Phase I Clinical Trial: Evaluating the Efficacy, Safety, and Patient Satisfaction of Platelet-Rich Plasma (PRP) Injections and Microneedling for Androgenetic Alopecia Treatment.
Study Design
- Jenis Studi
- RCT
- Ukuran Sampel
- 40
- Durasi
- 12 weeks
- Intervensi
- Phase I Clinical Trial: Evaluating the Efficacy, Safety, and Patient Satisfaction of Platelet-Rich Plasma (PRP) Injections and Microneedling for Androgenetic Alopecia Treatment. None
- Pembanding
- Placebo
- Arah Efek
- Positive
- Risiko Bias
- Moderate
Abstract
INTRODUCTION: Platelet-rich plasma (PRP) has been widely utilized in dermatological treatments, leading to the development of various administration methods. This study aims to evaluate and compare the effectiveness of PRP injections and microneedling techniques for treating androgenetic alopecia (AGA) in clinical practice. MATERIALS AND METHODS: A total of 40 participants diagnosed with AGA, aged between 18 and 50 years, were randomly assigned to receive either PRP injections or microneedling treatments. Each patient underwent two treatment sessions, with a 1-month interval between them. Hair density and thickness measurements were performed using TrichoScan before treatment and 2 months after the final session. Statistical analysis was conducted using SPSS software. RESULTS: Among the participants, 28.57% were male and 71.43% were female, with an average age of 40.2 years (±7.7). In the PRP injection group, hair count increased by approximately 62.4% (from 17.40 ± 2.074 to 28.26 ± 6.229), and hair thickness improved by 58.6% (from 58.0 ± 25.01 to 92.0 ± 16.31). In the microneedling group, hair count increased by 88.4% (from 14.71 ± 3.988 to 27.71 ± 4.499), while hair thickness improved by 51.3% (from 49.0 ± 11.30 to 74.14 ± 22.42). Although both groups showed statistically significant improvements (p < 0.05), the intergroup differences in hair count and thickness were not statistically significant (p > 0.05). CONCLUSION: The findings of this study confirm PRP as a viable treatment option for AGA. Both injection and microneedling methods provided therapeutic benefits. Additionally, microneedling appeared to enhance patient satisfaction and treatment tolerance.
Full Text
Figures
FIGURE 1
Study design and treatment allocation for the Phase I clinical trial comparing PRP injections versus microneedling-delivered PRP for androgenetic alopecia.
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FIGURE 2
Hair density or trichoscopic outcomes comparing PRP injection and PRP microneedling groups in the androgenetic alopecia treatment trial.
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FIGURE 3
Patient satisfaction scores and clinical improvement ratings across both PRP administration methods for androgenetic alopecia.
chart
FIGURE 4
Safety profile comparison showing adverse events and tolerability data for PRP injections versus microneedling-delivered PRP.
chartTables
TABLE 1
| Variables | Time | Mean ± SD | Percentiles |
| ||
|---|---|---|---|---|---|---|
| 25 | 50 (median) | 75 | ||||
|
| ||||||
| (Triple ×60) hair number in 4*5 Mm | Before | 17.40 ± 2.074 | 15.5 | 17.0 | 19.5 | 0.043 |
| After | 28.6 ± 6.229 | 24.0 | 27.0 | 34.0 | ||
| (Kpl ×150) hair thickness in Mm | Before | 58.0 ± 25.01 | 36.0 | 61.0 | 78.5 | 0.043 |
| After | 92.0 ± 16.31 | 78.5 | 87.0 | 108.0 | ||
TABLE 2
| Variables | Time | Mean ± SD | Percentiles |
| ||
|---|---|---|---|---|---|---|
| 25 | 50 (median) | 75 | ||||
|
| ||||||
| (Triple ×60) hair number in 4 × 5 Mm | Before | 14.71 ± 3.988 | 12.0 | 13.0 | 18.0 | 0.018 |
| After | 27.71 ± 4.499 | 25.0 | 30.0 | 32.0 | ||
| (Kpl ×150) hair thickness in Mm | Before | 49.0 ± 11.30 | 37.0 | 53.0 | 58.0 | 0.018 |
| After | 74.14 ± 22.42 | 47.0 | 84.0 | 92.0 | ||
TABLE 3
| Variables | Group | Mean ± SD | Percentiles |
| ||
|---|---|---|---|---|---|---|
| 25 | 50 (median) | 75 | ||||
| (Triple ×60) hair number in 4 × 5 Mm | PRP | 64.69 ± 30.29 | 35.15 | 66.67 | 93.26 | 0.219 |
| PRP + Micro | 95.18 ± 39.84 | 66.67 | 88.24 | 150.0 | ||
| (Kpl ×150) hair thickness in Mm | PRP | 76.64 ± 59.60 | 29.35 | 42.62 | 140.95 | 0.570 |
| PRP + Micro | 51.80 ± 39.73 | 23.68 | 50.79 | 69.811 | ||
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