Effectiveness of emollients with topical steroids vs emollients with oral apremilast in the management of palmoplantar psoriasis- A Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To compare the effectiveness of topical emollients with topical steroids versus emollients with oral apremilast in adults suffering from palmoplantar psoriasis
研究概览
简要总结
Background:
Palmoplantar psoriasis significantly impairs patient quality of life due to its location and symptoms. While topical steroids remain the standard first line treatment, they often provide inadequate long term control. Apremilast, as a systemic, non biologic agent with a favourable safety profile, presents a promising alternative. This study will provide much needed comparative data on two practical therapeutic options in a real world Indian setting, guiding clinicals towards evidence based management of palmoplantar psoriasis.
Purpose:
To compare the clinical efficacy of emollients with topical steroids versus emollients with oral Apremilast in the management of palmoplantar psoriasis.
To assess patient-reported improvement in quality of life using DLQI.
To assess the recurrence rate post treatment
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 18 to 65 years.
- •Diagnosed with palmoplantar psoriasis (with or without nail involvement).
- •DLQI score greater than or equal to
- •Patients who provide written informed consent.
排除标准
- •Patients with generalised Psoriasis or psoriatic arthritis.
- •Pregnant or lactating women.
- •Patients with liver or kidney dysfunction, active tuberculosis or immunosuppressive conditions Recent use (within 4 weeks) of systemic anti-Psoriatic drugs or biologics Hypersensitivity to apremilast or corticosteroids.
结局指标
主要结局
To compare the effectiveness of topical emollients with topical steroids versus emollients with oral apremilast in adults suffering from palmoplantar psoriasis
时间窗: Day 0 | Wk 4 | Wk 8 | Wk 12 | Wk 24
次要结局
未报告次要终点
研究者
Dr K V Pushpanjali
Chettinad Hospital And Research Institute