Treatment with sublingual minoxidil was safe and related to increased scalp hair growth in women and men with pattern hair loss, according to findings from a part 1b clinical trial published in the Journal of the European Academy of Dermatology and Venereology.
According to the study researchers, sublingual minoxidil is anticipated to scale back the risk for hemodynamic unwanted effects and enhance security compared with oral dosing. To evaluate the sublingual versus oral minoxidil formulation, the investigators randomly assigned 40 women and men (age vary, 30-65 years) to both 0.45 mg sublingual minoxidil (n=20) or placebo (n=20) daily for twenty-four weeks.
A total of 12 patients were subsequently rolled right into a 24-week, open-label extension study during which they obtained 1.35 or 4.05 mg sublingual minoxidil per day. The researchers examined macrophotography and terminal hair count on phototrichogram. The macro photographs were scored on a 7-point rating scale.
The men in the study had Hamilton Norwood stage 3 vertex to 5 while women had Sinclair phases 2 to 5 hair loss. On the 24-week follow-up interval, roughly 45% of patients in the sublingual 0.45 mg minoxidil group experienced improvements in frontal hair density, and 55% confirmed vertex improvement.
In all, 17% of patients who obtained 1.35 mg sublingual minoxidil in the extension experienced improvements in frontal density, and 50% had an improvement in vertex hair density. Besides, nearly 67% of patients who obtained the 4.05 mg dose skilled improvements in frontal and vertex hair density.
In the 0.45 mg dose group, phototrichograms showed an average increase in terminal hair count/cm2 of 4 for the frontal and 9 for the vertex scalp. Additionally, treatment with the 1.35 mg dose resulted in a mean increased terminal hair count/cm2 of 10 and 26, and the 4.05 mg dose led to a mean increase terminal hair count/cm2 of 38 for the frontal and 88 for the vertex scalp.
The researchers explained that the distinction in mean hair count 0 was statistically significant for the frontal and vertex scalp in any respect doses in contrast with placebo, with an exception noted for the 0.45 mg dose over the vertex. This lack of difference on the 0.45 mg dose on the vertex scalp was resulting from one patient in the placebo group who experienced an increase in vertex scalp hair density by 76 hair per cm2, which the investigators noted was surprising.
At half-hour following the preliminary sublingual dose, the mean peak minoxidil plasma focus was 1.62 ng/mL but ranged from 0.3 to 5.3 ng/mL. The medication was undetectable in the plasma after 24 hours. In response to the investigators, this was thought of “greater than an order of magnitude under the plasma focus threshold” of 20 ng/mL for the prevalence of any hemodynamic event.
The researchers wrote that “additional studies with bigger patient cohorts are warranted to find out the optimum dose of” sublingual minoxidil and to check the relative efficacy of sublingual vs oral formulations of the drug.
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full checklist of disclosures.
Bokhari L, Jones LN, Sinclair RD. Sublingual minoxidil for the treatment of female and male pattern hair loss: a randomized, double-blind, placebo-controlled, phase 1B clinical trial. J Eur Acad Dermatol Venereol. Published on-line August 22, 2021. doi:10.1111/jdv.17623