Comparison of the Maintenance Effect of Clobex® Shampoo 0.05% Used Twice Weekly vs. Vehicle on Scalp Psoriasis in Subjects Who Successfully Responded to a 4-week Daily Course of Clobex® Shampoo 0.05%
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- Maintenance Phase: Time to First Relapse
研究概览
简要总结
The objective of the study was to assess the maintenance effect on scalp psoriasis of Clobex® Shampoo 0.05% when used twice weekly.
详细描述
Psoriasis was a chronic disease that was affecting skin, the scalp and joints. Scalp psoriasis was very common and was having an important impact on people's life.
Primary objective of scalp psoriasis treatments was to gain initial and rapid control of the disease process with a minimum of side-effects and improve patient quality of life.
Still, one of the unmet needs of scalp psoriasis therapies was the maintenance of a long-term remission. For corticosteroids in particular, one of the drawbacks was the disease recurrences after cessation of the treatment.
Therefore, the establishment of a modified corticosteroid dosing regimen that would allow remission with minimal side-effects was suitable.
The purpose of this study was to assess how long a patient successfully maintained in a good condition after use of Clobex® shampoo only twice a week.
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
- 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 aged 18 years or older.
- •Subjects with moderate to severe scalp psoriasis
排除标准
- •Subjects who needed systemic treatment for their body psoriasis
- •Subjects with a washout period for topical treatment(s) on the scalp less than:
- •Corticosteroids 2 weeks
- •All other anti-psoriasis medications 2 weeks
- •Subjects with a washout period for systemic treatment(s) less than:
- •PUVA therapy 4 weeks
- •Biological therapies 12 weeks
- •Treatments other than biologicals with a possible efficacy on psoriasis 4 weeks
- •Treatment known to worsen psoriasis 2 weeks
研究组 & 干预措施
Initial Phase:- Clobex® Shampoo
In initial open-label phase, participants were applied Clobex® shampoo (Clobetasol Propionate) 0.05 percent (%) weight by weight (W/W) topically to the scalp once daily (twice a week) for 4 weeks (weekly dose was not more than 50 grams [50 Milliliter]).
干预措施: Clobex® Shampoo (Drug)
Maintenance Phase: Clobex® Shampoo
In maintenance double-blind phase, participants presented with a good efficacy (Global severity score [GSS] less than or equal to [<=] 2) in initial phase were randomized to apply Clobetasol Propionate shampoo 0.05 % weight by weight (W/W) twice weekly up to 6 months (wherein weekly dose were not exceeded beyond 50 grams [50 milliliter]). In case of relapse (that is [i.e.], GSS greater than [>] 2) participants were re-entered to 4-week daily treatment with Clobetasol Propionate shampoo 0.05%. After this 4-week period of daily treatment, if GSS <= 2, participants were re-entering the maintenance regimen (twice a week).
干预措施: Clobex® Shampoo (Drug)
Maintenance Phase: Clobex® Vehicle Shampoo
In maintenance double-blind phase, participants presented with a good efficacy (Global severity score [GSS] <= 2) in initial phase were randomized to apply Clobex® vehicle shampoo twice weekly up to 6 months (wherein weekly dose was not more than 50 grams [50 milliliter]). In case of relapse (i.e., GSS [greater than] > 2) participants were re-entered to 4-week daily treatment with Clobetasol Propionate Shampoo 0.05 % (W/W). After this 4-week period of daily treatment, if GSS <= 2, participants were re-entering the maintenance regimen (twice a week).
干预措施: Clobex® Vehicle Shampoo (Drug)
结局指标
主要结局
Maintenance Phase: Time to First Relapse
时间窗: Baseline up to 24 Weeks
Time to first relapse was defined as the duration between baseline of maintenance phase and the visit where the relapse occurred. The first relapse was defined as the first time during the maintenance phase when participant presented with a GSS \>2.
次要结局
- Initial Phase: Percentage of Participants With Pruritus Scores(Baseline, Weeks 2 and 4 LOCF)
- Initial Phase: Percentage of Participants With Global Severity Scores(Baseline, Weeks 2 and 4 LOCF)
- Maintenance Phase: Percentage of Participants Who Had First Relapse(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Maintenance Phase: Percentage of Participants With Scalp Psoriasis Pruritus Score at First Time of Relapse(Baseline up to Week 24)
- Maintenance Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores at First Time of Relapse(Baseline up to Week 24)
- Maintenance Phase: Percentage of Participants With Number of Relapses Experienced(Baseline up to Week 28)
- Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores(Baseline, Weeks 2 and 4 LOCF)