An open label, multi-center clinical trial of topical 5% minoxidil solution for the treatment of male androgenetic alopecia (a phase IV study)

Hwa Young Park, Won Soo Lee, Jangkyu Park, Do Won Kim, Seok Yong Ahn, Ye Jin Jung, Byung In Ro, Woo Young Sim, Sung Wook Park, Gwang Seong Choi, Hyung Ok Kim, Chang Hun Huh, Tae Young Yoon, Moon Bum Kim, Ki Ho Kim, Haejun Song, Sook Jung Yun

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5 Citations (Scopus)

Abstract

Background: Topical 5% minoxidil solution stimulates new hair growth and it helps stop the loss of hair on individuals with androgenetic alopecia (AGA). Objective: We wanted to assess the efficacy and safety of topical 5% minoxidil solution for treating Korean men with AGA. Methods: This was a 24-week, open label, clinical trial that was conducted at 14 university dermatologie centers nationwide throughout South Korea as a multicenter study of the Korean Hair Research Society. The eligible subjects for this study were 18- to 65 year-old men with androgenetic alopecia, as defined by the Norwood scale as type III vertex, IV and IVA. A total of 175 men (20-62 years old) with AGA applied topical 5% minoxidil solution twice daily. Efficacy was evaluated by 1) the total hair count per 1 cm2 and 2) the mean hair diameter and 3) the patient assessment and 4) the investigator assessment of the change in scalp coverage and the benefit of treatment. Results: At week 24 as compared with baseline, there was a statistically significant increase in the total hair counts and the mean hair diameter (p<.0001). Topical 5% minoxidil solution helped improve the investigator and patient assessments. The topical 5% minoxidil solution was well tolerated over a 24-week period. Conclusion: We believe that topical 5% minoxidil solution is a safe and effective drug for Korean men with AGA.

Original languageEnglish
Pages (from-to)295-302
Number of pages8
JournalKorean Journal of Dermatology
Volume47
Issue number3
Publication statusPublished - 2009 Mar

Keywords

  • 5% minoxidil
  • Androgenetic alopecia

ASJC Scopus subject areas

  • Dermatology

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    Park, H. Y., Lee, W. S., Park, J., Kim, D. W., Ahn, S. Y., Jung, Y. J., Ro, B. I., Sim, W. Y., Park, S. W., Choi, G. S., Kim, H. O., Huh, C. H., Yoon, T. Y., Kim, M. B., Kim, K. H., Song, H., & Yun, S. J. (2009). An open label, multi-center clinical trial of topical 5% minoxidil solution for the treatment of male androgenetic alopecia (a phase IV study). Korean Journal of Dermatology, 47(3), 295-302.