Efficacy and Safety of Nanofat Injection vs Either PRP Injection or Topical Minoxidil 5% in Female and Male Pattern Androgenetic Alopecia
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Clinical improvement by using trichoscopy and photographs
研究概览
简要总结
Androgenetic alopecia is a condition that bothers a lot of people. The disadvantage of the FDA approved topical minoxidil is that the patient needs to be compliant every day for extended periods of time. This is the main reason why this study is being conducted, to see if a single nanofat injection is superior to applying either topical Minoxidil or PRP
详细描述
Androgenetic alopecia (AGA) is a genetically predetermined, progressive hair loss disorder characterized by the gradual miniaturization of terminal hair follicles into vellus-like follicles. It is the most common cause of non-scarring hair loss worldwide.The pathogenesis involves a shortened anagen (growth) phase and an increased telogen (resting) phase, primarily driven by the action of dihydrotestosterone (DHT) on androgen-sensitive follicles in the scalp.
The clinical presentation of AGA is different in men and women. Typically, hair thinning in the frontotemporal areas, the recession of the frontotemporal hairline and hair loss in the vertex area occur in male androgenetic alopecia (MAGA). In female androgenetic alopecia (FAGA), hair thinning occurs over the frontal and parietal areas of the scalp (Ludwig type) or only in the central part of the frontal area (Olsen type, alternatively known as the "Christmas tree pattern"). Hair pull test help differentiate it from telogen effluvium.
The diagnosis of AGA is usually based on clinical appearance, but in doubtful cases, trichoscopy may help physicians to make a proper diagnosis and avoid other invasive diagnostic methods such as scalp biopsy. Key trichoscopic features include hair diameter diversity (HDD), where a variance exceeding 20% is considered diagnostic, and a predominance of single-hair units. Early stages of the condition are frequently characterized by the peripilar sign , while more advanced disease may present with honeycomb pigmentation, particularly in males with significant recession, or the presence of yellow dots, which are typically associated with late-stage follicular miniaturization.
Current therapeutic strategies focus on arresting hair loss progression and stimulating follicular regrowth through a combination of pharmacological and regenerative approaches, though they generally necessitate rigorous long-term adherence. Standard FDA-approved interventions include topical minoxidil, a potassium channel opener that prolongs the anagen phase but is often hampered by poor patient compliance, local irritation, and the requirement for lifelong, twice-daily application to maintain results, and oral finasteride, a Type II 5-alpha-reductase inhibitor that lowers systemic DHT levels. Beyond these primary treatments, the clinical landscape incorporates off-label options such as low-dose oral minoxidil, as well as adjuvant regenerative and combinatorial procedures including microneedling in conjunction with minoxidil, platelet-rich plasma (PRP) for the injection of autologous growth factors to promote follicle survival, exosome therapy, and the application of nanofat and stromal vascular fraction (SVF) injections.
PRP has gained widespread use as a minimally invasive regenerative treatment. By concentrating autologous platelets, PRP delivers a "burst" of alpha-granules containing high concentrations of growth factors (e.g., PDGF, TGF-beta, and IGF-1) . These factors promote follicular cell proliferation and prolong the anagen phase. While PRP is effective, its results are often transient, typically requiring a series of 3 to 6 monthly sessions to maintain density
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 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (ages 18-50).
- •A clinical diagnosis of androgenetic alopecia confirmed by dermoscopy of both males and females.
- •No previous topical treatment used in the past 3 months.
排除标准
- •Alopecia totalis and alopecia universalis.
- •Cicatricial alopecia.
- •Other causes of hair loss such as immunological disease.
- •Skin disease in the affected area.
- •Hypersensitivity or allergy to any of the treatment products used.
- •Patients using treatment (topical or systemic) for androgenetic alopecia in the last 3 months.
- •Pregnant and lactating females.
- •Patients with a history of hypertrophic scars or keloid formation.
- •Patients with active infection at the site of the lesion.
- •Skin disease in the affected area.
- •Hamilton norwood scale stage 6 and 7
- •Ludwig Scale stage 3
研究组 & 干预措施
Topical minoxidil 5/
Patients will be taught how to apply topical minoxidil daily for three months
干预措施: Minoxidil 5 % (Drug)
PRP injection
Patients will receive three PRP injections one month apart each
干预措施: PRP injection (Procedure)
nanofat injection
Patience well receive single nano fat injection
干预措施: Nanofat injection (Procedure)
结局指标
主要结局
Clinical improvement by using trichoscopy and photographs
时间窗: All patients will be evaluated at Day 1 and at 6, 12 and 16 weeks.
Photographs using Hamilton norwood scale for males and Ludwig Scale for females
Trichoscopic improvement
时间窗: All patients will be evaluated at Day 1 and at 6, 12 and 16 weeks.
Including hair diameter diversity
patient satisfaction score
时间窗: All patients will be evaluated at Day 1 and at 6, 12 and 16 weeks.
It will be used for objective evaluation: * 0 to 25% change = not satisfied, * 26 to 50% = mildly satisfied, * 51 to 75% = moderately satisfied, * 76 to 100% = very satisfied.
次要结局
- Temporal Hairline Position(All patients will be evaluated at Day 1 and at 6, 12 and 16 weeks.)
研究者
Marina Abdelmassieh Aiad Aboelsaad
Assistant lecturer
Assiut University
