Efficacy of Fractional CO2 Laser Alone and as Transepidermal Drug Delivery for Different Modalities of Treatment in Alopecia Areata
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- response rate
研究概览
简要总结
Alopecia areata is a non-scarring hair loss disorder that affects both sexes equally. Incidence of the disease varies for different populations and in different studies, with global incidence ranging from 0.57% to 3.8%.
Etiology of alopecia areata is not completely understood, and the majority of evidence suggests that genetically predisposed individuals, when exposed to an unknown trigger, develop a predominantly autoimmune reaction, leading to acute hair loss. Environmental triggers, including viral or bacterial infections, along with autoimmune disorders, seem to play a major role in the development of alopecia areata.
详细描述
The onset and progression of alopecia areata are unpredictable. Significant variations in the clinical presentation of alopecia areata have been observed, ranging from small, well-circumscribed patches of hair loss to a complete absence of body and scalp hair.
Although many patients improve spontaneously or respond to standard therapy, treatment can be quite challenging in those with more severe and refractory disease.
Recent advances in the understanding of alopecia areata pathophysiology hold promise for better treatments in the future.
Corticosteroids either topical or intralesional are the most popular drugs for the treatment of this disease. Other therapies like topical minoxidil, anthralin, immunotherapy, systemic corticosteroids, cyclosporine and Psoralen with Ultraviolet-A Light therapy are also commonly used with varying success.
Various lasers have been suggested in recent studies to treat alopecia areata . The effect of 308-nm excimer laser was the most studied, while others, including neodymium-doped yttrium aluminum garnet, erbium:glass laser, fractional carbon dioxide laser, and low-level laser therapy, have also been assessed.
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
- None
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
- 否
入选标准
- •patients with refractory alopecia areata above 10 years old
排除标准
- •Alopecia totalis or alopecia universalis.
- •Patients with alopecia other than alopecia areata.
- •Patients younger than 10 years.
- •Pregnant and lactating females.
- •Patients with history of hypertrophic scars or keloid formation.
- •Patients with active infection at the site of the lesion.
- •Patients with blood disorders and platelet abnormalities and chronic liver disease.
- •Patients using anticoagulation therapy and antiplatelet agents.
研究组 & 干预措施
fractional carbon dioxide laser alone
six sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata
干预措施: fractional carbon dioxide laser alone (Device)
fractional carbon dioxide laser and triamcinolone acetonide
six sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata followed immediately by topical application of triamcinolone acetonide (10mg/ml)
干预措施: fractional carbon dioxide laser alone (Device)
fractional carbon dioxide laser and triamcinolone acetonide
six sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata followed immediately by topical application of triamcinolone acetonide (10mg/ml)
干预措施: Triamcinolone Acetonide 10mg/mL (Drug)
fractional carbon dioxide laser and platelet rich plasma
six sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata followed immediately by topical application of autologous platelet rich plasma
干预措施: fractional carbon dioxide laser alone (Device)
fractional carbon dioxide laser and platelet rich plasma
six sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata followed immediately by topical application of autologous platelet rich plasma
干预措施: platelet rich plasma (Biological)
fractional carbon dioxide laser and vitamin D solution
six sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata followed immediately by topical application of vitamin D solution
干预措施: fractional carbon dioxide laser alone (Device)
fractional carbon dioxide laser and vitamin D solution
six sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata followed immediately by topical application of vitamin D solution
干预措施: vitamin D solution (Drug)
结局指标
主要结局
response rate
时间窗: 3 months after last session
hair regrowth in each group in response to treatment (hair density ) expressed in follicles/ cm2
次要结局
未报告次要终点
研究者
A Ghazally
principal investigator
Assiut University