Efficacy and Safety of Painless 5-aminolevulinic Acid Photodynamic Therapy for the Treatment of Moderate and Severe Acne Vulgaris-- A Multi-center, Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- The clearance rate of Moderate or Severe Acne
研究概览
简要总结
This study is being done to compare a new, continuous illumination and short Incubation time regimen of 5-aminolevulinic acid photodynamic therapy (painless ALA- PDT) to low-dose and conventional dose of oral isotretinoin for treatment of moderate or severe acne vulgaris. The hypothesis is that the painless ALA- PDT will be equally or more efficacious as oral isotretinoin, and taking effect more quickly with less adverse effect.
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
- Single (Outcomes Assessor)
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
- •Clinical diagnosed with moderate to severe acne
- •Male and female patients of age between 18-40 years old
- •All patients read the instructions of the subject, willing to follow the program requirements
- •No other topical treatment received within 2 weeks prior to enrollment
- •No systemic treatment was given within 4 weeks prior to enrollment
- •Patients were unsuitable for other treatments for various reasons and signed informed consent when they had informed other alternatives and agreed to take pictures of the lesion
排除标准
- •Those who did not complete the informed consent
- •The lesions belongs to any of the following conditions: There is damage and inflammation, which may lead to the drug entering the open wound
- •Patients with skin photoallergic diseases, porphyria
- •Known to have a history of allergies to test drugs (porphyrins) and their chemically similar drugs
- •Patients with other obvious diseases that may affect the evaluation of efficacy
- •Scars or patients with a tendency to form scars
- •Known to have severe immune dysfunction, or long-term use of glucocorticoids and immunosuppressants
- •Severe heart, liver, kidney disease; with hereditary or acquired coagulopathy
- •Those with severe neurological, psychiatric or endocrine diseases
- •Women who are pregnant, breast-feeding or using inappropriate contraceptives -Those with a history of drug abuse; those who have participated in other drug clinical trials within 4 weeks before treatment
研究组 & 干预措施
Painless Photodynamic Therapy(P-PDT) group
The painless photodynamic therapy group underwent narrow-band light-emitting diode (LED) irradiation (630 nm; 150 J/cm2) after applying 5% 5-aminolevulinic acid(ALA) cream for 30min. A repeat treatment was administered once weekly for a maximum of 5 times. Blood samples, urine routine, blood biochemistry and electrocardiogram were performed before treatment and after treatment.
干预措施: Aminolevulinic acid photodynamic therapy (Procedure)
conventional-dose isotretinoin group
Patients in the conventional-dose isotretinoin group were given oral isotretinoin 0.5 mg/kg daily for 6 months, and the cumulative dose was 90 mg/kg. Time for subsequent visit: once every two weeks during the 1st and 2nd months, monthly during 3rd to 6th months. Blood samples, urine routine, blood biochemistry and electrocardiogram were performed before treatment and 2nd , 6th months after treatment.
干预措施: Oral conventional-dose isotretinoin (Drug)
low-dose isotretinoin group
Patients in the low-dose isotretinoin group were given oral isotretinoin 0.2 mg/kg daily for 6 months, and the cumulative dose was 36 mg/kg. Time for subsequent visit: once every two weeks during the 1st and 2nd months, monthly during 3rd to 6th months. Blood samples, urine routine, blood biochemistry and electrocardiogram were performed before treatment and 2nd , 6th months after treatment.
干预措施: Oral low-dose isotretinoin (Drug)
结局指标
主要结局
The clearance rate of Moderate or Severe Acne
时间窗: The clearance rate of Moderate or Severe Acne will be measured at 1st month after the last treatment
The clearance rate of Moderate or Severe Acne will be measured at 1st month after the last treatment
次要结局
- Pain assessment(immediately, 1st minute, 3rd minute, 5th minute, 7th minute, 10th minute and 2nd hour, 12th hour, 24th hour and 48th hour after treatment)