Introduction
Currently there are two effective treatments available for the treatment of Androgenetic Alopecia (AGA) in men: topical minoxidil and oral finasteride. Both minoxidil and finasteride have demonstrated well established therapeutic effect in the management of AGA. A Combination of minoxidil and finasteride solution was developed for topical application in patient suffering from AGA which may improve patient compliance and combining two molecules acting on same ailment would provide faster improvement in hair growth.
Aim
To compare the safety and efficacy of combination of Minoxidil +Finasteride lipid solution) with Minoxidil (5%) solution in adult male patients suffering from Androgenetic Alopecia (AGA).
Patient Profile
- Pharmacokinetic study: Healthy adult, human male subjects with Androgenetic Alopecia
- Efficacy study: Male patients of 18 to 45 years of age with Androgenetic Alopecia with II to V grade on the modified Norwood Hamilton classification
Methods
- Effect on hair growth and scalp coverage was assessed by the investigator by using 5-point scale as following.
- Markedly improved: dense hair growth (bald area almost entirely covered with hair of density almost identical to that in the non-bald area).
- Moderately improved: moderate hair growth (bald area partly covered with newly growing hair, of density lower than that in the non-bald area).
- Slightly improved: minimum hair growth (hair growth present, but bald area clearly visible)
- Unchanged: no visual hair growth
- Worsened: decreased hair growth
Study Endpoints
- Primary efficacy criteria was comparison of change in the investigator assessment score for hair growth and scalp coverage in the two treatment groups compared to baseline
- Secondary efficacy criteria was comparison of the change in patient’s assessment score for hair growth and loss by hair growth questionnaire and change in global photographic assessment for hair growth by 7point scale at the end of the study compared to baseline
Results
Pharmacokinetics Results
|
|
Minoxidil |
Finasteride |
|
Parameters (Units) |
Mean ± SD (un-transformed data) Test Product |
Mean ± SD (un-transformed data) Test Product |
|
Tmax, ss (h)* |
4.000 (0.000 – 12.050) |
2.500 (0.000 – 12.050) |
|
Cmin, ss (pg / mL) |
1740.672 ± 753.8738 |
421.104 ± 225.7914 |
|
Cmax, ss (pg / mL) |
2701.228 ± 793.7069 |
636.962 ± 321.5293 |
|
AUC0-τ, ss (pg.h / mL) |
19278.993 ± 6162.2488 |
6340.593 ± 3308.5467 |
|
Cav, ss (pg / mL) |
1603.907 ± 511.9263 |
527.873 ± 276.0305 |
|
%Fluctuation |
62.476 ± 36.0118 |
33.156 ± 20.6475 |
|
%Swing |
68.691 ± 50.4714 |
41.694 ± 33.0579 |
|
AUC0-t (pg.h / mL) |
43678.209 ± 13048.4362 |
15260.864 ± 8475.4908 |
|
AUC0-¥ (pg.h / mL) |
71710.614 ± 28235.0966 |
18301.469 ± 11160.4722 |
|
AUC_%Extrap_obs (%) |
32.589 ± 20.7769 |
14.288 ± 6.9938 |
|
lz (1 / h) |
0.032 ± 0.0129 |
0.045 ± 0.0126 |
|
t½ (h) |
27.240 ± 20.0709 |
16.485 ± 4.6635 |
Efficacy Results
- Significantly more patients treated with Minoxidil + Finasteride combination showed greater improvement in Investigator score (64.7% in Minoxidil + Finasteride combination group versus 25.5% in Minoxidil alone group; p =0.0006)
- Significantly more patients treated with Minoxidil + Finasteride combination showed greater improvement (Slightly increased, moderately increased and greatly increased) in global photographic assessment for hair growth score as compared to those treated with Minoxidil alone (88.9% in Minoxidil + Finasteride combination group versus 60.0% in Minoxidil alone group)
- Significantly more patients (30) treated with Minoxidil + Finasteride combination showed improvement patient’s self-assessed questionnaire with Minoxidil alone.
|
|
Growth of Hairs Score |
|
|||||||||
|
Treatment
|
Greatly increase d |
Moderately increased |
Slightly increase d |
No change |
Moderately decreased |
Total |
|
||||
|
Minoxidil + Finasteride combination |
14 |
19 |
11 |
5 |
2 |
51 |
|
||||
|
|
|
|
|
|
|
|
|
||||
|
Minoxidil |
6 |
16 |
18 |
10 |
1 |
51 |
|
||||
|
Total |
20 |
35 |
29 |
15 |
3 |
102 |
|
||||
|
Treatment |
Slowing down hair loss score |
|
|||||||||
|
|
Very Effective |
Effective |
Partial Effective |
Not effective at all |
Total |
|
|||||
|
Minoxidil + Finasteride combination |
9 |
23 |
15 |
4 |
51 |
|
|||||
|
Minoxidil |
5 |
23 |
20 |
3 |
51 |
|
|||||
|
Total |
14 |
46 |
35 |
7 |
102 |
|
|||||
|
Treatment |
Bald Score (Balding Getting Smaller) |
||||||||||
|
|
Strongly Agree |
Agree |
Disagree |
No Opinion |
Total |
||||||
|
Minoxidil + Finasteride combination |
9 |
21 |
2 |
4 |
36 |
||||||
|
Minoxidil |
0 |
15 |
8 |
11 |
34 |
||||||
|
Total |
9 |
36 |
10 |
15 |
70 |
||||||
- Majority of patients treated with minoxidil + finasteride combination showed no adverse events or clinically significant abnormalities during laboratory assessments, vital recordings, ECG recordings etc
Conclusion
Treatment with topical formulation of minoxidil + finasteride combination demonstrated clinically significant improvement in terms of hair growth as compared to Minoxidil (5%) alone.
Reference
J Clin Exp Dermatol Res 2015; 6:1