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.
