To assess the pharmacodynamics, safety/tolerability and efficacy of topical Omiganan (CLS001) in patients with usual type vulvar intraepithelial neoplasia (uVIN).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
12
LUMC/Centre for Human Drug Research
Leiden, Netherlands
Pharmacodynamics (HPV Viral Load Assessment)
Assessment of target lesions by quantitative PCR including HPV genotyping in swabs and biopsies
Time frame: 24 Weeks
Pharmacodynamics (Local Immunity Status)
Histological changes in immune cells in the mucosa/submucosa
Time frame: 24 Weeks
Clinical Assessment (Lesions by RECIST)
Efficacy assessment of lesions by RECIST
Time frame: 24 Weeks
Clinical Assessment (Percent clearance of Lesions)
Efficacy assessment of percent clearance of lesions
Time frame: 24 Weeks
Clinical Assessment (Sum of the longest diameter (SLD))
Efficacy assessment of the sum of the longest diameter (SLD))
Time frame: 24 Weeks
Clinical Assessment (Histology)
Efficacy assessment of the histology (regression of uVIN to no dysplasia)
Time frame: 24 Weeks
Safety and Tolerability (Adverse Events)
Adverse Events will be collected throughout the study
Time frame: 48 Weeks
Safety and Tolerability (Laboratory Safety Testing)
Laboratory Samples will be collected throughout the study
Time frame: 48 Weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Safety and Tolerability (12-Lead ECGs)
12-Lead ECGs will be performed throughout the study
Time frame: 48 Weeks
Safety and Tolerability (Vital Signs)
Vital Signs will be collected throughout the study
Time frame: 48 Weeks
Pharmacokinetics (Area Under the Curve)
AUC will be computed
Time frame: 12 Weeks
Pharmacokinetics (Maximum Plasma Concentration)
Cmax will be determined
Time frame: 12 Weeks
Pharmacokinetics (Tmax)
Tmax will be determined
Time frame: 12 Weeks