Intralesional Vitamin D3 Injection in Treatment of Alopecia Areata: A Novel Approach
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Regrowth Score (RGS)
研究概览
简要总结
To evaluate the efficacy and safety of intralesional injection of vitamin D3 versus intralesional injection of corticosteroids in treatment of alopecia areata.
this will be carried out on 40 patients who attend hair outpatient clinic, department of dermatology, Faculty of medicine, Alexandria University, Egypt.
The patients will be randomly assigned into two groups (A and B), each group contains 20 patients. Patients will be blindly subjected to intralesional injection of triamcinolone acetonide (5mg/ml) using sterile saline for dilution every 4 weeks for 3 sessions (11,12) or intralesional injection of vitamin D (an aqueous preparation of cholecalciferol (Devarol® ampoule 200,000 IU/2 mL, Memphis, Egypt) (2.5 mg/mL) every 4 weeks for 3 sessions. The maximum total amount of vitamin D3 injected into a patient in 1 session will be 5 mg Injection will be preceded by topical anaesthesia under occlusion for 30 minutes.
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
- Single (Participant)
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Site: scalp. Extent: localized alopecia areata (less than 50% scalp involvement).
排除标准
- •Other skin diseases affecting the scalp
- •Pregnant or lactating women.
- •Bleeding or coagulation disorders
- •Immunocompromised patients.
- •Known hypersensitivity to vitamin D
- •Patients who received systemic or topical treatment for alopecia areata in the last month.
- •Patients taking vitamin D supplements in the last 6 months.
- •Patients treated with topical vitamin D analogues.
- •Patients with diseases known to alter vitamin D level as autoimmune diseases, liver or renal diseases.
- •Obesity (defined as body mass index ≥ 25).
研究组 & 干预措施
intralesional injection of triamcinolone acetonide
5mg/ml) using sterile saline for dilution every 4 weeks for 3 sessions
干预措施: triamcinolone acetonide (Drug)
intralesional injection of vitamin D
(2.5 mg/mL) every 4 weeks for 3 sessions
干预措施: vitamin D (Drug)
结局指标
主要结局
Regrowth Score (RGS)
时间窗: three month
calculation at week 12 using a 5-point semiquantitative score (RGS)(0 = regrowth \< 10%; 1 = regrowth 11- 25%; 2 = regrowth26 - 50%; 3 = regrowth 51- 75%; 4: regrowth \> 75%)
次要结局
未报告次要终点
研究者
marwa eldeeb
lecturer of dermatology
Alexandria University