Abstract
BACKGROUND: Topical minoxidil and oral finasteride are approved by the US Food and Drug Administration (FDA) for the treatment of male androgenetic alopecia (AGA). However, concerns about adverse events related to the use of oral finasteride have led to some apprehension about the treatment. Topical finasteride, though not FDA-approved, has demonstrated efficacy and safety in a limited number of clinical trials and may be a promising alternative, such that compounding pharmacies and telehealth companies in the United States now offer access to topical finasteride for patients with AGA. OBJECTIVE: This real-world, retrospective study is, to our knowledge, the largest study to date aimed to evaluate patient satisfaction and tolerability associated with the novel combinations of topical finasteride and topical minoxidil for the treatment of male AGA. METHODS: We conducted a retrospective analysis of patient data collected during routine clinical follow-up via Hims & Hers, a direct-to-consumer health and wellness platform, between April 1, 2021 and April 30, 2025 to assess the frequency of side effects and other possible medication reactions associated with the use of compounded topical finasteride and minoxidil. Data were gathered from two sources: (1) a follow-up check-in sent to patients approximately 130 days following the initiation of treatment; (2) unprompted communications sent via in-app or web-based messaging from patients to their care team. Data about patient satisfaction with treatment, the frequency of any side effect, frequency of specific side effects, need for a higher level of care, and treatment discontinuation due to a side effect were extracted from the data sources. RESULTS: A total of 638,629 male patients with AGA received a prescription for a compounded topical finasteride and minoxidil product between April 1, 2021 and April 30, 2025. Of 151,352 (23.7%) patients who completed a follow-up check-in, 121,615 (80.4%) reported being satisfied with treatment and 4034 (2.7%) reported experiencing a side effect. Of all the 638,629 patients, 230 (0.04%) sent their care team a message (outside of check-ins) indicating a side effect or other possible medication reactions. No patient reported seeking a higher level of care or discontinued treatment due to such an occurrence. CONCLUSIONS: Patients prescribed novel formulations of compounded topical finasteride and minoxidil for the treatment of AGA via a national telehealth platform reported satisfaction with the treatment and tolerated it well. The limitations of the study include the use of retrospective data and the lack of a control group, both of which preclude causal inference. Future research should include randomized controlled trials to assess the efficacy, safety, and tolerability of topical finasteride.