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A novel finasteride 0.25% topical solution for androgenetic alopecia: pharmacokinetics and effects on plasma androgen levels in healthy male volunteers

Maurizio Caserini, Milko Radicioni, Chiara Leuratti, Ottavia Annoni, and Renata Palmieri

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Volume 52 p. 842 - 849

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 10/2014 (842-849)

A novel finasteride 0.25% topical solution for androgenetic alopecia: pharmacokinetics and effects on plasma androgen levels in healthy male volunteers

Maurizio Caserini¹, Milko Radicioni², Chiara Leuratti², Ottavia Annoni², and Renata Palmieri¹

¹Polichem S.A., Lugano-Pazzallo, and ²CROSS Research S.A., Arzo, Switzerland
Objective: Finasteride, a selective inhibitor of type 2 5-α reductase isoenzyme, inhibits the conversion of testosterone to dihydrotestosterone (DHT) and is indicated in the treatment of male androgenetic alopecia. The study objective was to evaluate a newly developed finasteride 0.25% topical solution in comparison to the marketed finasteride 1 mg tablet, with respect to finasteride pharmacokinetics and suppressive effects on plasma DHT. Methods: 24 healthy men with androgenetic alopecia were randomized in a single center, open-label, parallel-group, exploratory study, and received either multiple scalp applications of the topical solution b.i.d. or oral doses of the reference tablet o.d. for 7 days. Plasma finasteride, testosterone and DHT concentrations were determined. Results: After multiple doses, mean (± SD) finasteride C_max and AUC_0–t corresponded to 0.46 ± 0.28 ng/mL and 6.64 ± 7.50 ng/mL×h for the topical solution and to 6.86 ± 1.78 ng/mL and 57.93 ± 29.38 ng/mL×h for the tablet. Plasma DHT was reduced by ~ 68 – 75% with the topical solution and by ~ 62 – 72% with the tablet. No relevant changes occurred for plasma testosterone with either treatment. No clinically significant adverse events occurred. Conclusions: A strong and similar inhibition of plasma DHT was found after 1 week of treatment with the topical and tablet finasteride ormulations, albeit finasteride plasma exposure was significantly lower with the topical than with the oral product (p < 0.0001).Correspondence to:
Dr. Renata Palmieri
Polichem S.A.
Via Senago 42D
CH-6912, Lugano-Pazzallo, Switzerland
Email: [email protected]

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