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

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

Study Overview

• Status: Completed
• Conditions: Plantar Warts
• Intervention / Treatment: Drug: Placebo; Drug: Nowarta110

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Huntington Beach, California, United States, 92648
      • Nowarta Biopharma Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Matching placebo liquid for topic administration.; Other Names: matching placbo
Experimental: Nowarta110 3 drops; Nowarta110 3 drops administration	Drug: Nowarta110; 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.
Experimental: Nowarta110 6 drops; Nowarta110 6 drops administration	Drug: Nowarta110; 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.
Experimental: Nowarta110 10 drops; Nowarta110 10 drops administration	Drug: Nowarta110; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nowarta Biopharma Inc
• Investigators: Study Chair: Dr. Iraj E Kiani, Chairman

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: January 10, 2015
• First Submitted That Met QC Criteria: January 13, 2015
• First Posted (Estimate): January 14, 2015

Study Record Updates

• Last Update Posted (Estimate): November 4, 2016
• Last Update Submitted That Met QC Criteria: October 6, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; Musculoskeletal Diseases; DNA Virus Infections; Skin Diseases, Infectious; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Warts; Foot Diseases
• Other Study ID Numbers: Nowarta111545

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes