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