Introduction

Female pattern hair loss (FPHL) is a nonscarring alopecia leading to hair loss in adult females. The standard treatment included topical minoxidil and oral antiandrogenic therapy.

Aim

To investigate the effectiveness and safety of combination of 655 nm low level laser helmet device with topical 2 % minoxidil solution at FPHL in Chinese population

Patient Profile

Healthy women aged 18- 44 years with FPHL (Ludwig classification I to II)

Methods

• Prospective, randomized, parallel, controlled, single-blind clinical trial

• Global macroscopic photographs and Standardized Trichoscopic pictures were used to evaluate the effectiveness of the treatment at baseline, at 12th week and 24th week
  • Hair parameters including terminal hair percentage (hair diameter≥0.06 mm), intermediate hair percentage (0.03mm≤hair diameter<0.06 mm), vellus hair percentage (0.03 < hair diameter), hair density (hair number in 1 cm² area) and mean hair diameter in two targeted areas of each subject’s scalp were calculated based upon the trichoscopic pictures
• Safety and adverse events were recorded at all scheduled visits.

Results

• In the 2 % minoxidil treated group, subjects showed improvement in hair densities and intermediate hair percentage as early as 12th week.
• The combination group also showed an evident response. Hair densities, terminal hair percentage, vellus hair percentage, and mean hair diameter were statistically improved.
• When the two treatments were compared, the combination group showed improvements in the terminal hair percentage and mean hair diameter as early as the 12th week. The vellus hair percentage also showed some improvement, but the intermediate hair percentage showed improvement at the same time in the 2% minoxidil group. Nevertheless, these differences were not statistically significant.
• The mean hair diameter and the intermediate hair percentage both demonstrated a significant difference at the 24-week . Notably, all the above changes were seen at the midscalp region . When the two groups were compared, there were no favourable results at the vertex.

Table 1: Hair changes in two groups at baseline, 12th week and 24th week at midscalp

	Minoxidil group				Combination group				P
Parameters(mean±SD)	df1	Pct-bas1 (%)	df2	Pct-bas2 (%)	df1	Pct-bas1(%)	df2	Pct-bas2 (%)
Total hair counts	10.66 ± 20.51**	8.80	28.31± 26.57**	23.40	8.34±19.21**	6.90	20.83 ±24.40**	17.30	0.26
Terminal hair percentage	2.07±34.21	3.00	17.44 ±33.41**	25.00	15.65±28.44**	24.20	27.37 ± 28.80**	42.30	0.22
Intermediate hair percentage	13.89 ±26.46**	40.80	9.63±19.62**	28.30	(-2.53) ±29.17	6.20	(-4.53) ± 30.80	11.20	0.038
Vellus hair percentage	(-3.04) ±16.79	19.90	(-5.38) ±14.10	-35.20	(-5.16) ±10.95*	33.22	-( 2.64) ±14.90	17.50	0.14
Mean hair diameter	0.79±12.95	1.20	( -0.92) ±11.70	1.40	6.98±11.41**	11.60	8.88±10.52**	14.70	0.002

The values in the table are expressed as mean ± SD. df1 and df2 represent the difference after 12-week and 24-week treatment, respectively. Pct-bas1 and Pct-bas2 represent the decrease/increased percentage compared with baseline after 12-week and 24-week treatment, respectively. The P-value in the right column represents the comparison of df2 between the 2 % minoxidil group and combination group. (** represents the comparison of difference between baseline and the 12th week or the 24th week in each group, P < 0.01; *represents the differences that P is less than 0.05).

Table 2: Hair changes in two groups at baseline, 12th week and 24th week At vertex

	Minoxidil group				Combination group
Parameters	df1	Pct-bas1 (%)	df2	Pct-bas2 (%)	df1	Pct-bas1 (%)	df2	Pct-bas2 (%)	P
Total hair counts	14.28+ 26.12**	11.60	22.53+ 28.65**	18.30	15.55+ 22.62**	12.50	27.67+ 24.22**	22.30	0.46
Terminal hair percentage	10.65+33.94	14.60	16.79+ 32.19**	23.00	13.07+ 33.02	18	23.48+ 33.04**	33.50	0.43
Intermediate hair percentage	3.44 + 34.58	9.10	3.79+ 28.63	10.00	2.88+ 27.15	7.10	6.26+ 30.35	15.50	0.75
Vellus hair percentage	-0.34 + 17.11	2.70	172+ 18.26	-13.90	-1.52+ 17.95	-10.30	-1.86+ 15.12	-12.60	0.41
Mean hair diameter	3.13 + 13.76	4.90	172+ 13.63	2.70	1.44+ 14.39	2.30	3.39+ 12.20	5.40	0.85

The values in the table are expressed as mean SD. df1 and df2 represent the difference after 12-week and 24-week treatment, respectively. Pct-bas1 and Pct-bas2 ± represent the decrease/increased percentage compared with baseline after 12-week and 24-week treatment, respectively. The P-value in the right column represents the comparison of df2 between the 2 % minoxidil group and combination group. (** represents the comparison of difference between baseline and the 12th week or the 24th week in each group, P < 0.01; *represents the differences that P is less than 0.05).

Subject’s satisfaction and doctor’s satisfaction

• At 24th week, in the minoxidil group and the combination group, subject’s satisfaction was 4.13±0.90 and 4.33±0.76 (P>0.05), respectively
• The doctor’s satisfaction was 4.53±0.68 in minoxidil and 4.67±0.55 in combination group (P > 0.05)

DLQI scores improvement rate

• The baseline DLQI score after 24 week’s treatment in 2 % minoxidil group was (5.0 ± 4.54) and it reduced to (4.31±3.20) with an improvement rate of 25 %
• The combination group showed DLQI score of (6.89 4.41) at baseline and it turned to (3.83±3.11) with improvement rate of 33.5 % at 24 weeks (P > 0.05)

Safety and Tolerability

• No serious adverse events observed with 2 % minoxidil treatment or the combination group.
• Slight hair loss (27.8 %), desquamation (19.0 %), pruritus (15.2 %), seborrhea (2.5 %) and hypertrichosis (2.5 %) were reported adverse events.

Conclusion

• Treatment of FPHL with both 2 % minoxidil and the combination of LLLT with 2 % minoxidil was effective and safe
• The combination treatment may provide better improvement in transformation of the intermediate hair to terminal hair and thickening of the hair diameter for FPHL than minoxidil monotherapy.

Reference

Photodiagnosis Photodyn Ther. 2024 Feb:45:103966.