Platelet-Rich Plasma in Combination With 5% Minoxidil Topical Solution and 1 mg Oral Finasteride for the Treatment of Androgenetic Alopecia: A Randomized Placebo-Controlled, Double-Blind, Half-Head Study

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Excerpt

Platelet-rich plasma (PRP) has been identified as a new therapy for androgenetic alopecia (AGA). Recently, we published a randomized placebo-controlled, double-blinded, half-head study to assess the efficacy of PRP on the treatment of AGA.1 Patients treated with pure PRP had a statistically significant improvement in hair regrowth at 3 and 6 months. Several studies of treatment with PRP in AGA have been described, although most of the available literature focused on patients who received treatment with PRP alone.2 Patients who received any topical and/or systemic treatments for AGA in the previous 6 or 12 months are typically excluded from studies with PRP.
As in clinical practice, most patients with the diagnosis of AGA are undergoing therapy for their alopecia, and we hypothesized if PRP could also improve hair regrowth if used simultaneously with the patient's current medication. In the second phase of our study,1 we performed a randomized placebo-controlled, double-blinded, half-head study to assess the efficacy of PRP in combination with minoxidil or finasteride on the treatment of AGA.
In this study, healthy male patients with clinical diagnosis of AGA (Stage II to V, according to Hamilton–Norwood classification) and healthy female patients with AGA (Stage I to III, according to Ludwig Classification) were recruited. Thirteen patients treated with 1 mL 5% topical minoxidil solution twice daily and 12 patients medicated with 1 mg/d oral finasteride were enrolled for a total of 25 patients. Twenty-four patients completed the entire protocol and were included in the main analysis (Table 1). One patient was lost to follow-up.
Patients provided written informed consent before participating. All patients were evaluated over 4 visits: V1, baseline and beginning of the study; V2, second treatment; V3, third treatment; and V4, follow-up. In the first 3 visits, a total of 3 treatments were given with an interval of 1 month from each other. Patients were followed for 6 months.
PRP was prepared with a closed system using sterile and disposable kits (Proteal; Soluciones Bioregenerativas, SL, Barcelona, Spain). Samples collected were handled in accordance with the manufacturer's instructions. Each patient received injections of pure PRP in one side of the head; the other half was injected with a placebo solution (saline solution) (Figure 1). Platelet-rich plasma administration was performed in 4 selected areas (2 areas in each half-head of the scalp: one frontal and one occipital). These were previously marked with a central dot tattoo. Platelet-rich plasma (4 mL total) was administered as 0.15 to 0.20 mL per point of injection.
The evaluation criteria were assessed in all patients by TrichoScan analysis using the system FotoFinder; TrichoScan Professional Version. The hair growth parameters were evaluated in all visits and data compared with the baseline and between treatment and control areas (placebo). All analysis was performed with SAS statistical software version 9.4 (SAS Institute Inc., Cary, NC).
At baseline, there were no significant differences in hair count, hair density, terminal density, and anagen or telogen hairs between the treatment (PRP + minoxidil 5% solution or PRP + oral finasteride) and control areas of the scalp (placebo + minoxidil 5% solution or placebo + oral finasteride). The detailed hair growth parameters are described in Table 2.
The results show that the administration of PRP led to a statistically significant increase in the mean hair count (hairs/0.65 cm2) and mean hair density (1/cm2) versus baseline values at 3 months (p < .05; month 3 vs baseline).
Six months after the first treatment, mean hair count (hairs/0.65 cm2), hair density (1/cm2), terminal hair density (1/cm2), anagen hairs (%), and telogen hairs (%) showed a statistically significant positive effect of PRP associated with medication versus baseline (p < .
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