NCT01146444已完成不适用
Investigation of the Efficacy of Different Sunscreens in Patients With Photosensitive Cutaneous Lupus Erythematosus
Spirig Pharma Ltd.2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2009年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Prevention of skin lesions following standardized photoprovokation with UVA/UVB light in patients with CLE
研究概览
简要总结
Part I: to investigate the efficacy of different sunscreens in the prevention of skin lesions following standardized photoprovocation with Ultraviolet A/Ultraviolet B (UVA/UVB) light in patients with CLE.
Part II: to evaluate the influence of different sunscreens on the expression of biomarkers in the skin of patients with CLE and of Healthy Controls following UV irradiation.
详细描述
Part I
Part I-interventions will be:
- Experimental intervention: Application of broad-spectrum sunscreens with a low, medium, and high Sun Protection Factor (SPF) in random order to uninvolved skin areas prior to standardized photoprovocation.
- Control intervention: Intra-individual application of vehicle in random order; standardized photoprovocation of vehicle treated and untreated areas.
Part II
Part II-interventions will be:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with subacute cutaneous lupus erythematosus (SCLE), discoid lupus erythematosus (DLE), or lupus erythematosus tumidus (LET) according to the Düsseldorf Classification 2004 (Kuhn and Ruzicka 2004) confirmed by histological analysis.
- •Women of childbearing potential with a negative pregnancy test at screening (urine test) and using a medically accepted contraceptive regimen (intra-uterine device, partner's vasectomy, >3 months previous hormonal contraception (oestrogen plus gestagen pill, depot injections, or subcutaneous depot) combined with a barrier method (preservative, vaginal diaphragm, cervical cap, spermicide) during the study and for 8 weeks after the last UV exposure.
- •Women clinically sterile (post-menopausal, undergone hysterectomy or tubal ligation).
- •Actively cooperating to participate in the study, to follow the instructions of the investigator and to attend the centre at the agreed times.
- •Development of skin lesions any time under current systemic treatment if patient is receiving systemic medication for the treatment of CLE.
- •Signed informed consent form after the nature of the study has been fully explained.
排除标准
- •Pregnancy or lactation and women with positive pregnancy test.
- •Known hypersensitivity or allergic contact reactions to components of the study agents.
- •Treatment with photosensitizing drugs.
- •Exposure to direct natural (sunlight) or artificial UV radiation on the back within 4 weeks prior to entering the study.
- •History of another photodermatosis, except polymorph light eruption (PLE).
- •Any current known skin malignancy or any history of skin malignancy within the previous 5 years or Xeroderma pigmentosum.
- •Initiation or change in the dose of any current systemic medication for the treatment of CLE within 8 weeks prior to standardized photoprovocation.
- •Local therapy for the treatment of CLE within two weeks prior to standardized photoprovocation at the back of the patient
- •Acute exacerbation of CLE skin disease within 2 weeks prior to entering the study.
- •Acute illness within 7 days prior to phototesting or major illness including infection or hospitalization within 1 month of study entry.
- •Anti-dsDNA (RIA) > 7 U/ml and/or at least one of the following criteria:
- •Serositis: pleuritis or pericarditis documented by electrocardiogram or rub or evidence of pericardial effusion;
- •Renal disorder: proteinuria greater than 0.5 g/d or greater than 3+, or cellular casts;
- •Neurologic disorder: seizures or psychosis without other cause.
- •Patients with a documented HIV and/or hepatitis B or C infection.
- •Any medical condition, which would place the subject at undue risk of, or make it unlikely that follow-up-measurements could be obtained
结局指标
主要结局
Prevention of skin lesions following standardized photoprovokation with UVA/UVB light in patients with CLE
时间窗: September 2011
次要结局
未报告次要终点
研究者
研究点 (2)
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