Comparative Study of the Efficacy and Safety of Combined Fractional CO₂ Laser and Topical Corticosteroid Versus Topical Corticosteroid Only in the Treatment of Palmoplantar Psoriasis: A Pilot Randomized Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Improvement in Palmoplantar Psoriasis Severity Index (ppPASI) by topical corticosteroids only vs fractional CO₂ laser-assisted delivery of topical corticosteroids
研究概览
简要总结
To assess whether adding fractional laser to topical corticosteroid improves treatment outcomes in palmoplanter psoriasis compared to topical corticosteroid alone.
详细描述
· To evaluate and compare the reduction in disease severity of palmoplantar psoriasis using the Palmoplantar Psoriasis Area and Severity Index (PPPASI) in both treatment groups
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥18 years
- •Stable psoriasis
- •Confirmed cases of palmoplantar psoriasis (with or without psoriasis elsewhere) dermoscopically(Hand _held dermoscopy) and histopathologically if required.
- •Willingness to comply with treatment and follow-up
- •Written informed consent obtained
排除标准
- •Other palmoplantar dermatoses (eczema, tinea, keratoderma)
- •Generlized Pustular psoriasis
- •Erythrodermic psoriasis
- •Systemic antipsoriatic therapy within 3 months
- •Biologic therapy within 12 weeks
- •Topical treatment on palms/soles within 2 weeks
- •Pregnancy or lactation
- •History of photosensitivity disorders
结局指标
主要结局
Improvement in Palmoplantar Psoriasis Severity Index (ppPASI) by topical corticosteroids only vs fractional CO₂ laser-assisted delivery of topical corticosteroids
时间窗: 3 month
The primary outcome will be the change in the Palmoplantar Psoriasis Severity Index (ppPASI) score from baseline to the end of treatment (at Week 12). The ppPASI assesses disease severity based on erythema, scaling, and induration/infiltration of the palms and soles, in addition to the affected surface area. Scores range from 0 to 72, with higher scores indicating more severe disease. Treatment success: Achievement of ppPASI-50, ppPASI-75, and ppPASI-90 (≥50%, ≥75%, and ≥90% reduction from baseline).
次要结局
- Physician Global Assessment (PGA)(3 months)