Concentrated Ascorbic Acid in DMSO for Treatment of Squamous Cell Carcinoma of the Skin
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Lesion Resolution
研究概览
简要总结
Randomized comparative trial of a 30% solution of ascorbic acid in 95% dimethylsulfoxide applied topically twice a day for 8 weeks vs 5% imiquimod cream in the treatment of biopsy proven squamous cell carcinomas of the skin in otherwise healthy adult patients. Outcome measure was biopsy proven resolution of the carcinoma.
详细描述
Importance:
Skin cancer is the most common cancer in the United States, with more people diagnosed each year than all other cancers combined. Basal cell and squamous cell cancers are the most common forms with an estimated 6-7 million cases diagnosed annually. Costs of treating these cancers in the U.S. are estimated at $9-10 billion annually. Task force consensus guidelines suggest Mohs surgery as the treatment of choice, and as the single most precise and effective treatment method. However, cost and issues of cosmesis are principal disadvantages. Previous studies show the effectiveness of a topical solution of ascorbic acid in the treatment of BCC. This study extends previous work to evaluate efficacy in the treatment of SCC of the skin.
Objective:
To evaluate efficacy of a therapeutic regimen in treating squamous cell cancer, consisting of 30% ascorbic acid in 95% dimethylsulfoxide topically applied at home by patients twice a day for 8 weeks, vs 5% imiquimod cream which is an FDA approved treatment for SCC.
Design, Setting, and Participants:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presence of biopsy proven squamous cell cancer of the skin -
排除标准
- •Previous history of malignancy, diabetes, immunocompromised
研究组 & 干预措施
30% Ascorbic Acid in DMSO
Topical application twice daily of 300ul 30% (w/v) solution of ascorbic acid in DMSO
干预措施: 30% ascorbic acid in DMSO (Drug)
结局指标
主要结局
Lesion Resolution
时间窗: 8 weeks
Number of lesions tumor free by 2 mm punch biopsy post treatment
次要结局
未报告次要终点