A randomized study to evaluate the efficacy of ingenol mebutate on actinic keratoses and field cancerization compared to cryotherapy - A study to evaluate the efficacy of ingenol mebutate on precancerosis and its contigous area compare

A.O.U. Università degli Studi della Campania Luigi Vanvitelli0 个研究点目标入组 50 人开始时间: 2021年6月1日最近更新: 2021年8月2日

适应症

试验速览

暂无简介。

•- Current diagnosis of AK, with =2 lesions of grade I and/or II located in two different anatomical districts (within a contiguous 25 cm2 area on the face, scalp or forehead);
•- Male = 18 years of age
•- Female = 60 years of age ;
•Skin type I or II according to Fitzpatrick;
•Patient has confirmed his/her willingness to participate in this study after being informed of all aspects of the study that are relevant to his/her decision to participate, by signing and dating the approved informed consent form, according to ICH and local laws.
•The 25 cm2 contiguous treatment areas could be of any shape, e.g. 5 cm x 5 cm, 2 cm x 12.5 cm, 3 cm x 8.3 cm.
•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 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•Has received any therapy for AK within the past 3 months
•Has AK of grade III
•Has currently a skin cancer or shows an early stage of skin cancer;
•Has another skin disease that requires treatment with other medications in the AK area or in distance of 3 cm;
•Use of cosmetic or therapeutic products and procedures which could interfere with assessments of the treatment area;
•Immunosuppressive therapies or current treatment for cancer;
•Clinically unstable medical condition;
•High risk group for HIV infection or presentation of other infectious diseases (HAV, HBV, HCV, TBC, etc);
•Allergies to the tested gel (ingenol mebutate and eccipients);
•Pregnancy and breastfeeding;
•Psychiatric disease that may interfere with follow-up of study procedures;
•Participation in other clinical trials up to 30 days prior to day 1 of the study;
•Patient is, for any reason, considered by the investigator to be an unsuitable candidate for the study

发起方

A.O.U. Università degli Studi della Campania Luigi Vanvitelli