Clinical Study ProtocolSafety and efficacy of escalating doses of LEO 43204 applied once daily for two consecutive days on full balding scalp in subjects with actinic keratosisPart 1: A phase 1, multicentre, open-label,dose escalation, 2-week trialPart 2: A phase 2, multicentre, randomised, double-blind, parallel group,vehicle-controlled, 8-week trial

EO Pharma A/S0 个研究点目标入组 220 人开始时间: 2014年5月9日最近更新: 2024年9月9日

适应症

试验速览

暂无简介。

•Part 1: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the full balding scalp.
•Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the full balding scalp
•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 110
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 110

•Location of the treatment area:
•- within 5 cm of an incompletely healed wound
•- within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
•Prior treatment with ingenol mebutate gel on the treatment area
•Lesions in the treatment areas 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