Efficacy, safety and economic analysis of topical preparations in patients with mild to moderate atopic dermatitis AD: a randomized open-labelled active controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To assess the Proportion of patients with treatment success (a score of 0 or 1 within the treatment area) based on the Investigator’s Global Assessment of Disease Severity (IGA) with topical preparations (Crisaborole Vs Tacrolimus Vs Steroid) in patients with mild to moderate Atopic Dermatitis
研究概览
简要总结
Atopic dermatitis, also called atopic eczema, is a persistent inflammatory condition involving skin, characterized by recurring periods of exacerbation and improvement, impacting approximately 10% individuals at some point in their lives. Atopic dermatitis arises from a multifaceted mechanism involving immune system dysfunction, genetic mutations in the epidermis, and environmental influences. This interaction disrupts the skin’s outer layer, leading to the development of intensely itchy skin lesions.
Topical corticosteroids (TCSs) are frequently employed as the primary therapeutic approach for treating atopic dermatitis, but their safety profile is a matter of concern on long term use. Tacrolimus is a topically used inhibitor of calcineurin that specifically hinders the activation of T cells and mast cells. Prescribers frequently suggest Tacrolimus as the initial treatment for atopic dermatitis in sensitive skin areas. Crisaborole 2% - the topically used inhibitor of PDE-4 approved for AD – has only been tested against placebo, and not against active treatment arms yet. There is lack of comparative efficacy, safety, and economic analysis among TCS, Tacrolimus and Crisaborole in patients presenting with mild to moderate AD.
90 patients will be enrolled with mild to moderate Atopic dermatitis and they will be randomized in ratio of 1:1:1 to topical age-appropriate dose of Tacrolimus group, topical 2% Crisaborole group and active control group of topical 0.1% Mometasone. Each group will be followed up after 2 weeks, and after 4 weeks for assessment of the efficacy, safety and economical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 2.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Non-immunocompromised males or females aged 2 years or older with a clinical diagnosis of mild to moderate Atopic Dermatitis 2.An IGA of disease severity of at least mild to moderate at baseline (a score of 2 or 3).
排除标准
- •1.Pigmented lesion(s) in any treatment area at baseline, which would interfere with evaluations 2.History of any confounding skin conditions 3.History or presence of HIV, diabetes, malignancy, serious active or recurrent infection, clinically significant severe renal insufficiency or severe hepatic disorders 4.Use within 14 days of baseline of: 1) systemic antibiotics, 2) calcipotriene or other vitamin D preparations, or 3) retinoids or 4) study drugs 5.Known allergy or hypersensitivity to study drugs.
结局指标
主要结局
To assess the Proportion of patients with treatment success (a score of 0 or 1 within the treatment area) based on the Investigator’s Global Assessment of Disease Severity (IGA) with topical preparations (Crisaborole Vs Tacrolimus Vs Steroid) in patients with mild to moderate Atopic Dermatitis
时间窗: 2 weeks and 4 weeks
次要结局
- To evaluate the Change from baseline to 4 weeks in IGA (investigators global assessment) score with topical preparations (Crisaborole Vs Tacrolimus Vs Steroid) in patients with mild to moderate Atopic Dermatitis(2 weeks and 4 weeks)
- To evaluate the Change from baseline to 4 weeks in PP-NRS (Peak Pruritus Numerical Rating Scale) with topical preparations (Crisaborole Vs Tacrolimus Vs Steroid) in patients with mild to moderate Atopic Dermatitis(2 weeks and 4 weeks)
- To evaluate the Change from baseline to 4 weeks in EASI (Eczema area and severity index) with topical preparations (Crisaborole Vs Tacrolimus Vs Steroid) in patients with mild to moderate Atopic Dermatitis(2 weeks and 4 weeks)
- To evaluate the Change from baseline to 4 weeks in SCORAD (Scoring Atopic Dermatitis) with topical preparations (Crisaborole Vs Tacrolimus Vs Steroid) in patients with mild to moderate Atopic Dermatitis(2 weeks and 4 weeks)
- To evaluate the Change from baseline to 4 weeks in QoL (Quality of life) with topical preparations (Crisaborole Vs Tacrolimus Vs Steroid) in patients with mild to moderate Atopic Dermatitis(2 weeks and 4 weeks)
- To evaluate the cost-effectiveness for the proportion of patients with treatment success (a score of 0 or 1 within the treatment area) based on the Investigator’s Global Assessment of Disease Severity (IGA) with topical preparations (Crisaborole Vs Tacrolimus Vs Steroid) in patients with mild to moderate Atopic Dermatitis(2 weeks and 4 weeks)
- To evaluate the cost-utility based on quality of life with topical preparations (Crisaborole Vs Tacrolimus Vs Steroid) in patients with mild to moderate Atopic Dermatitis(2 weeks and 4 weeks)
- To evaluate the Adverse events in each arm, coded as per MedDRA, with topical preparations (Crisaborole Vs Tacrolimus Vs Steroid) in patients with mild to moderate Atopic Dermatitis(2 weeks and 4 weeks)
- To assess the number of patients needed the rescue medicine therapy after 2 weeks of treatment(2 weeks and 4 weeks)
研究者
Dr Pradeep Dwivedi
AIIMS, Jodhpur