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 1 mg 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 ml−1 (±0.39), by 71.20% with P-3074 o.d., from 1.52 (±0.41) to 0.44 ng ml−1 (±0.08), and by 51.11% with the oral formulation, from 1.39 (±0.25) to 0.68 ng ml−1 (±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 1 mg oral finasteride administration for the same treatment period.
Topical minoxidil and oral finasteride have been used to treat men with androgenetic alopecia (AGA). There are concerns about side effects of oral finasteride especially erectile dysfunction.
To compare the efficacy and safety of the 24 weeks application of 3% minoxidil lotion (MNX) versus combined 3% minoxidil and 0.1% finasteride lotion (MFX) in men with AGA.
Forty men with AGA were randomized treated with MNX or MFX. Efficacy was evaluated by hair counts and global photographic assessment. Safety assessment was performed by history and physical examination.
At week 24, hair counts were increased from baseline in both groups. However paired t-test revealed statistical difference only in MFX group (p = 0.044). Unpaired t-test revealed no statistical difference between two groups with respect to change of hair counts at 24 weeks from baseline (p = 0.503). MFX showed significantly higher efficacy than MNX by global photographic assessment (p = 0.003). There was no significant difference in side effects between both groups.
Although change of hair counts was not statistically different between two groups, global photographic assessment showed significantly greater improvement in the MFX group than the MNX group. There was no sexual side effect. MFX may be a safe and effective treatment option.
Finasteride, a type II-selective 5alpha-reductase inhibitor, as a causative agent of decreasing dihydroxy testosterone (DHT) level, is effective in the treatment of male androgenic alopecia.
We compared the local and oral finasteride in the treatment of androgenic alopecia.
This is a double blind, randomized clinical trial study of 45 male patients, who were referred with alopecia to the private clinics and departments in Boo-Ali Sina Hospital, in Sari. Patients with male androgenic alopecia were selected according to the history and physical examinations. The patients were randomly divided into two: topical finasteride (A) and oral finasteride (B) groups. Topical finasteride group (A) received a topical gel of 1% finasteride and placebo tablets, while the oral finasteride group (B) received finasteride tablets (1 mg) and gel base (without drug) as placebo for 6 months. The patients were followed by clinical observation and recording of side effects prior to the treatment and at the end of first week, and then by a monthly follow-up. The size of bald area, total hair count, and terminal hair were studied. Data were analyzed by descriptive and Chi-square statistical test.
The mean duration of hair loss was 18.8+/-23.10 months. Each month the terminal hair, size of bald area and hair count between the two groups were compared. There were no significant differences between the two groups as a viewpoint of hair thickness, hair counts and the size of bald area. Serial measurements indicated a significant increase in hair counts and terminal hair counts between the two groups.
The results of this study showed that the therapeutic effects of both finasteride gel and finasteride tablet were relatively similar to each other.