A Seamless Phase 1/2 Exploratory Multi-centre, Investigator-blind, Dose Escalation Study (Study Part 1), Followed by a Randomised, Intra-subject, Active Controlled Efficacy Study of Different Ingenol Mebutate Formulations Applied to the Forearm for 2 Consecutive Days (Study Part 2)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Safety of 3 new vehicle formulations containing ingenol mebutate compared to Picato® gel applied topically once daily for two consecutive days to four separate treatment areas containing actinic keratosis on the forearm
研究概览
简要总结
The purpose of this study is to determine if the new vehicle formulations containing ingenol mebutate are as safe and effective as Picato® gel 0.05% (it's current vehicle formulation) when applied to AK lesions on the forearm for two consecutive days.
详细描述
This study will be run in 2 parts. The first part involves applying escalating concentrations of the new vehicle formulations containing ingenol mebutate to AKs on the forearms. Reactions and safety will be compared to Picato® (a registered and marketed ingenol mebutate gel) to ascertain if the new vehicle formulations are at least as safe and effective as Picato® . The purpose of part 2 is to select the concentration in the "new formulation" that produces this same, if not better response, as Picato® and with a similar or better safety profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be male or female and at least 18 years of age.
- •Female patients must be of non-childbearing potential or if of childbearing potential then negative serum and urine pregnancy test and using effective contraception.
- •Ability to provide informed consent.
排除标准
- •location of the selected treatment area within 5cm of an incompletely healed wound or within 5cm of a suspected basal cell carcinoma or squamous cell carcinoma
- •undergone Cosmetic or therapeutic procedures within 2cm of the selected treatment area in the 2 weeks prior to the treatment visit
- •presence of sunburn within the selected treatment areas
- •use of acid-containing therapeutic products within 2cm of the selected treatment area in the 2 weeks prior to the treatment visit
- •previous enrolment in this clinical trial
- •prior treatment with ingenol mebutate on the forearms
- •use of topical moisturisers/creams/lotions, artificial tanners or topical steroids within 2cm of the selected treatment areas in the 2 weeks prior to the treatment visit
- •treatment with immunomodulators, or interferon/interferon inducers or systemic medications that suppress the immune system within 4 weeks of the treatment visit
- •treatment with 5-FU, imiquimod, diclofenac,or photodynamic therapy within 2 cm of the treatment area in the 8 weeks prior to the treatment visit
- •use of systemic retinoids
- •those who are currently participating in any other clinical trial
- •females who are pregnant or are breastfeeding
- •those known or suspected or not being able to comply with the requirements of the protocol or provide consent
研究组 & 干预措施
ingenol mebutate vehicle formulation 1
once daily for two consecutive days
干预措施: once daily for two consecutive days (Picato) (Drug)
ingenol mebutate vehicle formulation 3
once daily for two consecutive days
干预措施: once daily for two consecutive days (Picato) (Drug)
Picato® 0.05% gel
once daily for two consecutive days
干预措施: once daily for two consecutive days (Picato) (Drug)
ingenol mebutate vehicle formulation 2
once daily for two consecutive days
干预措施: once daily for two consecutive days (Picato) (Drug)
结局指标
主要结局
Safety of 3 new vehicle formulations containing ingenol mebutate compared to Picato® gel applied topically once daily for two consecutive days to four separate treatment areas containing actinic keratosis on the forearm
时间窗: 2 weeks
Safety data to be collected via CRF entries of AEs/SAEs and photographs. Relative skin reactions for comparison to Picato®.
次要结局
- Evaluate treatment responses on AK of selected concentration of ingenol mebutate containing vehicle formulation from Part 1 compared to Picato® gel as assessed by reduction in the number of selected AK lesions 2 months after treatment(2 months)