A Randomized, Placebo-controlled, Double-blind, Phase II Chemoprevention Clinical Trial of Topical Diclofenac and DFMO in Subjects With a History of Skin Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Reduction of actinic keratoses
研究概览
简要总结
This is a single institution, randomized, placebo-controlled, double-blind phase IIB trial of 1) topical diclofenac and topical DFMO, or 2) placebo in participants with a history of non melanoma skin cancer/ keratinocytic cancers.
详细描述
There will be two groups to the study. Individuals, aged 18 years or older, who have extensive actinic damage, at least 8 AKs and a history of at least one non-melanoma skin cancer, but are in otherwise general good health, will be given topical diclofenac and topical DFMO. They will be compared to individuals, aged 18 years or older, who have extensive actinic damage, but are in otherwise general good health, will be given placebo. All participants must be at increased risk of non-melanoma skin cancer as evidenced by a history of prior squamous or basal cell skin cancer, ongoing or history of actinic keratoses, and the presence, at baseline, of at least eight actinic keratoses on the face, neck, scalp and arms. Subjects will be randomized to:
- topical diclofenac once daily and topical DFMO once daily
- placebo for the topical diclofenac once daily and placebo for the topical DFMO once daily
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This trial will be double-blinded. The clinical team and patient will remain blinded to the randomization.
All study drug will be blinded except to the pharmacists. Records will be kept to document receipt, distribution and disposition of the drugs. Unblinding will only be done at the end of the study or as medically indicated with consent of the study PI and the biostatistician, after consulting the NIH Project Officer.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Diclofenac + DFMO
Participants in this arm will apply topical diclofenac to bilateral forearms once per day and topical DFMO to bilateral forearms once per day.
干预措施: Solaraze and Vaniqa (Drug)
Placebo + Placebo
Participants in this arm will apply placebo for topical diclofenac to bilateral forearms once per day and placebo for topical DFMO to bilateral forearms once per day.
干预措施: Solaraze and Vaniqa (Drug)
结局指标
主要结局
Reduction of actinic keratoses
时间窗: one year (9 months on active, continuous treatment)
The purpose of the study is to determine whether participants randomized to a combination of two FDA approved topical medications topical diclofenac and topical DFMO have a significant change in incidence of (≥ 50% change, p ≤ 0.05) non-melanoma skin cancers (NMSC) than participants randomized to placebo as assessed by clinical and histopathological evaluation.
次要结局
- Safety assessment(one year (9 months on active, continuous treatment))
- Biomarker assessment(one year (9 months on active, continuous treatment))
- Biomarker assessment of NMSC(one year (9 months on active, continuous treatment))
研究者
Craig Elmets
Professor
University of Alabama at Birmingham