A comparison of topical corticosteroids versus topical tacrolimus with microneedling in alopecia areata.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- 1. Efficacy of topical tacrolimus with microneedling in alopecia areata using SALT score and dermascopy.
研究概览
简要总结
A detailed clinical history will be taken. A thorough general physical and dermatological examination will be carried out in all patients. In selected patients, patches on right side of scalp will be labelled as side A while patches on left side of scalp will be labelled as side B. Side A and Side B would be randomized to receive either topical corticosteroids or topical tacrolimus with 4 sessions of microneedling using computer-based sequence. Assessment will be done by SALT (Severity of Alopecia Tool) score, dermoscopy, photographic record and patient satisfaction score. Side effect documentation (if any) will also be done. All the above evaluation will be done at baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks and
12 weeks.
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically diagnosed as alopecia areata.
- •Patients ≥ 2 patches of hair loss over scalp.
- •Patients on topical or systemic treatment after washout period of 2 weeks and 4 weeks respectively.
排除标准
- •Patients with alopecia totalis/ universalis.
- •Patients with skin atrophy on alopecia patch.
- •Pregnancy/ lactation.
- •Active infection.
- •Patients with comorbidities.
- •Hemophilias/ bleeding tendency.
- •Tendency for scarring/ keloid formation.
结局指标
主要结局
1. Efficacy of topical tacrolimus with microneedling in alopecia areata using SALT score and dermascopy.
时间窗: 1 year
次要结局
- Comparative efficacy of topical tacrolimus with microneedling versus topical corticosteroids in alopecia areata.(1 year)
研究者
Dishika Goyal
Maulana Azad Medical College