Comparison of an Non-ablative Fractional 1565nm vs. an Ablative 2940-nm Fractional Erbium-glass Laser for the Treatment of Male Androgenetic Alopecia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- TAHC
研究概览
简要总结
Laser sources have established their potential effect in inducing hair regrowth. No study has compared the effect of ablative fractional 2940-nm erbium yttrium aluminum garnet (Er: YAG) laser and non-fractional 15650nm fractional laser in the treatment of androgenetic alopecia (AGA).
详细描述
The investigators performed a prospective study between to compare the efficacy and safety of ablative fractional 2940-nm erbium yttrium aluminum garnet (Er: YAG) laser and non-fractional 15650nm fractional laser in the treatment of androgenetic alopecia (AGA). The efficacy of the two therapies was evaluated by the investigator's Global Assessment (IGA) scores and the patient's Likert satisfaction scale at week 12 and week 24. Changes in total, terminal and villous hair count, total and terminal hair diameter, and AGA grade were also recorded. Adverse events were evaluated at each follow-up.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 65 years;；
- •clinical diagnosis of AGA；
- •AGA diagnosis was evaluated following Norwood Hamilton grade II-V criteria；
- •no previous laser treatments for AGA in the past six months before enrollment；
- •willingness to provide pictures and follow-up studies.
排除标准
- •if presented with severe diseases of internal organs, eyes, or skin;
- •inflammation, infection, or unhealed wounds on the skin around the site of treatment on the head;
- •systematic treatment with corticosteroids or other immunosuppressants and immunomodulators in the past 3 months
研究组 & 干预措施
non-ablative fractional 1565nm
干预措施: non-ablative fractional 1565nm (Device)
5% minoxidil
干预措施: 5% Minoxidil (Drug)
结局指标
主要结局
TAHC
时间窗: week 24
Use the trichoscopy to assess the changing number of non-vellus hairs in the target area .
次要结局
- IGA(week 8, week 12, week 16, week 24, week 36)
- Grade of Norwood-Hamilton(week 12, week 24, week 36)
- HGQA(week 8, week 12, week 16, week 24, week 36)
- TAHC(week 8, week 12, week 20, week 36)
- TAHW(week 8, week 12, week 16, week 24, week 36)
- SSA(week 8, week 12, week 16, week 24, week 36)