Plantar WartsPhase 1/2NCT02338336
A Phase I/II Double-blind Safety and Efficacy Evaluation of Nowarta110 in Patients With Plantar Warts
A Phase 1/2 study testing Nowarta110 in people with Plantar Warts, run by Nowarta Biopharma Inc at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plantar Warts
- What is being tested?
- Nowarta110
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Dec 2015
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nowarta Biopharma Inc
Huntington Beach, California, 92648
About this study
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
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
Read the 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.
- Conditions
- Plantar Warts
- Being tested
- Nowarta110, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nowarta110Drug
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.
PlaceboDrug
Also called matching placbo
Matching placebo liquid for topic administration.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Nowarta110 3 drops | Experimental | Nowarta110 3 drops administration Receives: Drug: Nowarta110 |
| Nowarta110 6 drops | Experimental | Nowarta110 6 drops administration Receives: Drug: Nowarta110 |
| Nowarta110 10 drops | Experimental | Nowarta110 10 drops administration Receives: Drug: Nowarta110 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion Assessment
Lesion (plantar wart) size measured in millimeters. Measurement of the longest dimension was recorded. Observed data
Measured: 6 weeks
Incidence of Zero Lesion Measurement
Percent of participants with lesion measurement either equal to 0 or greater than 0
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionSep 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Plantar WartsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nowarta Biopharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Iraj E Kiani, Study chair, Chairman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02338336
- Sponsor's protocol ID
- Nowarta111545
- Status last verified
- Oct 2016
- First submitted
- 10 Jan 2015
- Last updated
- 4 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02338336
- Acronym / sponsor ID
- Nowarta111545
- Conditions
- Plantar Warts
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Nowarta Biopharma IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 14 Jan 2015 (estimated)
- Results
- Posted 19 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| Nowarta110 3 drops | Experimental | Drug: Nowarta110Nowarta110 3 drops administration |
| Nowarta110 6 drops | Experimental | Drug: Nowarta110Nowarta110 6 drops administration |
| Nowarta110 10 drops | Experimental | Drug: Nowarta110Nowarta110 10 drops administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nowarta110Nowarta110 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. | Drug | Nowarta110 10 drops, Nowarta110 3 drops, Nowarta110 6 drops |
| PlaceboAlso: matching placboMatching placebo liquid for topic administration. | Drug | Placebo |
Primary outcome
Lesion Assessment
Time frame: 6 weeks
Lesion (plantar wart) size measured in millimeters. Measurement of the longest dimension was recorded. Observed data
Incidence of Zero Lesion Measurement
Time frame: 6 weeks
Percent of participants with lesion measurement either equal to 0 or greater than 0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
Related trials for Plantar Warts
Not yet recruitingPhase 3
Intralesional Acyclovir Versus Intralesional Zinc Sulphate in the Treatment of Plantar Warts
Warts, Plantar Warts
Not yet recruitingPhase 3
Hydrogen Peroxide 40% Versus Salicylic Acid 40% for Plantar Warts
Plantar Wart
RecruitingPhase 4
Randomized, Placebo-controlled, Double Blind Study to Evaluate the Efficacy of 2LVERU®JUNIOR and 2LVERU® on the Treatment of Warts
Common Wart, Flat Wart
RecruitingPhase 4
Intralesional Therapies For Cutaneous Viral Warts: A Comparative Analysis Of Vitamin D3 And Acyclovir
Viral Wart, Plantar Wart
Active, not recruitingPhase 4
A Self-controlled Study of Bleomycin and Pingyangmycin Injection in the Treatment of Plantar Warts
Plantar Wart
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Iraj E Kiani study chair
Chairman
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nowarta110 in people with Plantar Warts, run by Nowarta Biopharma Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion Assessment (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2016; AzTrials last refreshed its copy on 1 Nov 2026.