Impact and Costs of Health Care Education, Phone Reminders and enhanced follow-up intervention on Prescription adherence, Treatment Satisfaction and Effectiveness in patients with Multiple Actinic Keratosis treated with diclofenac in hyaluronic acid gel 3% (Solaraze 3%). No-profit study. - PER-DIC-16-001

FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE0 个研究点目标入组 182 人开始时间: 2020年11月4日最近更新: 2021年8月17日

适应症

试验速览

暂无简介。

•1.Patients with clinically typical, visible and discrete multiple AK, grade I/II according to Olsen’s classification, in a skin area of 50 cm2, for whom the treating dermatologist has prescribed diclofenac in hyaluronic acid gel 3% (Solaraze 3%). Those patients should have not started the treatment before the inclusion in the present study .
•2.Willing to participate in the study and able to provide informed consent.
•3.Age = 18 years
•4.Able to read and write in Italian Language
•5.Women with childbearing potential willing not to start a pregnancy during the course f the study and for 1 month after the conclusion of the treatment
•6.Men having relationships with women with childbearing potential willing not to procure a pregnancy during the course of the study and for 1 month after the conclusion of the treatment.
•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 91
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 91

•1.Unable to understand and execute simple instructions or patients in need of assistance from a caregiver (professional or non-professional) for the application of topical medication.
•2.Patients immunocompromised as per medical history (i.e. iatrogenic immunosuppression, HIV / AIDS)
•3.Any major surgery or major clinical events (i.e. ictus cerebri, myocardial infarction, etc) in the month prior to screening (may affect Patient-Reported Outcomes)
•4.Previous treatments with field-directed therapy in the past 3 months before the screening.
•5.Aspirin-sensitive patients, due to possible cross-reactivity with diclofenac in hyaluronic acid gel 3% (Solaraze %).
•6.Pregnant and breast-feeding women
•7. Forecast of moving to another region within the next 12 months following the potential inclusion in the study.

发起方

FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE