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

NCT07096323 | Completed

• 2 other identifiers: FMASU MS 167/2023Does not exist
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Female Pattern Hair Loss

Keywords

Adipose Derived Stem Cells; Nanofat; Platelet Rich Plasma

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  24 weeks

Study Arms (2)

Nanofat only

ACTIVE COMPARATOR

20 patients received a single session of scalp injection with nanofat only.

Procedure: Nanofat only

Nanofat mixed with PRP

ACTIVE COMPARATOR

20 patients received a single session of scalp injection with nanofat mixed with PRP.

Procedure: Nanofat mixed with PRP

Interventions

Nanofat only PROCEDURE

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 only

Nanofat mixed with PRP PROCEDURE

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

Nanofat mixed with PRP

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Female pattern hair loss is a condition that affects females only.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Dermatology Department- Ain Shams University

Cairo, Egypt

Location

Study Officials

• Mahy El-Bassiouny

  Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 31, 2025
• Study Start: December 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: August 1, 2023
• Last Updated: July 31, 2025

Record last verified: 2025-02

Locations

EG (1)