Thulium Laser and Growth Factors for Androgenetic Alopecia - a Prospective, Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Subject Global Aesthetic Improvement Scale
研究概览
简要总结
Androgenetic alopecia (AGA) is a common cause of hair loss worldwide. It mainly affects the frontal and parietal regions of the scalp in up to 70 % of men and 40 % of women and has a significant negative psychological and emotional impact on those affected.
Various therapies are currently approved for the treatment of AGA in men and women, including topical minoxidil, topical or systemic finasteride, platelet-rich plasma and hair transplantation. In addition to these pharmacological and surgical interventions, laser therapies including thulium laser with growth factors have gained popularity.
Despite the clinical use of the thulium laser with growth factors in combination with LED phototherapy, there are only a few studies to date that have adequately investigated the objective and patient-side benefits of this therapy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18 and over
- •Good general health, no relevant previous illnesses
- •Presence of an AGA
- •Cognitive ability and willingness to give consent (informed consent)
- •Be willing and able to attend follow-up visits
排除标准
- •Age < 18 years
- •Pregnant or breastfeeding women
- •Scarring alopecia, alopecia due to dermatoses (e.g. lichen ruber, lupus erythemodes,...), alopecia due to chemical or physical noxae, and other non-AGAs
- •Significant scarring of the region to be treated
- •Significant open wounds or lesions in the region to be treated
- •Metallic implants in the head region
- •Mental illnesses (psychoses, body perception disorders)
- •Use of isotretinoin or other retinoids, psychotropic drugs, coumarins or heparins in the last 2 weeks
- •Resurfacing (fractional, ablative, non-ablative) of the affected region < 2 months before and during the study period
- •Tendency to excessive scarring
- •Lack of informed consent and/or data protection declarations
研究组 & 干预措施
Thulium laser
Thulium laser
干预措施: Thulium laser (Procedure)
Thulium laser + growth factor serum + LED
Thulium laser + growth factor serum + LED
干预措施: Thulium laser + growth factor serum + LED (Procedure)
Thulium laser + growth factor serum
Thulium laser + growth factor serum
干预措施: Thulium laser + growth factor serum (Procedure)
结局指标
主要结局
Subject Global Aesthetic Improvement Scale
时间窗: 1 and 6 months post-treatment
scale from 0 (very much improved) to 4 (worse)
Hair density
时间窗: at baseline, and 1 and 6 months post-treatment
measurement of hair density before and after treatment
hair thickness
时间窗: at baseline, and 1 and 6 months post-treatment
hair thickness before and after treatment
次要结局
- pain intensity(Periprocedural)
研究者
Lynhda Nguyen
Dr. med.
Universitätsklinikum Hamburg-Eppendorf