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Effects of a novel finasteride 0.25% topical solution on scalp and serum dihydrotestosterone in healthy men with androgenetic alopecia

Maurizio Caserini, Milko Radicioni, Chiara Leuratti, Emanuela Terragni, Matilde Iorizzo, and Renata Palmieri

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Volume 54 p. 19 - 27

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 54 – No. 1/2016 (19-27)

Effects of a novel finasteride 0.25% topical solution on scalp and serum dihydrotestosterone in healthy men with androgenetic alopecia

Maurizio Caserini¹, Milko Radicioni², Chiara Leuratti², Emanuela Terragni², Matilde Iorizzo³, and Renata Palmieri¹

¹Polichem S.A., Lugano-Pazzallo, ²CROSS Research S.A., Phase I Unit, Arzo, and ³Private Practice in Dermatology, Bellinzona, Switzerland
Objective: The effects on scalp and serum dihydrotestosterone (DHT) of different doses of a novel topical solution of 0.25% finasteride (P-3074), a type 2 5α-reductase, were investigated in men with androgenetic alopecia. Methods: Two randomized, parallel-group studies were conducted. Study I: 18 men received 1 mL (2.275 mg) P-3074, applied to the scalp once a day (o.d.) or twice a day (b.i.d), or 1 mg oral tablet o.d. for 1 week. Study II: 32 men received P-3074 at the dose of 100 (0.2275 mg), 200 (0.455 mg), 300 (0.6285 mg), or 400 (0.91 mg) μL or the vehicle o.d. for 1 week. Scalp and serum DHT and serum testosterone were evaluated at baseline and treatment end. Results: Change from baseline in scalp DHT was –70% for P-3074 o.d. and approx. –50% for P-3074 b.i.d. and the tablet. Serum DHT decreased by 60 – 70%. The doses of 100 and 200 μL P-3074 resulted in a –47/–52% scalp DHT reduction, similar to the 300 and 400 μL doses (i.e., –37/–54%). A –5.6% inhibition was observed for the vehicle. Serum DHT was reduced by only –24/–26% with 100 and 200 μL P-3074 and by –44/–48% with 300 and 400 μL P-3074. No relevant changes occurred for serum testosterone. Conclusions: The novel finasteride 0.25% solution applied o.d. at the doses of 100 and 200 μL results in an appropriate inhibition of scalp DHT potentially minimizing the untoward sexual side-effects linked to a systemic DHT reduction.Correspondence to:
Renata Palmieri
Polichem S.A.
Via Senago 42D
CH-6912, Lugano-Pazzallo, Switzerland
Email: [email protected]

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