The Role of Calcipotriol in Treatment of Pre-cancerous Skin Lesions
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- percentage of change in the number of actinic keratoses from baseline
研究概览
简要总结
The main purpose of this study is to determine the effectiveness of a new combination therapy for actinic keratosis. This study investigates a new indication for an FDA-approved topical medication, calcipotriol, for treatment of actinic keratosis, including how well it works and how safe it is when used in combination with the standard of care medication (5-fluorouracil) for the skin condition.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of at least 50 years
- •Presence of four to fifteen clinically typical, visible, and discrete actinic keratoses in 25 cm2 on any of the four anatomical sites: scalp, face, right upper extremity and left upper extremity
- •Ability and willingness of the patient to participate in the study (Informed consent is obtained)
排除标准
- •Treatment area is within 5 cm of an incompletely healed wound or a suspected basal-cell or squamous-cell carcinoma
- •Treatment area contained hypertrophic and hyperkeratotic lesions, cutaneous horns, or lesions that had not responded to repeated cryotherapy
- •Recent (within a month) use of medications that could interfere with evaluation of the treatment area (e.g., topical medications, artificial tanners, immunosuppressive medications, immunomodulating agents, cytotoxic drugs, ultraviolet B phototherapy, other therapies for actinic keratoses, or oral retinoids)
- •Premenopausal Women (to avoid any risk of pregnancy)
- •History of hypercalcemia or clinical evidence of vitamin D toxicity
研究组 & 干预措施
calcipotriol plus 5-fluorouracil
calcipotriol 0.005% ointment and 5-fluorouracil 5% cream are mixed at 1:1 weight ratio. The compounded medication is applied topically twice a day for 4 days.
干预措施: 5-fluorouracil 5% cream (Drug)
calcipotriol plus 5-fluorouracil
calcipotriol 0.005% ointment and 5-fluorouracil 5% cream are mixed at 1:1 weight ratio. The compounded medication is applied topically twice a day for 4 days.
干预措施: Calcipotriol 0.005% ointment (Drug)
5-fluorouracil plus vaseline
5-fluorouracil 5% cream and vaseline are mixed at 1:1 weight ratio. The compounded medication is applied topically twice a day for 4 days.
干预措施: 5-fluorouracil 5% cream (Drug)
5-fluorouracil plus vaseline
5-fluorouracil 5% cream and vaseline are mixed at 1:1 weight ratio. The compounded medication is applied topically twice a day for 4 days.
干预措施: Vaseline (Drug)
结局指标
主要结局
percentage of change in the number of actinic keratoses from baseline
时间窗: 8 weeks
To compare the efficacy of topical 5-fluorouracil+calcipotriol vs. 5-fluorouracil alone in treatment of actinic keratosis in patients with multiple actinic keratoses at each of the four anatomical sites (scalp, face, right upper extremity and left upper extremity). The outcome of interest is percentage change from baseline number of actinic keratoses in the target treatment area on scalp, face, right upper extremity and left upper extremity at 8 weeks after treatment.
次要结局
- complete and partial (>75%) clearance of actinic keratoses(8wks)
- Composite score of erythema, itching and skin pain after topical 5-fluorouracil+calcipotriol vs. 5-fluorouracil alone treatment of actinic keratoses(4days)
- Induction of TSLP expression in keratinocytes by calcipotriol(4 days)
- differences in response to topical 5-fluorouracil+calcipotriol vs. 5-fluorouracil alone between the four anatomical sites(8wks)
研究者
Lynn Cornelius, MD
Chief, Division of Dermatology
Washington University School of Medicine