- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Marina Aiad Aboelsaad, Bachelor of Medicine and Surge
- Phone Number: +201282347199
- Email: marina.aiad16@gmail.com
Study Locations
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Asyut, Egypt
- Assiut University
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Contact:
- Vice president of graduate studies of Assiut University
- Phone Number: +2088 22080150
- Email: vp_grad@aun.edu.eg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Topical minoxidil 5/
Patients will be taught how to apply topical minoxidil daily for three months
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Topical application of minoxidil 5%
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Active Comparator: PRP injection
Patients will receive three PRP injections one month apart each
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3 PRP injections one month apart
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Experimental: nanofat injection
Patience well receive single nano fat injection
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Single nanofat injection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical improvement by using trichoscopy and photographs
Time Frame: All patients will be evaluated at Day 1 and at 6, 12 and 16 weeks.
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Photographs using Hamilton norwood scale for males and Ludwig Scale for females
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All patients will be evaluated at Day 1 and at 6, 12 and 16 weeks.
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Trichoscopic improvement
Time Frame: All patients will be evaluated at Day 1 and at 6, 12 and 16 weeks.
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Including hair diameter diversity
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All patients will be evaluated at Day 1 and at 6, 12 and 16 weeks.
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patient satisfaction score
Time Frame: All patients will be evaluated at Day 1 and at 6, 12 and 16 weeks.
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It will be used for objective evaluation:
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All patients will be evaluated at Day 1 and at 6, 12 and 16 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Temporal Hairline Position
Time Frame: All patients will be evaluated at Day 1 and at 6, 12 and 16 weeks.
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measuring the distance (in mm) from the lateral canthus to the most anterior terminal hair to track hairline "advancement."
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All patients will be evaluated at Day 1 and at 6, 12 and 16 weeks.
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Hanan Ahmed Morsy, Professor Doctor, Assiut University
- Study Director: Reham Maher Abdel Gaber, Doctor, Assiut University
Publications and helpful links
General Publications
- 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.
- 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.
- Stevens J,Khetarpal S
- 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.
- 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.
- 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.
- Suchonwanit P,Thammarucha S,Leerunyakul K
- 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/
- 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.
- 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.
- Kuczara A,Waśkiel-Burnat A,Rakowska A,Olszewska M,Rudnicka L
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Nanofat Androgenetic Alopecia
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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