Pilot Study to Evaluate Two Different Non-invasive Techniques to Monitor the Clearance of Actinic Keratosis Lesions (Clinical and Sub-clinical), When Treated With Aldara 5% (Imiquimod) Cream
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- To compare the performance of two techniques to monitor the clearance of AK lesions (clinical and subclinical) when treated with Aldara 5% cream by comparison of lesion counts.
研究概览
简要总结
The purpose of this study is to evaluate the performance of two techniques to monitor the clearance of AK lesions when treated with Aldara 5% cream.
详细描述
Each technique will be assessed by comparison of lesion counts (clinical and sub-clinical) revealed by the techniques, at start and end of the study and those demonstrated during treatment. In addition a qualitative assessment of each technique will be made for performance and ease of use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, 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
- •At least 5 clinically typical, visible, discrete, nonhyperkeratotic, nonhypertrophic AK lesions
- •Free of any significant findings (e.g tattoos) in the potential application site area.
- •Willing to discontinue sun-tanning and use of sunbed/sun parlour use
- •Willing to stop use of moisturisers, body oils, and over the counter retinol products or products containing alpha or beta hydroxyacids in the treatment or surrounding area.
- •Willing ot withhold sunscreen and/or moisturiser use for 24 hours prior to each clinical assessment
排除标准
- •Evidence of unstable or uncontrolled clinically significant medical condition.
- •Any dermatological disease and or condition in the treatment of the surrounding area that may be exacerbated by treatment with imiquimod.
- •Currently participating in another clinical study or have completed another study within an investigational drug within the past 30 days.
- •Have active chemical dependency or alcoholism
- •Have know allergies to any excipient or study cream
- •Have received previous treatment with imiquimod for any indication within the treatment area.
- •Known to be affected by porphyria
研究组 & 干预措施
1
250mg of Imiquimod cream application once daily 3 times per week.
干预措施: Aldara (Imiquimod) (Drug)
2
250mg vehicle cream for application once daily 3 times per week.
干预措施: Vehicle cream (Other)
结局指标
主要结局
To compare the performance of two techniques to monitor the clearance of AK lesions (clinical and subclinical) when treated with Aldara 5% cream by comparison of lesion counts.
时间窗: 8 weeks after the end of treatment
次要结局
- To obtain histological confirmation of the diagnosis of the lesions demonstrated by biopsy.(8 weeks after the end of treatment)