A Multicenter, Randomised Double Blind, Placebo Controlled Study of Efficacy, Safety and Tolerability of Two Topical K40 Formulations in Adults With Seborrhoeic Dermatitis (SD) of the Scalp.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 11
- 主要终点
- Erythema and desquamation scores
研究概览
简要总结
Seborrhoeic dermatitis (SD) is a papulosquamous (presence of both papules and scales) disorder patterned on the sebum-rich areas of the scalp, face, and trunk.
The current treatment does not cure the disease permanently. Therefore it must be repeated when the symptoms recur, or even prophylactically. Corticosteroids and antifungals are the mainstay of therapy. Topical corticosteroids rapidly reduce the cutaneous signs of disease, but are associated with a high frequency of relapse when treatment is stopped. They are reserved for acute flare-ups only as they may precipitate recurrences and dependence. In addition, chronic use of corticosteroids is associated with side-effects.
The scientific rationale for the use of K40 for treatment of SD was based on clinical evidence that K40 improves erythema and desquamation with mild adverse reactions in a few cases. The primary objective of the study was to evaluate the efficacy of K40 (K40a and K40b combined) compared to placebo after 4 weeks treatment as measured by the sum of erythema and desquamation scores at Week 4.
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 65 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)
- •18-65 years of age
- •Seborrhoeic dermatitis of the scalp for at least 2 months
- •Presenting erythema and desquamation of mild, moderate, pronounced or severe intensity
- •Signed written informed consent
排除标准
- •Patient on an antifungal, selenium sulphite or corticosteroid therapy within the last 2 weeks prior to start of study treatment
- •Any other cutaneous disease of the face requiring a specific topical treatment (corticosteroids, antifungals, 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
- •SD associated with Parkinson's disease, human immunodeficiency virus infection
- •Current or any history of ear, nose and throat carcinoma,
- •Current or any history of severe concomitant disease according to Investigator'sjudgement
- •Allergy to any of the tested treatment components
研究组 & 干预措施
K40a
K40a is to be applied to affected areas of the scalp once daily for 4 weeks. Thereafter, a maintenance phase of 4 weeks is to follow with application 3 times per week. Approximately one tablespoon of the respective formulation is to be applied before bed and to be washed out with the patient's normal shampoo in the morning.
干预措施: K40a (Drug)
K40b
K40b is to be applied to affected areas of the scalp once daily for 4 weeks. Thereafter, a maintenance phase of 4 weeks is to follow with application 3 times per week. Approximately one tablespoon of the respective formulation is to be applied before bed and to be washed out with the patient's normal shampoo in the morning.
干预措施: K40b (Drug)
Placebo
Placebo is to be applied to affected areas of the scalp once daily for 4 weeks. Thereafter, a maintenance phase of 4 weeks is to follow with application 3 times per week. Approximately one tablespoon of the respective formulation is to be applied before bed and to 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
Sum of erythema and desquamation scores at Week 4
次要结局
- Erythema and desquamation scores(Weeks 2 and 8)
- Responder(Weeks 2, 4 and 8)
- Erythema score(Weeks 2, 4 and 8)
- Desquamation score(Weeks 2, 4 and 8)
- Doctor's Global evaluation(Week 4 and 8)
- Patient's Global evaluation(Weeks 4 and 8)
- Pruritus score(Weeks 2, 4 and 8)
- Dandruff score(Weeks 2, 4 and 8)
- Dermatology Life Quality Index(Week 4 and 8)
- Ease of application(Weeks 4 and 8)
- Stickiness(Weeks 4 and 8)
- Effect on hair quality(Weeks 4 and 8)
- Adverse events(Weeks 0, 2, 4 and 8)