Introduction

Minoxidil is a topical treatment for Androgenetic alopecia (AGA), which has been proven to be effective in preventing progression or improving vertex AGA.

Aim

To evaluate the effect of 5% minoxidil topical foam (5% MTF) in the frontotemporal and vertex areas in patients with moderate AGA over 104 weeks.

Patient Profile

Patients aged 18 –70 years, in general good health with male-pattern AGA Hamilton-Norwood grade III_vertex to VI

Methods

• 80-week, open-label extension phase

  

• Patients were instructed to topically apply a half capful of 5% MTF to the dry scalp in the frontotemporal and vertex areas twice daily until week 104

Study Outcomes

• Primary outcome were the frontotemporal target area non-vellus hair counts (f-TAHC) between baseline and weeks 52, 76 and 104
• Other outcomes were changes in vertex target area non-vellus hair counts (v-TAHC), frontotemporal and vertex cumulative hair width (f-TAHW, v-TAHW) (mm/cm²) between baseline and weeks 52, 76 and 104 as well as subjects’ ratings of the change in scalp coverage at week 104 compared to baseline.

Results

• The study found that in Group 1, f-TAHC and f-TAHW increased significantly by week 52 and 76, respectively, compared to baseline. 
• After 104 weeks, a notable but statistically non-significant increase of was found.
• No significant differences were found between baseline and week 104 in v-TAHC in Group 1 as well as f-TAHC, v-TAHC, f-TAHW and v-TAHW values in Group 2

  Figure 1: Frontotemporal TAHC During the Study

  

   

  Figure 2: Vertex TAHC during the study

  

  Figure 3: Frontotemporal TAHW during the study

  

  Figure 4: Vertex TAHW during the study

  

• No significant differences in the growth profile of TAHC or TAHW were found between the frontotemporal and vertex area during the study (P=0.305)
• No significant differences in the course of frontotemporal and vertex TAHC or TAHW were found between the groups (P=0.101)
• According to the experts’ photographic review, frontotemporal scalp coverage improved in 35% and 8% in Group 1 and Group 2 respectively; vertex scalp coverage improved in 29% and 33% in Group 1 and Group 2 resp

• According to the subjects’ self-ratings
  • Group 1: Participants in this group reported a 47% improvement in both frontotemporal and vertex scalp coverage
  • Group 2: This group experienced a 63% improvement in self-rated scalp coverage for both areas
• Safety and Tolerability

• Group 1: No adverse events (AEs) related to the study product were observed. Nine local intolerance reactions (LIs) were reported, including erythema, itching, papules/pustules, flaking, and scalp dryness.
• Group 2: Three AEs related to the study product were observed: irritant contact dermatitis (1 case), scalp eczema (2 cases), and hair greasiness (1 case). Six LIs were reported, mainly flaking and one case of itching.
• These findings may indicate that AEs linked to 5% MTF, if any, predominantly occur soon after application start and that a long-term MTF application does not come with a higher incidence of AEs and LIs.

Conclusion

• The study demonstrated that 5% MTF is effective in stabilizing hair density, hair width and scalp coverage in both frontotemporal and vertex areas over an application period of 104 weeks, while showing a good safety and tolerability profile with a low rate of irritant contact dermatitis.

Reference

J Eur Acad Dermatol Venereol. 2016 Jul;30(7):1183-9.