Combination Calcipotriene 0.005% Foam and Fluorouracil 5% Cream for the Treatment of Actinic Keratoses on the Scalp
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Percentage of change in the number of scalp actinic keratoses from baseline
研究概览
简要总结
The aim of this study is to determine the effectiveness of combination calcipotriene 0.005% foam and 5% fluorouracil cream for the treatment of actinic keratoses on the scalp. The data obtained will be compared with the current standard of care, monotherapy with 5% fluorouracil cream. A recent randomized, double-blind clinical trial (NCT02019355) compared 0.005% calcipotriol ointment and fluorouracil 5% cream with Vaseline plus fluorouracil 5% cream for a 4-day treatment of actinic keratoses on the face, scalp and upper extremities. They found that calcipotriol plus 5-FU versus Vaseline plus fluorouracil 5% cream led to an 87.8% versus 26.3% mean reduction in the mean number of actinic keratoses. Our study will independently assess the effectiveness of combination treatment (calcipotriene 0.005% foam and fluorouracil 5% cream) on scalp actinic keratoses in a case series of up to 15 eligible participants. Participants will complete a 4-night application of combination treatment with follow-up immediately after and 8 weeks later.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age of at least 40 years.
- •Presence of four to fifteen clinically typical, visible, and discrete actinic keratoses in 25 cm2 on the scalp.
- •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 contains hypertrophic/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 (avoidance of calcipotriene toxicity).
研究组 & 干预措施
Combination treatment arm
Combination of calcipotriene 0.005% foam (Sorilux) and Fluorouracil Cream, 5% USP (generic) applied for four consecutive nights for the treatment of scalp actinic keratoses.
干预措施: Calcipotriene 0.005% Foam (Drug)
Combination treatment arm
Combination of calcipotriene 0.005% foam (Sorilux) and Fluorouracil Cream, 5% USP (generic) applied for four consecutive nights for the treatment of scalp actinic keratoses.
干预措施: Efudex 5% Topical Cream (Drug)
结局指标
主要结局
Percentage of change in the number of scalp actinic keratoses from baseline
时间窗: 8 weeks
Determine the efficacy of calcipotriene 0.005% foam and 5-fluorouracil 5% cream for the treatment of scalp actinic keratoses following 4 nights of combination treatment. The outcome of interest is percentage change from baseline number of actinic keratoses in the target treatment area on scalp at 8 weeks after treatment.
次要结局
- Complete and partial (>75%) clearance of actinic keratoses(8 weeks)
- Composite score of erythema, itching and skin pain after topical of calcipotriene 0.005% foam and 5-fluorouracil 5% cream application for four consecutive nights to scalp actinic keratoses.(4 days)