Expired Study
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Huntington Beach, California 92648


Purpose:

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 summary:

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.


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.


Study is Available At:


Original ID:

Nowarta111545


NCT ID:

NCT02338336


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 1/Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Nowarta Biopharma Inc


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

78


Enrollment Type:

Actual


Overall Contact Information

Official Name:Dr. Iraj E Kiani
Study Chair
Chairman

Study Dates

Start Date:February 2015
Completion Date:December 2015
Completion Type:Actual
Primary Completion Date:September 2015
Primary Completion Type:Actual
Verification Date:April 2016
Last Changed Date:April 5, 2016
First Received Date:January 10, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Local adverse event and site reaction
Time Frame:7 days
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Nowarta110
Arm Name:Treatment
Intervention Type:Drug
Name:Placebo
Arm Name:Placebo

Study Arms

Study Arm Type:Experimental
Arm Name:Treatment
Description:Nowarta110
Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:Placebo

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Nowarta Biopharma Inc

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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