NCT01656226Unknown4 期
A Randomised Double-blind Parallel-group Study to Evaluate the Long-term Effects of Eryfotona AK-NMSC® Cream in the Treatment of Cancerization Field in Patients With Actinic Keratosis.
适应症
试验速览
- 阶段
- 4 期
- 发起方
- ISDIN
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Percentage of patients with partial clearance of AK lesions
研究概览
简要总结
The purpose of this study is to assess the efficacy, safety and tolerability of Eryfotona AK-NMSC® topical application vs Sunscreen on cancerization field of actinic keratosis patients after 6 months of treatment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current diagnosis of AK, with ≥4 lesions located in the same anatomical district (within a contiguous 50 cm2 area on the face, bold scalp or forehead);
- •Female or male >18 years of age;
- •Skin type I or II according to Fitzpatrick;
- •Patient has confirmed his/her willingness to participate in this study;.
排除标准
- •Topical drug therapy for AK within the past 3 months or for photoaging in the last 6 months, or had lesion-directed therapy within 2 cm2 of the selected AK area during the previous month;
- •Suitable for surgical, photodynamic or any other topical treatment in the next 6 months;
- •Subjects who suffer/ had suffered from skin cancer or show an early stage of skin cancer or have a genetic predisposition for skin cancer;
- •Other skin disease that requires treatment with other medications in the treatment area or in the distance of 3 cm;
- •Immunosuppression or current treatment for cancer;
- •Clinically unstable medical condition;
- •High risk group for HIV infection or presentation of other infectious diseases
- •Presentation of contact allergies or allergies to compounds of the test substances;
- •Smoker (more than forty cigarettes per day) or heavy drinker (more than three standard drinks per day);
- •Psychiatric disease that may interfere with follow up of study procedures;
- •Participation in other clinical trials up to 30 days prior to day 1 of the study
- •Prior treatment with study medication in the area to be treated;
- •Considered by the investigator, for any other reason, to be an unsuitable candidate for the study.
结局指标
主要结局
Percentage of patients with partial clearance of AK lesions
时间窗: 6 months
Comparison between treatment groups at the end of the treatment period
次要结局
- Total number of AK lesions in the treated area (including all lesions present at baseline as well as subclinical lesions which appeared during therapy)(6 months)
- Percentage of patients with changes in Baseline Severity Index (BSI)(6 months)
- Number of patients with AEs and local AEs (skin reactions)(6 months)
- Percentage of patients with clearance and improvement of AK lesions(6 months)
- Percentage of patients with improvement (clinical and dermoscopic assessment) of the target area as for the erythema, scaling, pigmentation and follicular plugs(6 months)
- Percentage of patients with improvement in the target AK lesion by using RCM score.(6 months)
- Percentage of patients with improvement in the "cancerization filed" by RCM score(6 months)
- Percentage of patients compliant to treatment(6 months)
- Percentage of patients which report satisfaction to local tolerability(6 months)
- Percentage of patients which report satisfaction to treatment(6 months)
- Percentage of patients with changes in the Investigator Global Improvement Index(6 months)
研究者
研究点 (1)
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