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Trial record 2 of 2 for:    "Skin Papilloma" | "Anti-Bacterial Agents"

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

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ClinicalTrials.gov Identifier: NCT02849262
Recruitment Status : Completed
First Posted : July 29, 2016
Last Update Posted : March 31, 2017
Sponsor:
Collaborator:
Leiden University Medical Center
Information provided by (Responsible Party):
Maruho Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Condylomata Acuminata (External) Drug: Omiganan (CLS001) topical gel Drug: Vehicle topical gel Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : July 2016
Actual Primary Completion Date : March 21, 2017
Actual Study Completion Date : March 21, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genital Warts Warts

Arm Intervention/treatment
Experimental: Omiganan (CLS001)
CLS001 Topical Gel, 2.5%
Drug: Omiganan (CLS001) topical gel
Placebo Comparator: Vehicle
Vehicle Topical Gel
Drug: Vehicle topical gel



Primary Outcome Measures :
  1. Clinical Assessment (Visible Lesions) [ Time Frame: 24 Weeks ]
    Count of all visible lesions

  2. Clinical Assessment (Percent clearance of treated lesions) [ Time Frame: 24 Weeks ]
  3. Clinical Assessment (Reduction of wart size) [ Time Frame: 24 Weeks ]
    Includes 2D and 3D photography

  4. Clinical Assessment (PRO) [ Time Frame: 24 Weeks ]
    Change in Patient-reported outcomes

  5. Pharmacodynamics (Local Immunity Status) [ Time Frame: 24 Weeks ]
    Histological changes

  6. 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 Outcome Measures :
  1. Safety and Tolerability (e-diary) [ Time Frame: 24 Weeks ]
    Compliance with dosing instructions (patient completed e-diary)

  2. Safety (AE) [ Time Frame: 24 Weeks ]
    Adverse Events will be collected throughout the study

  3. Safety (Laboratory Safety Testing) [ Time Frame: 24 Weeks ]
    Lab samples will be collected throughout the study

  4. Safety (Treatment-emergent AE and SAE) [ Time Frame: 24 Weeks ]
    Treatment-emergent AE and SAE will be collected throughout the study

  5. Safety (Vital Signs) [ Time Frame: 24 Weeks ]
    Vital Signs will be collected throughout the study

  6. Safety (ECG) [ Time Frame: Screening and End of Study ]
    ECGs will be collected at before beginning and end of study



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849262


Locations
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Netherlands
LUMC/Centre for Human Drug Research
Leiden, Netherlands
Sponsors and Collaborators
Maruho Co., Ltd.
Leiden University Medical Center

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Responsible Party: Maruho Co., Ltd.
ClinicalTrials.gov Identifier: NCT02849262     History of Changes
Other Study ID Numbers: CLS001-CO-PR-011
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Warts
Antimicrobial Cationic Peptides
Condylomata Acuminata
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Anti-Infective Agents