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Omiganan in usual type vulvar intraepithelial neoplasia
NCT02596074Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2015
- Primary completion
- Mar 2017
- Countries
- 1
- Sponsor
- Maruho Co., Ltd.
- Conditions
- vulvar intraepithelial neoplasia (VIN)
01
Overview
Phase 2, randomised, double-blind trial of CLS001 topical gel vehicle in vulvar intraepithelial neoplasia (VIN) (2 arms), sponsored by Maruho Co., Ltd. Primary endpoints: Pharmacodynamics (HPV Viral Load Assessment) at 24 weeks, Pharmacodynamics (Local Immunity Status) at 24 weeks and 4 more. Started Nov 2015; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Omiganan
Omiganan (CLS001) topical gel, 2.5%
Vehicle
Vehicle topical gel
03
Endpoints
Primary
Pharmacodynamics (HPV Viral Load Assessment)
Pharmacodynamics (Local Immunity Status)
Clinical Assessment (Lesions by RECIST)
Clinical Assessment (Percent clearance of Lesions)
Clinical Assessment (Sum of the longest diameter (SLD))
Secondary
Safety and Tolerability (Adverse Events)
Safety and Tolerability (Laboratory Safety Testing)
Safety and Tolerability (12-Lead ECGs)
Safety and Tolerability (Vital Signs)
Pharmacokinetics (Area Under the Curve)
Pharmacokinetics (Maximum Plasma Concentration)
Pharmacokinetics (Tmax)
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