Subject Preference Comparison Between Clobetasol Propionate Shampoo, 0.05% and Three Other Topical Corticosteroids in the Treatment of Moderate to Severe Scalp Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 219
- 试验地点
- 1
- 主要终点
- Percentage of Subjects Preffering Clobetasol Propionate Shampoo Better Than Comparator
研究概览
简要总结
The scalp is one of the most common affected sites in psoriatic patients as 79% of them have scalp involvement.It has also a psychological aspect with 31% of patients with scalp psoriasis indicating distress.
Topical agents remain the mainstay of treatment for scalp psoriasis. However, they are not always ideal because they might be inconvenient and messy to use, stain or damage hair.
The test shampoo, Clobetasol propionate Shampoo 0.05% (marketed in the USA under the tradename of Clobex®) was developed to provide the strongest available corticosteroid as a short-contact therapy in order to improve the chances of it being effective and reduce the potential for traditional side-effects.
The objective of this study is to compare subject's overall preference between Clobetasol propionate shampoo 0.05% and three other topical corticosteroids in the treatment of moderate to severe scalp psoriasis.
详细描述
This study will be a multi-centre, investigator blinded, randomized, cross-over, intra-individual comparison in three parallel groups.
In each parallel group, Clobetasol propionate shampoo, 0.05% will be compared to one of the three chosen competitors, following a cross-over design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •Male or female subjects, 18 years of age or older,
- •Subjects with moderate to severe scalp psoriasis,
- •Subjects who signed written informed consent prior to any study procedures.
排除标准
- •Subjects who need systemic treatment for their body psoriasis,
- •Subjects who are at risk in terms of precautions, warnings and contra-indication,
- •Female subjects who are pregnant, nursing or planning a pregnancy during the study,
- •Subjects with a specific washout period for topical treatment(s) on the scalp,
- •Subjects with a specific washout period for systemic treatment(s).
研究组 & 干预措施
C. propionate-Wash out-Corticosteroid 1
Clobetasol propionate Shampoo:
- Dose or Concentration: Clobetasol propionate 0.05% shampoo
- Mode and Frequency of Administration: Topical Once daily to the dry scalp, to be lathered and rinsed after 15 minutes
- Duration of Treatment: 4 weeks as a maximum
Wash-out up to 8 weeks
Corticosteroid 1:
- Dose or Concentration: Corticosteroid 1 Foam
- Mode and Frequency of Administration:Twice daily, a "golf-ball" sized amount to be massaged into the affected area of the scalp
- Duration of Treatment: 4 weeks as a maximum
干预措施: C. propionate - Corticosteroid 1 (Drug)
C. propionate-Wash out-Corticosteroid 2
Clobetasol propionate Shampoo:
- Dose or Concentration: Clobetasol propionate 0.05% shampoo
- Mode and Frequency of Administration: Topical Once daily to the dry scalp, to be lathered and rinsed after 15 minutes
- Duration of Treatment: 4 weeks as a maximum
Corticosteroid 2:
- Dose or Concentration: Corticosteroid 2 Lotion
- Mode and Frequency of Administration: Twice daily, a thin film to be applied to the affected area of the scalp and massaged gently and thoroughly into the skin
- Duration of Treatment: 4 weeks as a maximum
干预措施: C. propionate- Corticosteroid 2 (Drug)
C. propionate-Wash out-Corticosteroid 3
Clobetasol propionate Shampoo:
- Dose or Concentration: Clobetasol propionate 0.05% shampoo
- Mode and Frequency of Administration: Topical Once daily to the dry scalp, to be lathered and rinsed after 15 minutes
- Duration of Treatment: 4 weeks as a maximum
Corticosteroid 3:
- Dose or Concentration: Corticosteroid 3 Scalp application
- Mode and Frequency of Administration: Twice daily, a thin film to be applied into the affected area of the dry scalp and rubbed gently into the scalp
- Duration of Treatment: 4 weeks as a maximum
干预措施: C. propionate -Corticosteroid 3 (Drug)
Corticosteroid 1-Wash out-C. propionate
Clobetasol propionate Shampoo:
- Dose or Concentration: Clobetasol propionate 0.05% shampoo
- Mode and Frequency of Administration: Topical Once daily to the dry scalp, to be lathered and rinsed after 15 minutes
- Duration of Treatment: 4 weeks as a maximum
Corticosteroid 1:
- Dose or Concentration: Corticosteroid 1 Foam
- Mode and Frequency of Administration:Twice daily, a "golf-ball" sized amount to be massaged into the affected area of the scalp
- Duration of Treatment: 4 weeks as a maximum
干预措施: Corticosteroid 1- C. propionate (Drug)
Corticosteroid 2-Wash out-C. propionate
Clobetasol propionate Shampoo:
- Dose or Concentration: Clobetasol propionate 0.05% shampoo
- Mode and Frequency of Administration: Topical Once daily to the dry scalp, to be lathered and rinsed after 15 minutes
- Duration of Treatment: 4 weeks as a maximum
Corticosteroid 2:
- Dose or Concentration: Corticosteroid 2 Lotion
- Mode and Frequency of Administration: Twice daily, a thin film to be applied to the affected area of the scalp and massaged gently and thoroughly into the skin
- Duration of Treatment: 4 weeks as a maximum
干预措施: Corticosteroid 2 - C. propionate (Drug)
Corticosteroid 3-Wash out-C. propionate
Clobetasol propionate Shampoo:
- Dose or Concentration: Clobetasol propionate 0.05% shampoo
- Mode and Frequency of Administration: Topical Once daily to the dry scalp, to be lathered and rinsed after 15 minutes
- Duration of Treatment: 4 weeks as a maximum
Corticosteroid 3:
- Dose or Concentration: Corticosteroid 3 Scalp application
- Mode and Frequency of Administration: Twice daily, a thin film to be applied into the affected area of the dry scalp and rubbed gently into the scalp
- Duration of Treatment: 4 weeks as a maximum
干预措施: Corticosteroid 3 - C. propionate (Drug)
结局指标
主要结局
Percentage of Subjects Preffering Clobetasol Propionate Shampoo Better Than Comparator
时间窗: End of period II (up to 16 weeks)
Subjects' Overall preference at the end of Period II. The purpose was to demonstrate a superiority of Clobetasol propionate shampoo 0.05% therapy compared to any of three other topical comparators, in terms of subject's overall preference: "C. propionate shampoo a lot better than the comparator",C. propionate shampoo a lillte bit better than the comparator", "Comparator a lot better than C. propionate shampoo", Comparator a lillte bit better than C. propionate shampoo". This was to be shown using a non parametric two-sided Wilcoxon rank Signed test, on Intention to Treat (ITT) population.
次要结局
未报告次要终点