Impact of a Cream Containing Madecassoside and 5 % Panthenol in Post Photodynamic Therapy Procedure for Actinic Keratosis: A Randomized, Controlled Trial
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
- Changes in local skin responses after PDT in Cicaplast Baume B5+ treated skin vs. non-post-treated skin
研究概览
简要总结
Premalignant AKs are highly frequent in the light-skinned populations with an increasing incidence. PDT is considered a well-establish treatment for these lesions, and therefore it is essential to achieve an optimal and effective treatment as possible. The present study proposes a new post-treatment modality with application of an anti-inflammatory moisturizer Cicaplast Baume B5+ to the treated areas that may improve the overall patient satisfaction and minimize the local skin reactions. Treatment regime consists of two daily applications of Cicaplast Baume B5+ for 14 days, and this regime is not associated with increased risk of systemic AEs or serious events.
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •> 18 years of age or older at baseline
- •Fitzpatrick skin type I-III
- •Clinical AKs in two symmetrical areas on the face or on the chest, presented with at least ten AKs
- •Female subjects of childbearing potential must be confirmed not pregnant by negative pregnancy test prior to study inclusion and must use a safe contraceptive method during the study
排除标准
- •Previous exposure to PDT, energy-based devices, or AK treatment on the study areas within 3 months
- •Pregnant or lactating women
- •Patients with known allergy to MAL or any ingredients in Cicaplast, Baume B5+
- •Concomitant treatment with immunosuppressant drugs
- •Infiltrating tumors in the treatment areas
- •Known porphyria
- •Other skin diseases present in the test area at baseline
- •Non-eligibility at the discretion of the investigator (e.g. non-compliance, unavailability or other reasons the subject is not believed to be able to comply with the clinical trial protocol)
结局指标
主要结局
Changes in local skin responses after PDT in Cicaplast Baume B5+ treated skin vs. non-post-treated skin
时间窗: From baseline to day 30
OCT system will be used to visualize the epidemis and upper dermis and changes in the cutanous microvascular morphology. All images will be evaluated qualitatively and quantitively using the integrated OCT software.
Evaluation of AK identification and grading before PDT and following PDT treatment in skin treated with Cicaplast Baume B5+ treated skin vs. non-post-treated skin
时间窗: Evaluated at baseline and at day 30
Evaluation of clinical response including AK identification and grading will be performed by trained physicians at baseline and at follow-up visits. AK identification and grading will be performed according to Olsen grade classification system: * Grade I: Flat, pink maculae without signs of hyperkeratosis and erythema often easier felt than seen * Grade II: Moderately thick hyperkeratosis on background of erythema that easily felt and seen * Grade III: Very thick hyperkeratosis Occurrence of new AKs in the treatment areas will be recorded at day 30 using the baseline template. The number and severity of the new lesion in the treatment areas will be recorded.
Changes in clinically assessed local skin responses after PDT in Cicaplast Baume B5+ treated skin vs. non-post-treated skin from baseline to day 30
时间窗: From baseline to day 30
Clinical evaluation of erythema, edema, and crusting will be done in the two treatment areas at all visits and scored on a four-point scale (0-3): None, mild, moderate, or severe
次要结局
- changes in the skin barrier function from baseline to day 30(from baseline to day 30)
- Pain during PDT treatment(During the procedure)
- Changes in pigmentation and redness of the skin from baseline to day 30(From baseline to day 30)
- Pain in the treatment areas(from day 1 to day 30)
- Incidence of prutitus in the treatment areas from day 1 to day 30(from day 1 to day 30)
- Patients satisfaction with the treatment of daylight PDT + Cicaplast Baume B5+ compared to daylight PDT alone(from baseline to day 30)
研究者
Merete Haedersdal
Professor, PhD., dr. med.
Bispebjerg Hospital