CyPep-1 in Cutaneous Warts

Cutaneous Warts Clinical Trial

Official title: A Randomized, Placebo-controlled, Double-blind Phase I Study to Explore Safety, Tolerability and Pharmacodynamics of CyPep-1 in Subjects With Cutaneous Warts

Status Completed

Clinical Trial 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.

Clinical Trial Description

This study has a phase 1, randomized, vehicle-controlled, double-blind, single center design to explore the safety, tolerability and pharmacodynamics (PD) of topically applied CyPep-1 in otherwise healthy patients with cutaneous warts.

The study will entail two parts. Part 1 will follow a target area of 5x5 cm healthy skin to study tolerability and safety of the formulation. During this study part also a maximum of 3 common warts, preferably at the dorsal or palmar side of the hand / finger(s), will be treated. Several assessments will be done to determine pharmacodynamics and to explore possible efficacy after a treatment period of 1 week.

Part 2 will evaluate the pharmacodynamics and efficacy of CyPep-1 after a treatment period of 4 weeks. Study part 2 will commence after an interim analysis, e.g. a blind data review, of study part 1 has been conducted. ;

Related Conditions & MeSH terms

• Cutaneous Warts
• Warts

• NCT number: NCT03846648
• Study type: Interventional
• Source: Centre for Human Drug Research, Netherlands
• Status: Completed
• Phase: Phase 1
• Start date: March 11, 2019
• Completion date: December 20, 2019