Safety of Topical Minoxidil Solution: A One-Year, Prospective, Observational Study

Abstract

Background: Topical minoxidil solution (TMS) is widely used for androgenetic alopecia (AGA), and this is the first report of a large safety trial. Objectives: The aim of the study was to evaluate the safety profile of TMS by comparing hospitalization and death rates among subjects using TMS with controls. Cardiovascular safety and pregnancy outcomes were evaluated, and usage patterns were described. Methods: All subjects were followed at baseline, 3, 6, 9, and 12 months. Usage patterns, pregnancy status, overnight hospital stays, and cardiovascular risk factors were evaluated. Subjects rated effectiveness of TMS in the treatment of AGA. Statistical analyses were conducted to determine if TMS was associated with an increased risk of death or hospitalization. Results: TMS is a safe and effective treatment for AGA. There were no increases in cardiovascular events and no apparent increased risk for adverse pregnancy outcomes. Conclusions: This large, prospective study demonstrated the overall safety of TMS in the treatment of AGA.

Sommaire

Antécédents: Le minoxidil en solution topique est fréquemment utilisé dans le traitement de la pelade. Nous présentons ici le premier rapport d’innocuité à large échelle. Objectifs: Évaluer le profil d’innocuité du minoxidil en solution topique en comparant les taux d’hospitalisation et de mortalité des sujets qui reçoivent un traitement contrôlé de la solution. L’innocuité cardiovasculaire a été évaluée, les grossesses ont été suivies et les tendances d’utilisation décrites. Méthodes: Tous les sujets ont été suivis dès le début du traitement avec les évaluations ayant lieu aux 3, 6, 9, et 12 mois. Les tendances d’utilisation, le statut des grossesses, les hospitalisations et les facteurs de risques cardiovasculaires ont été évalués. Les sujets ont évalué l’efficacité de la solution de minoxidil dans le traitement de la pelade. Des analyses statistiques ont été effectuées en vue de déterminer si le minoxidil en solution topique était associé à un risque plus élevé de décès ou d’hospitalisation. Résultats: Le traitement au minoxidil en solution topique contre la pelade est sécuritaire et n’augmente pas le risque des accidents cardiovasculaires. Également il n’y a eu aucune augmentation apparente des risques en cas de grossesse. Conclusions: Cette étude prospective à large échelle a démontré l’innocuité générale du traitement au minoxidil en solution topique centre la pelade.

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Correspondence to Jerry Shapiro.

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Shapiro, J. Safety of Topical Minoxidil Solution: A One-Year, Prospective, Observational Study . JCMS 7, 322–329 (2003). https://doi.org/10.1007/s10227-002-0121-6

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Keywords

  • Pregnancy Outcome
  • Hair Loss
  • Adverse Pregnancy Outcome
  • Minoxidil
  • Pregnancy Status