Clinical Trial: Pharmacodynamics, Safety and Efficacy of Topical Omiganan in Patients With External Genital Warts
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 2, Randomized, Vehicle-Controlled, Double-Blind, Parallel-Group Study to Explore the Pharmacodynamics, Safety and Efficacy of Topical Omiganan in Patients With External Genital Warts
Brief Summary: The purpose of this study is to assess the pharmacodynamics, safety and efficacy of omiganan in patients with external genital warts.
Detailed Summary:
Sponsor: Cutanea Life Sciences, Inc.
Current Primary Outcome:
- Clinical Assessment (Visible Lesions) [ Time Frame: 24 Weeks ]Count of all visible lesions
- Clinical Assessment (Percent clearance of treated lesions) [ Time Frame: 24 Weeks ]
- Clinical Assessment (Reduction of wart size) [ Time Frame: 24 Weeks ]Includes 2D and 3D photography
- Clinical Assessment (PRO) [ Time Frame: 24 Weeks ]Change in Patient-reported outcomes
- Pharmacodynamics (Local Immunity Status) [ Time Frame: 24 Weeks ]Histological changes
- Pharmacodynamics (HPV Viral Load Assessment) [ Time Frame: 24 Weeks ]Quantitative PCR including HPV genotyping in swabs, qPCR to assess change from baseline, mean HPV viral load at treatment weeks and overall
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Safety and Tolerability (e-diary) [ Time Frame: 24 Weeks ]Compliance with dosing instructions (patient completed e-diary)
- Safety (AE) [ Time Frame: 24 Weeks ]Adverse Events will be collected throughout the study
- Safety (Laboratory Safety Testing) [ Time Frame: 24 Weeks ]Lab samples will be collected throughout the study
- Safety (Treatment-emergent AE and SAE) [ Time Frame: 24 Weeks ]Treatment-emergent AE and SAE will be collected throughout the study
- Safety (Vital Signs) [ Time Frame: 24 Weeks ]Vital Signs will be collected throughout the study
- Safety (ECG) [ Time Frame: Screening and End of Study ]ECGs will be collected at before beginning and end of study
Original Secondary Outcome: Same as current
Information By: Cutanea Life Sciences, Inc.
Dates:
Date Received: July 27, 2016
Date Started: July 2016
Date Completion:
Last Updated: March 29, 2017
Last Verified: March 2017