The purpose of this study is to assess efficacy safety and tolerability of HB0043 in adult patients with moderate to severe AV.
The total duration of the study is 18 weeks and consists of: Screening (up to 2 weeks) and Treatment Period (16 weeks).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
21
Dermatology Hospital affiliated to Shandong First Medical University,
Jinan, Shandong, China
Change in inflammatory lesion counts
Absolute change from Baseline in the number of inflammatory acne lesions
Time frame: Week 16
Investigator's global assessment (IGA) - change from Baseline
Absolute change in IGA score from Baseline \[scores: 0-4; 0=clear, 4=severe\]
Time frame: Week 16
Investigator's global assessment (IGA) - percentage of subjects with improvement
Percentage of subjects with at least two-grade improvement in their Baseline IGA score (assessment of mild, clear or almost clear) \[scores: 0-4; 0=clear, 4=severe\]
Time frame: Week 2, 4, 8, 12, 16
Change in inflammatory lesion counts
Percentage change from Baseline in the number of inflammatory acne lesions
Time frame: Week 16
Investigator's global assessment (IGA) - percentage of subjects with improvement
Percentage of subjects with an IGA score of "clear" or "almost clear"
Time frame: Week 2, 4, 8, 12, 16
Investigator's global assessment (IGA) - percentage of subjects with improvement
Percentage of subjects with an IGA score of "clear" or "almost clear" and a reduction of at least two-grade compared to the baseline IGA score.
Time frame: Week 2, 4, 8, 12, 16
Incidence of AEs and serious adverse events (SAEs))
Incidence of AEs and SAEs
Time frame: Baseline to week 16
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