A phase 2, randomized, vehicle-controlled, double-blind study to assess the efficacy, safety and pharmacodynamics (PD) of topically applied CLS003 in otherwise healthy patients with cutaneous warts.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
81
LUMC/Centre for Human Drug Research
Leiden, Netherlands
Change from baseline in morphological wart assessment
Time frame: Days 14, 28, 42, 70, 98
Change from baseline in Wart size and morphology assessment by standardized clinical photography
Time frame: Days 14, 28, 42, 70, 98
Change from baseline in HPV viral load assessment of target lesions by quantitative PCR
Time frame: Days 14, 28, 42, 70, 98
Reduction in wart size
Time frame: Days 14, 28, 42, 70, 98
Change in the HPV viral load
Time frame: Days 14, 28, 42, 70, 98
Change from baseline in mean HPV viral load
Time frame: Days 14, 28, 42, 70, 98
Percent clearance of warts
Time frame: Days 14, 28, 42, 70, 98
Adverse event to evaluate safety and tolerability of CLS003
Time frame: Days 0-98
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