Serum TWEAK Levels in Acne Vulgaris Patients Treated With Oral Isotretinoin
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- serum level of TWEAK
研究概览
简要总结
Evaluate the serum level of TWEAK in patients with AV and their relations before and after treatment with isotretinoin.
详细描述
Acne vulgaris is a chronic inflammatory disease of the pilosebaceous follicles, characterized by comedones, papules, pustules, cysts, nodules, and occasionally scars. Its pathogenesis includes follicular hyperkeratinization, sebaceous hypersecretion due to androgen stimulation, follicular colonization by Propionibacterium acnes, immune and inflammatory responses. It affects the face, anterior chest, and upper back . Inflammation is regarded as a key component in the pathogenesis of acne . An increase in the activity of the pro inflammatory cytokine, interleukin (IL) 1, is observed before the beginning of hyperproliferation around the uninvolved follicles and is thought to trigger the activation of keratinocyte proliferation. Nuclear factor kappa beta (NF κβ) regulated mRNA gene levels of the cytokines tumour necrosis factor (TNF) α, IL 1 β, IL 8 and IL 10 levels also affected.
Isotretinoin (13-cis retinoic acid) is a synthetic analog of vitamin A. Its oral form is prescribed for severe cases which are resistant to other treatments.
Tumor necrosis factor (TNF)-like weak inducer of apoptosis (TWEAK) belongs to the TNF superfamily. It has an important role in the regulation of cell growth, apoptosis, angiogenesis, and immune reactions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 10 Years 至 60 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients classified according to the global acne grading system(GAGS) into moderate, severe, and very severe cases
排除标准
- •Pregnant and lactating women, patients with renal, GIT, skeletal, psychiatric, and endocrine disorders, sarcoidosis, and patients receiving drugs such as diuretics, multivitamins, anticonvulsants, glucocorticoids, erythromycin, estrogen compound pill were excluded.
研究组 & 干预措施
Group I patients
90 patients with acne vulgaris Patients classified according to the global acne grading system(GAGS) into moderate, severe, and very severe cases
干预措施: Isotretinoin (Drug)
Group I patients
90 patients with acne vulgaris Patients classified according to the global acne grading system(GAGS) into moderate, severe, and very severe cases
干预措施: ELISA Assays of Serum TWEAK. (Diagnostic Test)
Control group
60 age-sex-matched healthy subjects as a control group
干预措施: ELISA Assays of Serum TWEAK. (Diagnostic Test)
结局指标
主要结局
serum level of TWEAK
时间窗: 12 weeks
To evaluate the serum level of TWEAK in patients with moderate to severe acne vulgaris.
次要结局
- evaluate the effect of systemic isotretinoin on serum TWEAK level(12 weeks)
研究者
Hassan Mohammed Ibrahim
Associate professor
South Valley University
