Studio sul Fluridil

[HAL6969]

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[valy]

Efficacy and safety clinical assessment of fluridil

 

From: Dept. of Dermatology, Medical School, Palacky University, Olomouc, Czech Republic.

 

Background: Fluridil suppresses human androgen receptors and in animals has a high local and general tolerance. Highly hydrophobic and hydrolytically degradable, topical fluridil proved systemically non-resorbable.

 

Methods: In 20 males, for 21 days, occlusive forearm patches with 2, 4, and 6% fluridil, isopropanol, and/or vaseline were applied. 43 volunteers of mean age 33.6 years with androgenetic alopecia of II-V degree (Hamilton-Norwood), were randomized into 2 groups for a double-blind study. One group received a novel topical anti-androgen fluridil, 2% in anhydrous isopropyl alcohol; the placebo group received only solvent. Hair growth was assessed after 3, 6, 9 and 12 months clinically and by phototrichograms. Hematology and blood chemistry including analysis for fluridil were carried out.

 

Results: Neither fluridil nor isopropanol showed sensitization/irritation potential, unlike vaseline. There was no change in the hematological and blood chemistry values nor in the sexual functions or libido. No fluridil or its hydrolytic decomposition product were found in the serum at 0, 3 or 90 days. There was a slight average increase in serum testosterone, within physiological range, equal in both fluridil and placebo groups, and thus considered seasonal (Spring). There was no statistical difference in average percentage of anagens/telogens between the fluridil and placebo groups at the study's onset, indicating the clinical material's homogeneity. After 3 months, there was no significant change in the placebo trichograms but there was a statistically significant increase (p < 0.05) of anagens in the fluridil group (76% to 85 %); telogens decreased from 24 % to 15 % . As the efficacy of fluridil became apparent, according to the protocol provision, all participants received fluridil after 3 months. After 12 months there was a statistically significant increase (p < 0.05) of anagens (76% to 89 %), telogens decreased from 24 to 11 %, and there were no side effects attributable to fluridil.

 

Conclusion: Topical fluridil appears to be non-irritating, non-sensitizing, devoid of systemic activity and effective, after three months of daily use, in young males with androgenetic alopecia.