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Androgenetic AlopeciaPhase 4NCT07518342

The Effect of Nanofat Injection on Androgenetic Alopecia

A Phase 4 study testing Minoxidil 5 %, PRP injection and Nanofat injection in people with Androgenetic Alopecia and Androgenetic Alopecia (AGA), run by Assiut University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years
What is being tested?
Minoxidil 5 %, PRP injection and Nanofat injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
Apr 2026to Dec 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Marina Aiad Aboelsaad, Bachelor of Medicine and Surge contact

+201282347199

marina.aiad16@gmail.com

Egypt1 site
  • Assiut University

    Asyut

    Vice president of graduate studies of Assiut University, +2088 22080150, vp_grad@aun.edu.eg

Other trials in Egypt

About this study

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

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.

Being tested
Minoxidil 5 %, PRP injection, Nanofat injection
Keywords
Androgenetic Alopecia, Alopecia, PRP, nanofat, nanofat injection, Minoxidil, Topical minoxidil
Medical subject headings
Alopecia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Minoxidil 5 %Drug

    Topical application of minoxidil 5%

  • PRP injectionProcedure or surgery

    3 PRP injections one month apart

  • Nanofat injectionProcedure or surgery

    Single nanofat injection

Study groups in NCT07518342
Study groupRoleWhat they receive
Topical minoxidil 5/Active comparatorPatients will be taught how to apply topical minoxidil daily for three months
Receives: Drug: Minoxidil 5 %
PRP injectionActive comparatorPatients will receive three PRP injections one month apart each
Receives: Procedure: PRP injection
nanofat injectionExperimentalPatience well receive single nano fat injection
Receives: Procedure: Nanofat injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical improvement by using trichoscopy and photographs

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

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

  2. Trichoscopic improvement

    Including hair diameter diversity

    Measured: 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.

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

Secondary outcomes (1)
  1. Temporal Hairline Position

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2026
  2. Study startApr 2026 (estimated)
  3. Primary completionJun 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07518342
Sponsor's protocol ID
Nanofat Androgenetic Alopecia
Status last verified
Mar 2026
First submitted
29 Mar 2026
Last updated
13 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Minoxidil 5 %, PRP injection and Nanofat injection in people with Androgenetic Alopecia and Androgenetic Alopecia (AGA), run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marina Aiad Aboelsaad, Bachelor of Medicine and Surge (+201282347199, marina.aiad16@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical improvement by using trichoscopy and photographs (time frame: All patients will be evaluated at Day 1 and at 6, 12 and 16 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07518342, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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