Efficacy of Topical 5-FUvs Calcipotriol As PDT Pre-treatment for Field Actinic Keratoses
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Efficacy of treatment as assessed by proportion of participants with complete clearance of AKs from baseline (100% reduction)
研究概览
简要总结
The purpose of this study is to compare two different creams (5-fluorouracil, known as Efudix, and calcipotriol, known as Dovonex) to see which one works better when used before Photodynamic Therapy (PDT) to treat sun-damaged skin on the scalp (called actinic keratoses).
PDT is often used on its own to treat these spots, but it doesn't always remove them completely. Using Efudix or Dovonex before PDT might improve the results, but we don't yet know which is better.
The main questions are -
- Is efudix or dovonex better at treating actinic keratoses when used prior to PDT
- Is efudix or dovonex more tolerable for patients?
Participants will be randomised to treat their scalp with efudix or dovonex for seven days prior to their first PDT treatment. They will be reviewed on day 7, prior to starting PDT, and again a week later when they present for their second PDT treatment.
During follow up, patients will be reviewed at 28 days, 3, 6, 9, and 12 months after treatment.
At each of these visits, the number of actinic keratoses will be counted, graded, mapped and photographed to allow assessment of improvement before and after treatment.
详细描述
- Recruitment We will enrol 50 number of patients in our department who have been referred for daylight PDT treatment of actinic keratoses on the scalp and forehead. The patients will be given a study specific number based on the order of their enrolment. 25 patients will be randomised to be pre-treated with calcipotriol and 25 with 5-FU.
- Demographic data recorded Relevant baseline characteristics will be registered at baseline visit (prior history of skin cancer, smoking yes/no, history of sun exposure, use of immunosuppressant medication in history, prior treatments for AK.
- Initial visit - counting AKs / mapping / photos The boundaries of the area to be treated will be defined and marked using a skin marker. Photographs will be taken of right and left scalp, and the scalp straight on - with the study number and markings visible.
We will count the AKs in each treatment area, then grade, mark and map them. AKs will be graded using the Olsen classification system. Grade 1 means they are hardly visible but palpable. Grade 2 means they are visible and palpable. Grade 3 means they are hyperkeratotic. We will photograph the treatment areas again as outlined above, with the AKs marked.
In all patients hyperkeratotic lesions will be pre-treated with paraffin gel to remove keratotic debris. Photographs will be taken as above with the AKs marked using a skin marker.
A polythene map will be made by marking over each previously marked AK and the outline of template, marked with surface landmarks for purpose of locating treatment site at follow-up. This will be photographed as above. 4. Randomisation & Blinding Randomisation will be achieved by block randomisation (1:1) with the patient choosing an envelope with a card marked 5-FU or calcipotriol, which will determine which pre-treatment is used.
The phototherapy nurses will be unblinded and will apply the pre-treatments. Investigators MH, BM and AL will all be blinded to which treatment the patient is for patient reviews. 5. Pre-treatment Initially, patients will present to the department for pre-treatment. Prior to pre-treatment, the treatment will be marked out using the patients previous photos and polythene maps as a reference.
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 (Investigator, 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
- •Adult (>18 years old)
- •Field actinic keratoses on scalp
- •Generally good health
排除标准
- •Immunosuppression
- •Unable to provide consent
- •Abnormal photosensitivity
- •Contact allergy to metvix / 5-FU / calcipotriol / topical corticosteroids
- •Pregnancy or breastfeeding
研究组 & 干预措施
Calcipotriol / Dovonex
Randomised to PDT pre-treatment with calcipotriol
干预措施: 5-FU (fluorouracil) (Drug)
Calcipotriol / Dovonex
Randomised to PDT pre-treatment with calcipotriol
干预措施: Calcipotriol (Drug)
Calcipotriol /Dovonex
Calcipotriol pre-treatment prior to PDT
干预措施: 5-FU (fluorouracil) (Drug)
Calcipotriol /Dovonex
Calcipotriol pre-treatment prior to PDT
干预措施: Calcipotriol (Drug)
结局指标
主要结局
Efficacy of treatment as assessed by proportion of participants with complete clearance of AKs from baseline (100% reduction)
时间窗: 6 months post treatment
Assessed by number of participants with complete clearance of AKs at 6 months post treatment. Complete clearance is is defined as 100% reduction in the number of AKs from baseline. AKs will be counted, marked, mapped and photographed at each visit.
Tolerability of treatment
时间窗: Day of treatment, day 7 and day 28
assessed by pain scores (visual analogue scale, 0-10), documentation of local effects such as erythema and erosions and recording of any adverse events
次要结局
- Near-complete response(3, 6, 9 and 12 months post treatment)
- Partial response rate(3, 6, 9 and 12 months post treatment)
- Treatment failure rate(3, 6, 9 and 12 months post treatment)
- Decrease in number AK from baseline per patient(1, 3, 6, 9 and 12 months post final treatment.)
- Proportion of patients who develop a SCC in the treatment area during study follow-up period(12 months)
- Complete response at 3,9 & 12 months(3, 9 and 12 months post treatment)
研究者
Maeve Herlihy
Dr Maeve Herlihy
St Vincent's University Hospital, Ireland