Efficacy of 2% Minoxidil Alone against Combination of 2% Minoxidil & Low-level Laser Therapy in FPHL
Introduction
Female pattern hair loss (FPHL), a non-scarring alopecia common in adult women, is primarily treated with topical minoxidil and oral antiandrogenic therapy.
Aim
To compare the effectiveness and safety of low-level laser therapy (LLLT) combined with 2 % minoxidil solution versus 2 % minoxidil alone in the treatment of FPHL in Chinese population.
Patient Profile
Women aged 18–44 years with FPHL (Ludwig classification I to III)
Methods
- 24-week, prospective, randomized, single-blind clinical trial
- Efficacy evaluation was performed using global photographs and trichoscopic pictures
- Assessment timepoints: Baseline, 12th week and 24th week.
- Based on the trichoscopic pictures, hair parameters such as terminal hair percentage (hair diameter=0.06 mm), intermediate hair percentage (0.03mm=hair diameter<0.06 mm), vellus hair percentage (0.03 mm 1cm2 hair diameter), hair density (hair number in area) and mean hair diameter in the two targeted areas (midscalp and vertex) of each subject’s scalp were calculated
- Subject’s and doctor’s self-assessment of satisfaction was performed at the 12th and 24th week. Satisfaction was evaluated and scored by the linear analogue scale of 1–5 (“1″= very unsatisfied, “2″= unsatisfied, “3″= slightly satisfied, “4″= satisfied, “5″= extremely satisfied)
- Subjects were asked to fill in dermatology life quality index (DLQI) at baseline and the 24th week.
- Safety and adverse events were recorded at all visits.
Results
- 24-week findings: At midscalp area
- Hair density: Both treatments improved these features, but neither showed a statistically significant advantage over the other.
- Terminal hair: The improvement in terminal hair percentage was more in combination group (42.3%) than 2 % minoxidil group (25%) (P > 0.05).
- Intermediate hair: 2% minoxidil significantly increased intermediate hair, while the combination treatment significantly decreased it.
- Vellus hair: Both groups saw minimal changes in vellus hair percentage, with no significant difference.
- Mean hair diameter: The combination group had statistically significant increase than 2 % minoxidil group (P = 0.002).
At Vertex area
- Hair density and terminal hair percentage: Both combination and 2% minoxidil groups showed improvements in hair density and terminal hair percentage (Combination-33.5% and 2% minoxidil- 23%), but no statistically significant difference was found between them.
- Intermediate hair percentage: Combination group showed a larger increase than 2% minoxidil, statistically non-significant.
- Vellus hair percentage: Minimal changes in both groups with no significant difference.
- Mean hair diameter: Both 2 % minoxidil and combination group showed slight and insignificant increase.
Figure 1 Total Hair count at midscalp and vertex
Table 1: Hair parameters in two group at midscalp and at vertex
|
Parameters (mean) |
Minoxidil group |
Combination group
|
||||
|
|
Baseline (n=39) |
12th week (n=33) |
24th week (n=30) |
Baseline (n = 40) |
12th week (n = 38) |
24th week (n = 30) Total |
|
At Midscalp |
|
|
|
|
|
|
|
Terminal hair percentage |
69.82 |
73.81 |
89.84 |
64.74 |
80.92 |
90.37
|
|
Intermediate hair percentage |
34.07 |
46.91 |
41.10 |
40.54 |
38.64 |
39.56 |
|
Vellus hair percentage |
15.28 |
11.28 |
18.08 |
15.53 |
10.26 |
14.34 |
|
Mean hair diameter |
64.45 |
65.92 |
64.52 |
60.24 |
67.27 |
67.91 |
|
At vertex |
|
|
|
|
|
|
|
Terminal hair percentage |
73.14 |
82.66 |
89.87 |
70.09 |
83.89 |
93.26 |
|
Intermediate hair percentage |
37.97 |
42.54 |
41.44 |
40.44 |
42.85 |
47.18 |
|
Vellus hair percentage |
12.39 |
12.13 |
14.37 |
14.74 |
13.44 |
12.03 |
|
Mean hair diameter |
64.47 |
67.26 |
67.88 |
63.13 |
64.80 |
67.71 |
Table 2. Hair changes in two groups at baseline, 12th week and 24th week at midscalp and vertex.
|
Parameters |
Minoxidil group |
Combination group |
|||||||
|
|
df1
|
Pct-bas1 (%) |
df2
|
Pct-bas2 (%) |
df1
|
Pct-bas1 (%) |
df2
|
Pct-bas2 (%) |
P |
|
At midscalp |
|
|
|
|
|
|
|
|
|
|
Total hair counts |
10.66 |
8.80 |
28.31 |
23.40 |
8.34 |
6.90 |
20.83 |
17.30 |
0.26 |
|
Terminal hair percentage |
2.07 |
3.00 |
17.44 |
25.00 |
15.65 |
24.20 |
27.37 |
42.30 |
0.22 |
|
Intermediate hair percentage |
13.39 |
40.80 |
9.63 |
28.30 |
-2.53 |
-6.20 |
-4.53 |
11.20 |
0.38 |
|
Vellus hair percentage |
-3.04 |
-19.90 |
-5.38 |
-35.20 |
-5.16 |
-33.22 |
-2.64 |
-17.50 |
0.14 |
|
Mean hair diameter |
0.79 |
1.20 |
-0.92 |
1.40 |
6.98 |
11.60 |
8.88 |
14.70 |
0.002 |
|
At vertex |
|
|
|
|
|
|
|
|
|
|
Total hair counts |
14.28 |
11.60 |
22.53 |
18.30 |
15.55 |
12.50 |
27.67 |
22.30 |
0.46 |
|
Terminal hair percentage |
10.65 |
14.60 |
16.79 |
23.00 |
13.07 |
18.60 |
23.48 |
33.50 |
0.43 |
|
Intermediate hair percentage |
3.44 |
9.10 |
3.79 |
10.00 |
2.88 |
7.10 |
6.26 |
15.50 |
0.75 |
|
Vellus hair percentage |
-0.34 |
-2.70 |
1.72 |
-13.90 |
-1.52 |
-10.30 |
-1.86 |
-12.60 |
0.41 |
|
Mean hair diameter |
3.13 |
4.90 |
1.72 |
2.70 |
1.44 |
2.30 |
3.39 |
5.40 |
0.85 |
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.
Doctor and Subject Satisfaction
- Subject satisfaction at both 12 and 24 weeks with minoxidil and combination groups
- 12 weeks: 4.00 vs. 4.13
- 24 weeks: 4.13 vs. 4.33
- Doctor-reported satisfaction between the groups
- 12 weeks: 4.48 vs. 4.32
- 24 weeks: 4.53 vs. 4.67
DLQI Scores Improvement Rate
- 2% minoxidil group had a baseline DLQI score of 5.0, which was reduced to 4.31 after 24 weeks of treatment, with an improvement rate of 25%.
- The combination group had a baseline DLQI score of 6.89, which was reduced to 3.83 after 24 weeks of treatment, with an improvement rate of 44%.
Safety
- No serious adverse events were reported in any subject receiving the 2% minoxidil treatment or the combination group
- Reported relative adverse events included slight hair loss (27.8 %), desquamation (19.0 %), pruritus (15.2 %), seborrhea (2.5 %) and hypertrichosis (2.5 %)
Conclusion
- Both 2% minoxidil and the combination of low-level laser therapy with 2% minoxidil are safe and effective treatments for female pattern hair loss
- The combination therapy of LLT with 2% minoxidil demonstrated greater transformation of intermediate to terminal hair follicles and increased hair diameter in women with FPHL.
Reference
Photodiagnosis Photodyn. Ther. 2024; 45:103966
