Hair loss, particularly androgenetic alopecia (AGA), is a prevalent condition affecting both men and women, often leading to psychological distress and reduced self-esteem. The treatment landscape for hair regrowth has evolved significantly, with Platelet-Rich Plasma (PRP) and microneedling emerging as promising, minimally invasive therapeutic approaches. PRP, rich in growth factors and cytokines, has demonstrated the ability to stimulate follicular proliferation and prolong the anagen phase of the hair growth cycle [1]. Microneedling, traditionally used for dermatological applications, has been shown to enhance drug penetration, stimulate dermal remodelling, and trigger neovascularization, creating an optimal environment for hair regeneration [2].

Mechanism of PRP and Microneedling in Hair Regrowth: PRP therapy functions through growth factors such as vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), platelet-derived growth factor (PDGF), and transforming growth factor-beta (TGF-β), which collectively stimulate angiogenesis, follicular stem cell activation, and collagen synthesis [3]. Studies have demonstrated that activated PRP promotes follicular survival, increases hair shaft thickness, and enhances scalp vascularization, making it a clinically viable treatment for hair loss [4].Microneedling, on the other hand, induces controlled microtrauma to the scalp, promoting the release of platelet-derived factors while also activating the Wnt/β-catenin pathway, which plays a crucial role in hair follicle stem cell activation [5]. Notably, Gentile et al. (2020) observed that combining microneedling with PRP therapy leads to greater follicular stimulation and enhanced hair regrowth compared to either treatment alone [6].

Efficacy of PRP and Microneedling in Clinical Studies: Several randomized controlled trials (RCTs) and meta-analyses have reinforced the superiority of PRP-microneedling combination therapy in promoting hair density, thickness, and growth rate. A systematic review by Kaiser et al. in 2023 concluded that PRP combined with microneedling led to a 35% greater improvement in hair count compared to PRP alone [7]. Similarly, Xiao et al. (2024) found that microneedling enhances the retention and penetration of PRP-derived growth factors, leading to longer-lasting effects in androgenetic alopecia patients [8].

Furthermore, Chang et al. (2020) reported that PRP-microneedling therapy significantly improves follicular proliferation and keratinocyte function, offering a non-surgical alternative to hair transplantation for early-stage hair loss [9]. The findings of Houshmand (2021) corroborate these results, emphasizing that combination therapy accelerates the transition from telogen to anagen phase, thus promoting rapid hair regrowth [10].

Rationale for our Study: Despite the promising evidence supporting PRP and microneedling in hair restoration, there remains a gap in standardized protocols, optimal treatment regimens, and long-term efficacy assessments. This study aims to evaluate the synergistic effects of PRP and microneedling in a controlled clinical setting, examining their impact on hair regrowth, scalp health, and patient satisfaction in individuals affected by androgenetic alopecia.

Aims & Objectives

Aim

This study aims to evaluate the synergistic effects of Platelet-Rich Plasma (PRP) and microneedling in promoting hair regrowth in individuals with androgenetic alopecia (AGA). By comparing clinical outcomes, hair density changes, and patient satisfaction, this study seeks to determine the efficacy and feasibility of PRP-microneedling combination therapy as a minimally invasive treatment option.

Objectives

Primary Objectives

To evaluate the efficacy of PRP combined with microneedling in improving hair density and thickness compared to either treatment alone, using trichoscopic and dermoscopic imaging assessments.

To assess the sustainability of hair regrowth over time, comparing results between combination therapy and single-modality treatments (PRP or microneedling alone).

Secondary Objectives

To analyse patient satisfaction and quality-of-life improvements post-treatment using standardized dermatologic scales (e.g., DLQI, GAIS).

To assess the safety and tolerability of PRP-microneedling therapy, monitoring adverse effects, pain scores, and recovery profiles.

Study Design

This study was designed as a prospective, controlled clinical trial to evaluate the synergistic effects of Platelet-Rich Plasma (PRP) and microneedling in promoting hair regrowth among individuals with androgenetic alopecia (AGA). Conducted over 1 year (January 2024 to December 2024) simultaneously at two tertiary care centres in North India, this study compared PRP-microneedling combination therapy with single-modality treatments (PRP alone and microneedling alone). Participants were randomly assigned into three groups, ensuring equal distribution regarding age, sex, and AGA severity. The study followed Good Clinical Practice (GCP) guidelines, and its methodology adhered to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) criteria.

Study participants: Eligible participants were adult males and females (ages 20–55 years) diagnosed with mild-to-moderate AGA (Norwood-Hamilton grades II-IV or Ludwig stages I-II).

Inclusion and Exclusion Criteria:

The inclusion criteria required:

No prior hair restoration treatments (within six months before enrolment).

No history of active scalp infections, inflammatory conditions, or autoimmune diseases affecting hair growth.

Willingness to adhere to the treatment protocol and follow-up schedule.

Exclusion criteria included:

History of chronic dermatological conditions (e.g., psoriasis, lichen planopilaris).

Use of systemic steroids, minoxidil, or finasteride during the study period.

Known hypersensitivity to PRP or microneedling procedures.

Recruitment and Ethical consideration: Participants were recruited through dermatology outpatient clinics. Prior to enrolment, all subjects provided written informed consent after receiving a detailed explanation of the study. The trial was approved by the Institutional Review Board (IRB) and the Ethics Committee of the tertiary care centre (GMC/Bla/IRB/2024/Cert/04, dated 23-04-2024).

Participants' personal information was kept confidential, and data were anonymized for analysis and reporting purpose.

We ensured that the study subjects have a choice for voluntary participation and patient confidentiality and human subject protection was ensured. Ethical guidelines of the declaration of Helsinki of 1975, as revised in 2000 were followed in all aspects of the study.

Data Collection

Baseline and Follow-up Assessments: Upon enrolment, all participants underwent a comprehensive baseline assessment, including:

Demographic and clinical data: Age, gender, duration of hair loss, family history of AGA.

Scalp imaging and trichoscopy: Evaluated hair density, follicular count, and hair shaft diameter.

Global photography: Standardized macro and dermoscopic scalp images taken at baseline, 12 weeks, and 24 weeks post-treatment.

Patient-reported outcomes: Hair loss severity score and satisfaction ratings using the Dermatology Life Quality Index (DLQI) and Global Aesthetic Improvement Scale (GAIS).

All assessments were repeated at four-week intervals up to 24 weeks. Two independent dermatologists blinded to treatment groups analysed the clinical and imaging data to minimize bias.

Outcome Measures

Primary Outcome: The primary endpoint was the change in hair density (hairs/cm²) and thickness (mm) from baseline to one year, as measured via trichoscopic imaging and dermoscopic evaluations.

Secondary Outcomes:

• Percentage increase in follicular units and terminal-to-vellus hair ratio.
• Mean change in patient-reported DLQI and GAIS scores.
• Rate of adverse events and treatment tolerability.

Intervention Protocol

Platelet-Rich Plasma (PRP) Preparation & Administration: PRP was prepared using a double-spin centrifugation technique to obtain a highly concentrated plasma fraction rich in growth factors. The final PRP composition contained approximately 1,500,000 platelets/µL, which was activated using calcium chloride (CaCl2, 10%) before application.

For treatment administration:

PRP-alone group: 4 mL of activated PRP was injected intradermally across the scalp at 1 cm intervals using a 27-gauge needle.

PRP + Microneedling group: PRP was topically applied following microneedling to enhance penetration.

Microneedling Protocol: Microneedling was performed using a 1.5 mm derma roller with 192 titanium needles, applied in vertical, horizontal, and diagonal motions across the scalp. Each session lasted 10–15 minutes, inducing pinpoint bleeding to activate the Wnt/β-catenin pathway.

Participants received four treatment sessions at 4-week intervals, with standardized post-procedure scalp care.

Statistical Analysis

Sample Size Calculation: Based on prior studies reporting an average 25–35% increase in hair density following PRP-microneedling, a sample size of 60 participants (20 per group) was determined to provide 80% power with a 95% confidence interval (CI).

Data Analysis Plan:

Continuous variables (e.g., hair density, follicular count) were analysed using paired t-tests and repeated-measures ANOVA to compare pre- and post-treatment changes.

Inter-group comparisons were conducted using independent t-tests and one-way ANOVA, followed by post-hoc Bonferroni correction where applicable.

Categorical variables (e.g., patient satisfaction levels, adverse events) were analysed using Chi-square tests.

Regression models were applied to identify predictors of treatment response, including age, gender, and baseline hair characteristics.

All statistical analyses were performed using SPSS v.28 (IBM Corp.) and R software v.4.2, with p < 0.05 considered statistically significant.

This study was conducted per the CONSORT guidelines for clinical trials, ensuring methodological transparency, reproducibility, and standardized data reporting. To enhance validity:

Blinded expert dermatologists independently analysed imaging outcomes.

Standardized PRP and microneedling protocols ensured consistency across treatment groups.

Randomization and stratification minimized selection bias.

Missing data were handled using multiple imputation techniques to maintain statistical integrity.

37. Baseline Characteristics of Study Participants: A total of 60 participants were enrolled in the study, with 20 participants in each treatment group (PRP + Microneedling, PRP Alone, and Microneedling Alone). The mean age of participants was 37.4 ± 6.5 years, with a male predominance (70%) across all groups. The mean duration of hair loss was 5.8 ± 2.3 years, with no significant differences observed between groups (p = 0.79).

Baseline hair characteristics were comparable among groups. The mean baseline hair density was 99.2 ± 11.5 hairs/cm², while the baseline hair thickness was 50.2 ± 5.6 µm, showing no significant inter-group variability (p = 0.84). Additionally, baseline Dermatology Life Quality Index (DLQI) scores averaged 10.1 ± 2.8, indicating moderate impact of hair loss on quality of life with no statistically significant differences between groups (p = 0.72). These findings confirm homogeneity of baseline characteristics, ensuring that observed post-treatment differences are attributable to intervention effects. Table 1 summarizes the baseline characteristics of participants across the three treatment groups.

Table 1: Baseline Characteristics of Study Participants

p-values were calculated using ANOVA for continuous variables and Chi-square test for categorical variables.

12. Hair Density and Thickness Improvement Post-Treatment: Significant improvements in hair density and thickness were observed in all three treatment groups over the 24 weeks follow-up period, with PRP + Microneedling demonstrating the most pronounced effect.At week 12, the mean hair density increased by +12.4 ± 3.2 hairs/cm² in the PRP + Microneedling group, compared to +7.8 ± 2.9 hairs/cm² in the PRP Alone group and +6.2 ± 3.1 hairs/cm² in the Microneedling Alone group (p < 0.001, ANOVA). By week 24, hair density had further improved, reaching +22.1 ± 4.5 hairs/cm² in the PRP + Microneedling group, significantly higher than +13.6 ± 3.9 hairs/cm² (PRP Alone) and +10.9 ± 4.1 hairs/cm² (Microneedling Alone) (p < 0.001, post-hoc Bonferroni correction).Similarly, hair thickness measurements followed a comparable pattern. The PRP + Microneedling group exhibited a +7.2 ± 1.8 µm increase in thickness at week 24, significantly exceeding the PRP Alone (+4.9 ± 1.5 µm) and Microneedling Alone (+3.8 ± 1.6 µm) groups (p < 0.001).

The PRP + Microneedling group demonstrated the highest increase in hair density, showing a statistically significant improvement compared to the other groups (p < 0.001, ANOVA). These findings highlight the superior efficacy of the combined therapy in enhancing follicular proliferation and overall hair growth.Regarding the hair density progression (hairs/cm²) over Week 0, Week 12, and Week 24 for the three treatment groups, the PRP + Microneedling group exhibited the highest sustained improvement, demonstrating greater follicular proliferation compared to PRP Alone and Microneedling Alone.

2. Trichoscopic and Dermoscopic Analysis: Trichoscopic and dermoscopic assessments revealed significant improvements in hair follicle characteristics post-treatment, particularly in the PRP + Microneedling group. The Terminal-to-Vellus Hair Ratio (T/V ratio), a key marker of follicular maturation, demonstrated a marked increase over 24 weeks, suggesting enhanced transition of miniaturized (vellus) follicles into terminal, fully developed hair follicles. At baseline, the mean T/V ratio was 2.8 ± 0.5 across all groups, with no significant inter-group differences (p = 0.76, ANOVA). By Week 24, the T/V ratio improved significantly in the PRP + Microneedling group (+1.1 ± 0.4, p < 0.001), compared to PRP Alone (+0.7 ± 0.3, p = 0.004) and Microneedling Alone (+0.5 ± 0.3, p = 0.021). Dermoscopic findings qualitatively indicated higher follicular density, increased terminal hair count, and visible thickening of the hair shafts in the PRP + Microneedling group. Patients in this group exhibited improved scalp vascularization, likely due to enhanced angiogenesis from PRP growth factors and microneedling-induced wound healing responses.

These results suggest that PRP + Microneedling enhances follicular transition and hair shaft thickening, reinforcing its synergistic role in hair restoration therapy. The PRP + Microneedling group exhibited the greatest increase, indicating a higher proportion of mature, thick hair follicles compared to the other treatment groups.

12. Patient Satisfaction and Quality-of-Life Improvement: Patient satisfaction was assessed using the Global Aesthetic Improvement Scale (GAIS), where higher ratings indicate greater perceived improvement. The PRP + Microneedling group showed the highest satisfaction rates, with 78% of participants rating their improvement as 4 or 5, compared to 55% in the PRP Alone group and 43% in the Microneedling Alone group. Additionally, quality-of-life improvements were evaluated using the Dermatology Life Quality Index (DLQI). At baseline, the mean DLQI score was 12.1 ± 2.3 across all groups (no significant difference, p = 0.81). By Week 24, the DLQI scores decreased significantly, with:

PRP + Microneedling group: -5.8 ± 1.4 (p < 0.001, paired t-test)

PRP Alone group: -3.9 ± 1.2 (p = 0.002)

Microneedling Alone group: -3.2 ± 1.5 (p = 0.006)

A greater reduction in DLQI scores (lower scores = improved quality of life) was observed in the PRP + Microneedling group, reflecting better patient-perceived improvement in hair regrowth and self-image.

These findings highlight superior patient-reported outcomes in the PRP + Microneedling group, reinforcing its role as a preferred treatment strategy for hair restoration.

34. Adverse Events and Safety Profile: The safety and tolerability of each treatment were assessed based on the frequency and severity of common post-procedural adverse effects. Redness & Irritation was the most frequently reported side effect, affecting 34.2% of participants in the PRP + Microneedling group, compared to 27.6% in PRP Alone and 22.8% in Microneedling Alone. Mild pain and transient swelling were reported in all groups, with higher incidences in the PRP + Microneedling group due to the combined micro-injury effect. However, symptoms resolved within 24–48 hours in most cases. Temporary shedding, a well-documented phenomenon in hair regrowth therapies, was observed in 23.1% of PRP + Microneedling patients, compared to 17.4% in PRP Alone and 15.2% in Microneedling Alone. No severe complications (e.g., infection, persistent scalp sensitivity) were reported in any group.

The results confirm that PRP + Microneedling is a well-tolerated treatment, with no significant long-term safety concerns. The mild adverse effects observed were temporary, self-limiting, and consistent with expected post-procedural reactions.

1. Comparative Effectiveness & Subgroup Analysis: Subgroup analyses were conducted to evaluate age-related and gender-based variations in treatment efficacy.

Age-Based Analysis:

At Week 24, hair density improvements were significantly greater in participants aged <35 years than in those aged ≥35 years across all treatment groups (p = 0.017, ANOVA).

The PRP + Microneedling group exhibited the highest gains in both age groups, with younger participants showing an average increase of +23.2 ± 4.5 hairs/cm², compared to +18.6 ± 3.9 hairs/cm² in older participants.

Gender-Based Analysis:

Females demonstrated slightly higher overall hair density improvements across treatment groups (p = 0.042, t-test), likely due to differences in androgen sensitivity and follicular response to PRP growth factors. In the PRP + Microneedling group, female participants showed an average hair density increase of +22.8 ± 4.3 hairs/cm², compared to +19.5 ± 3.7 hairs/cm² in males. These findings suggest that younger and female participants may experience slightly greater benefits from PRP + Microneedling therapy, though all subgroups exhibited statistically significant improvements compared to baseline.

Most of the result findings are summarized in table 2.

Table 2: Summary of the result findings

Comparing PRP + Microneedling with Previous Clinical Evidence: Our study demonstrated that PRP + Microneedling resulted in the highest improvement in hair density and patient satisfaction, aligning with previous research on combined regenerative approaches for androgenetic alopecia (AGA). A systematic review by English et al. (2022) [05] highlighted that microneedling enhances transdermal delivery and absorption of growth factors, improving follicular stimulation when combined with PRP. This is consistent with our findings, where the PRP + Microneedling group exhibited significantly greater hair density improvements (+22.1 ± 4.5 hairs/cm²) compared to PRP Alone (+13.6 ± 3.9 hairs/cm²) and Microneedling Alone (+10.9 ± 4.1 hairs/cm²) (p < 0.001).

Similarly, a randomized controlled trial by Gentile et al. (2020) [6] found that PRP with microneedling resulted in increased hair shaft thickness and follicular density compared to PRP alone. Our study supports these findings, reinforcing the idea that microneedling enhances the regenerative potential of PRP by activating the Wnt/β-catenin pathway and promoting angiogenesis. A network meta-analysis by Gupta et al. (2023) [11] comparing monotherapy (PRP, microneedling, and minoxidil) versus combined approaches reported that PRP + Microneedling was superior to any single treatment modality. These results confirm that PRP + Microneedling maximizes follicular regrowth potential through synergistic activation of wound healing and stem cell proliferation.

Trichoscopic Findings and Hair Follicle Maturation: The Terminal-to-Vellus Hair Ratio (T/V ratio) significantly improved in the PRP + Microneedling group (+1.1 ± 0.4, p < 0.001), indicating a greater transition of miniaturized vellus hairs into terminal hairs. This aligns with findings by Pakhomova et al. (2020) [12], who demonstrated that PRP therapy enhances anagen phase duration and promotes terminal follicle development. Additionally, a recent clinical study by Leonik et al. (2024) [13] highlighted that PRP + Microneedling improved vascular remodeling in the scalp, leading to enhanced blood supply and oxygenation to the hair follicles. This phenomenon was also noted in our study, where increased scalp vascularization was observed in PRP + Microneedling patients.

These results reinforce that PRP + Microneedling not only increases hair density but also improves overall hair quality by stimulating follicular transition and thickening of hair shafts.

Patient Satisfaction and Quality-of-Life Outcomes: Our study found that patient satisfaction was highest in the PRP + Microneedling group, with 78% of participants rating their treatment as ‘Very Satisfied’ (GAIS Score 4–5).

This is in line with research by Farid et al. (2016) [14], who reported that PRP + Microneedling resulted in significantly higher patient-reported hair coverage scores compared to PRP alone. Similarly, a meta-analysis by Li et al. (2024) [15] concluded that PRP is well-tolerated and leads to significant improvements in self-perceived hair density and scalp health.

Our findings further support PRP’s positive psychological and social impact on patients suffering from hair loss, as reflected in the significant reduction in DLQI scores (-5.8 ± 1.4, p < 0.001) in PRP + Microneedling patients.

Safety and Adverse Events: A Risk-Benefit Perspective: The safety profile of PRP + Microneedling observed in our study is consistent with prior literature, showing mild, transient side effects that resolved without intervention. Gentile et al. (2020) [6] previously reported that PRP-related side effects (redness, swelling, and temporary shedding) were common but self-limiting, a finding that aligns with our study, where redness & irritation occurred in 34.2% of PRP + Microneedling patients, compared to 27.6% (PRP Alone) and 22.8% (Microneedling Alone).

Furthermore, a systematic review by Fertig et al. (2018) [16] confirmed that PRP and microneedling treatments have an excellent safety profile, with no long-term complications reported. These findings reinforce that PRP + Microneedling remains a safe and well-tolerated procedure with no severe adverse events (infection, scarring, or persistent inflammation) observed in our study.

Subgroup Analysis: Age and Gender Differences in Treatment Response: Our study identified age and gender-based variations in treatment response, which are consistent with previous research.

Age-Based Differences: Younger participants (<35 years) exhibited greater hair density improvements (+23.2 ± 4.5 hairs/cm² vs. +18.6 ± 3.9 in ≥35 years, p = 0.017).

This is supported by research from Gupta et al. (2022) [17], who found that younger patients show enhanced PRP response due to higher follicular stem cell activity and superior vascularization.

Gender-Based Differences: Female participants showed slightly greater hair density gains (+22.8 ± 4.3 vs. +19.5 ± 3.7 in males, p = 0.042). This is consistent with a randomized comparative study by Elena EP et al. (2020) [18], which found that female participants exhibited a more robust response to PRP therapy due to differences in hormonal regulation and lower androgenic miniaturization compared to males.

These findings suggest that younger individuals and female participants may benefit more from PRP + Microneedling therapy, though all subgroups demonstrated significant improvements.

Clinical Implications and Future Directions

Based on these findings, we propose the following clinical implications and research directions:

PRP + Microneedling should be prioritized as a first-line, non-surgical intervention for hair restoration.

Personalized treatment protocols considering age, gender, and baseline hair density may optimize outcomes.Further research should evaluate long-term efficacy beyond 24 weeks and explore cost-effectiveness in clinical settings.

Our findings confirm that PRP + Microneedling is the most effective approach for hair regrowth, enhancing follicular density, patient satisfaction, and overall treatment efficacy, while maintaining an excellent safety profile. These findings closely align with previous clinical trials and systematic reviews, reinforcing PRP + Microneedling as a leading non-invasive therapy for androgenetic alopecia.

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