Role of Intercellular Adhesion Molecule -1 in Acne Vulgaris Patients : Effect of Montelukast Therapy
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Evaluation of serum soluble intercellular adhesion molecule-1 (sICAM-1) level in acne vulgaris (moderate -severe )
研究概览
简要总结
The aim of this study is to:
- Evaluation of serum soluble intercellular adhesion molecule-1 (sICAM-1) level in acne vulgaris and compare it to control group
- Evaluate its role in acne pathogenesis and its correlation with acne vulgaris severity
- Evaluate the effect of Montelukast on serum (sICAM-1) level in acne vulgaris
详细描述
Acne vulgaris is a common chronic skin disease involving blockage and inflammation of pilosebaceous units
. It is characterized by non-inflammatory, open or closed comedones and by inflammatory lesions include papules, pustules and nodules. Affecting mostly the face, but also the back and chest .
Acne vulgaris may have a psychological impact on any patient, regardless of the severity or the grade of the disease .
Prevalence of self-reported acne was 34.7%. Females significantly reported acne more frequently than males (39.1% vs. 30.3%) Prevalence of clinically confirmed acne was 24.4%, with higher rates among females (28.6%) than males (20.2%).
Its pathogenesis result from increased sebum production (due to increased activity of androgens and insulin growth factor-1), excessive deposition of keratin in pilosebaceous follicles leading to comedo formation, colonization of the follicle by Propionibacterium acnes bacteria, and the local release of pro-inflammatory chemicals in the skin through certain inflammatory mechanisms.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 15 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy persons of both sexes with moderate and severe acne vulgaris.
- •Patients age between 15-35 years
- •Patients with acne vulgaris not receiving any topical or systemic treatments for acne at least 2 weeks and 2 month before the study ,respectively
排除标准
- •Pregnant and lactating women
- •Diabetics
- •Hypertensive patients
- •acne conglobate patients and acne fulminans patients
- •patients with history of polycystic ovaries syndrome
- •Patients with history of thyroid dysfunction
- •Patients with history of chronic inflammatory or immune-mediated diseases as Crohn's disease, vascular dementia, systemic sclerosis, systemic lupus erythematosus, ankylosing spondylitis, psoriatic arthritis and SAPHO syndrome.
- •Any history of hypersensitivity reaction to the studied drug
研究组 & 干预措施
group moderate acne
patients with moderate acne vulgaris who will receive Montelukast therapy dose: 10mg/day, duration of therapy: three months, serum level of intercellular adhesion molecule -1 will be measured by performing an enzyme-linked immune sorbent assay (E LISA) before and after treatment
干预措施: Montelukast 10 Mg Oral Tablet (Drug)
group severe acne
patients with severe acne vulgaris who will receive Montelukast therapy dose: 10mg/day, duration of therapy: three months, serum level of intercellular adhesion molecule -1 will be measured by performing an enzyme-linked immune sorbent assay (E LISA) before and after treatment
干预措施: Montelukast 10 Mg Oral Tablet (Drug)
结局指标
主要结局
Evaluation of serum soluble intercellular adhesion molecule-1 (sICAM-1) level in acne vulgaris (moderate -severe )
时间窗: baseline and three months at the end of treatment
evaluation of serum soluble intercellular adhesion molecule-1 (sICAM-1) level by ELISA in acne vulgaris(moderate -severe) and compare it to control group, correlation with acne vulgaris severity and its role in pathogenesis
Montelukast in treatment of acne vulgaris patients
时间窗: three months following end of treatment
Evaluate the effect of Montelukast on serum (sICAM-1) level in acne vulgaris (group moderate acne vs group severe acne )and its side effects
次要结局
未报告次要终点
研究者
Alshayma Gamal Fouad
doctor
South Valley University