EFFICACY AND SAFETY OF ACITRETIN IN DOSES OF 25mg,35mg or50mg IN PATIENTS WITH SEVERE PLAQUE TYPE PSORIASIS: A RANDOMISED,DOUBLE BLIND , PARALLEL GROUP DOSE- RANGING STUDY
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Change in Psoriasis area severity index from baseline to 12 weeks after acitretin therapy
研究概览
简要总结
In this study, the investigators will intend to compare the efficacy and safety of various doses of acitretin in a randomized double blind manner in patients with severe plaque-type psoriasis, by i) studying the change PASI score from baseline as a measure of efficacy ii) determining the frequency of side effects at various doses. Sixty patients will be recruited from Psoriasis Clinic of Department of Dermatology, Venerology and Leprology, PGIMER. Patients will be randomly assigned to one of the three groups: Group A, consisting of 20 patients, will be administered acitretin 25 mg/ day ,Group B, consisting of 20 patients, will be administered acitretin 35 mg/day and GROUP C consisting of 20 patients, will be administered acitretin 50 mg/day This therapy will be continued until PSORIASIS AREA AND SEVERITY INDEX (PASI) scores are reduced to < 25% of the original scores or 12 weeks, whichever comes earlier. It is expected that acitretin at higher doses will be more efficacious . As the exact etiopathogenesis of psoriasis is not fully known, it is difficult to provide a definite cure to all patients, though the disease activity can be controlled to a great extent with various treatment modalities. However the dosage of acitretin be adjusted according to response of the patients and tolerability of side effects.
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
- •Patients with plaque-type psoriasis having <90%of body surface area involvement, whose disease activity had been stable for the last 1month.
- •Age range 18-65 years of either sex
- •Females who are postmenopausal or tubectomised or have completed their family and are willing to maintain contraception 1 month before, during and 2 years after completion of treatment and negative pregnancy tests within 2 months of starting of treatment.
- •Compliance for scheduled visit.
排除标准
- •Patients with severe hepatic, renal or other systemic disorders (serum bilirubin,AST,ALT and alkaline phosphatase>1.5 times upper limit of normal;serum creatinine >1.5 mg% in males and >1.4mg% in females)
- •Pregnant or lactating women,contemplating pregnancy in next 2 -3 years
- •Alcoholic
- •Metabolic disorders such as hyperlipidemia
- •Obese/BMI≥ 30 kg/m2
- •Ischemic heart diseases,neuropsychiatric illness
研究组 & 干预措施
25 mg acitretin
capsule acitretin 25 mg/day will be administered to each patient for a period of 12 weeks
干预措施: Acitretin (Drug)
35 mg acitretin
capsule acitretin 35 mg/day will be administered to each patient for a period of 12 weeks
干预措施: Acitretin (Drug)
50 mg acitretin
capsule acitretin 50 mg/day will be administered to each patient for a period of 12 weeks
干预措施: Acitretin (Drug)
结局指标
主要结局
Change in Psoriasis area severity index from baseline to 12 weeks after acitretin therapy
时间窗: 12 weeks
次要结局
- Frequency of adverse effects at 3 different doses of acitretin(12 weeks)
