Evaluation of the Efficacy of Crisaborole 2% Cream Compared to Placebo in the Management of Mild to Moderate Atopic Eczema
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 270
- 主要终点
- Proportion of Participants Achieving Treatment Success Based on Investigator's Static Global Assessment (ISGA)
研究概览
简要总结
This randomized controlled trial (RCT) aims to evaluate the efficacy and safety of Crisaborole 2% cream compared with placebo in patients with mild to moderate atopic dermatitis (AD), also known as atopic eczema. AD is a chronic inflammatory skin condition characterized by itching, redness, and recurrent flares that can significantly impair quality of life.
Eligible participants aged 12 to 50 years with mild to moderate AD will be randomly assigned to receive either Crisaborole 2% cream or a placebo cream applied twice daily for four weeks. The primary outcome is treatment success at Day 28, defined using the Investigator's Static Global Assessment (ISGA) as a score of 0 (clear) or 1 (almost clear) with at least a two-grade improvement from baseline.
Participants will be evaluated at baseline, Day 14, and Day 28. Safety, tolerability, and compliance will also be assessed. The results of this RCT may provide locally relevant evidence to guide the management of mild to moderate AD.
详细描述
Atopic dermatitis (AD), commonly referred to as atopic eczema, is a chronic, relapsing inflammatory skin disorder characterized by pruritus, erythema, and impaired skin barrier function. AD affects both children and adults and is associated with significant psychosocial burden, sleep disturbance, and reduced quality of life. Standard treatment options include topical corticosteroids and calcineurin inhibitors; however, prolonged use of these agents may be associated with adverse effects such as skin atrophy, irritation, and tachyphylaxis, highlighting the need for effective non-steroidal alternatives.
Crisaborole 2% cream is a topical phosphodiesterase-4 (PDE4) inhibitor that reduces inflammation by inhibiting cyclic adenosine monophosphate degradation and decreasing pro-inflammatory cytokine production. International clinical trials have demonstrated its efficacy in mild to moderate AD, but limited data are available from South Asian populations.
This study is a single-center, randomized, placebo-controlled trial conducted at the Department of Dermatology, Jinnah Postgraduate Medical Centre, Karachi. Participants aged 12 to 50 years with clinically diagnosed mild to moderate AD, defined by an ISGA score of 2 (mild) or 3 (moderate), will be enrolled after obtaining written informed consent.
Participants will be randomized in a 1:1 ratio into two groups:
Group A: Crisaborole 2% cream applied twice daily
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, care providers, investigators, and outcome assessors will be blinded to treatment allocation. Study medications will be identical in appearance, packaging, and labeling to maintain blinding.
入排标准
- 年龄范围
- 12 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12 to 50 years
- •Clinically diagnosed mild to moderate atopic dermatitis (ISGA score 2 or 3)
- •Willing and able to apply topical medication twice daily for four weeks
- •Able to provide written informed consent (parental consent for participants under 18 years)
排除标准
- •Severe atopic dermatitis (ISGA score 4)
- •Use of systemic corticosteroids, immunosuppressants, or antibiotics within the past two weeks
- •Known hypersensitivity to crisaborole or any component of the formulation
- •Pregnant or lactating women
- •Presence of other significant dermatological conditions that may interfere with evaluation (e.g., psoriasis, scabies)
- •Immunocompromised status (e.g., HIV infection, organ transplant recipient)
研究组 & 干预措施
Crisaborole 2% Cream
Participants will apply Crisaborole 2% cream as a thin layer to affected areas twice daily for four weeks.
干预措施: Crisaborole 2% Cream (Drug)
Placebo Cream
Participants will apply a placebo cream identical in appearance and consistency to Crisaborole 2% cream, twice daily for four weeks.
干预措施: Placebo Cream (Drug)
结局指标
主要结局
Proportion of Participants Achieving Treatment Success Based on Investigator's Static Global Assessment (ISGA)
时间窗: Day 28 (End of Treatment)
Treatment success is defined as achieving an ISGA score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline.
次要结局
未报告次要终点
研究者
Uroosa Shailkh
PGR
Jinnah Postgraduate Medical Centre