Methotrexate With Microneedling Versus Triamcinilone Acetonide With Microneedling in Treatment of Recalcitrant Alopecia Areata
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of methotrexate with microneedling versus triamcinolone with microneedling in treatment of recalcitrant alopecia areata.
研究概览
简要总结
Alopecia areata is the second most common cause of hair loss following androgenic alopecia.
It is affecting 2% of global population with an increasing prevalence. Briefly, it is a chronic, immunomediated disease characterized by acute onset of non-scarring hair loss ranging from small circumscribed patchy areas on the scalp to complete scalp and body hair loss. Until recently our understanding of the pathophysiology of alopecia areata is scarce, despite being so common.
Methotrexate is an immunosuppressant drug that has been widely used for a range of inflammatory and immune-mediated skin disorders.
Methotrexate has been recently proven to inhibit Jak/STAT Pathway. Triamcinolone acetonide as another type of treatment of alopecia areata either intralesionally or topically remains the first line of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age groups: > 12 years old.
- •Sex: both sexes.
- •Co-operative Patients.
- •Recalcitrant or resistant cases to treatment (meaning that all patients had received various modalities of treatment in the past with poor/partial response or relapse after discontinuing therapy.
排除标准
- •Patients <12 years.
- •Pregnant and lactating women.
- •Patients with any underlying Systemic disorders.
- •Patients with HBV or HCV.
- •Patient with active infection of T.B.
- •Patients with bone marrow suppression (leukopenia, thrombocytopenia)
- •Patients who had received any other modalities of treatment in last 3-6 months.
研究组 & 干预措施
Group 1= Methotrexate
After microneedling, we will apply methotrexate topically (25 mg/ml) on half of the scalp at a dose of 0.02ml/cm2 with a maximum of 0.1-0.2 ml (2,5-5 mg) and rub it gently. The patient will take a session every 2 weeks for 12 weeks, on the same patient on the other patch or half of the scalp according to the pattern.
干预措施: Methotrexate (Drug)
Group2=Triamcinilone
we will use Triamcinolone acetonide 40 mg/1ml after microneedking at dose 5mg/ml concentration;1/8/ 1:7 dilution session every 3 weeks for 12 weeks. then after 12 weeks of treatment we will follow up our patients after discontinuing therapy for other 12 weeks and evaluate.
干预措施: Triamcinolone Acetonide (Drug)
结局指标
主要结局
To evaluate the efficacy of methotrexate with microneedling versus triamcinolone with microneedling in treatment of recalcitrant alopecia areata.
时间窗: 6 months
Mcdonald Hull and Norris regrowth scale by trichoscope (Time frame 6 months). Grade 1: Regrowth of vellus hair, Grade 2: Regrowth of sparse pigmented terminal hair (\<50% increment in % SALT score according to NAAF guideline), Grade 3: regrowth of terminal hair with patches of alopecia (50-75% increase in % SALT score), Grade 4: regrowth of terminal hair on the whole alopecia patch (\> 75% increase in% SALT score).
次要结局
未报告次要终点
研究者
Athar Fathy Abodief
Doctor
Al-Azhar University