A Comparative Study on the Efficacy of The Combined Use of Cyclosporine and Metformin in the Treatment of Psoriasis vs Cyclosporine Alone
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Primary Outcome Measure 1 Change in Psoriasis Area and Severity Index (PASI)
研究概览
简要总结
This study is a comparative clinical study evaluating the efficacy of combined therapy using cyclosporine and metformin versus cyclosporine alone in the treatment of psoriasis. Psoriasis is a chronic inflammatory skin disease that often requires systemic therapy in moderate to severe cases. Cyclosporine is an effective immunosuppressive agent; however, its long-term use is limited by potential adverse effects.
Metformin, a commonly used antidiabetic drug, has shown anti-inflammatory and immunomodulatory properties, which may enhance treatment outcomes in psoriasis. This study aims to assess whether adding metformin to cyclosporine improves clinical response compared to cyclosporine monotherapy.
详细描述
Psoriasis is a chronic, immune-mediated inflammatory skin disease characterized by erythematous, scaly plaques and a relapsing course. It has a significant negative impact on patients' quality of life and is frequently associated with metabolic comorbidities, including insulin resistance and obesity. Management of moderate to severe psoriasis often requires systemic therapy to achieve adequate disease control.
Cyclosporine is a well-established systemic immunosuppressive drug used in the treatment of moderate to severe psoriasis due to its rapid onset of action and effectiveness in reducing disease severity. Its mechanism involves inhibition of T-cell activation and cytokine production. However, long-term use of cyclosporine is limited by potential adverse effects, particularly nephrotoxicity, hypertension, and metabolic disturbances. Therefore, strategies to enhance its efficacy while potentially allowing dose reduction are of clinical importance.
Metformin is an oral hypoglycemic agent widely used in the management of type 2 diabetes mellitus. Beyond its glucose-lowering effect, metformin has demonstrated anti-inflammatory, immunomodulatory, and antiproliferative properties. Recent evidence suggests that metformin may play a beneficial role in inflammatory and immune-mediated diseases, including psoriasis, through modulation of inflammatory cytokines and improvement of insulin resistance, which is commonly observed in psoriatic patients.
This study is designed as a comparative clinical study to evaluate the efficacy of combined therapy using cyclosporine and metformin versus cyclosporine monotherapy in the treatment of psoriasis. The primary objective is to assess whether the addition of metformin enhances the clinical response compared to cyclosporine alone. Treatment efficacy will be evaluated using standardized clinical assessment tools for psoriasis severity, along with monitoring of treatment safety and tolerability.
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
- Single (Participant)
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
- •Patients ≥ 18 years old
- •Patients of both genders
- •Patients clinically diagnosed as moderate to severe psoriasis candidate for systemic treatment with Psoriasis Area Severity Index (PASI >10), Body Surface Area (BSA>10), Dermatology Life Quality Index (DLQI>10).(Laura Salgado-Boquete et al., 2021).
- •Patients with new active lesions and also patient with chronic lesions (with periods of remission and exacerbation)
排除标准
- •Erythrodermic and pustular psoriasis.
- •Patients with systemic illness ( renal, hepatic and uncontrolled hypertension ).
- •Pregnant and lactating females.
- •Patients receiving systemic treatment relevant to psoriasis within 3 months before enrollment into the study or topical treatment relevant to psoriasis within 1 month before.
- •Patients with other dermatological conditions.
- •Patients with high uric acid level .
研究组 & 干预措施
Cyclosporin (CSA)
Group A: (16) patients will receive Cyclosporine (dose 3 mg/kg),orally twice per day for 3months
干预措施: Cyclosporin (CSA) (Drug)
Cyclosporin plus Metformin
Group B: (16) patients will receive Cyclosporine(3mg/kg/day), orally and Metformin (500 mg twice daily) ,orally for 3 months
干预措施: Cyclosporin (CSA) (Drug)
Cyclosporin plus Metformin
Group B: (16) patients will receive Cyclosporine(3mg/kg/day), orally and Metformin (500 mg twice daily) ,orally for 3 months
干预措施: Metformin (500 mg Twice a day) (Drug)
结局指标
主要结局
Primary Outcome Measure 1 Change in Psoriasis Area and Severity Index (PASI)
时间窗: Baseline (Pretreatment) ,Post-treatment(At 3 months),At 6 months
Comparison of PASI scores before and after treatment within each group and between both treatment groups. Unit of Measure: PASI score Scale: 0-72 (higher scores indicate more severe psoriasis)
Primary Outcome Measure 2 Change in Body Surface Area (BSA)
时间窗: Baseline (pretreatment), 3 months, and 6 months post-treatment
Comparison of the percentage of body surface area affected by psoriasis before and after treatment within each group and between both treatment groups. Unit of Measure: Percentage of body surface area (%) Scale: 0-100% (higher percentages indicate greater skin involvement)
Primary Outcome Measure 3 Change in Dermatology Life Quality Index (DLQI)
时间窗: Baseline (pretreatment), 3 months, and 6 months post-treatment
Comparison of DLQI scores before and after treatment within each group and between both treatment groups. Unit of Measure: DLQI score Scale: 0-30 (higher scores indicate greater impairment of quality of life)
次要结局
- Patient satisfaction .(Post treatment(AT 3 months))
研究者
Aya Mohamed Fahim
Assistant Professor of Dermatology,Faculty of Medicine ,Cairo University
Cairo University