Condylomata Acuminata (External)
Conditions
Brief summary
The purpose of this study is to assess the pharmacodynamics, safety and efficacy of omiganan in patients with external genital warts.
Interventions
Sponsors
Leiden University Medical Center
Maruho Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacodynamics (HPV Viral Load Assessment) | 24 Weeks | Quantitative PCR including HPV genotyping in swabs, qPCR to assess change from baseline, mean HPV viral load at treatment weeks and overall |
| Clinical Assessment (Visible Lesions) | 24 Weeks | Count of all visible lesions |
| Clinical Assessment (Percent clearance of treated lesions) | 24 Weeks | — |
| Clinical Assessment (Reduction of wart size) | 24 Weeks | Includes 2D and 3D photography |
| Clinical Assessment (PRO) | 24 Weeks | Change in Patient-reported outcomes |
| Pharmacodynamics (Local Immunity Status) | 24 Weeks | Histological changes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability (e-diary) | 24 Weeks | Compliance with dosing instructions (patient completed e-diary) |
| Safety (AE) | 24 Weeks | Adverse Events will be collected throughout the study |
| Safety (Laboratory Safety Testing) | 24 Weeks | Lab samples will be collected throughout the study |
| Safety (Treatment-emergent AE and SAE) | 24 Weeks | Treatment-emergent AE and SAE will be collected throughout the study |
| Safety (Vital Signs) | 24 Weeks | Vital Signs will be collected throughout the study |
| Safety (ECG) | Screening and End of Study | ECGs will be collected at before beginning and end of study |
Countries
Netherlands
Outcome results
None listed