NCT07518342

The Effect of Nanofat Injection on Androgenetic Alopecia

Efficacy and Safety of Nanofat Injection vs Either PRP Injection or Topical Minoxidil 5% in Female and Male Pattern Androgenetic Alopecia

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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 The emergence of nanofat has redefined the approach to follicle restoration. Unlike traditional fat grafting, nanofat is a liquid suspension obtained by emulsifying lipoaspirate, which filters out mature adipocytes while concentrating the stromal vascular fraction (SVF). Recent studies suggest that a single injection of nanofat can produce clinically significant increases in hair density and diameter within 3 months. In a study conducted outside of Egypt, trichoscopic evaluation of treated areas across all patients demonstrated a significant increase in hair density and thickness compared to control areas; these improvements became statistically and clinically evident at the 3-month follow-up. Parallel to these clinical findings, patient satisfaction exhibited a similar trend.Another study conducted within Egypt, clinical results demonstrated significant improvement as evidenced by comparative photographic analysis across the majority of the treated cohort, correlating with high mean patient satisfaction and minimal reported adverse effects . Given the specific aesthetic importance of the temporal area and the limited data comparing single-intervention regenerative therapies with long-term topical treatments, this study aims to evaluate the comparative efficacy and safety of a single nanofat injection versus daily 5% topical minoxidil in both male and female patients.

Conditions

• Androgenetic Alopecia
• Androgenetic Alopecia (AGA)

Interventions

Type	Name	Description
DRUG	Minoxidil 5 %	Topical application of minoxidil 5%
PROCEDURE	PRP injection	3 PRP injections one month apart
PROCEDURE	Nanofat injection	Single nanofat injection

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-06-01
• Completion: 2028-12-01
• First posted: 2026-04-08
• Last updated: 2026-04-13

Locations

1 site across 1 country: Egypt