TreatMent of ActInic KerAtosis Lesions : pharmacoepiDemiological Study of the Impact in Real Life of ingenOl Mebutate Gel (Picato®) on Patients Satisfaction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 1,218
- 主要终点
- Treatment Satisfaction Questionnaire of Medication (TSQM-9)
研究概览
简要总结
This is an observational longitudinal study, prospective, multicenter, performed in metropolitan France, on a representative sample of dermatologists.
Data will be collected by physicians during 2 or 3 visits (according to their usual practice), from the patient file, questioning and clinical examination performed during these visits.
Data about the patient's perception (satisfaction, perception of local skin reactions, quality of life) will be collected directly by the patient using self-administered questionnaires at inclusion visit, day 7 and 2 months later.
详细描述
Actinic keratosis (AKs) are common skin diseases affecting areas previously overexposed to the sun (in particular face, nape of the neck, hands). They affect mainly elderly people (mean age: 74 years old, with 97% who are over 50 years old) and preferably men (60%). In Europe, prevalence of AK in the adult population over 40 years is estimated to be between 6% and 25%.
Subjects at risk are light-skinned people (phototype I and II according to Fitzpatrick scale) with high cumulative sun exposure or phototherapy. Over 80% of patients have a light phototype and 37% of patients with AK have an outside professional activity.
Diagnosis of AK is usually clinical, during skin examination which is recommended for any physician's visit. There are often multiple lesions, some of which, in the absence of effective treatment, can progress to squamous cell carcinoma (0.025% to 20% per year/lesion).
Although the evolution rate of AKs to carcinoma remains low and disappearance or sole persistence of the lesion is possible, their evolution is unpredictable, and it is therefore recommended to monitor and treat the AKs.
Treatment options include cryotherapy, topical treatments, photodynamic therapy, vaporization of lesions by CO2 laser or electrocoagulation and curretage.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 at least 18 years old, seen by the dermatologist during a consultation, whether actinic keratosis is the reason for consultation or not.
- •Patient with AK lesions and for whom the dermatologist decided to initiate a treatment with Picato®* 150 or Picato®* 500
- •Patient informed and accepting the automatic processing of medical data * To respect the physicians' independence, this study is conducted among patients for whom the decision of therapeutic care is not related to their inclusion.
排除标准
- •Patient with a contraindication to treatment with Picato®.
- •Patient unable to read and/or to understand a self-administered questionnaire.
- •Patient already included in the study.
- •Patient participating or having participated in the previous month in a clinical trial in dermatology.
结局指标
主要结局
Treatment Satisfaction Questionnaire of Medication (TSQM-9)
时间窗: 2 months after end of treatment
The TSQM-9 scale is a 7-item instrument to be completed by patients. The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domaine.
次要结局
- Dermatology Life Quality Index - DLQI(Baseline and 2 months after end of treatment)
- Real-life efficacy of Picato(Between Day 1 after the treatment application and 12 months (maximum 2 follow-up visits after the inclusion))