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τοπικη φιναστεριδη με αποτελεσματα ακομα καλυτερα και απο oral
P040
Pharmacodynamic of P-3074 (finasteride 0.25% topical solution) in subjects with
androgenetic alopecia
M Caserini1, R Palmieri1, M Radicioni2 and E Terragni2 1Polichem S.A., Lugano, Switzerland and
2Cross Research S.A., Arzo, Switzerland
A new proprietary topical formulation, P-3074, containing finasteride 0.25% as active ingredient
and hydroxypropyl-chitosan (HPCH) as film-forming agent, was developed for androgenetic
alopecia. The present study was aimed at investigating the pharmacodynamic profile of
finasteride in terms of dihydrotestosterone (DHT) concentrations in the scalp and in serum after
multiple topical application of P-3074 or oral finasteride intake in subjects with androgenetic
alopecia. Eighteen healthy men were randomly allocated to P-3074 or oral treatment after
providing written informed consent. Twelve volunteers applied P-3074 topical solution for 7
days: six subjects once daily (o.d.) in the morning and the others twice daily (b.i.d.) in the morning
and in the evening. The third group of six volunteers was administered 1mg oral finasteride once
daily in the morning for 1 week. Scalp (vertex) biopsies were collected at baseline and 6 hours
after last dose administration, while serum samples were collected at baseline, before last
administration, and 6 and 12 hours after the last multiple dose. A marked decrease in scalp DHT
levels was observed: by 47.22% with P-3074 b.i.d., from 1.91 (±0.54) to 1.01 ng ml1 (±0.39),
by 71.20% with P-3074 o.d., from 1.52 (±0.41) to 0.44 ng ml1 (±0.08), and by 51.11% with
the oral formulation, from 1.39 (±0.25) to 0.68 ng ml1 (±0.34). Serum DHT was reduced by
69.3–74.0% with P-3074 b.i.d., 67.6–80.4% with P-3074 o.d., and 69.7–76.1% with the oral
formulation. These results showed a similar inhibition of serum DHT after 1 week of finasteride
administration with the three dose regimens and were consistent with the results obtained in a
previous P-3074 PK study. These findings show that DHT concentration in the scalp, after 7-day
treatment course of P-3074 o.d., was more reduced (about 40%) than after 1mg oral finasteride
administration for the same treatment period
τοπικη φιναστεριδη με αποτελεσματα ακομα καλυτερα και απο oral
P040
Pharmacodynamic of P-3074 (finasteride 0.25% topical solution) in subjects with
androgenetic alopecia
M Caserini1, R Palmieri1, M Radicioni2 and E Terragni2 1Polichem S.A., Lugano, Switzerland and
2Cross Research S.A., Arzo, Switzerland
A new proprietary topical formulation, P-3074, containing finasteride 0.25% as active ingredient
and hydroxypropyl-chitosan (HPCH) as film-forming agent, was developed for androgenetic
alopecia. The present study was aimed at investigating the pharmacodynamic profile of
finasteride in terms of dihydrotestosterone (DHT) concentrations in the scalp and in serum after
multiple topical application of P-3074 or oral finasteride intake in subjects with androgenetic
alopecia. Eighteen healthy men were randomly allocated to P-3074 or oral treatment after
providing written informed consent. Twelve volunteers applied P-3074 topical solution for 7
days: six subjects once daily (o.d.) in the morning and the others twice daily (b.i.d.) in the morning
and in the evening. The third group of six volunteers was administered 1mg oral finasteride once
daily in the morning for 1 week. Scalp (vertex) biopsies were collected at baseline and 6 hours
after last dose administration, while serum samples were collected at baseline, before last
administration, and 6 and 12 hours after the last multiple dose. A marked decrease in scalp DHT
levels was observed: by 47.22% with P-3074 b.i.d., from 1.91 (±0.54) to 1.01 ng ml1 (±0.39),
by 71.20% with P-3074 o.d., from 1.52 (±0.41) to 0.44 ng ml1 (±0.08), and by 51.11% with
the oral formulation, from 1.39 (±0.25) to 0.68 ng ml1 (±0.34). Serum DHT was reduced by
69.3–74.0% with P-3074 b.i.d., 67.6–80.4% with P-3074 o.d., and 69.7–76.1% with the oral
formulation. These results showed a similar inhibition of serum DHT after 1 week of finasteride
administration with the three dose regimens and were consistent with the results obtained in a
previous P-3074 PK study. These findings show that DHT concentration in the scalp, after 7-day
treatment course of P-3074 o.d., was more reduced (about 40%) than after 1mg oral finasteride
administration for the same treatment period
