This study will evaluate the safety, efficacy and pharmacokinetics of KR230109 cream compared with placebo in Patients (18-40 Years) with Acne vulgaris
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
180
KR230109 cream 0.025% is indicated for the topical treatment of acne vulgaris in patients
KR230109 cream 0.05% is indicated for the topical treatment of acne vulgaris in patients
Vehicle cream manufactured to mimic look and feel of KR230109 Cream but without the active ingredient.
The percentage change from baseline in the count of non-inflammatory facial lesions
The percentage change from baseline in the count of non-inflammatory facial lesions at Week 12 compared with placebo in each treatment group.
Time frame: week 12
The percentage change from baseline in the count of inflammatory facial lesions
The percentage change from baseline in the count of inflammatory facial lesions at Week 12 compared with placebo in each treatment group.
Time frame: week 12
The average percentage change from baseline in the counts of inflammatory and non-inflammatory skin lesions
The average percentage change from baseline in the counts of inflammatory and non-inflammatory skin lesions at weeks 2, 4, 8 of treatment compared with placebo for each treatment group.
Time frame: week 2,4,8
The absolute change from baseline in the counts of inflammatory and non-inflammatory skin lesions
The absolute change from baseline in the counts of inflammatory and non-inflammatory skin lesions at weeks 2, 4, 8, 12 of treatment compared with placebo for each treatment group.
Time frame: week 2,4,8,12
The average percentage change and absolute change from baseline in the total skin lesion count
The average percentage change and absolute change from baseline in the total skin lesion count at weeks 2, 4, 8, 12 of treatment compared with placebo for each treatment group.
Time frame: week 2,4,8,12
The proportion of participants in each treatment group with at least a 2-point reduction in IGA score from baseline and an IGA score of 0 or 1
The proportion of participants in each treatment group with at least a 2-point reduction in IGA score from baseline and an IGA score of 0 or 1 at weeks 2, 4, 8, 12 of treatment compared with placebo.
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Time frame: week 2,4,8,12
Safety endpoints
Adverse events (AEs), local skin reactions (LSRs), physical examinations, vital signs, electrocardiograms (ECGs), and abnormal clinical laboratory tests (blood routine, blood biochemistry, urine routine).
Time frame: from day 1 to week 12
Steady-state PK parameters of KR230109: Cmax,ss.
Steady-state PK parameters of KR230109: Cmax,ss.
Time frame: week 4
Steady-state PK parameters of KR230109: AUC0-24h,ss, etc.
Steady-state PK parameters of KR230109: AUC0-24h,ss, etc.
Time frame: weeks 4