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| Name | Class |
|---|---|
| Leiden University Medical Center | OTHER |
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The purpose of this study is to assess the pharmacodynamics, safety and efficacy of omiganan in patients with external genital warts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omiganan (CLS001) | Experimental | CLS001 Topical Gel, 2.5% |
|
| Vehicle | Placebo Comparator | Vehicle Topical Gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omiganan (CLS001) topical gel | Drug |
| ||
| Vehicle topical gel |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Assessment (Visible Lesions) | Count of all visible lesions | 24 Weeks |
| Clinical Assessment (Percent clearance of treated lesions) | 24 Weeks | |
| Clinical Assessment (Reduction of wart size) | Includes 2D and 3D photography | 24 Weeks |
| Clinical Assessment (PRO) | Change in Patient-reported outcomes | 24 Weeks |
| Pharmacodynamics (Local Immunity Status) | Histological changes | 24 Weeks |
| Pharmacodynamics (HPV Viral Load Assessment) | Quantitative PCR including HPV genotyping in swabs, qPCR to assess change from baseline, mean HPV viral load at treatment weeks and overall | 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability (e-diary) | Compliance with dosing instructions (patient completed e-diary) | 24 Weeks |
| Safety (AE) | Adverse Events will be collected throughout the study |
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Inclusion Criteria:
Exclusion Criteria:
Eligible subjects must meet none of the following exclusion criteria at screening:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LUMC/Centre for Human Drug Research | Leiden | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31755993 | Derived | Rijsbergen M, Rijneveld R, Todd M, Feiss GL, Kouwenhoven STP, Quint KD, van Alewijk DCJG, de Koning MNC, Klaassen ES, Burggraaf J, Rissmann R, van Poelgeest MIE. Results of phase 2 trials exploring the safety and efficacy of omiganan in patients with human papillomavirus-induced genital lesions. Br J Clin Pharmacol. 2020 Nov;86(11):2133-2143. doi: 10.1111/bcp.14181. Epub 2020 Sep 28. |
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| ID | Term |
|---|---|
| D003218 | Condylomata Acuminata |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
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| ID | Term |
|---|---|
| C000625752 | Omiganan |
| D005782 | Gels |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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|
| 24 Weeks |
| Safety (Laboratory Safety Testing) | Lab samples will be collected throughout the study | 24 Weeks |
| Safety (Treatment-emergent AE and SAE) | Treatment-emergent AE and SAE will be collected throughout the study | 24 Weeks |
| Safety (Vital Signs) | Vital Signs will be collected throughout the study | 24 Weeks |
| Safety (ECG) | ECGs will be collected at before beginning and end of study | Screening and End of Study |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014860 | Warts |
| D017193 | Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |