title: Effects of a novel finasteride 0.25% topical solution on scalp and serum dihydrotestosterone in healthy men with androgenetic alopecia.
abstract: 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.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Caserini
authors.forename: Milko
authors.initials: M
authors.lastname: Radicioni
authors.forename: Chiara
authors.initials: C
authors.lastname: Leuratti
authors.forename: Emanuela
authors.initials: E
authors.lastname: Terragni
authors.forename: Matilde
authors.initials: M
authors.lastname: Iorizzo
authors.forename: Renata
authors.initials: R
authors.lastname: Palmieri
mesh_terms: D058891:5-alpha Reductase Inhibitors / Q000008:administration & dosage*; D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000505:Alopecia / Q000188:drug therapy* / Q000378:metabolism; D013196:Dihydrotestosterone / Q000032:analysis* / Q000097:blood; D018120:Finasteride / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D012535:Scalp / Q000737:chemistry*
chemical_list: D058891:5-alpha Reductase Inhibitors; D013196:Dihydrotestosterone; D018120:Finasteride