A Phase 1 Exploratory Trial Evaluating Safety and Tolerability of Topical Administration of Different Concentrations of an Ingenol Derivative Compared to Ingenol Mebutate Gel 0.05% Applied on Two Consecutive Days to Four Separate 25cm2 Treatment Areas on the Forearms of Subjects With Actinic Keratosis (Field Therapy)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Safety of a new ingenol derivative compared to ingenol mebutate 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 ingenol derivative gels are as safe as and as well tolerated as ingenol mebutate gel when applied to AK lesions on the forearm for two consecutive days.
详细描述
Various concentrations of new ingenol derivatives will be applied to AKs on the forearms. Reactions and safety will be compared to a US registered and marketed ingenol gel to ascertain if the new ingenol is at least as safe and as well tolerated as the registered ingenol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 Visit 2
- •use of acid-containing therapeutic products within 2cm of the selected treatment area in the 2 weeks prior to Visit 2
- •use of topical moisturisers/creams/lotions, artificial tanners or topical steroids within 2cm of the selected treatment areas in the 2 weeks prior to visit 2 Treatment with immunomodulators, or interferon/interferon inducers or systemic medications that suppress the immune system within 4 weeks of Visit 2
- •Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy within 2 cm of the treatment area in the 8 weeks prior to visit 2
- •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 of not being able to comply with the requirements of the protocol or provide consent
研究组 & 干预措施
Ingenol mebutate gel 0.05%
once daily for two consecutive days
干预措施: Ingenol once daily for two consecutive days (Drug)
Ingenol derivative concentration 1
once daily for two consecutive days
干预措施: Ingenol once daily for two consecutive days (Drug)
Ingenol derivative concentration 2
once daily for two consecutive days
干预措施: Ingenol once daily for two consecutive days (Drug)
Ingenol derivative concentration 3
once daily for two consecutive days
干预措施: Ingenol once daily for two consecutive days (Drug)
结局指标
主要结局
Safety of a new ingenol derivative compared to ingenol mebutate gel applied topically once daily for two consecutive days to four separate treatment areas containing actinic keratosis on the forearm
时间窗: 8 weeks
Safety data to be collected via CRF entries of AEs/SAEs and photographs.
次要结局
- Evaluate treatment responses on Actinic Keratosis of different concentrations of a new ingenol derivative gel compared to the ingenol mebutate gel as assessed by reduction in number of clinically visible selected AK lesions eight weeks after treatment(8 weeks)