An Exploratory, Open-label Study of Sequential Field-directed Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 21
- 试验地点
- 3
- 主要终点
- Actinic Keratosis Count
研究概览
简要总结
The purpose of this study is to explore the effect of treating actinic keratoses of the face with imiquimod 3.75% cream followed by photodynamic therapy in comparison to treatment with imiquimod alone
详细描述
Actinic keratoses are common skin lesions associated with solar ultraviolet radiation exposure. Some actinic keratoses may develop into skin cancers.
Imiquimod 3.75% cream is an approved treatment for actinic keratoses that utilizes a regimen of application to the entire face or balding scalp of up to 2 packets of cream daily for two 2-week cycles, separated by a 2-week no treatment interval.
Photodynamic therapy with aminolevulinic acid (ALA) 20% topical solution is also an approved treatment for actinic keratoses. ALA is applied to actinic keratoses, and after an incubation period, is excited with light. Although approved as a lesion-directed treatment for actinic keratoses, treatment of a field (e.g. face) with photodynamic therapy is commonly performed.
Treatment with photodynamic therapy followed by imiquimod 5% cream has been reported in patients with actinic keratoses, basal cell carcinoma and Bowen's disease, and treatment with imiquimod 5% cream followed by photodynamic therapy in patients with vulvar intraepithelial neoplasia. There are, however, no prior studies on the safety and/or efficacy of using topical imiquimod 3.75% in conjunction with photodynamic therapy in the treatment of actinic keratoses.
This study will use an open-label parallel cohort design in which all patients will received treatment with imiquimod 3.75% cream, and subsequently will be randomized to either photodynamic therapy or observation.
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
- None
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
- •Male and female adults; 18 and over
- •At least 10 and no more than 30 clinically typical actinic keratoses on the face
排除标准
- •Hypertrophic actinic keratoses or other skin lesions on the head that might required excluded treatment during the study
- •Known contraindication to treatment with imiquimod or photodynamic therapy
- •Condition that would limit compliance, be a potential safety risk, or require therapy with an excluded treatment
- •Systemically immunocompromised
- •Pregnant or nursing
- •Dermatologic disease and/or condition in treatment area that might exacerbated by treatment with imiquimod, cause difficulty with examination, or require therapy with an excluded treatment
- •Participation in another clinical study
- •Treatment within the past 60 days with:
- •Ultraviolet therapy
- •Systemic immunomodulators
- •Chemotherapeutic or cytotoxic agents
- •Investigational agents
- •Treatment on the head within the past 60 days with:
- •Imiquimod
- •Photodynamic therapy
- •Red or blue light source therapy
- •Cryotherapy or chemotherapy
- •Surgical excision or curettage
- •Topical corticosteroids
- •Dermabrasion
- •Chemical peel
- •Topical retinoids
- •Topical 5-fluorouracil
- •Topical pimecrolimus or tacrolimus
- •Topical diclofenac
- •Treatment for actinic keratoses on the head within the past 60 days
研究组 & 干预措施
Imiquimod & photodynamic therapy
Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
干预措施: Photodynamic therapy (Drug)
Imiquimod & photodynamic therapy
Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
干预措施: Imiquimod (Drug)
Imiquimod
Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
干预措施: Imiquimod (Drug)
结局指标
主要结局
Actinic Keratosis Count
时间窗: Week 18 (4 weeks after randomization visit)
The percent change in actinic keratosis count as compared to the baseline lesion count
次要结局
- Cosmetic Appearance(Week 18 (4 weeks after randomization visit))
- Complete Clearance(Week 18 (4 weeks after randomization visit))