EUCTR2007-000093-23-DE进行中（未招募）不适用
Clinical trial to investigate clinical efficacy and tolerability of Tretinoin in actinic keratosis - Tretinoin bei AK
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •All of the following criteria have to be met for inclusion of a subject in the study:
- •Male or female aged at least 18 years
- •Patients with no more than 10 clinically assessed AK (face/ scalp, mild - moderate) in a treatment area of approx 10 x 10 cm
- •Lesions with a grade of AK I + II ( acc to EDF guideline)
- •Willingness to accept a 4 weeks washout-phase for e.g. 5-FU, Diclofenac or Imiquimod and to avoid extended UV-exposure during the study period
- •Physical examination without further disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study;
- •Skin type I – IV (Fitzpatrick)
- •Women with childbearing potential must use a reliable method of contraception which result in a low failure rate (i.e. less than 1% per year) like implants, injectables, combines oral contraceptives, some intrauterine-devices, sexual abstinence or vasectomised partner
- •Pregnancy test negative
- •Physical ability to apply the product correctly and to follow the study restrictions and visits
- •Written informed consent obtained.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects are to be excluded from the study when one or more of the following conditions are met:
- •Current evidence of a Basal cell carcinoma, BCC or Squamous cell carcinoma, SCC in the treatment area
- •Treatment with topical AK-treatment (e.g. Solaraze®, Efudix®, Aldara®,) within the past 4 weeks
- •Treatment with PDT and/ or systemic Retinoids within the past 3 month
- •Indication for a biopsy for histological diagnostic
- •Cornu cutaneum like changes in the treatment area
- •Erosions or ulcers in the application area
- •Dermatological diseases in the target area, e.g. acute skin inflammation, acute eczema, rosacea, peri-oral dermatitis or hyper-pigmentation
- •Simultaneous application of further topical products in the target area, e.g. BPO
- •Immunosuppressive drugs (e.g. Methotrexat, Sulfonylurea)
- •Pregnancy or breastfeeding
- •Evidence of drug or alcohol abuse;
- •Symptoms of another clinically significant illness that may influence the outcome of the study in the four weeks before and during the study;
- •Participation in another clinical study in the 4 weeks preceding the study;
- •Known allergic reactions to components of the study preparations, e.g. butylhydroxytoluol, cetylstearic alcohole, sorbin acid, propylene glycol, perfume
- •Treatment with systemic or locally acting medications which might counter or influence the study aim
- •Noneligibility for this study by discretion of the investigator or physician performing the initial examination, e.g. due to probable non-compliance or inability to understand the study or give adequately informed consent.
研究者
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