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

Primary Purpose

Plantar Warts

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Nowarta110

Placebo

About this trial

This is an interventional treatment trial for Plantar Warts

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Nowarta Biopharma Inc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Nowarta110 3 drops

Nowarta110 6 drops

Nowarta110 10 drops

Arm Description

Placebo

Nowarta110 3 drops administration

Nowarta110 6 drops administration

Nowarta110 10 drops administration

Outcomes

Primary Outcome Measures

Lesion Assessment

Lesion (plantar wart) size measured in millimeters. Measurement of the longest dimension was recorded. Observed data

Incidence of Zero Lesion Measurement

Percent of participants with lesion measurement either equal to 0 or greater than 0

Secondary Outcome Measures

Full Information

NCT ID

NCT02338336

First Posted

January 10, 2015

Last Updated

October 6, 2016

Sponsor

Nowarta Biopharma Inc

1. Study Identification

Unique Protocol Identification Number

NCT02338336

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

February 2015 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nowarta Biopharma Inc

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Plantar Warts

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Arm Title

Nowarta110 3 drops

Arm Type

Experimental

Arm Description

Nowarta110 3 drops administration

Arm Title

Nowarta110 6 drops

Arm Type

Experimental

Arm Description

Nowarta110 6 drops administration

Arm Title

Nowarta110 10 drops

Arm Type

Experimental

Arm Description

Nowarta110 10 drops administration

Intervention Type

Drug

Intervention Name(s)

Nowarta110

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

matching placbo

Intervention Description

Matching placebo liquid for topic administration.

Primary Outcome Measure Information:

Title

Lesion Assessment

Description

Lesion (plantar wart) size measured in millimeters. Measurement of the longest dimension was recorded. Observed data

Time Frame

6 weeks

Title

Incidence of Zero Lesion Measurement

Description

Percent of participants with lesion measurement either equal to 0 or greater than 0

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr. Iraj E Kiani

Organizational Affiliation

Chairman

Official's Role

Study Chair

Facility Information:

Facility Name

Nowarta Biopharma Inc

City

Huntington Beach

State/Province

California

ZIP/Postal Code

92648

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

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

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