A Comparison of White-light and Daylight Topical Methyl 5-aminolaevulinic Acid Photodynamic Therapy for Actinic Keratoses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 主要终点
- The reduction in the actinic keratosis count per treatment field
研究概览
简要总结
Photodynamic therapy (PDT) uses visible light to treat a premalignant condition, called actinic keratosis, which results on chronically sun exposed skin such as on a balding scalp. A cream is applied containing aminolaevulinic acid or methyl aminolaevulinate and this is converted in the cells to the photodegradable product protoporphyrin IX (PpIX). Visible light causes the degradation of PpIX resulting in the production of reactive oxygen species and then cell death in the actinic keratosis. In conventional PDT a lamp is used to supply the visible light. The main draw back to treatment is pain. Recent studies have shown that daylight can be used as the source of visible light and is as effective as conventional PDT. Patients find this form of treatment less painful and therefore preferable. The reduction in pain seen in daylight PDT appears to be related to the fact that no significant quantity of PpIX accumulates prior to exposure to the light source and small quantities of PpIX are activated continuously during daylight exposure. The drawback of performing daylight PDT in Ireland is the climate, both in terms of cloud cover and temperature. The typical daylight treatment times is 2 hours and it would be difficult for patients to stay outside in winter, spring and autumn. This study investigates the use of an artificial white light source, a Maquet PWD 50SF theatre-light, as an alternative.
详细描述
Study Summary:
Title:
A Randomized Single-blinded, Prospective Study to compare a Maquet PWD 50SF theatre-light as a light source with natural daylight for the application of photodynamic therapy (PDT) to treat actinic keratoses.
Photodynamic therapy (PDT) is of proven efficacy for treatment of actinic keratosis (AK) and is increasingly used internationally. It involves the topical application of 5-aminolaevulinic acid cream (ALA) or its methyl ester methyl 5-aminolaevulinic acid (MAL), which is absorbed into the AK and converted into a photosensitizing compound protoporphyrin IX. When the AK is then exposed to visible light an oxygen dependent photochemical reaction is induced which results in cell death through apoptosis and necrosis.
Pain is the main limiting factor with PDT. Recently researchers have used natural daylight as the source of visible light for photodynamic therapy, a process called daylight PDT. This has been found to be equally effective as conventional PDT but less painful. Patients prefer this treatment option and in fact in Copenhagen, where they routinely offer daylight PDT from April to October, they have found that patients will frequently opt to defer their treatment until a time of year when daylight PDT is an option. The drawback of performing daylight PDT in Ireland is the climate, both in terms of cloud cover and temperature. The typical daylight treatment time is 2 hours and it would be difficult for patients to stay outside in winter, spring and autumn. This study investigates the use of an artificial white light source as an alternative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •patient requiring treatment for actinic keratoses on forehead or scalp
排除标准
- •immunosuppressed patients, those with abnormal photosensitivity, contact allergy to topical therapy for use in the study or pregnancy and breastfeeding
结局指标
主要结局
The reduction in the actinic keratosis count per treatment field
时间窗: 9 months follow up
Palpable AKs within those areas defined as treatment fields will be counted, mapped and photographed at baseline and at 1, 3, 6 and 9 months
次要结局
- Pain scores on visual analogue scale (VAS) at 1, 30, 60, 90 and 120 minutes during treatment(2 hours of treatment duration)
- Patient satisfaction with treatment, on a scale of zero to ten(At follow up one to three days post treatment)
- Erythema or erosions (mild/moderate/severe)(1 - 3 days post treatment)
研究者
Dr Paul Collins
Consultant Dermatologist
St Vincent's University Hospital, Ireland