A Phase I/II Double-blind Study to Evaluate the Safety and Efficacy of Nowarta110 in Patients With Plantar Warts Successfully Completed



Status:Completed
Conditions:Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:February 2015
End Date:December 2015

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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

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

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.

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.
We found this trial at
1
site
Huntington Beach, California 92648
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from
Huntington Beach, CA
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