A comparative study on the efficacy of topical 2 percent CRISABOROLE Cream vs 0.1 percent BETAMETHASONE VALEREATE Ointment in the treatment of Plaque Psoriasis-A Non Blinded Randomised Control Study.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Resolution of psoriatic plaque assessed by PASI score
研究概览
简要总结
It is a Non-Blinded Randomised Control Study. Selected patients who fulfil the inclusion criteria will be included in the study. After clinical diagnosis of Psoriasis Vulgaris patients will be randomized into two groups A and B
.Patients in group A will receive topical 2 percent Crisaborole cream twice daily for 4 weeks and tapered to once daily for next 2 weeks and once daily on alternative days for next 2 weeks. After stopping treatment on week 8 , patient will be followed up on 10th and 12th week to look for recurrence and adverse events if any.
Patients in group B will receive topical 0.1 percent Betamethasone Valereate ointment twice daily for 4 weeks and tapered to once daily for next 2 weeks and once daily on alternative days for next 2 weeks. After stopping treatment on week 8, patient will be followed up on 10th and 12th week to look for recurrence and adverse events if any.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 12.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient clinically diagnosed as Psoriasis vulgaris with less than 10 percent Body Surface Area involvement.
- •2.Age above 12 years
- •Patient willing for consent , study and follow up.
- •Patient willing to take clinical photos.
- •Patient not on any other treatment with topical and systemic drugs for Psoriasis for at least past 1 month.
排除标准
- •1.Patients below 12 years.
- •2.Patients with Psoriasis involving more than 10 percent Body Surface Area.
- •3.Patients with Severe Psoriasis Vulgaris and Erythrodermic Psoriasis, Pustular Psoriasis, Guttate Psoriasis, Nail Psoriasis, Psoriatic Arthritis.
- •4.Patients who are on treatment with topical or systemic drugs specific to Psoriasis within past 1 month.
- •5.Patients with active infection at the study site.
- •6.Patient not willing for regular follow-up or to take clinical pictures.
- •7.Lactating or Pregnant women.
结局指标
主要结局
Resolution of psoriatic plaque assessed by PASI score
时间窗: Every week
次要结局
- Remission of the Psoriatic Plaque(12 WEEKS)
研究者
Dr Guruprakash A V
Government Stanley Medical College and Hospitak