Efficacy and Safety of 5% Minoxidil Foam Once Daily Vs 2% Minoxidil Solution Twice Daily in AGA
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28 Jul, 23
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Introduction

  

Minoxidil topical solution is the only approved topical medication for increasing hair density in women with androgenetic alopecia (AGA). In several countries all over the world, either 2% or up to 5% Minoxidil topical solution (MTS) has an approval for use in women.

  

Aim

  

To compare the efficacy, safety, and acceptability of once daily 5% minoxidil topical foam (MTF) with twice-daily 2% MTS in women with androgenetic alopecia

  

Patient Profile

  

Women with androgenetic alopecia

  

Methods

  

  • Randomized, phase III study, 2-arm comparative study

  • N=113 women with androgenetic alopecia were randomized to 24 weeks

  • n=56, 5% MTF ((50 mg of minoxidil per day)

  • n=57, 2% MTS (40 mg of minoxidil per day)

 

Study Endpoints

  

  • Primary efficacy: Change from baseline in nonvellus target area hair count at week 24

  • Secondary efficacy: Change in nonvellus target area hair width, overall efficacy by global photographic review as assessed by treatment-blinded evaluators and the subject herself, adverse events, and participants’ assessment of product aesthetics

 

Results

  

  • 5% MTF was noninferior to 2% minoxidil topical solution for promoting hair growth and increasing hair width

  • Mean increase in hair count by 16.2% and 13.8% in women randomized to 5% MTF and 2% MTS

 

Figure 1:  Change in Nonvellus target area hair count (TAHC) from baseline

  

Text Box

  

  • Mean increase in hair density was 13.8% in 5% MTF and 17.8% in 2% MTS

 

Figure 2: Change in Nonvellus target area hair width (TAHW) from baseline

  

  

  • Hair volume increased from baseline through week 24 in 67.7% of patients in the 5% MTF group compared with 56.1% of participants in the 2% MTS group

  • Participant questionnaires results showed that at the end of the study, 

  • 73.2% of participants randomized to 5% MTF reported an increase in hair volume compared with 80.7% of participants randomized to 2% MTS

  • Overall, participants tended to rate the efficacy of both treatments somewhat higher in comparison with the investigators’ ratings

  • 5% MTF was significantly superior to 2% MTS in participants’ agreement with ‘the treatment does not interfere with styling my hair’ (P = .002) participants randomized to 5% MTF, 46.4% strongly agreed with the statement compared with 19.3% of participants randomized to 2% MTS 

  • Women randomized to 5% MTF experienced significantly lower rates of local intolerance (P = .046) especially in pruritus and dandruff compared with 2% MTS 

 

Conclusion

  

  • Once-daily 5% MTF demonstrated noninferiority and was effective for stimulating hair growth as twice-daily 2% MTS in women with androgenetic alopecia 

  • 5% MTF was well tolerated, with rates of pruritus and dandruff significantly lower than for 2% minoxidil topical solution

  • Once-daily 5% MTF offers advantages over twice-daily 2% MTS with respect to convenience of use, improved compliance, and better product acceptability.

 

Reference

  

J Am Acad Dermatol. 2011; 65; 6: 1126-1134.e2