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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nowarta Biopharma Inc

Criteria

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.