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

NCT02338336 | Completed Phase 1 Results DMC

• 1 other identifier: Nowarta111545
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Plantar Warts

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Nowarta110 3 drops

EXPERIMENTAL

Nowarta110 3 drops administration

Drug: Nowarta110

Nowarta110 6 drops

EXPERIMENTAL

Nowarta110 6 drops administration

Drug: Nowarta110

Nowarta110 10 drops

EXPERIMENTAL

Nowarta110 10 drops administration

Drug: Nowarta110

Interventions

Nowarta110 DRUG

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.

Nowarta110 10 drops; Nowarta110 3 drops; Nowarta110 6 drops

Placebo DRUG

Matching placebo liquid for topic administration.

Also known as: matching placbo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nowarta Biopharma Inc: lead

Study Sites (1)

Nowarta Biopharma Inc

Huntington Beach, California, 92648, United States

Location

Results Point of Contact

• Title: Peggy Hagerty
• Organization: Norwarta

hagertymws@comcast.net

267-240-4010

Study Officials

• Dr. Iraj E Kiani

  Chairman

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2015
• First Posted: January 14, 2015
• Study Start: February 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 4, 2016
• Results First Posted: July 19, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)