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

Plantar Warts Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02338336
• Other study ID #: Nowarta111545
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 10, 2015
• Last updated: April 5, 2016
• Start date: February 2015
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Nowarta Biopharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Foot Diseases
• Plantar Warts
• Warts

Intervention

Drug:
• Nowarta110

• Placebo

Locations

Country	Name	City	State
United States	Nowarta Biopharma Inc	Huntington Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Nowarta Biopharma Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local adverse event and site reaction		7 days	No