A Multicenter, Randomised, Double Blind, Placebo-controlled Study of Efficacy, Safety, and Tolerability of Kaprolac® K301 for the Treatment of Seborrhoeic Eczema (SE) of the Scalp
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 19
- 主要终点
- Erythema and desquamation scores
研究概览
简要总结
Seborrhoeic eczema (SE) is a chronic, inflammatory skin disorder confined to areas of the head and trunk where sebaceous glands are most prominent. The severity varies from mild dandruff to exfoliative erythroderma that ranges from mild, patchy scaling to widespread, and thick, adherent crusts. The worldwide prevalence of SE is 3-5%, although dandruff, the mildest form of the disorder affects up to 15-20% of the population.
In this multicentre, randomised, double-blind, placebo-controlled phase III study, adult SE patients are treated once daily for 4 weeks. The population for this study is patients with mild to moderate SE.
The primary endpoint for this study is the efficacy of K301 compared to placebo which was based on the sum score for erythema and desquamation after 4 weeks of daily application. Secondary endpoints are to evaluate safety and tolerability as well as efficacy.
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)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female (including fertile women)
- •18-70 years of age
- •Seborrhoeic eczema of the scalp for at least 2 months
- •Presenting erythema and desquamation of mild to moderate intensity
- •Signed written informed consent
排除标准
- •Seborrhoeic eczema or any other cutaneous disease of the face or scalp requiring a specific topical treatment (corticosteroids, antifungals, selenium sulphide, antibiotics, retinoids, benzoyl peroxide or a-hydroxyacids) during the previous 15 days
- •Oral treatment with cyclines, lithium, antifungals or inhaled corticosteroids during the previous month
- •Use of systemic corticosteroids and retinoids during the previous 2 months
- •Seborrhoeic eczema associated with Parkinson's disease or HIV infection
- •Current or any history of ear, nose, and throat carcinoma
- •Current or any history of severe concomitant disease according to Investigator's judgement
- •Allergy to any of the tested treatment components
- •Subject who has been previously enrolled in the phase II study K40-3 investigating Kaprolac® K40
研究组 & 干预措施
K301
K301 applied topically to the affected area of the scalp once daily during the 4 weeks. Treatment is to be applied before bedtime and can be washed out with the patient's normal shampoo in the morning.
干预措施: K301 (Drug)
Placebo
Placebo applied topically to the affected area of the scalp once daily during the 4 weeks. Treatment is to be applied before bedtime and can be washed out with the patient's normal shampoo in the morning.
干预措施: Placebo (Drug)
结局指标
主要结局
Erythema and desquamation scores
时间窗: Week 4
The sum of erythema and desquamation scores at Week 4
次要结局
- Erythema and desquamation scores(Week 2)
- Erythema score(Weeks 2 and 4)
- Desquamation score(Weeks 2 and 4)
- Investigator's global evaluation(Week 4)
- Patient's global evaluation(Week 4)
- Pruritus/burning score(Weeks 2 and 4)
- Dandruff score(Weeks 2 and 4)
- Proportion of responders(Weeks 2 and 4)
- Adverse events(Weeks 2, 4 and 5)