Fluridil, a rationally designed topical agent for androgenetic alopecia: first clinical experience.

Abstract

BACKGROUND:

Fluridil, a novel topical antiandrogen, suppresses the human androgen receptor. While highly hydrophobic and hydrolytically degradable, it is systemically nonresorbable. In animals, fluridil demonstrated high local and general tolerance.

OBJECTIVE:

To evaluate the safety and efficacy of a topical anti- androgen, fluridil, in male androgenetic alopecia.

METHODS:

In 20 men, for 21 days, occlusive forearm patches with 2, 4, and 6% fluridil, isopropanol, and/or vaseline were applied. In 43 men with androgenetic alopecia (AGA), Norwood grade II-Va, 2% fluridil was evaluated in a double-blind, placebo-controlled study after 3 months clinically by phototrichograms, hematology, and blood chemistry including analysis for fluridil, and at 9 months by phototrichograms.

RESULTS:

Neither fluridil nor isopropanol showed sensitization/irritation potential, unlike vaseline. In all AGA subjects, baseline anagen/telogen counts were equal. After 3 months, the average anagen percentage did not change in placebo subjects, but increased in fluridil subjects from 76% to 85%, and at 9 months to 87%. In former placebo subjects, fluridil increased the anagen percentage after 6 months from 76% to 85%. Sexual functions, libido, hematology, and blood chemistry values were normal throughout, except that at 3 months, in the spring, serum testosterone increased within the normal range equally in placebo and fluridil groups. No fluridil or its decomposition product, BP-34, was detectable in the serum at 0, 3, or 90 days.

CONCLUSION:

Topical fluridil is nonirritating, nonsensitizing, nonresorbable, devoid of systemic activity, and anagen promoting after daily use in most AGA males.

• Authors: Milos Sovak, Allen L Seligson, Renata Kucerova, Marie Bienova, Marian Hajduch, Milan Bucek
• Journal: Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.] (Dermatol Surg) Vol. 28 Issue 8 Pg. 678-85 (Aug 2002) ISSN: 1076-0512 [Print] United States
• PMID: 12174057 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Amides
• Androgen Antagonists
• Hydrocarbons, Fluorinated
• fluridil

Topics

• Administration, Topical
• Adult
• Alopecia (drug therapy)
• Amides (therapeutic use)
• Androgen Antagonists (administration & dosage, chemistry, therapeutic use)
• Double-Blind Method
• Humans
• Hydrocarbons, Fluorinated (therapeutic use)
• Male
• Middle Aged
• Treatment Outcome