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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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LETTERS AND COMMUNICATIONS
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
Platelet-rich plasma (PRP) has been identied as a new
therapy for androgenetic alopecia (AGA). Recently, we
published a randomized placebo-controlled, double-
blinded, half-head study to assess theefcacy of PRP on
the treatment of AGA.
1
Patients treated with pure PRP
had a statistically signicant improvement in hair
regrowth at 3 and 6 months. Several studies of treat-
ment 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 patients current medica-
tion. In the second phase of our study,
1
we performed
a randomized placebo-controlled, double-blinded, half-
head study to assess the efcacy of PRP in combination
with minoxidil or nasteride on the treatment of AGA.
In this study, healthy male patients with clinical diagnosis
of AGA (Stage II to V, according to HamiltonNorwood
classication) and healthy female patients with AGA
(Stage I to III, according to Ludwig Classication) were
recruited. Thirteen patients treated with 1 mL 5%
topical minoxidil solution twice daily and 12 patients
medicatedwith1mg/doralnasteride 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 rst 3 visits, a total of 3 treatments were given with
an interval of 1 month from each other. Patients were
followed for 6 months.
TABLE 1. Baseline Patient Demographic and
Clinical Characteristics
Demographic Data
Group B
(n = 24)
Age (mean), yrs 39.9 (18–65)
Sex
Female n = 13 (54.2%)
Male n = 11 (45.8%)
Family History
Positive n = 21 (87.5%)
Mother n = 5 (23.8%)
Father n = 16 (76.2%)
Negative n = 3 (12.5%)
Beginning of AGA, yrs
<25 n = 12 (50%)
$25 n = 12 (50%)
Smoking status
Yes n = 4 (16.7%)
No n = 20 (83.3%)
Ethnic origin
Caucasian n = 24 (100%)
Nordwood–Hamilton
Classification (n = 11)
Stage II n = 2 (18.2%)
Stage III n = 7 (63.6%)
Stage IV n = 1 (9.1%)
Stage V n = 1 (9.1%)
Ludwig classification (n = 13)
Stage I n = 3 (23.1%)
Stage II n = 9 (69.2%)
Stage III n = 1 (7.7%)
AGA, androgenetic alopecia.
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ISSN: 1076-0512 ·Dermatol Surg 2017;0:14·
1
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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 manufacturers 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 admin-
istrationwasperformedin4selectedareas(2areasin
each half-head of the scalp: one frontal and one occipital).
Thesewerepreviouslymarkedwithacentraldottattoo.
Platelet-rich plasma (4 mL total) was administered as
0.15 to 0.20 mL per point of injection.
Figure 1. A 28-year-old woman with androgenetic alopecia treated with PRP on the left half-head and placebo on the right half-
head. Global photographs of the scalp were performed at baseline (A), 3 months (B), and 6 months (C). PRP, platelet-rich plasma.
TABLE 2. Relevant Hair Growth Parameters for the Half-Head Areas Treated With PRP and Placebo at
Baseline, 3 and 6 Months
Placebo (n = 24) PRP (n = 24) Placebo vs PRP
Mean 6SD p Mean 6SD p p
Hair count (hairs/0.65 cm
2
)
Baseline 97.9 629.2 >.05 96.8 627.5 >.05 >.05
3 mo 99.8 628.1 >.05 105.3 632.3 <.05 >.05
6 mo 95.9 627 >.05 108.2 633.3 <.05 <.05
Hair density (1/cm
2
)
Baseline 150.8 646.1 >.05 149.5 642 >.05 >.05
3 mo 153.3 642.2 >.05 160.5 647.1 <.05 >.05
6 mo 147.5 641.6 >.05 163.6 647.1 <.05 <.05
Terminal hair density
Baseline 142.4 643.8 >.05 141.3 640.4 >.05 >.05
3 mo 145.2 642.2 >.05 145.9 645.8 >.05 >.05
6 mo 136.8 644.1 >.05 152.9 644.6 <.05 <.05
Anagen hair (%)
Baseline 68.6 613.2 >.05 67.5 615.6 >.05 >.05
3 mo 69.9 69.9 >.05 70.5 614.7 >.05 >.05
6 mo 69.1 69.9 >.05 72.7 610.7 <.05 >.05
Telogen hair (%)
Baseline 31.6 613.2 >.05 32.5 615.6 >.05 >.05
3 mo 30.1 69.9 >.05 29.7 614.6 >.05 >.05
6 mo 30.9 69.9 >.05 27.3 610.7 <.05 >.05
Anagen/telogen ratio (%)
Baseline 173.7 6159.6 >.05 168.9 6155.8 >.05 >.05
3 mo 176.6 6156.5 >.05 228 6238.3 >.05 >.05
6 mo 158.2 6119.3 >.05 213.6 6152.4 >.05 >.05
Data assessed by Trichoscan analysis.
Bold indicates p< .05 statistical significant.
PRP, platelet-rich plasma; SD, standard deviation.
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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 per-
formed with SAS statistical software version 9.4 (SAS
Institute Inc., Cary, NC).
At baseline, there were no signicant differences in
hair count, hair density, terminal density, and anagen
or telogen hairs between the treatment (PRP + minox-
idil 5% solution or PRP + oral nasteride) and control
areas of the scalp (placebo + minoxidil 5% solution or
placebo + oral nasteride). The detailed hair growth
parameters are described in Table 2.
The results show that the administration of PRP led to
a statistically signicant increase in the mean hair
count (hairs/0.65 cm
2
) and mean hair density (1/cm
2
)
versus baseline values at 3 months (p< .05; month 3 vs
baseline).
Six months after the rst treatment, mean hair count
(hairs/0.65 cm
2
), hair density (1/cm
2
), terminal hair
density (1/cm
2
), anagen hairs (%), and telogen hairs
(%) showed a statistically signicant positive effect of
PRP associated with medication versus baseline
(p< .05; month 6 vs baseline). In addition, the changes
observed in the mean hair count, hair density, and
terminal density were statistically signicant versus
placebo (p< .05; control vs treatment). No differences
in anagen/telogen ratio between the PRP and placebo
areas were observed.
The hair parameters were also evaluated for compar-
ison between PRP and minoxidil versus PRP and
nasteride (Table 3).
In the areas treated with placebo, there were no
statistical differences between minoxidil or nasteride.
The combination of PRP and minoxidil 5% solution in
comparison with PRP and nasteride 1 mg displayed
a total mean hair count change of 9.8 626.9 hairs
versus 0.6 610.8 hairs; a total mean hair density of
12.3 634.2 hairs/cm
2
versus 1.8 616.7 hairs/cm
2
;
a mean anagen hairs (%) of 5.5 619.7 versus -2 6
12.2, respectively (p< .05: PRP + minoxidil vs PRP +
nasteride). Overall, after 6 months, combination of
TABLE 3. Description of Hair Growth Parameters
Regarding the 2 Different Subgroups: PRP and
Minoxidil 5% and PRP and Finasteride, at 6
Months
Month 6
Placebo PRP
Mean 6SD Mean 6SD
Hair count
(hairs/0.65 cm
2
)
Finasteride
(n = 11)
0.9 616.3 0.6 610.8
Minoxidil 5%
(n = 13)
3.7 614.5 9.8 626.9
p0.4004 0.0105
Hair density
(1/cm
2
)
Finasteride
(n = 11)
1.4 625.1 1.8 616.7
Minoxidil 5%
(n = 13)
5.1 623.9 12.3 634.2
p0.2831 0.0104
Terminal hair
density
Finasteride
(n = 11)
21.9 628.3 3.9 615.2
Minoxidil 5%
(n = 13)
5.6 621.9 3.2 638.4
p0.1379 0.1749
Anagen hair (%)
Finasteride
(n = 11)
22.1 615 22612.2
Minoxidil 5%
(n = 13)
1.5 613.8 5.5 619.7
p0.0777 0.0015
Telogen
hair (%)
Finasteride
(n = 11)
2.1 615 1.8 612.2
Minoxidil 5%
(n = 13)
21.7 614 25.5 619.9
p0.0724 0.0019
Anagen/telogen
ratio (%)
Finasteride
(n = 11)
240.5 6169.7 26.6 6155.7
Minoxidil 5%
(n = 13)
1.7 6192.5 69.6 6234
p0.1667 0.0179
Data assessed by Trichoscan analysis.
Bold indicates p< .05 statistical significant.
PRP, platelet-rich plasma; SD, standard deviation.
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PRP and minoxidil 5% showed superiority in mean
hair count, hair density, anagen and telogen percen-
tages, and mean anagen/telogen ratio in comparison
with the association of PRP and nasteride 1 mg
(p< .05: PRP + minoxidil vs PRP + nasteride).
Minoxidil is known to promote hair regrowth and
a possible effect of minoxidil is the increased expres-
sion of some growth factors (GFs) such as vascular
endothelial GF in cultured dermal papilla (DP) cells as
shown by Lachgar and colleagues
3
This could induce
angiogenesis. Platelet-rich plasma is known to
produce different GFs and that might lead to an intense
neovascularization
4
with increased proliferation of
human DP cells.
5
Although this is a novelty in the treatment of AGA, and
the mechanism is not fully understood, the association
of 5% minoxidil topical solution with pure PRP might
have a cumulative effect in DP cells and promote
greater angiogenesis and improvement in hair
regrowth of AGA patients.
Our study is limited by the short follow-up. An
advantage of the study is as both treatment and placebo
are performed in the same patient, the baseline char-
acteristics are the same for both groups. This minimizes
the inuence of bias. No adverse effectswere reported.
Based on this study, we conclude the following: (1) the
administration of PRP associated with ongoing
medication is effective on the evolution of AGA; (2) the
application of PRP improved the mean hair parame-
ters, and that was statistically signicant versus base-
line at month 6; (3) both minoxidil or nasteride with
PRP improved hair regrowth; and (4) PRP in combi-
nation with minoxidil showed a greater improvement
than PRP with nasteride, at 6 months.
The use of PRP is effective, safe, and worthwhile as
a complementary treatment for AGA, but additional
placebo-controlled studies are needed to compare the
efcacy of PRP with minoxidil solution versus PRP
with nasteride. Larger samples sizes and longer
follow-up periods are needed.
References
1. Alves R, Grimalt R. Randomized placebo-controlled, double-blind, half-
head study to assess the efcacy of platelet-rich plasma on the treatment
of androgenetic alopecia. Dermatol Surg 2016;42:4917.
2. Gupta AK, Carviel JL. Meta-analysis of efcacy of platelet-rich plasma
therapy for androgenetic alopecia. J Dermatolog Treat 2016;28:14.
3. Lachgar S, Charveron M, Gall Y, Bonafe JL. Minoxidil upregulates the
expression of vascular endothelial growth factor in human hair dermal
papilla cells. Br J Dermatol 1998;138:40711.
4. Uebel CO, da Silva JB, Cantarelli D, Martins P. The role of platelet
plasma growth factors in male pattern baldness surgery. Plast Reconstr
Surg 2006;118:145866.
5. Li ZJ, Choi HI, Choi DK, Sohn KC, et al. Autologous platelet-rich
plasma: a potential therapeutic tool for promoting hair growth.
Dermatol Surg 2012;38:10406.
Rubina Alves, MD
Ramon Grimalt, MD, PhD
Department of Dermatology
Universitat Internacional de Catalunya
Barcelona, Spain
The authors have indicated no signicant interest with
commercial supporters.
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... Key amongst those are (1) whether PRP is more effective than standard of care (Minoxidil and Finasteride) in reversing hair loss and (2) whether the effects of PRP can be compounded with that of minoxidil and finasteride to increase hair growth. In an attempt to address these questions, Alves et al. (99) in 2018 conducted a randomized controlled doubleblind half-head clinical trial involving 11 male patients with grade II-V AGA (Hamilton-Norwood Scale) and 13 female patients with grade I-III AGA (Ludwig Scale). For a duration of 3 months, half the patients received 1 mg of oral finasteride daily while the other half received twice-daily topical 5% minoxidil application. ...
... Clinical trial numbers are also provided for the studies that were performed in the U.S. and/or registered on ClinicalTrials.gov. Of the seventeen studies, excluding the two by Kapoor et al. and Butt et al. fifteen were evaluated and discussed within this narrative review(92)(93)(94)(95)(96)(97)(98)(99)(100)(101)(102)(103)(104)(105)(106)(107)(108). ...
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... PRP combined with minoxidil 5% revealed superior results concerning hair density, mean hair count, anagen and telogen percentages, and mean anagen/telogen ratio, compared to the combination of PRP and finasteride 1 mg (p< .05: PRP plus minoxidil vs. PRP plus finasteride) in a randomized placebo-controlled, double-blind, half-head study [15]. According to Shah et al., microneedling with PRP plus topical minoxidil 5% has been significantly more effective than topical minoxidil 5% alone [16]. ...
... Several randomized controlled trials have demonstrated synergistic effects of the combination of PRP with oral finasteride and topical minoxidil. [31][32][33][34] Overall, the evidence suggests that PRP is a safe and effective treatment for hair loss due to AGA. ...
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... The effect was even greater in the group treated with PRP and minoxidil combination compared to the PRP and finasteride combination group. 164 169 Ongoing hair loss will affect the density and cosmetic appearance of a hair transplant procedure so it is often useful to combine transplantation with medical therapy. ...
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Background Androgenetic alopecia (AGA) is the most common form of hair loss consisting of a characteristic receding frontal hairline in men and diffuse hair thinning in women, with frontal hairline retention, and can impact an individual's quality of life. The condition is primarily mediated by 5-alpha-reductase and dihydrotestosterone (DHT) which causes hair follicles to undergo miniaturization and shortening of successive anagen cycles. Although a variety of medical, surgical, light-based and nutraceutical treatment options are available to slow or reverse the progression of AGA, it can be challenging to select appropriate therapies for this chronic condition. Aims To highlight treatment options for androgenetic alopecia taking into consideration the efficacy, side effect profiles, practicality of treatment (compliance), and costs to help clinicians offer ethically appropriate treatment regimens to their patients. Materials and Methods A literature search was conducted using electronic databases (Medline, PubMed, Embase, CINAHL, EBSCO) and textbooks, in addition to the authors' and other practitioners' clinical experiences in treating androgenetic alopecia, and the findings are presented here. Results Although topical minoxidil, oral finasteride, and low-level light therapy are the only FDA-approved therapies to treat AGA, they are just a fraction of the treatment options available, including other oral and topical modalities, hormonal therapies, nutraceuticals, PRP and exosome treatments, and hair transplantation. Discussion Androgenetic alopecia therapy remains challenging as treatment selection involves ethical, evidence-based decision-making and consideration of each individual patient's needs, compliance, budget, extent of hair loss, and aesthetic goals, independent of potential financial benefits to the practitioners.
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Platelet-rich plasma (PRP) therapy is a new method for the treatment of androgenetic alopecia (AGA), the effectiveness and safety of which continues to be studied. Information on comparative efficacy when combining PRP with other methods of treatment is limited. The aim of the study was a comparative evaluation of the clinical efficacy of minoxidil, PRP therapy, and their combination in the treatment of men with AGA. Materials and methods: The study included 69 men. The patients were divided into three observation groups: the main group (25 people, received applications of a 5% solution of minoxidil in combination with PRP injections), the comparison group (22 people, received intradermal injections of PRP), and the control group (22 people, received applications of a 5% solution of minoxidil). The clinical efficacy of the therapy was evaluated by the dynamics of morphometric indicators of hair growth using a digital camera and the software. Results: It was established that after complex therapy in the form of minoxidil applications and injections of PRP, the hair density increased by 32% (P = 0.00004), the diameter of the hair shafts by 26% (P = 0.00004), the share of vellus hair decreased by 30% (P = 0.00082), and the proportion of telogen hair decreased by 39% (P = 0.00008). The results of using complex therapy significantly exceeded the clinical effect of platelet-rich plasma and topical applications of a 5% solution of minoxidil. Conclusions: The data obtained allows suggesting that PRP and minoxidil potentiate each other's action when used together and their complex application seems promising for the treatment of androgenetic alopecia.
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Background: Platelet-rich plasma (PRP) was identified as having a beneficial effect in alopecia and has been postulated as a new therapy for androgenetic alopecia (AGA). Objective: To assess the efficacy of PRP for the treatment of AGA. Materials and methods: This was a randomized, placebo-controlled, double-blind study in 25 patients with AGA. Platelet-rich plasma was injected in half-head and the other half-head with placebo. Each patient received a total of 3 treatments of PRP, 1 month apart. Results: Six months after the first treatment with PRP, significant differences were seen in mean anagen hairs (67.6 ± 13.1), telogen hairs (32.4 ± 13.1), hair density (179.9 ± 62.7), and terminal hair density (165.8 ± 56.8) when compared with baseline (p < .05). Platelet-rich plasma was also found to increase hair density when comparing with the control side (p < .05). For the first time, the authors found a correlation between anagen hairs and patients >40 years and beginning of AGA ≥25 years old (p < .05) and hair density and male sex, age ≤40 years, positive family history of AGA and >10 years of duration of the disease (p < 0.05). Conclusion: Application of PRP showed a positive effect on AGA and could be regarded as an adjuvant therapy for AGA.
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Recently, autologous platelet-rich plasma (PRP) has attracted attention in various medical fields, including plastic and orthopedic surgery and dermatology, for its ability to promote wound healing. PRP has been tested during facelift and hair transplantation to reduce swelling and pain and to increase hair density. To investigate the effects of PRP on hair growth using in vivo and in vitro models. PRP was prepared using the double-spin method and applied to dermal papilla (DP) cells. The proliferative effect of activated PRP on DP cells was measured. To understand the mechanisms of activated PRP on hair growth, we evaluated signaling pathways. In an in vivo study, mice received subcutaneous injections of activated PRP, and their results were compared with control mice. Activated PRP increased the proliferation of DP cells and stimulated extracellular signal-regulated kinase (ERK) and Akt signaling. Fibroblast growth factor 7 (FGF-7) and beta-catenin, which are potent stimuli for hair growth, were upregulated in DP cells. The injection of mice with activated PRP induced faster telogen-to-anagen transition than was seen on control mice. Although few studies tested the effects of activated PRP on hair growth, this research provides support for possible clinical application of autologous PRP and its secretory factors for promotion of hair growth.
Article
The hair follicle dermal papilla which controls hair growth, is characterized in the anagen phase by a highly developed vascular network. We have demonstrated in a previous study that the expression of an angiogenic growth factor called vascular endothelial growth factor (VEGF) mRNA varied during the hair cycle. VEGF mRNA is strongly expressed in dermal papilla cells (DPC) in the anagen phase, but during the catagen and telogen phases. VEGF mRNA is less strongly expressed. This involvement of VEGF during the hair cycle allowed us to determine whether VEGF mRNA expression by DPC was regulated by minoxidil. In addition, the effect of minoxidil on VEGF protein synthesis in both cell extracts and DPC-conditioned medium, was investigated immunoenzymatically. Both VEGF mRNA and protein were significantly elevated in treated DPC compared with controls. DPC incubated with increasing minoxidil concentrations (0.2, 2, 6, 12 and 24 mumol/L) induced a dose-dependent expression of VEGF mRNA. Quantification of transcripts showed that DPC stimulated with 24 mumol/L minoxidil express six times more VEGF mRNA than controls. Similarly, VEGF protein production increases in cell extracts and conditioned media following minoxidil stimulation. These studies strongly support the likely involvement of minoxidil in the development of dermal papilla vascularization via a stimulation of VEGF expression, and support the hypothesis that minoxidil has a physiological role in maintaining a good vascularization of hair follicles in androgenetic alopecia.