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Structure of skin
Structure of skin
Eucapil® (fluridil): a new cosmetic approach to hair loss
 
Our lives depend on hormones. Of those, the sex hormones are of major importance, influencing almost every part of our physiology and our social life. Their levels change with age. In men, after reaching a peak in the twenties, their levels continuously decline. Women also produce male sex hormones, and inversely, men produce female hormones – initially in very small quantities, but with years the levels increase so that after menopause, women actually may produce about as much male sex hormone as men do at that age.
 
Hair loss in both men and women is most often caused by the effects of male hormones. This condition is to be distinguished from other much more rare hair loss syndromes. After age 25, for reasons not yet explained, in genetically predisposed males, the male hormones start affecting the hair roots which slowly degenerate. This results in thinner hair which ultimately is pushed out of the hair follicle. A similar phenomenon occurs in predisposed women in a stage of life when they produce substantial levels of male hormones [Price, 1999]. Hair loss ultimately results in baldness. There are also other reasons for baldness which dermatologists diagnose and often can treat, but by far the most prevalent is the condition caused by male hormones.
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One approach to the treatment of hair loss has been to inhibit conversion of male hormone into its very active form by a drug. Such a drug Propecia® (finasteride), however must be taken daily and orally. The effectiveness of Propecia® has been reported as varying from 30-50% in arresting hair loss, while side effects such as loss of libido in males were minimal and reversible. Propecia® is a pill requiring a long term administration. The few studies with topical Propecia® have found very little effect, and if there was any, it was attributable to systemic resorption from the scalp skin [Price et al., 2000; Rushton et al., 1996]. Although the current clinical studies do not indicate adverse effects, nobody knows for sure what a systemic manipulation of normal hormonal turnover might produce after a very extended use.
 
Another drug, minoxidil, originally developed for high blood pressure, was found to induce upon longer use some hair growth in the bald vertex. The overall efficacy of its topical application to the scalp was reported around 30%; the effect was attributed to a number of factors, including an increase of scalp blood flow.
 
Various vitamins, plant extracts as food supplements or topical preparations were also developed, but no studies consistently prove that such products affect the hair follicles.
 
A substance capable of improving the state of hair follicles, thus reversing or arresting the thinning of hair, must be a cosmetic agent, which means that it must act only on the skin, and not be systemically resorbed. The researchers Sawaya and Hordinsky, 1993, have stated that an “ideal compound would have to be safe and effective to prevent hair loss and/or stabilize hair quality and growth and should act only on the skin and not penetrate into the body”.
The existing oral or injectable drugs employed in endocrine therapies once topically applied on the scalp were found to be resorbed into the body. This is why none of these drugs could ever be utilized as a cosmetic product.
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The laboratories Biophysica, Inc. California, developed a novel class of substances which affect the skin only, and are not resorbed topically. The structure of the promising molecule precludes its resorption, and further, should it accidentally be digested, even the smallest amount of water would cause its decomposition. This innovative drug design represents an effective safety feature. In order to prove that this substance called fluridil, EU registration (through French Environmental Ministry) VII-B, 02010743-00, CAS 260980-89-0 is not resorbed, a number of experimental studies were conducted using rats and rabbits, who are known to have the capability to take up substances through their skin 6 to 10 times more effectively than humans.
Numerous studies ascertained the low systemic and topical toxicity in animals. In human volunteers at the Experimental Dermatology Institute of the University of California, San Francisco (Professor Howard Maibach) no skin irritation whatsoever was observed.
 
Evaluation of Eucapil®, applied daily by male and later female volunteers, was conducted at the University Medical School, Department of Dermatology ( Olomouc, Czech Republic). As a measure of efficacy, a change in the number of growing versus dying hairs was determined by phototrichograms. In most subjects, increase in anagens (growing hair) and decrease in telogens (dying hair) was substantial. In the study of female hair loss, a significant increase of hair diameter was found. With daily application of 2 ml Eucapil® there were no changes in the hematological or hormonal profiles and no adverse systemic effects were observed. Using sophisticated equipment of high sensitivity (5 nanograms/ml) not even traces of fluridil or its decomposition fragments could be found in the blood. For a complete description of the clinical data, please refer to the articles and abstracts listed below.
 
Preliminary feedback from post-marketing following its authorization as a cosmetic product in Czech Republic, as well as the ongoing studies show that Eucapil® induces a substantial reduction or cessation of hair loss, seen after only a few weeks of use. Upon longer use, an increase in average hair diameter, giving the impression of greater scalp hair fullness, may be seen. The best results seem to be achieved in those subjects who have not been suffering from hair loss for a long time and who have viable hair follicles.
 
When hair has been missing from the scalp for a long time and the hair follicles were obliterated by the ingrowth of connective tissue, there is very little chance for growing new hair. Here only transplants can reasonably work. Eucapil® can be active only when the hair follicles are active. The best results so far were reported by subjects who started using Eucapil® at the time they first encountered hair loss. In men, this can start any time after 20 years of age; in women, dramatic hair loss sometimes appears concurrently with menopause.
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We observed that hair loss ceases after 3 to 6 weeks of once-a-day Eucapil® application, while strengthening of existing hair (increase of hair diameter) usually can be seen after 3 months. In some subjects who had been hairless for many years we found that after 3 to 4 months use, new hair growth (“peach fuzz,” i.e., the appearance of baby hair) was induced in the scalp. With time, imposed by the hair growth cycle (it may be several years), the hair may strengthen, but it is uncertain whether later the baby hair would gradually transform into hair of normal appearance.
 
beginning using of Eucapil / 12 month later
 
The synthesis and formulation of Eucapil® was confined to Interpharma Praha, a pharmaceutical producer. Eucapil® as 2% solution of fluridil in rubbing alcohol, is filled into 2 ml ampoules under GMP (good manufacturing practice) rules. Fluridil has been registered, as a substance, in the EU by notification VII-B, 02010743-00 of the Ministry of Environment of France, with CAS 260980-89-0.
 
Eucapil® has been authorized by the Czech and Slovak Republics’ health authorities as a cosmetic product aiming at the hair loss and improving the hair growth. Thus, Eucapil® can be used in all other European Union countries. In conclusion, in Eucapil® , we have an effective and safe topical cosmetic agent for advanced hair care.
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References
 
Price TM, Allen S, Pegram GV. 2000. Lack of effect of topical finasteride suggests an endocrine role for dihydrotestosterone. Fertil Steril 74:414-415.
 
Price VH. 1999. Treatment of hair loss. N Engl J Med 341:964-973.
 
Rushton DH, Norris MJ, Ramsay ID. 1996. Topical 0.05% finasteride significantly reduces serum DHT concentrations, but had no effect in preventing the expression of genetic hair loss in men. In: D. Van Neste and V. Randall, D. Van Neste and V. Randall. Hair Research for the Next Millenium, Amsterdam: Elsevier. p. 359-362.
 
Sawaya ME, Hordinsky MK. 1993. The antiandrogens. When and how they should be used. Dermatol Clin 11:65-72.
 
Seligson AL, Campion B, Brown JW, Terry RC, Kucerova R, Bienova M, Hajduch M, Bucek M, Sovak M. 2003. Development of fluridil, a topical suppressor of the androgen receptor in androgenetic alopecia. Drug Dev Res 59:292-306).
 
Sovak M, Seligson AL, Kucerova R, Bienova M, Hajduch M, Bucek M. 2002. Fluridil, a rationally designed topical agent for androgenetic alopecia: first clinical experience. Dermatol Surg 28:678-685, with an erratum on p.971.
 
M. Bienova, R. Kucerova, M. Hajduch, M. Fiuraskova, M. Sovak
Efficacy and Safety of Eucapil Gel in hirsutism (Pilot Study)
Proceedings of 14th Congress of European Academy of Dermatology and Venereology, London, October 12-16, 2005
 
R. Kucerova, M. Bienova , R. Novotny, M. Hajduch, M. Fiuraskova, Seligson A.L , M. Sovak
Eucapil in Female Androgenetic Alopecia: Efficacy and Safety after 9-month use
Proceedings of 14th Congress of European Academy of Dermatology and Venereology, London, October 12-16, 2005
 
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