Pharmacodynamics, Safety and Efficacy of Topical Omiganan in Patients With External Genital Warts

Overview

The purpose of this study is to assess the pharmacodynamics, safety and efficacy of omiganan in patients with external genital warts.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 21, 2017

Interventions

  • Drug: Omiganan (CLS001) topical gel
  • Drug: Vehicle topical gel

Arms, Groups and Cohorts

  • Experimental: Omiganan (CLS001)
    • CLS001 Topical Gel, 2.5%
  • Placebo Comparator: Vehicle
    • Vehicle Topical Gel

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

Inclusion Criteria

1. Healthy male and female subjects ≥ 18 years of age, with external genital warts. The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease other than genital warts following a detailed medical history and a complete physical examination including vital signs and 12-lead ECG. In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy subjects. 2. Clinically diagnosed and biopsy confirmed external genital warts. Subject has at least 3 external genital warts. 3. Willing to give written informed consent and willing and able to comply with the study protocol. Exclusion Criteria:

Eligible subjects must meet none of the following exclusion criteria at screening: 1. Clinically significant abnormalities, as judged by the Investigator, in laboratory test results including haematology, blood chemistry panel, virology or urinalysis. In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy subjects. 2. Current clinically significant skin conditions in the anogenital area (e.g. atopic dermatitis, lichen sclerosus, lichen planus or psoriasis). 3. Pregnant, breast feeding or trying to conceive. 4. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year. 5. Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening. 6. Use of active treatment (i.e. cryotherapy, laser therapy, topical medication and/or surgical treatments) for genital warts within 28 days prior to first study drug administration. 7. Immunosuppressed patients, having an immunodeficiency (primary or secondary, like HIV) or receiving immunosuppressive therapy (i.e. Transplant patients). 8. Males or Females who received a vaccination with Gardasil or Cervarix. 9. Any (medical) condition that would, in the opinion of the Investigator, potentially compromise the safety or compliance of the patient or may preclude the patient's successful completion of the clinical trial.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Maruho Co., Ltd.
  • Collaborator
    • Leiden University Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor

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