Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Small Genital Warts：a Randomized, Open-label Trial
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 Genital Warts
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 aminolevulinic acid photodynamic therapy（ALA-PDT) to a conventional regimen for treatment of small genital warts. The hypothesis is that the continuous illumination approach will be less or even no painful, but equally efficacious, as the old regimen.
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)
盲法说明
Evaluator assesses photographs without prior knowledge of intervention
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosed with Genital Warts;
- •Aged > 18 years;
- •All patients are unfit and reluctant to undergo surgery for any reasons, and volunteered to participate in the study and ability to understand and the willingness to sign a written informed consent. Patents agreed to take a picture of the skin lesions.
- •The maximum diameter of a single carcass does not exceed 0.5cm; the skin lesions are at least 6 or more or substantially symmetric
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; the individual corpus callosum is more than 0.5cm in diameter; the corpus callosum is located in the vagina, the anal canal, the cervix;
- •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; (6)Scars or patients with a tendency to form scars;
- •(7)Known to have severe immune dysfunction, or long-term use of glucocorticoids and immunosuppressants; (8)Severe heart, liver, kidney disease; with hereditary or acquired People with sexual coagulopathy; (9)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
Painless Photodynamic Therapy（P-PDT）
The painless photodynamic therapy（P-PDT）group underwent narrow-band light-emitting diode (LED) irradiation (630 nm; 400 J/cm2) after applying 20% 5-aminolevulinic acid（ALA）cream for 30min. A repeat treatment was administered once weekly for a maximum of 3 weeks.
干预措施: Aminolevulinic acid photodynamic therapy (Procedure)
Conventional Photodynamic Therapy（C-PDT）
The conventional photodynamic therapy(C-PDT) group underwent narrow-band light-emitting diode (LED) irradiation (630 nm; 100 J/cm2) after applying 20% 5-aminolevulinic acid cream for 3h.A repeat treatment was administered once weekly for a maximum of 3 weeks.
干预措施: Aminolevulinic acid photodynamic therapy (Procedure)
结局指标
主要结局
The clearance rate of Genital Warts
时间窗: one week after the last treatment
The clearance rate of Genital Warts will be measured at one week after the last treatment.
次要结局
- The recurrence rates after treatment(3 months after the last treatment)
- Pain assessment(Immediately, 1st minute, 3rd minute, 5th minute, 7th minute, 10th minute , and every 10 minute to the end of treatment and 2 hours, 12 hours, 24hours and 48 hours after treatment)
研究者
Xiuli Wang
Director, Clinical Professor
Shanghai Dermatology Hospital