A Phase I/II Double-blind Safety and Efficacy Evaluation of Nowarta110 in Patients With Plantar Warts

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase I/II, Two- Staged Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Nowarta110 in Patients With Plantar Warts and Clinical Recovery Successfully Completed

Conditions
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Plantar Warts

Intervention / Treatment
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* Drug: Nowarta110
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Matching placebo liquid for topic administration.<br>* Other names: matching placbo;|
| Experimental: Nowarta110 3 drops<br>Nowarta110 3 drops administration | Drug: Nowarta110<br>* 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.<br>|
| Experimental: Nowarta110 6 drops<br>Nowarta110 6 drops administration | Drug: Nowarta110<br>* 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.<br>|
| Experimental: Nowarta110 10 drops<br>Nowarta110 10 drops administration | Drug: Nowarta110<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |