An Important Announcement from Richard Lee, M.D.
A non-greasy 12.5% Minoxidil Solution
is available as of May 15, 2006
Good news. After years of intensive research, exhaustive experimentation, assistance from a consulting pharmaceutical biochemist and extensive clinical testing, Regrowth, LLC is able to offer 12.5% Minoxidil in a solution form, which is a stable, clear, colorless, non-greasy liquid that dries rapidly after it has been applied.
To date, topical minoxidil is the only FDA approved, safe and effective medication that is a non-specific promoter of hair growth. When topical minoxidil is used in conjunction with a medication or medications, which decrease the amounts of DHT in the scalp, the treatment of male pattern baldness is effective for most patients.
There are many benefits to using the 12.5% Minoxidil Solution: (1) Success with topical minoxidil in promoting hair growth is dose dependent. (2) In solution form, more minoxidil absorbs into the scalp than in lotion, cream or gel compounds of minoxidil. (3) The 12.5% Minoxidil Solution has a smooth, pleasant, non-sticky and non-greasy quality. (4) The 12.5% Minoxidil Solution can be applied twice per day without compromising the aesthetic appearance of the hair. (5) For patients beginning treatment of male pattern baldness, the high concentration of minoxidil is more likely than the standard 5% minoxidil solutions to recruit more miniaturized hair follicles to mature again. (6) And for those patients who have been using 5% minoxidil for more than two or three years, better maintenance or new recruitment of hair follicles to mature again is more likely with the 12.5% Minoxidil Solution.
FAQ's
Q. How does minoxidil work to promote hair growth?
A. Despite decades of widespread use, exactly how minoxidil works to promote hair growth is not understood. One of the most comprehensive articles, entitled 'Hair growth effect of minoxidil' was published in 2002 (Nippon Yakurigaku Zasshi. 2002 Mar; 119(3): 167-74). "The mode of action of hair growth effect of minoxidil is not completely elucidated, but the most plausible explanation proposed here is that minoxidil works as a sulfonylurea receptor (SUR) activator and prolongs the anagen phase of hair follicles."
Q. Can you cite a scientific reference demonstrating that higher doses of topical minoxidil improve the results in the treatment of male pattern baldness?
A. An excellent study relating dosage to results was reported in this article: Olsen, EA, DeLong ER, Weiner MS. Dose-response study of topical minoxidil in male pattern baldness. J Am Acad Dermatol. 1986;15:30-37.
Q. Why is a 12.5% Minoxidil Solution more effective than a 12.5% minoxidil lotion, cream or gel?
A. The absorption of minoxidil from a cream, gel or lotion is less efficient than with a solution because only the molecules directly adjacent to the skin can absorb into the scalp. In a true solution, such as the 12.5% Minoxidil Solution, the solute (minoxidil molecules), move freely within the solvent, whereas in a cream, lotion or gel, a substantial quantity of the minoxidil molecules remain suspended and unavailable within the viscous base.
Q. If more minoxidil absorbs into the scalp with the new 12.5% minoxidil solution than with a lotion, cream or gel, why do you still offer Xandrox 12.5% lotion?
A. Xandrox formulations are notably different from minoxidil compounds. All Xandrox products contain azelaic acid to decrease DHT in the scalp.
Q. How safe is it to use a 12.5% Minoxidil Solution?
A. It requires a serum concentration of 20 ng/mL of minoxidil to cause any hemodynamic or other systemic effect in the human body. Allowing for the average 1.4% absorption of minoxidil from topical application, a 5% minoxidil solution will result in 1.16 ng / mL of minoxidil in the serum and a 12.5% solution will result in a 2.9 ng / mL of minoxidil in the serum level. So, there is more than a 16-fold safety margin from the use of 5% topical minoxidil and a 7-fold safety margin from the use of 12.5% Minoxidil Solution.
Q. Can the 12.5% Minoxidil Solution be used twice / day?
A. For almost all patients, yes. The safety margin with 1mL of the 12.5% Minoxidil Solution applied twice per day allows for the recommended routine use of topical minoxidil for the treatment of male pattern baldness.
Q. Is the 12.5% Minoxidil Solution an alcohol based solution?
A. Fifty percent of the solvent base is 200 proof denatured ethyl alcohol. The ethyl alcohol allows optimal absorption into the scalp and dries quickly.
Q. Does the alcohol in the solution harm the skin or hair follicles?
A. Not at all. When you apply the recommended 1mL of the 12.5% Minoxidil Solution to your scalp, the total amount of alcohol in the dosage is going to be at most 0.5mL. That's a very, very small quantity of alcohol, which will neither be harmful to the hair follicles nor to the skin. When alcohol, e.g. rubbing alcohol, is applied to the skin, it is very quickly absorbed and diluted by the body fluids and there is no harm to the body tissues.
Q. What is phosphoric acid? And why is it an ingredient of the 12.5% Minoxidil Solution?
A. Phosphoric acid is an inorganic acid commonly used in cosmetic products to enhance their water retention. As an ingredient in the
12.5% Minoxidil Solution, the phosphoric acid serves several important functions. (1) It helps to stabilize the minoxidil, which is more soluble in an acidic base. (2) Retaining water in the 12.5% Minoxidil Solution has an effect similar to hydrating the scalp and enhances the absorption of minoxidil. And (3) stabilizing the acidity of the 12.5% Minoxidil Solution balances the pH to approximate the pH of the skin, which is optimal at a pH of ~5.5. This degree of acidity helps the skin to ward off the advances of harmful bacteria and fungi.
Q. Are there any patients who should not use the 12.5% Minoxidil Solution?
A. Patients who have untoward reactions to minoxidil or to any of the ingredients in the base should not use 12.5% Minoxidil Solution. Also patients who are hypersensitive to the action of minoxidil should not use the 12.5% Minoxidil Solution.
Q. If minoxidil is soluble in alcohol only to ~5%, how can you make a true 12.5% solution?
A. That is going to have to remain a closely guarded trade secret. After years of personal research and experimentation, an international patent (PCT/US2003/041196) is pending for our technique of compounding higher (much greater than 5%) alcohol-based solutions of minoxidil.
Q. If it's possible to make a 12.5% Minoxidil Solution, why not increase the concentration even more? Wouldn't a higher concentration make the medication even more effective in treating male pattern baldness?
A. Not necessarily. As previously noted, the increased efficacy of minoxidil in promoting hair growth is not directly proportional to the increases in the concentrations of minoxidil. There are diminishing returns. In fact, in a study reported in Skin Pharmacology [Skin Pharmacol 1997;10(4):206-20] it was shown that 'minoxidil had biphasic effects on the proliferation and differentiation of normal human keratinocytes (NHK): Minoxidil stimulated NHK proliferation at micromolar doses, while antiproliferative, pro-differentiative and partially cytotoxic effects were observed with millimolar concentrations.' In other words, too much minoxidil becomes counter productive in promoting hair growth.
Q. If I shouldn't use Xandrox15 twice / day, why can I use 12.5% twice a day?
A. The reason Xandrox15 is not recommended for twice/day use is that the addition of azelaic acid results in a solution that has a sticky residual and may cause the hair to look unkempt. For that reason alone, it is suggested that Xandrox15 be applied at night. If a patient is not hypersensitive to minoxidil, there is no safety issue with the application of either Xandrox15 or 12.5% Minoxidil Solution twice /day.
Q. How stable is the 12.5% Minoxidil Solution?
A. Extremely stable. Before making the 12.5% Minoxidil Solution available on the market, batches of the solution were subjected to temperatures up to 149o Fahrenheit (65o Celsius) and were also stored for months in sub-freezing temperatures with no change in the chemical or physical characteristics of the solution.
Q. Under what conditions should the 12.5% Minoxidil Solution be stored?
A. The 12.5% Minoxidil Solution should be stored with the container's cap tightly attached, in a dark environment. Very bright lights can cause the solution to become amber colored, although there will be no compromise to the pharmacological action.
Q. What are the physical characteristics of the 12.5% Minoxidil Solution?
A. The 12.5% Minoxidil Solution is clear, odorless and almost colorless (except for a faintly yellow hue). It is non- viscous and does not have the greasiness of Rogaine Extra Strength® 5% minoxidil solution or of the generic versions of it.
Q. Can the 12.5% Minoxidil Solution be used by both males and females?
A. Absolutely, yes. For optimal results, it is recommended that male patients use the 12.5% Minoxidil Solution in combination with an agent or agents that decrease the DHT in the scalp. The 12.5% Minoxidil Solution can be used as the sole medication in the treatment of female pattern baldness (FPB), but should not be used by nursing mothers.
Q. What should male patients use to decrease the dihydrotestosterone (DHT) in the scalp?
A. There are many medications, which have been shown to decrease DHT in the scalp. These include topical azelaic acid, topical spironolactone, ketoconazole shampoo, oral finasteride, etc. Recent observations suggest shampoos with 1% pyrithione zinc (Denorex, Head & Shoulders, DHS, etc.) may also be helpful in decreasing DHT in the scalp.
Q. Is Proscar (5 mg finasteride) available in a generic form?
A. If you access the Teva Pharmaceutical website (
http://www.tevapharm.com/pr/2004/pr_485.asp), you will read "Jerusalem, Israel, October 27, 2004 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's ANDA (Abbreviated New Drug Application) for Finasteride Tablets USP, 5 mg. Final approval is subject to the expiration of patent protection on June 19, 2006 and any exclusivity period."
Q. How much does the new 12.5% Solution cost?
A. A large, 125 mL bottle of the new 12.5% Solution costs $67.00.
