Risk of Squamous Cell Carcinoma on Skin Areas Treated with Ingenol Mebutate Gel, 0.015% and Imiquimod Cream, 5% - Not applicable

EO Pharma A/S0 个研究点目标入组 480 人开始时间: 2013年4月30日最近更新: 2013年12月23日

试验速览

暂无简介。

•1.Signed Informed Consent Form (ICF) prior to any trial-related procedures
•2.Subjects with 5 to 9 clinically typical, visible and discrete AKs within a contiguous 25 cm² treatment area on the face or scalp.
•3.Subject at least 18 years of age
•4.Female subjects must be of either:
•a.Non-childbearing potential, or,
•b.Childbearing potential, provided there is a confirmed negative urine pregnancy test
•5.Female subjects of childbearing potential must be willing to use highly effective methods of contraception (Pearl index < 1%)
•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 96
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 384

•1.Location of the selected treatment area:
•on the periorbital skin
•on the perioral skin/around the nostrils
•within 5 cm of an incompletely healed wound
•within 10 cm of a suspected BCC or SCC or other neoplasia
•2.Selected treatment area lesions that have atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horn).
•3.History of SCC, BCC, malignant melanoma or other neoplasia in the selected treatment area.
•4.History or evidence of skin conditions other than the trial indication that would interfere with evaluation of the trial medication in the selected treatment area
•5.Use of ingenol mebutate and/or imiquimod in and within 5 cm of the selected treatment area within 2 years prior to Screening (Visit 1)
•6.Organ transplant recipients
•7.Immunosuppressed subjects (for example HIV patients)
•8.Female subjects who are breastfeeding.
•9.Subjects who are institutionalised by court order or by the local authority
•10.In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state)

发起方

EO Pharma A/S