Introduction

Topical minoxidil (MNX) 2%–5% and oral finasteride (F) 1 mg/day are the only pharmacological treatments approved for androgenetic alopecia (AGA). A topical formulation of finasteride (F) has been developed to reduce systemic adverse effects associated with the oral formulation. MNX and F act through distinct mechanisms of action. Combining them could potentially enhance clinical efficacy in treating AGA.

Aim

To evaluate and compare the efficacy and safety of the combination of 5% propylene glycol (PG)-free MNX and 0.25% topical F, applied in different times of the day (MNX in the morning and topical F in the evening), compared to their use in monotherapy in subjects with AGA.

Patient Profile

Males aged > >18 years with AGA (I–VII Hamilton-Norwood grading scale) and treatment naive or free from any therapy for at least 6 months.

Method

Study Endpoints

• Primary Efficacy Endpoint: Hair count, hair density, vellus rate count, terminal rate count and hair thickness evaluated via trichoscopic analysis using Medican 1000 and Trichoscale, Analysis area : 0.9cm².
• Secondary Efficacy Endpoint: Percentage of subjects achieving a Global Photographic Assessment Score (GPAS) score of ≥2 at 3 and 6 months. GPAS is a 7-point scale ranging from -3 (severe worsening) to +3 (excellent improvement), used to evaluate AGA severity through serial digital photography.
• Tolerability and Cosmetic Acceptability: Assessed via a self-administered questionnaire after 6 months, evaluating: Fragrance, ease of application, satisfaction with applicability, product absorption, hair volume, sensation of greasiness, hair manageability (combing, hairstyle) using a score ranged from -2 (low acceptability) to +2 (high acceptability).

Results

Trichoscopic Evaluation

• All treatments resulted in an increase in hair density compared to baseline. However, improvement was significant only for group A (MNX + F), both at three (+56 density/cm², p < 0.05) and six (+81 density//cm², p < 0.001) months.

Table 1: Mean change from baseline in hair density in 3 groups

Data are expressed as mean ± standard error (SE).

• All groups showed increase in terminal hair counts over time, however, statistically significant improvement was seen only in group A
• The mean change in hair terminal density from baseline also showed a significant difference between group A (MNX + F) and group B (F) (p < 0.05), with no significant differences observed between group A (MNX + F) and group C (MNX) at both 3 and 6 months.
• No statistical differences in hair diameter, vellus hair density was observed between groups and during the treatment period.

  Global Photographic Assessment

• The global photographic assessment score (GPAS) was significantly higher in Group A compared to both Group B and Group C at 3 and 6 months ((2.0 ± 0.7 vs. 0.6 ± 0.8 and 1.3 ± 0.6; respectively)
• A significantly greater percentage of subjects in Group A achieved a GPAS score of >2 in comparison with Groups B and C both after 3 and 6 months (Figure 1)

Figure 1: Global photographic assessment results

Tolerability and cosmetic acceptability

• Good tolerability was observed in all treated groups.
• Overall, Group A (MNX + F) had significantly higher tolerability and cosmetic acceptability compared to Group C (MNX).

Conclusion

• The combination of 5% MNX lotion and 0.25% F in a spray formulation demonstrated significantly greater clinical and instrumental efficacy in treating patients with AGA compared to the monotherapies.
• It also exhibited a similar tolerability and safety profile.
• This combination therapy may enhance adherence to AGA treatment due to its faster efficacy compared to monotherapy.

Reference

J Cosmet Dermatol. 2024;23:502–509.