Evaluation of the Efficacy and Safety of Oral Roflumilast Versus Intralesional Corticosteroids Injection (ILCs) in the Treatment of Alopecia Areata: A Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To assess the degree of improvement in hair regrowth according to the change in SALT score from baseline to Week 16.
研究概览
简要总结
Evaluation of the Efficacy and Safety of a drug called Oral Roflumilast versus Intralesional Corticosteroids Injection (ILCs) in the Treatment of Alopecia Areata.
详细描述
we are going to evaluate using oral immunomodulator called Roflumilast and compare its safety and efficacy to intralesional steroid injection in the treatment of Alopecia areata
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Weeks 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with mild to moderate patchy alopecia areata as assessed by SALT score (S1: 1-24% hair loss (limited); S2: 25-49% hair loss (moderate))
- •Patients with patchy alopecia areata with viable hair follicles by trichoscopy.
- •Patients of both genders aged >18 years.
- •Patients able and willing to provide informed consent.
排除标准
- •Patients with other types of AA (surface area >50%, alopecia totalis, alopecia universalis and ophiasis).
- •Patients less than 18 years old.
- •Patients receiving systemic treatment relevant to AA or biologics, phototherapy, or topical treatment within 4 weeks before enrollment into the study.
- •Patients with a history of/ or existing scalp skin diseases apart from AA, such as eczema, seborrheic dermatitis, psoriasis, scalp infections, or skin cancer.
- •Pregnant and lactating females.
- •Patients with a history of other inflammatory skin conditions
- •History of hypersensitivity to roflumilast or its components.
- •History of severe anxiety or depression (Gupta, 2012)
- •Patients with history of bleeding disorders or on anticoagulant medications,
- •Patients with active infection at the local site, patients with keloidal tendency, and patients with low pain threshold.
研究组 & 干预措施
Arm A: 25 participants with AA will be on Roflumilast group
patients in arm A will receive daily oral Roflumilast (immunomodulator) 500 mcg for 16Consecutive weeks.
干预措施: Roflumilast (Drug)
25 participants will receive intralesional steroid injection
ILCs group: 5 mg/mL every 4 weeks for 16 weeks
干预措施: intralesional steroid (Drug)
结局指标
主要结局
To assess the degree of improvement in hair regrowth according to the change in SALT score from baseline to Week 16.
时间窗: 4 months
To assess the degree of improvement in hair regrowth according to the change in SALT score from baseline to Week 16.
次要结局
未报告次要终点
研究者
Nahla Maher Mahmoud Mahran
Lecturer of Dermatology
Cairo University