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.
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
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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.
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.
- Conditions
- Female Pattern Hair Loss
- 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 group | Role | What they receive |
|---|---|---|
| Nanofat only | Active comparator | 20 patients received a single session of scalp injection with nanofat only. Receives: Procedure: Nanofat only |
| Nanofat mixed with PRP | Active comparator | 20 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.
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
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.
- First posted31 Jul 2025
- Study start1 Dec 2022
- Primary completion1 Jul 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Pattern Hair LossStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahy El-Bassiouny, Study director, Ain Shams University
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07096323
- Acronym / sponsor ID
- FMASU MS 167/2023
- Conditions
- Female Pattern Hair Loss
- Keywords
- Adipose Derived Stem Cells, Nanofat, Platelet Rich Plasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Nanofat only | Active comparator | Procedure: Nanofat only20 patients received a single session of scalp injection with nanofat only. |
| Nanofat mixed with PRP | Active comparator | Procedure: Nanofat mixed with PRP20 patients received a single session of scalp injection with nanofat mixed with PRP. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Females aged 18-50 years with moderate to severe FPHL, classified as Sinclair grades 2-4.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nanofat onlyFat 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." | Procedure or surgery | Nanofat only |
| Nanofat mixed with PRPNanofat 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 | Procedure or surgery | Nanofat mixed with PRP |
Primary outcome
Increase in terminal hair count
Time frame: 24 weeks
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.
Increase in terminal hair thickness
Time frame: 24 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahy El-Bassiouny study director
Ain Shams University
1 site in 1 country: see every site and its status.
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.