Clinical effectiveness and effect on COX-2 expression of the sequential treatment of actinic keratoses (AK) with photodynamic therapy (PDT) and diclofenac 3% gel: a phase IV clinical trial.

Fundacion para la investigación biomédica del hospital Ramón y Cajal de Madrid0 个研究点开始时间: 2013年3月6日最近更新: 2013年5月13日

适应症

试验速览

暂无简介。

•Patients eligible for inclusion in the study should:
•1. Be 18 years or older.
•2. Give written informed consent after receiving adequate information about the design of the study, its objectives and the potential risks associated with their participation in the study.
•3. Be able to understand the aim of the study and be able to visit the hospital for the different consultations and follow-up visits.
•4. Have at least 5 nonhyperkeratotic AKs on the face and/or scalp
•5. Female patients agrees to use
•a double barrier method of contraception from the moment of signing
•the informed consent until 30 days after the end of treatment period
•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 80
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•pregnancy, breastfeeding, allergy to methyl aminolevulinate, AAS, diclofenac or to any of the excipients of these topical products, immunosuppression, porphyria, hereditary diseases that predispose to skin cancer (e.g. Gorlin syndrome, xeroderma pigmentosum), photosensitive disorders, photosensitizing treatments, previous treatments for AK in the three months prior to the beginning of the study (including imiquimod, PDT or any other therapy for AK), AKs in the perioral and periocular regions and the inability to follow the instructions or to collaborate during the development of the stud

发起方

Fundacion para la investigación biomédica del hospital Ramón y Cajal de Madrid