Patients with external genital warts MedDRA version: 19.0 Level: LLT Classification code 10018182 Term: Genital warts System Organ Class: 100000004864
Conditions
Interventions
Product Name: Omiganan Topical Gel
Product Code: CLS001
Pharmaceutical Form: Gel
INN or Proposed INN: Omiganan Pentahydrochloride
CAS Number: 269-062-93-3
Current Sponsor code: Omiganan 5HCL
Other des
Sponsors
Cutanea Life Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For enrollment of subjects the following criteria must be met: 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective • To explore the pharmacodynamic effects of topically applied omiganan in patients with external genital warts • To explore clinical efficacy of omiganan compared to placebo in patients with external genital warts. ;Secondary Objective: Secondary Objectives • To assess safety and tolerability of topically applied omiganan in patients with external genital warts. ;Primary end point(s): Exploratory clinical efficacy / pharmacodynamics Exploratory clinical efficacy / pharmacodynamic endpoints have been defined according to standard exploratory trials including: • Count of all lesions visible • Percent clearance of treated lesions o Proportion of all baseline lesions cleared o Proportion of all (baseline and new) lesions cleared o Proportion of subjects with cleared treated lesions (90% / 75% / 50% ) • Absolute reduction in target wart size • Target wart size reduction (percentage) • Change in patient-reported outcomes (QoL and patient-reported clearance) • Histology / Local immunity status • Wart size of all warts of interest (target and biopsy warts) by standardized clinical 2D and 3D photography • HPV viral load assessment of primary wart by quantitative PCR including HPV genotyping in swabs • Change from baseline in the HPV viral load (nominal, natural log transformed, and natural log of viral load per DNA copies) as determined by qPCR • Mean HPV viral load (nominal, natural log transformed, and natural log of viral load per DNA copies) at treatment weeks and overall • Biomarkers in biopsies (IFN-a, IFN-beta, IL-1beta, IL-8) ;Timepoint(s) of evaluation of this end point: - Lesion size will be analyzed at every study visit: screening, day 0, 14, 28, 56, 84, 126, 168. - Morphology will be analyzed at study visit: screening, day 84 and 168. - Biopsies will be taken at: screening, day 84 and day 168 if there are still visible lesions. - Swabs are taken on each visit: day 0, 14, 28, 56, 84, 126, 168. - 2D/3D photos are take | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Tolerability / safety endpoints • Compliance with dosing instructions (patient completed e-diary) • Adverse events (AE) • Laboratory safety testing o Chemistry o Hematology o Urinalysis • Treatment-emergent (serious) adverse events ((S)AEs). • Vital signs o Pulse Rate (bpm) o Systolic blood presuure (mmHg) o Diastolic blood pressure (mmHg) o Temperature • Electrocardiogram (ECG) o Heart Rate (HR) (bpm), PR, QRS, QT, QTcB, QTcF ;Timepoint(s) of evaluation of this end point: -Compliance with dosing instructions will be checked every visit during the treatment period: day 0, 14, 28, 56, 84. - Adverse events: continuously - Blood samples are taken at screening, day 84 and 168 - ECGs are performed at screening, day 84 and 168 - Vital signs are performed at screening, day 0, 14, 28, 56, 84, 126 and 168. | — |
Countries
Netherlands
Contacts
Public ContactJ. Burggraaf
Centre for Human Drug Research
Outcome results
None listed