Efficacy and Safety of STBF Photodynamic Therapy for Moderate and Severe Acne Vulgaris
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 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 evaluate the efficacy and safety of Shengtaibufen photodynamic therapy (STBF-PDT) for treatment of moderate or severe acne vulgaris.
详细描述
This study is a split randomized controlled trial and being done to evaluate the efficacy and safety of Shengtaibufen photodynamic therapy (STBF-PDT) for treatment of moderate or 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
- Single (Participant)
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 18-30 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 surgery for various reasons,unwilling to undergo surgery, 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 People with sexual coagulopathy
- •Those with severe neurological, psychiatric or endocrine diseases; (10)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
Red light
The Shengtaibufen photodynamic therapy group underwent narrow-band light-emitting diode (LED) irradiation (630 nm; 150 J/cm2) after applying normal saline solution for 45min. A repeat treatment was administered once weekly for a maximum of 3 weeks.
干预措施: Red light (Procedure)
Shengtaibufen Photodynamic Therapy(STBF-PDT)
The Shengtaibufen photodynamic therapy group underwent narrow-band light-emitting diode (LED) irradiation (630 nm; 150 J/cm2) after applying 0.5mg/ml Shengtaibufen solution for 45min. A repeat treatment was administered once weekly for a maximum of 3 weeks.
干预措施: Shengtaibufen Photodynamic Therapy(STBF-PDT) (Procedure)
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 one month after the last treatment
The clearance rate of Moderate or Severe Acne will be measured at one month after the last treatment
次要结局
- Adverse effect(Immediately, 1 hour, 12 hours, 24hours and 48 hours after treatment)