The Effect of Nanofat Injection on Androgenetic Alopecia
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Minoxidil 5 %, PRP injection, Nanofat injection.
- Кому может быть актуально
- Состояния в реестре: Androgenetic Alopecia, Androgenetic Alopecia (AGA). Базовые параметры: 18 лет — 50 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Египет
- Следующий шаг
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Официальное название
Efficacy and Safety of Nanofat Injection vs Either PRP Injection or Topical Minoxidil 5% in Female and Male Pattern Androgenetic Alopecia
Обзор
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
Подробное описание
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.
Вмешательства
- Препарат Minoxidil 5 %
Topical application of minoxidil 5% - Процедура PRP injection
3 PRP injections one month apart - Процедура Nanofat injection
Single nanofat injection
Первичные конечные точки
- Clinical improvement by using trichoscopy and photographs [Срок оценки: All patients will be evaluated at Day 1 and at 6, 12 and 16 weeks.]
- Trichoscopic improvement [Срок оценки: All patients will be evaluated at Day 1 and at 6, 12 and 16 weeks.]
- patient satisfaction score [Срок оценки: All patients will be evaluated at Day 1 and at 6, 12 and 16 weeks.]
Вторичные конечные точки (1)
- Temporal Hairline Position [Срок оценки: All patients will be evaluated at Day 1 and at 6, 12 and 16 weeks.]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Египет · 1 центр
- Assiut University — Asyut
Публикации
- Stevens J, Khetarpal S. Platelet-rich plasma for androgenetic alopecia: A review of the literature and proposed treatment protocol. Int J Womens Dermatol. 2018 Sep 21;5(1):46-51. doi: 10.1016/j.ijwd.2018.08.004. eCollection 2019 Feb. PMID 30809579
- Coleman SR. Structural fat grafting: more than a permanent filler. Plast Reconstr Surg. 2006 Sep;118(3 Suppl):108S-120S. doi: 10.1097/01.prs.0000234610.81672.e7. PMID 16936550
- Zhang Z, Chen N, Xiao L, Li K, Liu H. Injection of the Concentrate Derived from Nanofat Graft Promotes Hair Growth in Patients of Male Androgenetic Alopecia: A Clinical Pilot Study. Aesthetic Plast Surg. 2025 Oct;49(19):5548-5558. doi: 10.1007/s00266-025-05291-z. Epub 2025 Sep 30. PMID 41028613
- Awasthi C, Khan A, Islam SS. PdSe2/MoSe2: a promising van der Waals heterostructure for field effect transistor application. Nanotechnology. 2024 Feb 19;35(19). doi: 10.1088/1361-6528/ad2482. PMID 38295411
- Xia Y, Chen H, Chen Y, Chen Z. Relative efficacy of minoxidil in combination with other treatments for androgenic alopecia: a network meta-analysis based on randomized controlled trials. Front Med (Lausanne). 2025 Sep 17;12:1638496. doi: 10.3389/fmed.2025.1638496. eCollection 2025. PMID 41041440
- Suchonwanit P, Thammarucha S, Leerunyakul K. Minoxidil and its use in hair disorders: a review. Drug Des Devel Ther. 2019 Aug 9;13:2777-2786. doi: 10.2147/DDDT.S214907. eCollection 2019. PMID 31496654
- Ho CH, Sood T, Zito PM. Androgenetic Alopecia. 2024 Jan 7. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK430924/ PMID 28613674
- Kaiser M, Abdin R, Gaumond SI, Issa NT, Jimenez JJ. Treatment of Androgenetic Alopecia: Current Guidance and Unmet Needs. Clin Cosmet Investig Dermatol. 2023 May 31;16:1387-1406. doi: 10.2147/CCID.S385861. eCollection 2023. PMID 37284568
Идентификаторы
NCT: NCT07518342 · Nanofat Androgenetic Alopecia