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临床试验/EUCTR2014-003602-32-FR
EUCTR2014-003602-32-FR进行中(未招募)1 期

Comparison of Efficacy and Safety of Metvixia® Natural Daylight Photodynamic Therapy Versus Conventional Metvixia® Photodynamic Therapy in patients With grade I and II actinic keratosis of the scalp: a phase III trial - Metvix®, Natural Daylight Photodynamic Therapy, Actinic keratosis

CHU de Limoges0 个研究点目标入组 26 人开始时间: 2015年6月22日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
26

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

  • Clinical diagnosis of at least 10 previously untreated AK lesions of Grade 1 and/or 2 of the scalp (at least 5 KA at each hlf of the scalp)
  • 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 11
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 15

排除标准

  • - Patients with porphyria.
  • -Known allergy to metvixia® compound or excipients of the cream.
  • -Patients with history of hypersensitivity to nut products
  • -Patients receiving local treatment in the scalp areaea within the last 30 days.
  • -Patients receiving topical treatment,chemotherapy or immunotherapy in scalp area within the last 2 months.
  • -Sclerodermiform / nodular basal cell/intraepithelial carcinoma in the treated area
  • -Pregnant or breast-feeding women

研究者

发起方
CHU de Limoges

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