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

Nowarta Biopharma

Status and phase: Completed; Phase 2; Phase 1

Conditions: Plantar Warts

Treatments: Drug: Placebo; Drug: Nowarta110

Study type: Interventional

Funder types: Industry

Identifiers

NCT02338336

Nowarta111545

Details and patient eligibility

About

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

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Nowarta110 3 drops

Experimental group

Description:

Nowarta110 3 drops administration

Treatment:

Drug: Nowarta110

Nowarta110 6 drops

Experimental group

Description:

Nowarta110 6 drops administration

Treatment:

Drug: Nowarta110

Nowarta110 10 drops

Experimental group

Description:

Nowarta110 10 drops administration

Treatment:

Drug: Nowarta110