The Efficacy of Topical Formulation Containing Ciplukan (Physalis Angulata Linn.) on Modified Psoriasis Area and Severity Index, Thickness, and Inflammation of Psoriasis Vulgaris Lesions
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Modified Psoriasis Area and Severity Index (MPASI)
研究概览
简要总结
Psoriasis vulgaris is a chronic inflammatory skin disease mediated by the immune system, with a complex pathogenesis that requires long-term therapy. Various inflammatory mediators that activate and are produced from the NF-κB signaling pathway play a role in the pathogenesis of psoriasis vulgaris. Topical corticosteroids are the first-line therapy for all severity levels of psoriasis vulgaris, possessing immunosuppressive, anti-inflammatory, and antimitotic effects. However, long-term use can lead to side effects such as atrophy, striae, telangiectasia, hypopigmentation, acneiform eruptions, perioral dermatitis, and hypertrichosis.
详细描述
Ciplukan (Physalis angulata Linn.) contains seco-steroids and flavonoids, which exhibit anti-inflammatory, antiproliferative, and immunosuppressive effects. These effects suggest that ciplukan (Physalis angulata Linn.) could serve as an adjuvant topical therapy for psoriasis vulgaris. However, studies on the effectiveness of ciplukan (Physalis angulata Linn.) extract in topical formulations for patients with psoriasis vulgaris have not yet been conducted.
Therefore, a study is needed to assess psoriasis vulgaris lesions both subjectively using the modified PASI score and objectively using high-frequency ultrasonography and spectral Doppler ultrasonography. This would evaluate the effectiveness of ciplukan (Physalis angulata Linn.) cream as an adjuvant topical therapy for psoriasis vulgaris in reducing inflammation and accelerating clinical improvement of skin lesions in patients with psoriasis vulgaris.
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
- None
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
- •Age 18 - 60 years
- •Diagnosed with psoriasis vulgaris based on medical history, physical examination, and severity assessment using the PASI score
排除标准
- •Pregnant or breastfeeding women.
- •Patients currently undergoing systemic therapy for psoriasis vulgaris.
- •Patients who have not discontinued systemic therapy/phototherapy for psoriasis vulgaris ≤ 30 days.
- •Patients with psoriasis vulgaris who have not discontinued topical therapy (other than moisturizers) ≤ 14 days.
- •Psoriasis vulgaris lesions located in trauma-prone areas, palms, soles, face, and skin folds.
研究组 & 干预措施
Bethametasone valerat 0,1%
A minimum amount of 20 psoriasis vulgaris lesion treated with the bethametasone valerate 0,1% cream, applied twice daily for 14 days.
干预措施: Bethametasone valerate 0,1% cream (Drug)
Ciplukan
A minimum amount of 20 psoriasis vulgaris lesion treated with the topical formulation containing 20% ciplukan (Physalis angulata Linn.) extract, applied twice a day for 14 days.
干预措施: Ciplukan (Drug)
结局指标
主要结局
Modified Psoriasis Area and Severity Index (MPASI)
时间窗: 14 days
The scoring method that will be used to assess the clinical severity of each observed lesion. The minimum value is 0, and maximum value is 12. A higher scores indicate a worse outcome.
Lesion thickness
时间窗: 14 days
High frequency ultrasonography will be used to measure the thickness of each observed lesion (measured in milimeter)
Inflammation
时间窗: 14 days
Resistive index detected by high frequency ultrasonography will be used to assess the severity of inflammation in each observed lesion.
次要结局
未报告次要终点