drugset / Trial / NCT03846648
CyPep-1 in Cutaneous Warts
RandomizedParallel-groupDouble-blindTreatment
Summary
This Phase 1 study is intended to explore the safety, tolerability, pharmacodynamics and efficacy of topical CyPep-1 as a potential treatment for HPV-associated conditions. Since this is a first-on-human study of a topical formulation, the first subjects will be monitored more frequently in order to establish the safety profile. Because clinical outcomes (i.e. reduction/clearance of the lesion) often require lengthy treatment / observation periods, the study design will primarily utilize clinical measurements of wart dimensions, along with HPV viral load as a biomarker of anti-viral effect.
Timeline
- Start
- 2019-03-11
- Primary completion
- 2019-12-20
- Completion
- 2019-12-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | CyPep-1 | Peptide | 1 % | Topical |