biophysica
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Dear Forum Participants,
It has come to our attention that Lipoxidil, a company selling various hair growth formulas, has recently published our article, “Fluridil, a rationally designed topical agent for androgenetic alopecia: first clinical experience†(Dermatol Surg. 2002 Aug;28(8):678-85), on their website (lipoxidil.com) with their comments marked in red.
Publishing an article on the internet without permission from the publisher is against the law; it is considered copyright infringement (thus, the publisher of Dermatologic Surgery has been notified and is taking the appropriate legal action). Dermatologic Surgery is a very respected, high quality, peer-reviewed scientific journal (all articles are reviewed by a panel of experts in the field). Any comments or editorials are normally directed to the journal. By unilaterally publishing their comments only on their website, Lipoxidil offers no forum for rebuttal. We are responding to their remarks as follows:
1. Lipoxidil’s comment that fluridil suppresses but does not block the androgen receptor (AR).
Fluridil is an anti-androgen and may block the AR like other anti-androgens, however, we have also found that fluridil suppresses or down-regulates the AR, which in simpler terminology means fluridil reduces the actual number of AR’s in cells.
2. Lipoxidil’s comment that Dr. Sovak has commercial interest in fluridil since he is the head of Biophysica, Inc.
A clerical error by the editorial office conveying the commercial interest of the authors was addressed by the publisher of Dermatologic Surgery in an erratum published in a subsequent issue of the journal and is given here:
Dermatologic Surgery
Volume 28, Issue 10, Page 971 - October 2002
doi:10.1046/j.1524-4725.2002.281002.x
Erratum
‘In the August issue of Dermatologic Surgery, the article "Fluridil, a Rationally Designed Topical Agent for Androgenetic Alopecia: First Clinical Experience" by Sovak et al should have included the disclaimer, "M. Sovak, MD and A.L. Seligson, PhD are patent holders for the compound fluridil. This work was supported by Interpharma Praha a.s., Czech Republic." The publisher apologizes for the omission.’
3. Lipoxidil’s comment about RU-58841 and its metabolite RU-56279 having little risk of systemic effects.
In the referenced article, “Pharmacokinetics and metabolism of novel non-steroidal antiandrogens in the rat: relation of their systemic activity to the formation of a common metabolite†(J Steroid Biochem Mol Biol 1994;51:47-55), the authors themselves state that the metabolite of RU-58841, RU-56279, induces a large decrease in rat prostate and seminal vesicle weight, thus indicating potent anti-androgenic activity. Although they estimate only 1% conversion to this metabolite in the rat, the possibility for anti-androgenic effects from such a quantity is real. Its elimination half-life of about 20 hours can result in long acting systemic anti-androgenic activity. Furthermore, the absence of a full toxicological report on RU-58841 in any species and the lack of human clinical data has led us to the assumption that product development has been abandoned.
4. Lipoxidil’s comment about reducing the frequency of shampooing and the use of dry shampoos.
In the clinical study, the placebo group (applying only isopropanol, i.e. rubbing alcohol) did after three months show some improvement in the anagen/telogen counts. This could be attributed to the stimulating effect of alcohol alone, and possibly the reduction in frequency of shampooing and/or use of dry shampoos. However, this change was not statistically significant. After three months, according to the study protocol, the placebo group began applying fluridil, so we do not know whether this trend would have continued. Reducing the frequency of shampooing or using dry shampoos is a personal choice, and if it did in fact increase the effectiveness of a hair growth product, many people may find it more “realistic.â€
5. Lipoxidil’s comment about three and 9-month data (placebo versus fluridil groups).
As stated above the placebo group did show some improvement in anagen/telogen counts after three months but this change was not statistically significant. After three months the fluridil group displayed a statistically significant increase in anagen and decrease in telogen count that persisted throughout the 12 month study. The placebo arm of the study, according to the protocol, began fluridil application after three months and showed a statistically significant change after 9 months (6 months of fluridil use), improving the anagen levels in these patients to that of the original fluridil group.
6. Lipoxidil’s comment that hair will fall out later.
We have heard no reports from fluridil users about an increase in hair loss after extended periods of use. To the contrary, users report a substantial reduction in hair loss, fullness of scalp hair attributable to an increase of hair diameter, as well as regrowth of vellus hair in certain cases.
We hope this clears up any confusion about fluridil and its cosmetic formulation Eucapil.
Sincerely,
Biophysica, Inc.
It has come to our attention that Lipoxidil, a company selling various hair growth formulas, has recently published our article, “Fluridil, a rationally designed topical agent for androgenetic alopecia: first clinical experience†(Dermatol Surg. 2002 Aug;28(8):678-85), on their website (lipoxidil.com) with their comments marked in red.
Publishing an article on the internet without permission from the publisher is against the law; it is considered copyright infringement (thus, the publisher of Dermatologic Surgery has been notified and is taking the appropriate legal action). Dermatologic Surgery is a very respected, high quality, peer-reviewed scientific journal (all articles are reviewed by a panel of experts in the field). Any comments or editorials are normally directed to the journal. By unilaterally publishing their comments only on their website, Lipoxidil offers no forum for rebuttal. We are responding to their remarks as follows:
1. Lipoxidil’s comment that fluridil suppresses but does not block the androgen receptor (AR).
Fluridil is an anti-androgen and may block the AR like other anti-androgens, however, we have also found that fluridil suppresses or down-regulates the AR, which in simpler terminology means fluridil reduces the actual number of AR’s in cells.
2. Lipoxidil’s comment that Dr. Sovak has commercial interest in fluridil since he is the head of Biophysica, Inc.
A clerical error by the editorial office conveying the commercial interest of the authors was addressed by the publisher of Dermatologic Surgery in an erratum published in a subsequent issue of the journal and is given here:
Dermatologic Surgery
Volume 28, Issue 10, Page 971 - October 2002
doi:10.1046/j.1524-4725.2002.281002.x
Erratum
‘In the August issue of Dermatologic Surgery, the article "Fluridil, a Rationally Designed Topical Agent for Androgenetic Alopecia: First Clinical Experience" by Sovak et al should have included the disclaimer, "M. Sovak, MD and A.L. Seligson, PhD are patent holders for the compound fluridil. This work was supported by Interpharma Praha a.s., Czech Republic." The publisher apologizes for the omission.’
3. Lipoxidil’s comment about RU-58841 and its metabolite RU-56279 having little risk of systemic effects.
In the referenced article, “Pharmacokinetics and metabolism of novel non-steroidal antiandrogens in the rat: relation of their systemic activity to the formation of a common metabolite†(J Steroid Biochem Mol Biol 1994;51:47-55), the authors themselves state that the metabolite of RU-58841, RU-56279, induces a large decrease in rat prostate and seminal vesicle weight, thus indicating potent anti-androgenic activity. Although they estimate only 1% conversion to this metabolite in the rat, the possibility for anti-androgenic effects from such a quantity is real. Its elimination half-life of about 20 hours can result in long acting systemic anti-androgenic activity. Furthermore, the absence of a full toxicological report on RU-58841 in any species and the lack of human clinical data has led us to the assumption that product development has been abandoned.
4. Lipoxidil’s comment about reducing the frequency of shampooing and the use of dry shampoos.
In the clinical study, the placebo group (applying only isopropanol, i.e. rubbing alcohol) did after three months show some improvement in the anagen/telogen counts. This could be attributed to the stimulating effect of alcohol alone, and possibly the reduction in frequency of shampooing and/or use of dry shampoos. However, this change was not statistically significant. After three months, according to the study protocol, the placebo group began applying fluridil, so we do not know whether this trend would have continued. Reducing the frequency of shampooing or using dry shampoos is a personal choice, and if it did in fact increase the effectiveness of a hair growth product, many people may find it more “realistic.â€
5. Lipoxidil’s comment about three and 9-month data (placebo versus fluridil groups).
As stated above the placebo group did show some improvement in anagen/telogen counts after three months but this change was not statistically significant. After three months the fluridil group displayed a statistically significant increase in anagen and decrease in telogen count that persisted throughout the 12 month study. The placebo arm of the study, according to the protocol, began fluridil application after three months and showed a statistically significant change after 9 months (6 months of fluridil use), improving the anagen levels in these patients to that of the original fluridil group.
6. Lipoxidil’s comment that hair will fall out later.
We have heard no reports from fluridil users about an increase in hair loss after extended periods of use. To the contrary, users report a substantial reduction in hair loss, fullness of scalp hair attributable to an increase of hair diameter, as well as regrowth of vellus hair in certain cases.
We hope this clears up any confusion about fluridil and its cosmetic formulation Eucapil.
Sincerely,
Biophysica, Inc.
