RESUMEN
BACKGROUND: Microneedle devices have been used to reduce scarring and wrinkling as well as for the treatment of pattern hair loss. AIMS: Here, we investigated the efficacy and safety of a newly developed home-use microneedle device for the treatment of pattern hair loss. METHODS: Twenty-nine patients were assigned into three groups based on block randomization: home-use microneedle device only, a combination of home-use microneedle device and 5% minoxidil solution and 5% minoxidil topical solution only. Each treatment was performed twice a week. The study outcomes included hair counts, patient self-assessments, and adverse events at baseline and at 6 months. Statistical analyses were performed using analysis of variance (ANOVA), repeated measures ANOVA and Kruskal-Wallis test. RESULTS: The improvements in hair count were seen in the combination group at month 6, but the differences observed did not reach statistical significance in each group and among the three groups. The patient self-assessment showed the highest score in the combination group, but it did not reveal a statistically significant difference among the three groups. Mild and transient pruritus were reported by one patient who was using the microneedle device only. CONCLUSIONS: Our study shows that the home-use microneedle device may be a safe and 5% minoxidil solution penetration-enhancing therapeutic modality for stimulating hair growth.