Evaluating the efficacy and safety of combined microneedling therapy versus topical Minoxidil in androgenetic alopecia: a systematic review and meta-analysis.

Khalid M A Ahmed, Yasmeena Abdelall Kozaa, Mohammad T Abuawwad, Alaa I Al-Najdawi, Yomna W Mahmoud et al.

Meta-Analysis Archives of dermatological research 2025 6 trích dẫn

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Study Design

Loại nghiên cứu: systematic review and meta-analysis
Cỡ mẫu: 631

Can thiệp: Evaluating the efficacy and safety of combined microneedling therapy versus topical Minoxidil in androgenetic alopecia: a systematic review and meta-analysis. None
Đối chứng: Placebo
Xu hướng hiệu quả: Positive
Nguy cơ sai lệch: Moderate

Abstract

This study evaluates the efficacy and safety of the combined microneedling (CMNT) with minoxidil versus minoxidil monotherapy for the treatment of androgenetic alopecia (AGA), with a focus on the impact of microneedling parameters on treatment outcomes. We conducted a systematic review and meta-analysis (PROSPERO: CRD42024594487) of randomized controlled trials (RCTs) comparing CMNT versus minoxidil alone for AGA, following PRISMA guidelines. A comprehensive search across six databases was performed up to September 8, 2024. We identified 12 RCTs involving 631 AGA patients, with a total of 11 RCTs included in the meta-analyses. CMNT significantly improved hair count compared to minoxidil monotherapy (SMD 1.32, 95% CI 0.73-1.92, p < 0.01), with substantial heterogeneity (I² = 88%, p < 0.01). Subgroup analyses indicated no significant effect of microneedling (MN) depth (≤ 1 mm vs. >1 mm), duration (≤ 12 weeks vs. >12 weeks), or technique(device) (electrodynamic vs. rolling) on hair count outcomes. Additionally, A meta-analysis of six RCTs demonstrated a significant improvement in hair diameter with CMNT (SMD 0.34, 95% CI 0.11-0.58; p < 0.01), with no observed heterogeneity (I² = 0%). Investigators and patient's self-assessment scores were also improved. Adverse events were more frequent with CMNT (74 vs. 59 events), however they were generally considered mild or self-limiting. CMNT significantly enhances hair count and diameter in AGA patients with mild adverse events. MN parameters including depth, duration, and technique variations did not significantly affect hair count outcome, suggesting microneedling as a promising adjunctive AGA treatment.

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Figures

Fig. 1

Study design or CONSORT flow diagram for the trial comparing combined microneedling therapy with topical treatment alone for hair loss.

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Fig. 2

Baseline characteristics or initial hair density measurements in the microneedling combination therapy versus topical-only treatment groups.

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Fig. 3

Hair density or hair count improvement data at follow-up timepoints, comparing microneedling combination therapy with topical treatment alone.

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Fig. 4

Trichoscopic images or dermoscopy findings from patients receiving microneedling combination therapy, showing changes in hair shaft diameter.

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Fig. 5

Patient satisfaction or global assessment scores comparing the microneedling combination arm with the topical-only arm.

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Fig. 6

Safety data including adverse events (erythema, pain, scaling) recorded across treatment groups in the microneedling hair loss trial.

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Fig. 7

Photographic documentation showing representative before-and-after results from the microneedling combination therapy group.

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Fig. 8

Hair pull test or shedding rate data comparing the two treatment approaches at different timepoints.

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Fig. 9

Subgroup analysis of treatment response by alopecia severity, gender, or other baseline factors in the microneedling trial.

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Fig. 10

Vellus to terminal hair ratio changes measured by trichoscopy in the microneedling versus topical treatment groups.

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Fig. 11

Durability of response data from extended follow-up of microneedling combination therapy patients.

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Fig. 12

Correlation analysis between treatment parameters (needle depth, session frequency) and hair regrowth outcomes.

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Fig. 13

Summary of efficacy and safety outcomes from the microneedling combination therapy trial, supporting its clinical utility for hair loss management.

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Tables

Table 1

Study	Country	RCT Type	Total Participants	Age		% Male	AGA Scale
				Mean	(Range)		Hamilton-Norwood	Ludwing (female)
				Mean	(Range)		(male)	Ludwing (female)
Dhurat [39]	India	Single-blinded, parallel, two-arms	100	28.6	(20-35)	100%	III vertex-IV	N/A
Yu [21]	China	Single-blinded, parallel, two-arms	19	35.2 ± 6.8	(23-45)	100%	III-VI	N/A
Kumar [40]	India	Single-blinded, parallel, two-arms	68	N/A	(18-40)	100%	III-IV	N/A
Bao [27]	China	Single-blinded, parallel, three-arms	60	N/A	(20-50)	100%	III-VI	N/A
Faghihi [26]	Iran	Single-blinded, parallel, three-arms	60	30.32 ±	(18-45)	51%	III-VI	Types 2, 3
Faghihi [26]	Iran	Single-blinded, parallel, three-arms	60	7.06	(18-45)	51%	III-VI	Types 2, 3
Malhotra & Herakal [29]	India	Non-blinded, parallel,	60	N/A	(21-40)	100%	III-IV	N/A
	India	two-arms	60	N/A	(21-40)	100%	III-IV	N/A
Sohng [23]	Korea	Non-blinded, parallel,	29	N/A	(31-54)	83%	II-V	Type 1
Sohng [23]	Korea	three-arms	29	N/A	(31-54)	83%	II-V	Type 1
Bao [30]	China	Non-blinded, parallel,	75	N/A	(20-60)	100%	III-VI	N/A
Bao [30]	China	three-arms	75	N/A	(20-60)	100%	III-VI	N/A
Liang [25]	China	Single-blinded, parallel, three-arms	120	N/A	(18-45)	0%	N/A	Types 2, 3
Zhang [28]	China	Single-blinded, parallel, two-arms	40	30.87 ±	(18-50)	0%	N/A	N/A
Zhang [28]	China	Single-blinded, parallel, two-arms	40	5.2	(18-50)	0%	N/A	N/A
Adistri [24]	Indonesia	Non-blinded, parallel,	36	34 ± 6.75	(26-51)	100%	III-VI	N/A
Adistri [24]	Indonesia	two-arms	36	34 ± 6.75	(26-51)	100%	III-VI	N/A
Yasmeen & Haque [22]	Bangladesh	Non-blinded, parallel,	90	29.90 ±	(18-45)	50%	II-IV	N/A
	Bangladesh	three-arms	90	5.5	(18-45)	50%	II-IV	N/A

Table 2

Study	Minoxidil Group (M)	M Characteristics		CMNT Group	MN Characteristics			Duration of treatment (weeks)
Study	Minoxidil Group (M)	M%	M Frequency	CMNT Group	MN Type	MN Depth (mm)	MN Interval (week)	Duration of treatment (weeks)
Dhurat [39]	M (44)	5%	Twice daily (BID)	MN+M (50)	Rolling	1.5	Once / Week	12
Yu [21]	M (19)	5%	Twice daily (BID)	MN+M (19)	Fractional Radiofrequency MN (FRM)		Once / 4 Weeks	20
Yu [21]	M (19)	5%	Twice daily (BID)	MN+M (19)	Fractional Radiofrequency MN (FRM)	1.5	Once / 4 Weeks	20
Kumar [40]	M (29)	5%	Twice daily (BID)	MN+M (31)			Once / Week	12
Kumar [40]	M (29)	5%	Twice daily (BID)	MN+M (31)	Rolling	1.5	Once / Week	12
Bao [27]	M (18)	5%	Twice daily (BID)	MN+M (20)	Electrodynamic	1.5-2.5	Once / 2 Weeks	24
Faghihi [26]	M (20)	5%	Twice daily (BID)	MN+M (39)	Electrodynamic	0.6,1.2	Once / 2 Weeks	12
Malhotra & Herakal [29]	M (30)	5%	Twice daily (BID)	MN+M (30)	Rolling		Once / 2 Weeks	24
Malhotra & Herakal [29]	M (30)	5%	Twice daily (BID)	MN+M (30)	Rolling	1.5	Once / 2 Weeks	24
Sohng [23]	M (9)	5%	N/A	MN+M (9)	Spiral grooved MN		Twice / Week	26
Sohng [23]	M (9)	5%	N/A	MN+M (9)	Spiral grooved MN	0.25	Twice / Week	26
Bao [30]	M (23)	5%	Twice daily (BID)	MN+M (25)	Electrodynamic	01-Feb	Once / 3 Weeks	24
Liang [25]	M (38)	5%	Once daily	MN+M (40)	Electrodynamic	0.7-1	Once / 2 Weeks	24
Zhang [28]	M (20)	2%	Twice daily (BID)	MN+M (20)	Nano-device: 3DL-GG: Nanomed Device Inc.	0.26	Once / Week	24
Adistri [24]	M (18)	5%	Twice daily (BID)	MN+M (18)	Rolling	0.6	Once / 4 Weeks	12
Yasmeen & Haque [22]	M (30)	5%	Twice daily (BID)	MN+M (30)	Rolling	1.5	Once / 4 Weeks	20

Table 3

Model	Estimate	SE	z-value	p-value	95% C.I.
Intercept	-6.4954	4.6528	-1.396	0.1627	-15.6147	2.6239
Sample size (Intervention)	-0.219	0.4355	-0.5029	0.6151	-1.0727	0.6346
Sample size (Control)	0.2747	0.4471	0.6144	0.539	-0.6016	1.151
Age	0.1547	0.1385	1.1168	0.2641	-0.1168	0.4262
Follow-up	0.0852	0.0759	1.1231	0.2614	-0.0635	0.234

Table 4

Adverse event	M Group	CMNT Group
Headache	4 [25, 29]	6 [28, 29]
Hypertrichosis	12 [25, 26, 28, 29]	19 [25, 26, 28, 29]
Scalp itching	25 [24, 27, 28, 29]	18 [24, 28]
Seborrheic dermatitis	2 [27, 30]	2 [27, 30]
Eczema	2 [27, 30]	0
Enlarged lymph nodes	0	9 [26, 27, 30]
Increased scurf	7 [25]	6 [25, 27]
Discomfort over the scalp	1 [29]	3 [25]
Contact dermatitis	1 [25]	1 [25]
Erythema	2 [25]	7 [24, 29]
Dandruff	7 [25]	7 [25, 27, 30]
Palpitation	1 [25]	0
Postural hypotension	1 [25]	1 [25]
Urticaria	1 [25]	0
Infection	0	1 [25]
Total	59	74

Table 5

Study ID	Outcome	Result
Bao [27]	VAS pain score	The mean VAS score for participants who received MN therapy was 4.52 ± 3.7.
Bao [30]	Molecule expression in the Wnt/β-catenin signaling pathway	There was a statistically significant difference (p < 0.05) in the upregulation of FZD3, β-catenin, and LEF-1 expression at both the mRNA and protein levels in the treated areas of the MN + M group.
Yu [21]	VAS pain score	The mean VAS score for all participants treated with FRM therapy was 3.63 ± 1.38.
Liang [25]	Change in scalp tissue structure	The epidermal thickness was significantly increased only in MN + M group (p < 0.001) The dermis thickness was significantly increased in two groups (p < 0.001) The average follicle diameter was significantly increased only in MN + M group (p < 0.001)
Adistri [24]	Changes in terminal and vellus hair	After 12 weeks, the MN + M group had a higher percentage of terminal hair (73.2%) compared to the M group (58.8%), while the vellus hair percentage was lower in the MN + M group (26.8%) compared to the M group (41.1%).

References

Used In Evidence Reviews

A Minoxidil cho Rụng Tóc Androgen

A Vi Kim cho Rụng Tóc Androgen

Evaluating the efficacy and safety of combined microneedling therapy versus topical Minoxidil in androgenetic alopecia: a systematic review and meta-analysis.

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