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Not yet recruitingNCT07518342Updated Apr 13, 2026

The Effect of Nanofat Injection on Androgenetic Alopecia

A Phase 4 interventional study of Minoxidil 5 % and PRP injection in Androgenetic Alopecia and Androgenetic Alopecia (AGA), sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-04-13.

Sponsored by Assiut University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Androgenetic Alopecia
  • Androgenetic Alopecia (AGA)

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Keywords

  • Androgenetic Alopecia
  • Alopecia
  • PRP
  • nanofat
  • nanofat injection
  • Minoxidil
  • Topical minoxidil
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion criteria:

  • 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
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Topical minoxidil 5/

    Patients will be taught how to apply topical minoxidil daily for three months

    Drug: Minoxidil 5 %

  • Active comparator
    PRP injection

    Patients will receive three PRP injections one month apart each

    Procedure: PRP injection

  • Experimental
    nanofat injection

    Patience well receive single nano fat injection

    Procedure: Nanofat injection

Interventions

  • DrugMinoxidil 5 %

    Topical application of minoxidil 5%

  • ProcedurePRP injection

    3 PRP injections one month apart

  • ProcedureNanofat injection

    Single nanofat injection

05

What researchers measure

Primary outcomes

  1. Clinical improvement by using trichoscopy and photographs

    Photographs using Hamilton norwood scale for males and Ludwig Scale for females

    Time frame: All patients will be evaluated at Day 1 and at 6, 12 and 16 weeks.

  2. Trichoscopic improvement

    Including hair diameter diversity

    Time frame: All patients will be evaluated at Day 1 and at 6, 12 and 16 weeks.

  3. patient satisfaction score

    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.

    Time frame: All patients will be evaluated at Day 1 and at 6, 12 and 16 weeks.

Secondary outcomes

  1. Temporal Hairline Position

    measuring the distance (in mm) from the lateral canthus to the most anterior terminal hair to track hairline "advancement."

    Time frame: All patients will be evaluated at Day 1 and at 6, 12 and 16 weeks.

06

Study locations

1 site
  • Assiut University
    Asyut, Egypt
    • Vice president of graduate studies of Assiut University · Contact · vp_grad@aun.edu.eg · +2088 22080150
07

References and documents

Publications

  • 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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/ PubMed 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. PubMed 37284568 ↗
  • Wang Y, Ding W, Yao M, Li Y, Wang M, Wang L, Li Z, Sun S, Yang M, Zhu Y, Zhou N. Diagnostic and grading criteria for androgenetic alopecia using dermoscopy. Skin Res Technol. 2024 Apr;30(4):e13649. doi: 10.1111/srt.13649. PubMed 38533753 ↗
  • Al Sayed NM, El Morsy EH, Hussein TM, Hassan EM. Clinical and Trichoscopic Evaluations of Topical Finasteride 1%, Topical Spironolactone 5%, and Minoxidil 5% in Female Pattern Hair Loss Treatment. Dermatol Pract Concept. 2025 Jan 30;15(1):4698. doi: 10.5826/dpc.1501a4698. PubMed 40117614 ↗
  • Kuczara A, Waskiel-Burnat A, Rakowska A, Olszewska M, Rudnicka L. Trichoscopy of Androgenetic Alopecia: A Systematic Review. J Clin Med. 2024 Mar 28;13(7):1962. doi: 10.3390/jcm13071962. PubMed 38610726 ↗
08

Registry details

Key details

Study ID
NCT07518342
Lead sponsor
Assiut University
Responsible party
Marina Abdelmassieh Aiad Aboelsaad (Assistant lecturer, Assiut University) — Principal investigator
First posted
Apr 8, 2026
Start date
Apr 2026 (estimated)
Primary completion
Jun 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Apr 13, 2026

Study contacts

Marina Aiad Aboelsaad, Bachelor of Medicine and Surge
Contact
marina.aiad16@gmail.com
+201282347199
Hanan Ahmed Morsy, Professor Doctor
study chair · Assiut University
Reham Maher Abdel Gaber, Doctor
study director · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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