A Comparative Study between the Efficacy and Safety of 5% Minoxidil Solution and 5% Minoxidil Milky Lotion in the Treatment of Male Androgenic Alopecia.

BACKGROUND: 5% minoxidil solution is approved for the treatment of male androgenetic alopecia (AGA). However, there have been occasional reports of adverse events that were caused mostly by propylene glycol sensitivity. As an alternative treatment, Siriraj hair team developed a proprietary preparation referred to as “minoxidil milky lotion” that uses butylene glycol as a substitute for propylene glycol. OBJECTIVE: To compare the efficacy and safety of 5% minoxidil solution with 5% minoxidil milky lotion in the treatment of male AGA. MATERIALS AND METHOD: Twenty males with AGA were recruited for this prospective randomized study. Subjects were randomly treated with 5% minoxidil solution or 5% minoxidil milky lotion. Clinical outcomes and adverse events were recorded at 8, 16, and 24 weeks. RESULTS: The mean age of subjects was 43.5±12.5 years (range, 26-65 years). Percentage increase in hair density at 8 weeks after receiving 5% minoxidil solution and 5% minoxidil milky lotion was 8.8% and 37.4%, respectively (p = 0.01). However, there was no statistically significant difference between the two preparations at the 16 and 24 week visits. Mild irritation was reported in 1 case in the 5% minoxidil milky lotion group. STUDY LIMITATION: Small sample size. CONCLUSION: Both formulations were found to be effective and safe in the treatment of male AGA. 5% minoxidil milky lotion may be an alternative treatment in propylene glycol-sensitive patients, with efficacy that is comparable to that of 5% minoxidil solution.