Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp including 12-month follow-upPart 1: 3-day treatment period including an 8-week follow-up period Part 2: extended 12-month follow-up periodA phase 3, multi-centre, randomised, parallel group, double-blind, vehicle controlled trial - N/A

EO Pharma A/S0 个研究点目标入组 306 人开始时间: 2015年10月20日最近更新: 2018年6月5日

适应症

试验速览

暂无简介。

•Signed and dated informed consent has been obtained.
•Subjects with 5 to 20 clinically typical, visible and discrete AKs within a treatment area of
•sun-damaged skin on the full balding scalp (the balding part of the scalp should be greater
•than 25 cm2 and up to approximately 250 cm2).
•Subjects at least 18 years of age.
•Female subjects of childbearing potential must be confirmed not pregnant by a negative
•urine pregnancy test prior to trial 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 153
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 153

•-Location of the treatment area (full balding scalp)
•within 5 cm of an incompletely healed wound
•within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
•-Treatment with ingenol mebutate gel in the treatment area within the last 12 months
•-Lesions in the treatment area that have: atypical clinical appearance (e.g. hypertrophic, hyperkeratotic or cutaneous horns) and/or recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions.

发起方

EO Pharma A/S