A Comparative Clinical Trial to Evaluate the Efficacy and Safety of Tacrolimus Versus Hydrocortisone in Treatment of Children With Atopic Dermatitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- evaluate the effect of topical tacrolimus ointment as compared to topical hydrocortisone cream on the serum level of different inflammatory cytokines using enzyme linked immunosorbent assay technique (ELISA)
研究概览
简要总结
Atopic dermatitis (AD) is a very common inflammatory, genetic skin disorder that occurs more frequently in children. Its exact etiology is not known but it is characterized by pruritic skin reactions with elevation in the levels of inflammatory markers. Corticosteroids are the first line and the mainstay therapy in management of atopic dermatitis but have many local and systemic adverse effects. The study aims to evaluate the efficacy and safety of topical tacrolimus ointment in comparison to topical hydrocortisone cream in management of children diagnosed with atopic dermatitis.
详细描述
Atopic dermatitis is a common pruritic inflammatory skin disorder. The prevalence of atopic dermatitis increased in the last three decades by two or three folds worldwide. In the developed countries, atopic dermatitis is estimated to affect 15% to 30% of children and 2% to 10% of adults. This type of dermatitis is usually associated with family history of other atopic disorders such as allergic rhinitis or asthma.
The clinical presentation of Atopic dermatitis differs depending on the age of the patient, it usually begins in infancy with erythematous, papular skin rash that may first appear on the cheeks and chin. In childhood, the skin appears dry, flaky, rough, cracked, and may bleed because of scratching, in adults the lesions are more diffuse with underlying erythema.
This condition is characterized by acute phase where the skin has red scaly patches and chronic phase in which the skin thickens.
Atopic dermatitis is a complex genetic disease where the exact etiology is not entirely known, but it is most probably due to interaction between environmental and genetic factors. The two major groups of involved genes are the genes encoding for epidermal and epithelial structural proteins and the genes regulating the production of cytokines for the immune response.
In atopic dermatitis patients, imbalance occurs between T helper-1 (TH1) and T helper-2 (TH2) immune responses, increased TH2 activity causes the release of interleukin (IL)-3, IL-4, IL-5, IL-10, and IL-13 which results in blood eosinophilia, increased total serum immunoglobulin (Ig) E, and increased growth and development of mast cells.
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, Care Provider)
盲法说明
200 opaque envelopes will be numbered serially and the corresponding letter which denotes the allocation will be put according to the electronic randomization table. Then all envelopes will be closed and put in one box. When the first patient arrives, the envelope will be opened and the patient will be allocated according to the letter inside.
入排标准
- 年龄范围
- 2 Years 至 16 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients
- •2-16 years old
- •diagnosed with Atopic Dermatitis according to Hanifin and Rajka criteria
排除标准
- •patients with serious skin disorder other than Atopic Dermatitis
- •patients taking systemic corticosteroids or anti-inflammatory medications.
研究组 & 干预措施
Tacrolimus group
100 patients treated by thin layer of 0.03% topical tacrolimus ointment on the affected areas twice daily for 4 months.
干预措施: Tacrolimus (Drug)
Hydrocortisone group
100 patients treated by thin layer of 1% hydrocortisone cream on the affected areas twice daily for 4 months.
干预措施: Hydrocortisone (Drug)
结局指标
主要结局
evaluate the effect of topical tacrolimus ointment as compared to topical hydrocortisone cream on the serum level of different inflammatory cytokines using enzyme linked immunosorbent assay technique (ELISA)
时间窗: 4 months
estimation of the serum level of inflammatory cytokines (biochemical evaluation of IL-10 (pg/ml), IL-17 (pg/ml), IL-23 (pg/ml) using enzyme linked immunosorbent assay technique (ELISA)
severity assessment
时间窗: 4 months
Estimation of the effect on the dermatitis severity scale using the modified Eczema Area and Severity Index (mEASI) score. It is a tool used to evaluate the severity of eczema based on body surface area affected by lesions, morphology of lesions (erythema, papules, excoriation, and lichenification), severity of lesions (0-3), and pruritus. The scores range from 0 to 72 for the main symptoms of AD and from 0 to 18 for pruritus, giving a maximum possible score of 0 (no involvement) to 90 (maximum involvement), (0-0.9 clear, 1-8.9 mild, 9.0-29.9 moderate, 30.0-90 severe).
次要结局
- evaluate the tacrolimus safety(4 months)
- evaluation of tacrolimus safety(4 months)
- evaluation of safety of tacrolimus(4 months)
- evaluate the hydrocortisone safety(4 months)
