NCT00673933已完成2 期
A Blinded, Randomized, Intra-individual, Vehicle-controlled and Multi-centre Study of Photodynamic Therapy With MAL Cream in Patients With Skin Type V or VI With Acne Vulgaris
Photocure2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2008年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Proportion of Patients With Moderate to Severe Hypopigmentation and Hyperpigmentation Assessed After Treatment
研究概览
简要总结
In this multicenter study, patients with dark skin and acne vulgaris will be included. The patients will receive treatment with MAL PDT and placebo PDT.
详细描述
The treatment period started within 2 weeks of the study screen. Patients received two treatments (MAL PDT and vehicle PDT) to each of the treatment areas, 2 weeks apart, and were followed-up 4 weeks after last treatment. The total duration of the study was 6-8 weeks.
Methyl aminolevulinate 80 mg/g cream (MAL cream 8%)and vehicle was applied for 1.5 hours before illumination (Aktilite® CL128), total light dose 37 J/cm2
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 15 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male patients, age 15 to 40 years with acne vulgaris.
- •Patients with skin type V or VI (Fitzpatrick).
- •Patients with two areas of each 8x8 cm2 on the back that include at least 5 inflammatory lesions (papules, pustules, and nodules) each. The minimum distance between the two areas should be at least 4 cm.
- •Patients with no more than 2 nodular lesions in any of the two areas of each 8x8 cm2 on the back.
- •Patients who are surgically sterile, postmenopausal, abstinent, or willing to use an adequate means of contraception including birth control pills, or barrier methods and spermicide for at least 14 days prior to Day
- •Patients using birth control pills must have used the same product and dose for at least 3 months and must agree to stay with the same product and dose for an additional 3 months.
- •Patients must be willing and capable of following study instructions to the extent and degree required by the protocol.
- •Patients must sign the approved informed consent form prior to any study procedures.
- •Patients must be willing to be photographed. Patients must be willing to sign a photography consent form.
排除标准
- •Known allergy to MAL, to a similar PDT compound, or to excipients of the cream.
- •Participation in other clinical studies either concurrently or within the last 30 days.
- •Patients who have a condition or who are in a situation, which, in the investigator's opinion, may put the patient at risk, may confound the study results, or may interfere with the patient's participation in the study.
- •Clinically significant sensitivity to visible light, or has porphyria or porphyrin sensitivity.
- •Exposure to ultraviolet radiation (UVB phototherapy) within the last 30 days.
- •Patients with a washout period for topical treatments for their acne in the two treatment areas of less than 14 days. Any topical treatment on the face or other areas outside the two treatment areas will be allowed.
- •Patients with a washout period for oral antibiotics for treatment of their acne of less than 1 month.
- •Patients with a washout period for oral isotretinoin of less than 6 months.
研究组 & 干预措施
1
Experimental
PDT using MAL crem
干预措施: Methyl aminolevulinate (MAL) PDT (Drug)
2
Placebo Comparator
PDT using Placebo cream
干预措施: Methyl aminolevulinate (MAL) PDT (Drug)
结局指标
主要结局
Proportion of Patients With Moderate to Severe Hypopigmentation and Hyperpigmentation Assessed After Treatment
时间窗: 4 weeks after last treatment, 6 weeks after baseline
次要结局
- Erythema Score (Mild and Moderate)Immediately After First PDT(Immediately after treatment at baseline)
- Change in Inflammatory Lesion Counts From Baseline(4 weeks after last treatment, 6 weeks after baseline)
- Change in Noninflammatory Lesion Counts From Baseline(4 weeks after last treatment, 6 weeks after baseline)
- Erythema Score (Mild and Moderate)1 Day After First Treatment(1 day after 1st treatment and baseline)
- Erythema Score (Mild and Moderate)Immediately After Second Treatment(Immediately after second treatment, 2 weeks after baseline)
研究者
研究点 (2)
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