Single centre, open-label, intra-individual, comparison, proof of concept study to determine the efficacy of an artemether topical formulation in subjects with seborrheic keratosis

EpiPharm AG0 个研究点目标入组 15 人开始时间: 2015年2月25日最近更新: 2016年10月17日

适应症

试验速览

暂无简介。

•1. Age above 40 years old
•2. Phototype II, III and IV
•3. At least 8 flat or slightly elevated SK lesions with a pasted-on” look and typical
•characteristics
•4. Lesion size: longest axis (dimension) 2 mm to 10mm
•5. Willingness to participate in the study and to comply with the study protocol
•6. Written informed consent

•1. Presence of pregnancy, lactation, childbearing potential without contraception
•2. Female participants of childbearing potential not using and not willing to continue using a medically reliable method of contraception
•4. SK lesion close to the eye or mucosa (mouth, genitals)
•5. Lesion in a skin fold or an area where clothing (e.g. belt) may cause physical irritation
•6. Pedunculated, verrucous, papilomatous and irritated lesions
•7. Presence of clinically significant skin or systemic disease
•8. Pathological findings at screening (melanoma, lentigo maligna, inflammation, bleeding)
•9. Concomitant participation in another study
•10. Traveling to regions with endemic malaria
•11. Previous use of treatment of the lesions within 2 years prior to visit 1
•12. Known or suspected non-compliance, drug or alcohol abuse
•13. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
•14. Enrolment of the investigator, his/her family members, employees and other dependent persons

发起方