A trial comparing Metvix® photodynamic therapy followed by Mohs micrographic surgery against Mohs micrographic surgery alone for the treatment of basal cell carcinoma

Guy's and St Thomas' NHS Foundation Trust (UK)0 个研究点目标入组 20 人开始时间: 2006年4月3日最近更新: 2019年5月27日

适应症

试验速览

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•1. Male or female subjects older than 18 years
•2. The above should have a basal cell carcinoma at least 100 mm^2 in surface area and appropriate for treatment with Mohs micrographic surgery
•3. Female subject of non-childbearing potential
•4. Subject must be willing and capable of cooperating with the study protocol
•5. Subject has to be able to read the patient information sheet as well as read and sign the informed consent form prior to any procedure

•1. BCCs with less than 100 mm^2 in surface area
•2. Clinically or histologically morphoeic basal cell carcinoma
•3. Female of child-bearing potential
•4. Subject with a history of porphyria, xeroderma pigmentosa or other photosensitive skin condition
•5. Subject with known hypersensitivity to methyl 5-aminolevulinate, a similar compound or excipients of the cream
•6. Subject who is at risk in terms of precautions and contraindications in the package insert for Metvix®
•7. Subject who has participated in another investigational drug or device research study within 30 days of enrolment
•8. Subject with a condition or who is in a situation, which in the investigator?s opinion may put the subject at significant risk, may confound the study results or may interfere significantly with the subject?s participation in the study. This includes individuals unable to understand the implications or procedures of the trial, for example if they cannot adequately understand written or spoken English.

发起方

Guy's and St Thomas' NHS Foundation Trust (UK)