EUCTR2006-005432-24-DE进行中（未招募）不适用
Clinical trial to investigate clinical efficacy and tolerability of Verrumal in actinic keratosis (PoC) - Verrumal in 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）
- 入组人数
- 15
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 18 + years;
- •clinical assessment of max 5 actinic keratoses on face, scalp and/ or hands
- •mild to moderate actinic keratosis lesions (AK I + II) up to 1,5 cm in diameter
- •minimal distance between lesions of 1,5 cm
- •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 (in women with childbearing potential)
- •physical ability to apply the product correctly
- •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:
- •Acute or pre-existing Basal cell carcinoma, BCC or Squamous cell carcinoma, SCC
- •Treatment with topical treatment (e.g. Diclofenac/ Solaraze®) within the past 4 weeks
- •Treatment with PDT within the past 3 month
- •Indication to perform a biopsy for histological diagnostic
- •„Cornu cutaneum-like phenomena in treatment area
- •Non-responder to previous 5-FU treatment
- •Erosion or ulcera in the application area
- •Acute skin inflammation in the target area
- •Indication for immunosuppressive drugs (e.g. Methotrexat, Sulfonylharnstoff)
- •Indication for treatment with Brivudin (Zostex®) within the past 4 weeks (interaction with 5-FU)
- •Known lack of Dihydropyrimidine dehydrogenase (DPD) activity
- •Indication for treatment with Phenytoin (Phenhydan®, Phenytoin-AWD®, Zentropil®) within the past 4 weeks (interaction with 5-FU)
- •Pregnancy or breastfeeding
- •Known renal insufficiency
- •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
- •treatment with systemic or locally acting medications which might counter or influence the study aim
- •in the opinion of the investigator or physician performing the initial examination the subject should not participate in the study, e.g. due to probable non-compliance or inability to understand the study and give adequately informed consent.
研究者
相似试验
进行中（未招募）
不适用
Clinical trial to investigate clinical efficacy and tolerability of Tretinoin in actinic keratosis - Tretinoin bei AKMedDRA version: 9.1Level: LLTClassification code 10000614Term: Actinic keratosisactinic keratosisEUCTR2007-000093-23-DEAlmirall Hermal GmbH
已完成
不适用
A clinical trial to investigate the efficacy and safety of video-laryngoscopes for education of tracheal intubatioJPRN-UMIN000011477Department of Anesthesiology and Critical Care, Hiroshima University Hospital500
进行中（未招募）
2 期
Study on efficacy of herbal drugs in reducing viral load in HIV/AIDS patientsCTRI/2022/09/045548MVR Ayurveda medical college
招募中
3 期
Thalidomide effects in COVID-19Covid 19.Covid 19IRCT20110423006257N3Arak University of Medical Sciences66
尚未招募
不适用
Clinical trial to investigate the efficacy and safety of fish skin-derived collagen on wall thickness in the carotid artery and clinical symptom, etc. in healthy adults and subjects with mild carotid artery hypertrophy by a double-blind parallel group comparison desigHealthy adults and subjects with mild carotid artery hypertrophyJPRN-UMIN000026277Kojinkai Medical Corporation Shin-Nihonbashi Ishii clinic120