A multicenter, double blind, vehicle-controlled, randomized study of photodynamic therapy (PDT) with Metvix®160 mg/g cream and Aktilite CL128 LED light in patients with multiple actinic keratoses on the face and/or scalp.

PhotoCure ASA0 个研究点目标入组 80 人开始时间: 2005年12月27日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•- Clinical diagnosis of 4-10 previously untreated, not pigmented, non-hyperkeratotic AK lesions of 3 mm or more diameter of Grade 1 and/or 2 (see Section 6.1) of the face and/or scalp where other therapies are unacceptable or considered medically less appropriate.
•- Males or females above 18 years of age.
•- Written informed consent.
•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

•- Patients with porphyria.
•- Patients immunosuppressed for idiopathic, disease specific or therapeutic reasons.
•- Known allergy to methyl aminolevulinate, a similar PDT compound or excipients of the cream.
•- Patients with history of hypersensitivity to nut products or other known protein antigens.
•- Participation in other clinical studies either currently or within the last 30 days.
•- Patients receiving local treatment (including cryotherapy and curretage) in face / scalp area within the last 30 days.
•- Patients receiving topical treatment (including imiquimod, 5-FU and diclofenac) in face / scalp area within the last 3 months.
•- Pregnant or breast-feeding: All women of child-bearing potential must use adequate contraception (oral contraceptives, intrauterine device, contraceptive skin patch, etc) during the treatment period and one month thereafter. In addition, they must have a negative pregnancy test prior to treatment.
•- Any conditions that may be associated with a risk of poor protocol compliance.
•- Patients currently receiving regular ultraviolet radiation therapy.

发起方