A Multi-center, Open, Randomized, Parallel Group Study to Assess Safety, Tolerance and Preliminary Efficacy of ALA for the Treatment of Moderate to Severe Acne Vulgaris
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 4
- 主要终点
- Success rate in Investigator's Global Assessment (IGA)(8wks)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chinese male or female patients aged 18 - 40 years;
- •Grade III-IV facial acne vulgaris according to the Pillsbury International Improvement scale.;
- •All patients claimed to take effective contraception from 14 days before to 1 month after the end of the study, (among those who had used contraceptive two weeks prior to the study, the dosage of the drug should remain the same throughout the study) and had no fertility or donation of sperm/egg plan;
- •Informed consents were signed.
排除标准
- •Suffering with malignant tumors, cardiac, endocrine, blood, liver, immunity, metabolism, urinary system, lungs, nervous system, rheumatism / joint, psychology and kidney diseases;
- •Obviously abnormal liver and kidney function;
- •Suffering with allergy diseases; suspected or known to have porphyria; allergic to studying drugs and / or porphyrin; allergic to visible light; allergic constitution (allergic to two or more drugs, food or pollen);
- •Secondary acne patients, such as occupational acne or acne caused by corticosteroids;
- •Complicated with other obvious facial skin diseases such as actinic dermatitis, psoriasis, seborrheic dermatitis, eczema, skin tumors, etc;
- •Other diseases that may significantly affect the efficacy evaluation;
- •Pregnancy, lactation patients;
- •Exposed to systemic retinoids 2 months prior to the study (acitretin for 6 months);
- •Exposed to systemic antibiotics, glucocorticoids, spironolactone and other drugs for treating acne 4 weeks prior to the study; physical therapy for the treatment of acne;
- •Exposed to topical retinoids on the face 4 weeks prior to the study or topical antibiotics, glucocorticoids, and other topical treatment 2 weeks prior to the study;
- •Participated in other clinical trials 3 months prior to the study;
- •Other reasons that the investigator considered inappropriate for participation in the study.
研究组 & 干预措施
ALA 2.5% 0.5h
Topical application of 2.5% ALA for 0.5 hour
干预措施: ALA 2.5% (Drug)
ALA 2.5% 1.5h
Topical application of 2.5% ALA for 1.5 hours
干预措施: ALA 2.5% (Drug)
ALA 2.5% 3h
Topical application of 2.5% ALA for 3 hours
干预措施: ALA 2.5% (Drug)
ALA 5% 3h
Topical application of 5% ALA for 3 hours
干预措施: ALA 5% (Drug)
ALA 5% 1.5h
Topical application of 5% ALA for 1.5 hours
干预措施: ALA 5% (Drug)
ALA 10% 0.5h
Topical application of 10% ALA for 0.5 hour
干预措施: ALA 10% (Drug)
ALA 10% 3h
Topical application of 10% ALA for 3 hours
干预措施: ALA 10% (Drug)
ALA 10% 1.5h
Topical application of 10% ALA for 1.5 hours
干预措施: ALA 10% (Drug)
ALA 5% 0.5h
Topical application of 5% ALA for 0.5 hour
干预措施: ALA 5% (Drug)
结局指标
主要结局
Success rate in Investigator's Global Assessment (IGA)(8wks)
时间窗: 8 weeks after the last treatment
Proportion of subjects with an assessment of clear or almost clear with at least a 2-grade improvement in IGA
Number of Participants With Treatment Related Adverse Events
时间窗: up to 8 weeks after last treatment
Number of participants with treatment related adverse events as assessed by physical examination, vital signs, clinical laboratory values, local skin responses
Percent Changes From Baseline in Total Lesion Counts
时间窗: 8 weeks after the last treatment
次要结局
- Proportion of acne severity improvement as assessed with the Investigator's Global Assessment (IGA)(4, 8 weeks after the last treatment)
- Percent Change from Baseline in inflammatory and non-inflammatory lesion counts(4, 8 weeks after the last treatment)
- Success rate in Investigator's Global Assessment (IGA)(4wks)(4 weeks after the last treatment)
- Change in Quality of Life of Subjects from Baseline(4, 8 weeks after the last treatment)