The purpose of this study is to explore the safety, tolerability, and preliminary efficacy of ALA used with photodynamic therapy for the treatment of moderate to severe acne vulgaris.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Topical treatment for photodynamic therapy, after drug incubation subsequent illumination with red light (72 J/cm2). 4 treatments at an interval of 10 (± 4) days.
Topical treatment for photodynamic therapy, after drug incubation subsequent illumination with red light (72 J/cm2). 4 treatments at an interval of 10 (± 4) days.
Topical treatment for photodynamic therapy, after drug incubation subsequent illumination with red light (72 J/cm2). 4 treatments at an interval of 10 (± 4) days.
Hospital for Skin Diseases, Chinese Academy of Medical Sciences
Nanjing, Jiangsu, China
Huashan Hospital
Shanghai, Shanghai Municipality, China
Shanghai Dermatology Hospital
Shanghai, Shanghai Municipality, China
The General Hospital of the People's Liberation Army
Beijing, China
Success rate in Investigator's Global Assessment (IGA)(8wks)
Proportion of subjects with an assessment of clear or almost clear with at least a 2-grade improvement in IGA
Time frame: 8 weeks after the last treatment
Percent Changes From Baseline in Total Lesion Counts
Time frame: 8 weeks after the last treatment
Number of Participants With Treatment Related Adverse Events
Number of participants with treatment related adverse events as assessed by physical examination, vital signs, clinical laboratory values, local skin responses
Time frame: up to 8 weeks after last treatment
Percent Change from Baseline in inflammatory and non-inflammatory lesion counts
Time frame: 4, 8 weeks after the last treatment
Success rate in Investigator's Global Assessment (IGA)(4wks)
Proportion of subjects with an assessment of clear or almost clear with at least a 2-grade improvement in IGA
Time frame: 4 weeks after the last treatment
Proportion of acne severity improvement as assessed with the Investigator's Global Assessment (IGA)
Time frame: 4, 8 weeks after the last treatment
Change in Quality of Life of Subjects from Baseline
Change in Quality of life will be assessed based on Acne-specific Quality of Life Questionnaire to be filled by subjects before and 4/8 weeks after last treatment
Time frame: 4, 8 weeks after the last treatment
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