Abstract:
Androgenetic alopecia (AGA) constitutes a progressive, polygenic, heterogenous disorder diagnosed in more than ninety percent of male and female adults presenting with scalp hair loss. While a number of treatment approaches offer limited benefit, a safe, pain free, consistently efficacious regimen remains an elusive goal. In 2020, we re ported positive findings arising from a 270-day, clinical study trialing a Nano-enabled, botanically-based, oral and topical concomitant regimen dosed in two male subjects with advanced-stage AGA. As follow on to that work, this non-randomized, uncontrolled test of innovation report describes unforeseen, highly positive response to therapy observed in five AGA-affected male volunteers and one female AGA-affected volunteer tested with a cryo-carboxy dispensing device. Conceived as an augmented enhancement of a demonstrably safe and efficacious, low-risk therapy, this point-of-service tool delivered a cryo-chilled, CO2 bolstered, hydrogel solubilized iteration of the previously tested botanical formula topically to the balding scalp of enrolled volunteers, once-weekly. To limit variables, daily use oral and topical iterations of the previously trialed formula were incorporated as concomitants. Originally conceived as a nine-month (270-day) evaluation, quite unexpectedly, by day-90 a profoundly accelerat ed response to therapy was observed in all subjects involved, most strikingly in those initially presenting with ad vanced stage phenotype. Eclipsing predicted, best-case scenario endpoint outcomes, results at day-90 were judged sufficiently positive to conclude the innovative practice experiment 180 days earlier than planned. As the effort focused upon the tested device as the critical differentiator, this paper explores the history of cryo and carboxy and considers whether, in light of the outcomes observed within the tested novel innovation, a transition to generalized knowledge pursuit, as via controlled studies coupled with basic science interrogation, constitute reasonable, next step follow on.