlacebo
Matching placebo liquid for topic administration.
Sponsors
Nowarta Biopharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with refractory or recurrent Plantar Warts. * No wart treatment for the last 12 weeks * Healthy male or non-pregnant, non-lactating female aged ≥ 18 years or greater * If female of childbearing potential, use an acceptable form of birth control during the study * Provide written informed consent or (HIPAA consent/authorization, as applicable
Exclusion criteria
* Concurrent medical disorder or disease making implementation or interpretation of the protocol or results difficult or unsafe * Female subjects who are breast-feeding or planning to become pregnant * Patients with a history of allergy to silver or fruits * Subjects with clinically significant unstable medical disorder, life threatening disease, or current malignancies * Subjects with History of Alcohol abuse or other drug abuse within 2 years prior to Randomization * Subjects who have been treated with an investigational drug or investigational device within a period of 30 days prior to study enrollment * Concomitant Medications: any other wart therapy is prohibited during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lesion Assessment | 6 weeks | Lesion (plantar wart) size measured in millimeters. Measurement of the longest dimension was recorded. Observed data |
| Incidence of Zero Lesion Measurement | 6 weeks | Percent of participants with lesion measurement either equal to 0 or greater than 0 |
Countries
United States
Participant flow
Recruitment details
Recruited at a single center
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| Placebo Matching Placebo | 26 |
| Nowarta110 All combined Nowarta110 doses | 28 |
| Total | 54 |
Baseline characteristics
| Characteristic | Nowarta110 | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 34.5 years STANDARD_DEVIATION 12.65 | 34.3 years STANDARD_DEVIATION 11.59 | 34.0 years STANDARD_DEVIATION 10.58 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 22 Participants | 40 Participants | 18 Participants |
| Sex: Female, Male Female | 17 Participants | 29 Participants | 12 Participants |
| Sex: Female, Male Male | 11 Participants | 25 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 26 | 1 / 28 |
| serious Total, serious adverse events | 0 / 26 | 0 / 28 |
Outcome results
Primary
Incidence of Zero Lesion Measurement
Percent of participants with lesion measurement either equal to 0 or greater than 0
Time frame: 6 weeks
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Incidence of Zero Lesion Measurement | Lesion Measurement = 0 | 7.7 percentage of participants |
| Placebo | Incidence of Zero Lesion Measurement | Lesion Measurment > 0 | 84.6 percentage of participants |
| TREATMENT | Incidence of Zero Lesion Measurement | Lesion Measurement = 0 | 64.3 percentage of participants |
| TREATMENT | Incidence of Zero Lesion Measurement | Lesion Measurment > 0 | 35.7 percentage of participants |
Primary
Lesion Assessment
Lesion (plantar wart) size measured in millimeters. Measurement of the longest dimension was recorded. Observed data
Time frame: 6 weeks
Population: Intent-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Lesion Assessment | Week 2 | 7.92 millimeters | Standard Deviation 7.227 |
| Placebo | Lesion Assessment | Week 4 | 7.58 millimeters | Standard Deviation 7.3 |
| Placebo | Lesion Assessment | Week 1 | 8.42 millimeters | Standard Deviation 7.229 |
| Placebo | Lesion Assessment | Week 5 | 7.38 millimeters | Standard Deviation 7.149 |
| Placebo | Lesion Assessment | Week 3 | 7.85 millimeters | Standard Deviation 7.182 |
| Placebo | Lesion Assessment | Week 6 | 7.13 millimeters | Standard Deviation 7.267 |
| Placebo | Lesion Assessment | Baseline | 8.42 millimeters | Standard Deviation 7.229 |
| TREATMENT | Lesion Assessment | Week 6 | 2.25 millimeters | Standard Deviation 4.334 |
| TREATMENT | Lesion Assessment | Baseline | 9.14 millimeters | Standard Deviation 6.072 |
| TREATMENT | Lesion Assessment | Week 1 | 8.71 millimeters | Standard Deviation 5.843 |
| TREATMENT | Lesion Assessment | Week 2 | 7.36 millimeters | Standard Deviation 5.864 |
| TREATMENT | Lesion Assessment | Week 3 | 6.00 millimeters | Standard Deviation 4.974 |
| TREATMENT | Lesion Assessment | Week 4 | 4.86 millimeters | Standard Deviation 4.411 |
| TREATMENT | Lesion Assessment | Week 5 | 3.61 millimeters | Standard Deviation 4.076 |
p-value: <0.001ANOVA