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临床试验/NCT05684861
NCT05684861已完成2 期

Serum TWEAK Levels in Acne Vulgaris Patients Treated With Oral Isotretinoin

South Valley University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年1月1日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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

Active Comparator

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hassan Mohammed Ibrahim

Associate professor

South Valley University

研究点 (1)

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