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Female Pattern Hair LossNCT07096323

Successful Treatment of Female Pattern Hair Loss With Injection of Nanofat With and Without Platelet-Rich Plasma

A study testing Nanofat only and Nanofat mixed with PRP in people with Female Pattern Hair Loss, run by Ain Shams University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: FPHL is a chronic progressive condition that necessitates lifelong management. Over time, patients who respond to conventional therapy may experience a decrease in the effectiveness of their treatment and may require alternative interventions to delay disease progression and enhance the efficacy of current… Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Female Pattern Hair Loss
What is being tested?
Nanofat only and Nanofat mixed with PRP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteEgypt
Study dates
1 Dec 2022to 1 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

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
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Females aged 18-50 years with moderate to severe FPHL, classified as Sinclair grades 2-4.

Who cannot join

  • Age less than 18 years or more than 50 years
  • Chronic telogen effluvium
  • Use of topical or systemic FPHL treatments in the preceding 6 months
  • Infection at the treatment site or elsewhere
  • Uncontrolled iabetes, hemorrhagic disorders, anticoagulant therapy, pregnancy or lactation
  • Personal or family history of malignancy, immunosuppression or lidocaine allergy.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Dermatology Department- Ain Shams University

    Cairo

Other trials in Egypt

About this study

Official title: Successful Treatment of Female Pattern Hair Loss With Non-Cultured Adipose Derived Stem Cells (ADSCs) in Mechanically Emulsified Adipose Tissue (Nanofat) With and Without Platelet-Rich Plasma (PRP): A Randomized Clinical Trial

Background: FPHL is a chronic progressive condition that necessitates lifelong management. Over time, patients who respond to conventional therapy may experience a decrease in the effectiveness of their treatment and may require alternative interventions to delay disease progression and enhance the efficacy of current therapies. ADSCs have demonstrated potential as a regenerative interventional modality for the treatment of such conditions.

Objective: To compare efficacy of nanofat alone and nanofat combined with platelet-rich plasma (PRP) for the treatment of female-pattern hair loss.

Read more

Methods: This study is a randomized controlled prospective intervention. Forty patients with mild to moderate FPHL were selected and randomly allocated into two groups (A and B). Both groups received a single session of nanofat scalp injection. Nanofat was prepared from lipoaspirates by mechanical agitation of adipose tissue, and was mixed with PRP for patients allocated in group B.

Results: Nanofat alone and combined with PRP promoted hair regrowth. However, the adjunctive use of PRP with nanofat yielded a statistically significant enhancement in terminal hair thickness (P <0.001) and count (P <0.001) compared with nanofat alone. Mean satisfaction score was 3 out of 5 at 24 weeks post-injection, with no significant difference between the two treatment groups (P= 0.937). The side effects were mild and well-tolerated.

Conclusion: Both nanofat, alone and in combination with PRP, improved hair thickness and count in patients with FPHL. The combination with PRP demonstrated a statistically significant improvement compared with nanofat alone.

Read the detailed description

Patients and Methods This randomized controlled clinical trial was conducted on 40 female patients presenting with pattern hair loss, selected from the outpatient clinic of Dermatology, Venereology, and Andrology Department, Ain Shams University Hospitals, between December 2022 and July 2023.

Following approval from the research ethics committee of the Faculty of Medicine, Ain Shams University (FMASU MS 167/2023), written informed consent was obtained from each patient after providing information regarding procedural steps and potential side effects or complications.

The study population comprised females aged 18-50 years with moderate to severe FPHL, classified as Sinclair grades 3-4. Exclusion criteria included age < 18 years and >50 years, chronic telogen effluvium, use of topical or systemic FPHL treatments in the preceding 6 months, infection at the treatment site or elsewhere, diabetes, hemorrhagic disorders, anticoagulant therapy, pregnancy or lactation, personal or family history of malignancy, immunosuppression or lidocaine allergy.

The clinical diagnosis of FPHL was confirmed according to Rakowska et al., 2009 trichoscopic criteria for diagnosis of FPHL. FPHL is diagnosed by the presence of two major criteria or one major and two minor criteria.

Digital photography was documented at a point 10 cm directly above the midpoint of the glabella at the initial visit and at all subsequent visits. Patients were evaluated clinically and trichoscopically at baseline, then at 12 and 24 weeks after treatment.

Patients were divided into two groups (20 patients each) using simple (computer-generated) randomization. Group A: Nanofat was prepared and injected intradermally into the frontoparietal scalp. Group B: Nanofat was prepared, then mixed with PRP, and injected as in group A.

A single session was performed for patients in both groups. Nanofat Preparation: Fat was collected from either the lower abdomen or lateral upper thigh. A blunt-tipped infiltration cannula (Luer Lock Mercedes Gold Liposuction Cannula 4mm x 30 cm, Pakistan) was used for injection of Klein solution for tumescent anesthesia. Liposuction cannula was then used, connected to a 50 ml syringe mounted with a stopper to generate negative pressure for liposuction. The lipoaspirate was washed to obtain pure adipose tissue, and mechanical emulsification was achieved by transferring the fat through progressively smaller sieves (2.2 mm, 1.5 mm, 1.2 mm) between two 10 ml syringes connected with Luer-Lock connectors, with at least 30 passages each. The emulsion was not filtered and is referred to as "Nanofat 2.0." PRP preparation: Ten milliliters of venous autologous whole blood were collected with tri-sodium citrate as an anticoagulant, then centrifuged at 112g (1000 rpm) for 10 minutes. The plasma was transferred to new tubes without tri-sodium citrate and centrifuged again at 448g (2000 rpm) for 10 minutes to separate the platelet pellet and platelet-poor plasma (PPP). PRP was kept for mixing it with nanofat while PPP was discarded.

Evaluation of the results The results were evaluated using the following assessments. A- Clinical Evaluation: Clinical photographs of the centrally parted scalp were taken with an iPhone 13 Pro Max camera 12-megapixel camera, ensuring standardization in light, angle, and position. Two blinded investigators evaluated hair fullness and clinical grade using the Sinclair classification and Investigator Global Assessment (IGA) scale, ranging from -1 (worsening) to 3 (excellent improvement).

B- Trichoscopic Examination: Trichoscopic images were obtained using a Dermlite DLIII dermoscope (3Gen Inc., California, USA) at 10x magnification. They were analysed using a simple morphometric software (ImageJ, National Institutes of Health, Bethesda, Maryland, USA) to manually count and measure the mean diameter of terminal hairs.

C- Patient Satisfaction: Patients completed a 5-point Likert scale questionnaire to assess their subjective satisfaction with changes in hair density, hair quality and hair fall at week 24.

Being tested
Nanofat only, Nanofat mixed with PRP
Keywords
Adipose Derived Stem Cells, Nanofat, Platelet Rich Plasma

What participants receive

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

  • Nanofat onlyProcedure or surgery

    Fat was collected from either the lower abdomen or lateral upper thigh. A blunt-tipped infiltration cannula (Luer Lock Mercedes Gold Liposuction Cannula 4mm x 30 cm, Pakistan) was used for injection of Klein solution for tumescent anesthesia. Liposuction cannula was then used, connected to a 50 ml syringe mounted with a stopper to generate negative pressure for liposuction. The lipoaspirate was washed to obtain pure adipose tissue, and mechanical emulsification was achieved by transferring the fat through progressively smaller sieves (2.2 mm, 1.5 mm, 1.2 mm) between two 10 ml syringes connected with Luer-Lock connectors, with at least 30 passages each. The emulsion was not filtered and is referred to as "Nanofat 2.0."

  • Nanofat mixed with PRPProcedure or surgery

    Nanofat is prepared the same way as arm 1. PRP was prepared as follows: Ten milliliters of venous autologous whole blood were collected with tri-sodium citrate as an anticoagulant, then centrifuged at 112g (1000 rpm) for 10 minutes. The plasma was transferred to new tubes without tri-sodium citrate and centrifuged again at 448g (2000 rpm) for 10 minutes to separate the platelet pellet and platelet-poor plasma (PPP). PRP was kept for mixing it with nanofat while PPP was discarded

Study groups in NCT07096323
Study groupRoleWhat they receive
Nanofat onlyActive comparator20 patients received a single session of scalp injection with nanofat only.
Receives: Procedure: Nanofat only
Nanofat mixed with PRPActive comparator20 patients received a single session of scalp injection with nanofat mixed with PRP.
Receives: Procedure: Nanofat mixed with PRP

What is being measured

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

  1. Increase in terminal hair count

    After treatment with ADSCs, the anticipated primary outcome measure is trichoscopic increase in terminal hair count. This was compared with nanofat alone versus mixed with PRP.

    Measured: 24 weeks

  2. Increase in terminal hair thickness

    After treatment with ADSCs, the anticipated primary outcome measure is trichoscopic increase in terminal hair thickness. This was compared with nanofat alone versus mixed with PRP.

    Measured: 24 weeks

Timeline

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

  1. First posted31 Jul 2025
  2. Study start1 Dec 2022
  3. Primary completion1 Jul 2023
  4. Study completion1 Aug 2023

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study included 40 patients with FPHL. Patients were divided into two groups (20 patients each) using simple (computer-generated) randomization. Group A: Nanofat was prepared and injected intradermally into the frontoparietal scalp. Group B: Nanofat was prepared, then mixed with PRP, and injected as in group A. A single session was performed for patients in both groups.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07096323
Sponsor's protocol ID
FMASU MS 167/2023
Other IDs
Does not exist
Status last verified
Feb 2025
First submitted
29 Jun 2025
Last updated
31 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Nanofat only and Nanofat mixed with PRP in people with Female Pattern Hair Loss, run by Ain Shams 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 1 inclusion and 6 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: finished, as of the sponsor's last update on 31 Jul 2025. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Increase in terminal hair count (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 31 Jul 2025.

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