A Comparison of Ingenol Mebutate and Cryotherapy for Treatment of Actinic Keratoses.
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 主要终点
- Change from baseline in visual assessment scores at 3 months
研究概览
简要总结
The purpose of this study is to find out the effectiveness of ingenol mebutate compared to cryotherapy (freezing of the tissue) for the treatment of face and scalp skin lesions.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects between 18 and 89 years old.
- •Have at least a total of 10 non-hypertrophic actinic keratoses (AKs) on the face and scalp
- •The subjects are in good health
- •The subjects have the willingness and the ability to understand and provide informed consent for the use of their tissue and are able to communicate with the investigator
排除标准
- •Subjects under 18 years of age and over the age of 89
- •Subjects who are pregnant or lactating
- •Subjects with sensitivity to cold
- •Subjects with use of topical medications such as corticosteroids, alpha-hydroxyacids or retinoids 2 weeks before study entry
- •Subjects who received previous treatment of target AKs
- •Subjects whose target treatment area was within 5 cm of an incompletely healed wound or within 10 cm of a suspected basal-cell or squamous-cell carcinoma
- •Subjects with use of medications or other treatments that could interfere with evaluation of the treatment area within 2 months before study entry (e.g., topical medications, artificial tanners, immunosuppressive medications, immunomodulating agents, cytotoxic drugs, ultraviolet B phototherapy, other therapies for actinic keratoses, or oral retinoids)
- •Subjects who are unable to understand the protocol or to give informed consent
研究组 & 干预措施
Ingenol Mebutate
Ingenol Mebutate applied to one side of face with skin lesions
干预措施: Ingenol mebutate (Drug)
Cryotherapy
Cryotherapy applied to other side of face with skin lesions
干预措施: cryotherapy (Procedure)
结局指标
主要结局
Change from baseline in visual assessment scores at 3 months
时间窗: Baseline and 3 months
The visual assessment evaluates seven clinical signs: erythema, edema, wheal vesiculation, ulceration, hemorrhage, purpura, and crusting. Each sign is assigned a score of 0 to 3, where a score of 0 is associated with no expression of the clinical sign and a better outcome, and a score of 3 is associated with severe expression of the clinical sign and a worse outcome.
次要结局
未报告次要终点
研究者
Murad Alam
Professor in Dermatology, Otolaryngology- Head and Neck Surgery and Surgery-Organ Transplantation
Northwestern University