Phase 2
N=54
A Phase I/II Double-blind Safety and Efficacy Evaluation of Nowarta110 in Patients With Plantar Warts
Plantar Warts
Bottom Line
View on ClinicalTrials.gov: NCT02338336 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Lesion Assessment — 8.42; 9.14; 8.42; 8.71 millimeters — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nowarta110 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Nowarta Biopharma Inc
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lesion Assessment |
8.42; 9.14; 8.42; 8.71; 7.92; 7.36 | <0.001 sig |
| PRIMARY Incidence of Zero Lesion Measurement |
7.7; 64.3; 84.6; 35.7 | — |
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
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.
Data sourced from ClinicalTrials.gov (NCT02338336). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.