Efficacy and Safety of Topical Formulation of Minoxidil 5%+Finasteride 0.1% vs Minoxidil Alone in Adult Male Patients with Androgenetic Alopecia

Table of Content

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

Table 1: Pharmacokinetics parameters of minoxidil and finasteride after topical administration of subjects with androgenetic alopecia

 

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)
Figure 1:  Investigator assessment score for hair growth and scalp coverage in the two treatment groups, (Minoxidil+ Finasteride) vs Minoxidil alone

  • 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)
 Figure 2:  Global photographic assessment for hair growth score in the two treatment groups, (Minoxidil + Finasteride) or Minoxidil alone

  • Significantly more patients (30) treated with Minoxidil + Finasteride combination showed improvement patient’s self-assessed questionnaire with Minoxidil alone.
Table 2: Patients self-assessment score based on Bald Score (Balding Getting Smaller), hair growth and slowing down of hairs loss when treated with MorrF or 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