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

NCT ID: NCT02338336

Last Updated: 2016-11-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Plantar Warts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo liquid for topic administration.

Nowarta110 3 drops

Nowarta110 3 drops administration

Group Type EXPERIMENTAL

Nowarta110

Intervention Type 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 6 drops

Nowarta110 6 drops administration

Group Type EXPERIMENTAL

Nowarta110

Intervention Type 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 10 drops administration

Group Type EXPERIMENTAL

Nowarta110

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Placebo

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Intervention Type DRUG

Other Intervention Names

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matching placbo

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nowarta Biopharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr. Iraj E Kiani

Role: STUDY_CHAIR

Chairman

Locations

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Nowarta Biopharma Inc

Huntington Beach, California, United States

Site Status

Countries

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United States

Other Identifiers

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Nowarta111545

Identifier Type: -

Identifier Source: org_study_id