Clinical Evaluation of Film forming spray (FFS)in Patients with Plaque Psoriasis A Prospective Open labelled Split Body Comparative Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- To asses the Change from baseline in the overall severity score (OSS) of psoriatic plaques at the end of 4 weeks.
研究概览
简要总结
Informed consent will be taken from patient before enrollment, A detailed history including any associated medical condition followed by general physical examination will be done to see any abnormal parameters ,After meeting all inclusion criteria ,enrollment will be done and all baseline photographs will be taken, overall severity score & HD PASI will be calculated
patient will be asked to apply film forming spray with steroid ointment on one side and steriod ointment alone on other side for 4 weeks
follow up will be done at week1,week2,week4
at every week OSS & HD -PASI assessment will be done ,at week-4 IAGI,PAGI ,CAS assessment would be done
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •outpatients aged ≥18 years with mild to moderate chronic stable plaque psoriasis affecting ≤10% BSA Patients having at least 2 symmetrical psoriatic lesions that are similar in erythema, induration, and scaling.
- •Target lesions (plaques) diameter ≤5 cm Target lesions (plaques) must have had a total modified HD PASI score of 4 or greater and are within 1 point of each other for each of the 3 parameters (erythema, induration, and scaling) Willing to comply with study procedures, treatments (topical steroid ointment application) and assessments.
排除标准
- •Lesion localized to scalp, face, groin area Use of biological therapies/systemic anti-psoriatic treatment (previous 12 weeks).
- •Patients with evidence of a skin disorder other than plaque-type psoriasis, clinically infected psoriasis, and/or skin atrophy in the area of the target lesion.
- •Hypersensitivity to alcohol-based preparation Pregnancy , Lactation Severe renal impairment or severe hepatic disorders Use of topical Anti-psoriatic in last 4 weeks.
结局指标
主要结局
To asses the Change from baseline in the overall severity score (OSS) of psoriatic plaques at the end of 4 weeks.
时间窗: 4 weeks
次要结局
- To asses the Change from baseline in the overall severity score (OSS) of psoriatic plaques at the week 1 and week 2.(To assess Change from baseline in the scores for Modified HD PASI (High Discrimination Psoriasis Area and Severity Index) for target lesion at the end of 4 weeks.)
研究者
Bikash Ranjan Kar
Institute of medical science and sum Hospital