Fractional Photothermolysis for the Induction of Hair Follicles Via Skin Rejuvenation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Hair Density Change by as Seen by Dermoscopy
研究概览
简要总结
This study is being done to evaluate the effects of fractional photothermolysis (known as laser resurfacing) using fractional laser for the induction of hair follicles via skin rejuvenation in subjects with scalp alopecia (specifically, alopecia on the superior forehead at the frontal hairline). Fractional photothermolysis has been shown to be effective in promoting hair growth. The investigators will study 50 subjects who will be treated 6-10 times at 2-4 week intervals. Each participant will have half of their head treated with a laser, either Fraxel DUAL 1550 or Halo by Sciton, and the other half of their head will be left untreated as a control. Half of the individuals will randomly be assigned to the group to be treated with Fraxel DUAL 1550, and the other half will be treated with Halo by Sciton. Visual observation and digital, photographic, non-invasive imaging will be used to compare the treated and untreated area to assess for differences in hair follicle stimulation rates, number and density of hairs.
As noted above, the types of lasers we plan to use include the non-ablative fractional laser settings for the Fraxel DUAL 1550 and Halo by Sciton. A fractional laser is a laser that directs an intense burst of laser energy on the skin. The treatment deposits heat deep into the dermis to tighten skin and stimulate collagen remodeling. The necrotic (death of cells or tissue) injury heals rapidly and adverse effects are few. Laser resurfacing is commonly used for rejuvenation of the skin to improve quality, tone, and texture.
详细描述
Introduction Alopecia is also known as hair loss, and it occurs due to aging, nutritional or hormonal imbalance, or immune system etiology. It affects both males and females of different ages and races. Hair may fall out in clumps, break off leaving short stubs, or become thinner over time. The alopecia can be of a scarring or non-scarring nature. The most common form of hair loss is non-scarring, or noncicatricial, alopecia. In this case, the damage is not permanent, and although hair loss cannot be cured, it can be treated. Hair loss is usually not a sign of an underlying medical disorder. However, hair loss may affect self-esteem and cause anxiety affecting the quality of life. Scarring, or cicatricial, alopecia is a rare disorder that destroys the hair follicle and replaces it with scar tissue, resulting in permanent hair loss.
Causes
There are many genes that contribute to hair loss, so it can be hereditary. There are also other causes, including:
- Thyroid disorders
- Pregnancy
- Anemia
- Autoimmune diseases like polycystic ovarian syndrome
- Skin conditions like Psoriasis and seborrheic dermatitis
Treatment Options Topical Minoxidil (Rogaine) and anti-inflammatory medications, such as topical and intra-lesional steroids, are used for alopecia. It is a solution that is applied directly to the scalp to stimulate the hair follicle. It slows hair loss, and some people grow new hair. Hair loss returns when the medication is stopped.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be between the ages of 18 to 90 years old
- •Diagnosed with hair loss on scalp by a dermatology
- •No other treatments for hair loss have been done in the past 1 month
- •No evidence of spontaneous hair growth
- •Good health
- •Must agree to comply with study treatment and protocol
- •Healthy scalp without evidence of neoplasm
- •Scarring and/or non-scarring alopecia acceptable
排除标准
- •Any visible signs of neoplasm, infection, inflammatory disease of the scalp
- •No history of photosensitivity, impaired wound healing, chronic liver or kidney disease
- •No concurrent use of minoxidil/Rogaine, platelet-rich plasma (PRP), or light devices for hair regrowth
- •Has not initiated use of finasteride/Propecia or spironolactone in the 3 months preceding the study
研究组 & 干预措施
Fraxel DUAL 1550 nm
The Fraxel DUAL 1550 nm laser will be used at 7 mJ, 8 pulses, 120 spots/cm2, treatment level 3 (9% coverage) for hair regrowth. 25 patients with alopecia will be part of this group.
干预措施: Fraxel Dual laser (Device)
Halo Hybrid Laser 1550 nm
The Halo laser will be used per protocol due to the dynamic thermal optimization technology for hair regrowth. 25 patients with alopecia will be part of this group.
干预措施: Halo laser (Device)
结局指标
主要结局
Hair Density Change by as Seen by Dermoscopy
时间窗: 24 weeks
Hair density will be measured as increased or decreased before and after treatment using dermoscopy on both the treated and untreated scalp.
Hair Density Change as Seen by Optical Coherence Tomography (OCT).
时间窗: 24 weeks
Hair density will be measured as increased or decreased before and after treatment using OCT on both the treated and untreated scalp.
次要结局
- Hair Regrowth Impact on Quality of Life (Improved or Not Improved)(24 weeks)
研究者
Natasha Mesinkovska
Associate Professor, Vice Chair of Dermatology Clinical Research
University of California, Irvine