XANDROX 12.5% Lotion

There was infectious excitement about the introduction of Xandrox 12.5%. After exhaustive research and work on the development of the high concentration minoxidil lotion, we finally made it available to our patients on April 29 of 1999.

The following letter was sent to patients in the United States and Canada. There is additional information that has been incorporated into the FAQ section of this website (Please see, below). I hope many of your questions about XANDROX 12.5% Lotion are addressed and answered there.

April ‘99

Dear Patient:

It is infrequent that I write letters to my patients. When I do, they are important.

On April 30^th we introduced the most effective hair growth drug available as of that date [editor's note:  Please scroll to bottom of this page for an update].* It is called XANDROX 12.5%. It is a lotion that contains 12.5% micronized minoxidil and 5% azelaic acid. Its base is water-soluble and absorbs into the skin. It also contains an effective transdermal absorption enhancer. Because the concentration of minoxidil is so high in this new lotion, it is suggested that no more than one mL of it be applied daily. It is formulated to be used as a supplement to the Xandrox 5% solutions, which were made available seven months ago from Regrowth. The worldwide success of the 5% Xandrox solutions has been exciting.

XANDROX 12.5% is designed to fill the void and treat those stubborn areas of the scalp, which may not be responding adequately to other therapies. These areas often include the temples, frontal hairline or, in some cases, the vertex and crown. Because minoxidil is dose dependent, XANDROX 12.5% is specifically beneficial in these areas

The results of combining the hair growth properties of minoxidil with the ability of azelaic acid to inhibit virtually all dihydrotestosterone (DHT) in the scalp have proven to be extremely effective in halting and reversing MPB for the vast majority of our patients. Nighttime and daytime Xandrox 5% solutions are available with and without 0.025% retinoic acid, respectively. Xandrox 12.5% lotion incorporates an absorption enhancer and does not contain Retin-A.

Our website, www.minoxidil.com, has been updated to include additional information about XANDROX 12.5%. We have tried to anticipate your questions in the FAQ (Frequently Asked Questions) section of the site.

We have enough 30-mL bottles of XANDROX 12.5% in stock so that we can offer one bottle to each patient. These bottles cost $27.86 and are fitted with a pump dispenser. We also have in stock the larger, more economical 125-mL bottles of XANDROX 12.5%, which cost $89.94. Price reductions are available to encourage using the 12.5% lotion in conjunction with 5% Xandrox. This price incentive program is explained in the Products and Prices section and also within the Secure Order Form at www.minoxidil.com.

Because they are downloaded several time a day and made into hard copy which is difficult to misunderstand or misplace, the most efficient and convenient means of placing orders is to use the Secure Order Form found within www.minoxidil.com. The hard copy of these Secure Orders is shredded at the end of each business day. Telephone orders can be placed toll free from within the U.S.A. at 1 (888) HAIR-HAIR. Outside the U.S.A., please call (562) 696-2700. Orders can be faxed to (562) 696-2707.

I trust you are having a pleasant year to date and are looking forward to a new millennium with a fuller head of hair.

Best Regards,

Richard Lee, M.D.

Consulting Physician

FAQ's on XANDROX 12.5% Lotion

The immediate liquefaction of Xandrox 12.5% lotion upon application is activated by normal body temperature and is one of the keys to Xandrox 12.5% lotion's tremendous success. You may have to reconstitute the lotion if it has been subjected to high temperatures during transit. Directions for reconstitution are described below.

Q. What is Xandrox 12.5% Lotion?

A. Xandrox 12.5% Lotion is an exclusive formulation by Regrowth of topical 12.5% minoxidil and 5% azelaic acid with an absorption enhancer. It has been designed for the treatment of MPB, and is trade marked.

Q. If 5% Xandrox is effective in treating MPB, why produce a Xandrox 12.5%?

A. The effect of minoxidil on hair follicles is dose dependent. Xandrox 12.5% Lotion has been successful in halting and/or reversing MPB in cases where other therapeutic measures have not worked well.

Q. If Xandrox 12.5% is an 'opaque, white lotion', won’t it leave a visible residue on the scalp?

A. Not at all. Using one's fingertips and with minimum massaging, the lotion disappears almost immediately into the scalp. There is almost no visible residual on the skin or hair. This is due to one of our most valuable trade secrets. The lotion changes its physical properties so absorption and penetration occurs when activated by normal body heat.

Q. On the Xandrox 12.5% bottle label it says that the bottles should be refrigerated. What happens if it takes a while for the product to arrive from Los Angeles, or if I go on a month's vacation where there isn't an available refrigerator?

A. It's usually not a problem. Xandrox 12.5% lotion is best kept refrigerated, under which conditions it has a shelf life of 18 months. At room temperatures between 59 to 86 degrees Fahrenheit ( 15 to 30 degrees Centigrade), Xandrox can be kept for up to four months without deterioration or loss of efficacy.

Q. I live in a warm climate where Xandrox 12.5% lotion may be subjected to heated
delivery vehicles or storage facilities for extended periods of time. Does this effect the
potency of the drug?

A. No. But it surely can effect the appearance of the lotion. When the lotion leaves the Los Angeles area of California, it has a smooth, creamy consistency. As it travels over hot desert areas or remains in heated delivery vehicles and warehouses, it may take on the consistency of "liquid on top of the bottle over a glob of white stuff." If this happens in your climate zone, vigorously agitate the bottle until it becomes a smooth, white lotion again. There are likely other mechanical methods patients will discover which will allow them to reconstitute the compound into a lotion which allows for efficient penetration and absorption despite the excessive heat it is subjected to before it is finally applied to your scalp. If reconstitution attempts result a white lotion results that feels lumpy, sand like, please be aware than the 'sandy' feel to the compound may actually help in penetration of the active ingredients.  

One thing is certain. If it has been subjected to temperatures above normal body heat and you don't reconstitute it back into an homogenous lotion, you will have problems with the pump.

If the lotion has been subjected to super-heated temperatures for long periods of time, it still retains its potency, but the "glob of white stuff" will now contain the large 'sandy' crystals which cannot pass through the pump. This happens almost automatically when the lotion is taken on summertime automobile trips and is left in the trunk of a vehicle. If you end up with a quantity of this type of lotion, throw the pump away, remix as best as possible, and transfer an amount about the size of an American penny to the palm of your hand. Use your index finger to apply the lotion to your scalp.

The reason for the change in appearance of the lotion at temperatures above 95 degrees F (~35 degrees C) has to do with the fact that the lotion is designed to liquefy and absorb into the skin at normal body temperatures. When subjected to similar temperatures while still in the bottle, it will change its physical appearance. There is no change in its chemical structure or pharmacological action, however.

The lotion should be refrigerated or kept in a cool environment after it has been reconstituted into a homogenous lotion.

Q. Why didn't you simplify this whole process and just make a high concentration gel or cream which wouldn't be heat sensitive.

A. This is the compounding method used by others. We knew, however, that such compounds would not allow for the type of liquefaction necessary for absorption. The concentration of the minoxidil in the suspending agent is important, but if proper absorption does not take place, minoxidil, time and money have been wasted.

Q. How about others who try to duplicate the ingredients in your formulae. Will these products work for me like Xandrox solutions and 12.5% lotion?

A. No. There are many trade secrets associated with the proper compounding of Xandrox solutions and 12.5% lotion. Others may try to copy the Xandrox formulae, but none will succeed in exactly duplicating them.

Q. Now that you are dispensing Xandrox 12.5% lotion, there are others who have started to offer what sound like the same thing. They claim there are no problems associated with reconstitution inherent in their imitation products. Should I order from them?

A. There are doctors who will write prescriptions for products imitating Xandrox solutions and 12.5% lotion. These products are not Xandrox, however. Caveat emptor.

Q. Will Doctor Lee write me a prescription for one of these imitation products?

A. No. But there are probably doctors who will. Doctor Lee's primary interest is in providing products that work. He knows Xandrox 12.5% lotion works, but does not have confidence that the imitation products will work. His chief interest is not that you spend money to try and regrow hair. His chief interest is that you actually regrow hair.

Q. Why is there a slight abrasiveness to the lotion?

A. By design, you may experience a slight abrasiveness designed to abrade and remove the epidermal layers of the skin to allow for improved penetration of the minoxidil and azelaic acid.

Q. What is the absorption enhancer used in the Xandrox 12.5%?

A. Benzyl nicotinate. It is chemically related to niacin and can cause a temporary ‘flushing’ of the scalp where it is applied.

Q. If benzyl nicotinate is such a good absorption enhancer, why isn't it used in the 5% Xandrox solution?

A. The 5% Xandrox does not need an absorption enhancer because it has an alcohol base. Minoxidil in a 12.5% concentration is not compatible with an alcohol base. Therefore an absorption enhancer was incorporated into the Xandrox 12.5% formula to make the absorption rates equivalent.

Q. If you put benzyl nicotinate into any high concentration minoxidil gel or lotion, wouldn't the resulting gel or lotion absorb like the Xandrox 12.5% lotion?

A. Not necessarily. The minoxidil suspended in any gel or lotion may not get released to the scalp as we know it does in the Xandrox 12.5% lotion.

Q. Why are there suddenly others who have jumped on the bandwagon of micronized minoxidil/azelaic acid formulae?

A. Simply stated, because Xandrox works. Also, because there have always been individuals in every society whose scam has been: "Give me your wallet, and I'll give you hair." As soon as someone tells you how much like Xandrox their compound is, immediately place your hand on your wallet and keep it securely in your pocket.

Fortunately there is finally something which works and which doesn't cost you your wallet. It's known by the name Xandrox.... and only by the name Xandrox.

Q. Has Xandrox 12.5% been tested?

A. Extensively. It required more than a year just to produce the body temperature-activated type of lotion that met the criteria of effectiveness, safety and cosmetics.

Q. What have been the results of clinical trials with Xandrox 12.5%?

A. Although many San Diego area patients were test subjects for over a year, we do not consider this to be an adequate sampling to qualify for conclusive data regarding end results. We do know from these limited tests that the majority of these patients regrew considerable amounts of hair in problem areas where other therapies had little or no effect. In essence, you will have to judge for yourself. Feedback via e-mail and chat groups continues to validate what the San Diego patients found to be true; i.e., that minoxidil's effectiveness is, indeed, dose dependant, and that the combination of azelaic acid with targeted doses of 12.5% micronized minoxidil lotion is the key to regrowth in areas like the frontal hairline and/or temples where other therapies had no effect.

Q. You indicate that the minoxidil used in Xandrox 12.5% is micronized. What does this mean, and why is it done?

A. The type of minoxidil crystals used in 2% - 5% minoxidil solutions are coarse and hard, similar to table salt. Costly precision equipment at Regrowth's compounding lab is used to pulverize these crystals so they are approximately 25 micron in size (similar to talcum powder). Micronization results in improved dissolution, and in a smooth lotion which, because it is heat activated, is better absorbed as evidenced by an almost total lack of residue where it is applied.

Q. How much Xandrox 12.5% should be used with each application?

A. Because the concentration of minoxidil is so high, we suggest that approximately 1 mL of Xandrox 12.5% be used per day. The 30 mL bottles of Xandrox 12.5% have treatment pumps that dispense ~0.25 mL of lotion with each complete depression of the pump. The 125 mL bottles of Xandrox 12.5% dispense ~1.25 mL with each full depression of the pumping spout.

Q. The pump on my Xandrox 12.5% lotion bottle doesn't work. Will you send me new pumps?

A. The pumps must be primed in order to function correctly. If priming them in the bottle takes too long, prime them in water, and then affix them to the bottle. The first depression of the pump will produce water, but thereafter lotion will be dispensed. If proper priming does not work, your lotion has almost certainly been subjected to excessive heat. Please see FAQ's above, for possible correction of heat-related problems.

Q. If pump priming doesn't work, what should I do?

A. Call or e-mail Regrowth.

Q. Where should Xandrox 12.5% be used?

A. Only on those areas of the scalp that are refractory to treatment of MPB by any other means. For most patients, this means the areas of both temples and/or the frontal hairline. But some patients will want or need to use it in the vertex and/or on the crown. It should not take the place of 5% Xandrox for general application on other parts of the scalp.

Q. Do I use it in addition to 5% Xandrox?

A. Yes. The Xandrox 12.5% lotion is meant to be used as a supplement and not a replacement for the use of 5% Xandrox. The Xandrox 12.5% lotion should only be used in areas unresponsive or poorly responsive to 5% Xandrox solutions.

Q. Why not just use Xandrox 12.5% lotion everywhere and forget about the Xandrox 5% solution?

A. It's a matter of dosage and safety. Even 5% minoxidil solutions have been known to cause rare side effects such as dizziness and headaches. The most innocuous substances can be harmful in large doses. For example, vitamin A is essential to good health. Too much vitamin A may cause bone pain and hair loss.

Q. Can I overdose or have systemic effects from using such high concentrations of minoxidil?

A. For essentially all patients, there is not sufficient absorption of minoxidil into the blood stream to cause any systemic symptoms. In fact, allowing for the average amount of absorption (1.4%), the safety margin is almost ten-fold. However, there will be those few patients who will have unavoidable idiosyncratic reactions to Xandrox 12.5%. We anticipate the number will be less than 0.1%.

Q. What should I do if I experience an idiosyncratic reaction to Xandrox 12.5%?

A. Stop using it immediately.

Q. Is there any way to screen for patients who are hypersensitive to Xandrox 12.5%?

A. No. By definition, idiosyncratic reactions are peculiar to the specific patient. Mild side effects related to lowered blood pressure have been reported by some test subjects.

Q. When should I apply the Xandrox 12.5%

A. At any time of the 24 hour cycle when it can best be left undisturbed on the scalp for the longest period of time. Since the lotion becomes virtually invisible after application, it can be applied at any time of the day or night.

Q. How long should I wait until I know if Xandrox 12.5% is working for me?

A. Since the Xandrox 12.5% is recruiting previously unresponsive hair follicles to grow again, these hairs will first have to be shed. They will remain inactive during the ~100 days of telogen, and will then grow back thick enough so that you can appreciate the difference. This process usually takes a minimum of 4 to 6 months.

Q. Can the increased concentration of minoxidil in Xandrox 12.5% cause temporary shedding?

A. Yes, it can. Hair that is approaching the telogen phase, or is already in the telogen phase, is prompted to shed earlier than usual. Rarely will more than 10% of the hair be in the telogen phase at any given time. This means that under the worst-case scenario, approximately 10% of one's hair would be shed. If this does happen, most patients will not even notice the process. The shedding is due to the stimulatory effect of the minoxidil and is limited only to those areas where the Xandrox 12.5% is being applied. This is another reason why the Xandrox 12.5% should be used only on targeted areas. If it is used in place of 5% Xandrox, the shedding could be excessive. Although the shed hair will be regrown, in the meantime you would likely be frantic, and we would have a difficult time answering e-mail and phone calls. DON'T OVERUSE XANDROX 12.5%.

Q. Will Xandrox 12.5% cause a telogen effluvium or a permanent hair loss?

A. Absolutely not. That is not to say that there haven't been patients who have experienced shedding after using minoxidil and/or azelaic acid. Although there have been, sound medical evidence does not show a direct ‘cause and effect’. The subject of shedding is complicated and we will shortly create an entire new section of the website to address this topic.

Q. Is Xandrox 12.5% expensive?

A. Treatment with Xandrox 12.5% can cost as little as 66 cents per day. The 30 mL bottle with the treatment pump dispenser costs $27.86. Xandrox 12.5% in 125 mL bottles with a lotion pump dispenser costs $89.94. There are also price incentives designed to encourage using the Xandrox 12.5% lotion wisely and as directed. This means using it only on targeted areas and in conjunction with 5% Xandrox lotion.

Q. Are there generic versions of Xandrox 12.5% Lotion?

A. No. By definition, generic means identical. There are now, and will continue to be, products which try to imitate Xandrox. However none of these products are compounded in the same manner as is Xandrox. It took Dr. Lee over a year of laboratory testing to perfect the exact process whereby Xandrox is compounded. Xandrox 12.5% Lotion took two years to perfect and is, and will remain, unique. There are countless trade secrets, protected by patents pending, associated with the proper compounding of Xandrox solutions and 12.5% lotion.

Q. Then why is Xandrox 12.5% lotion so relatively inexpensive?

A. Dr. Lee has spent 11 years perfecting his products and has many thousands of patients. This world-wide base of patients has afforded him the means to invest in independent research and development and to purchase ingredients in bulk. Although Xandrox is the Mercedes V-12 of minoxidil-based hair medications, there is more profit in selling thousands of Fords than in selling hundreds of Mercedes V-12's. Xandrox could be compared to a Mercedes V-12 with a Ford price sticker price.

Q. Why doesn't Xandrox 12.5% lotion contain retinoic acid?

A. Retinoic acid is a very powerful drug, which some patients cannot tolerate. The absorption enhancer in the Xandrox 12.5% makes the addition of retinoic acid unnecessary and allows the Xandrox 12.5% to be used at any time of the day or night.

Q. Does this mean I no longer have to use 5% Xandrox Night formula which contains Retin-A?

A. Although Retin-A does allow for better absorption, that is not its only reason for being in the 5% night formula. Retin-A encourages rapid cell division. Rapid cell division can lead to larger follicles which are capable of producing thicker hair shafts.

Q. Is there any advantage to adding grape seed extract and other 'buzz word' ingredients to the Xandrox 12.5% lotion?

A. Grape seed extract seems to be the latest fad in suggested treatments for MPB, but there is no medically sound research and data associated with using it. Grape seed extract is an anti-oxidant, but so are azelaic acid and vitamin E, both of which are present in the Xandrox formulations. Anti-oxidants may retard aging changes in the skin, but they do not specifically treat MPB. The vitamin E in Xandrox formulae also acts as a natural preservative.

Q. If Xandrox 12.5% is so effective, why even use 5% Xandrox?

A. The 5% Xandrox solutions are extremely effective on most parts of the scalp. Xandrox 12.5% should only be used on those parts of the scalp which are stubborn in responding to 5% Xandrox. Save money and only use the Xandrox 12.5% lotion where directed. It's a powerful drug. Use it sparingly.

Q. My bottle seems to be only about 3/4 full.

A. The large bottle of 12.5% Xandrox is five ounces in size. Slightly more than
four ounces are put into the bottle. Furthermore, a portion of the 125 mL contents are aerated to provide for a smoother consistency. Subjecting the bottle to heat will minimize the aeration. The uncapped bottles weigh a minimum of 130 grams before any doses are removed. Also, almost always, the bottles actually contain 130 mL of lotion, and can contain as much as 140 mL of lotion. The reason for this rather unscientific filling process has to do with timing. The filling machines are calibrated to fill the large bottles with 125 mL of lotion. The laws regarding weights and measures are strict. As such, each bottle must be weighed to guarantee it contains at least the minimum amount of lotion stated on the label (125 mL). If the filling process falls behind schedule, which is most often the case, the bottles are simply filled to their necks and are not weighed. This saves a considerable amount of time and results in the bottles containing up to 140 mL of lotion. In essence, Dr. Lee must make a decision as to which is more pressing - saving time or saving product. He never intended to become a slave to filling machines, and generally chooses to guard what little time he does have. By California law, it is he who must fill the bottles.

Likewise, the small 12.5% bottles are 1 1/4 ounce in size. They are filled with a minimum of 30 mL, which means that they are slightly more than 2/3 full. The same principles of aeration, etc., apply to them that apply to the larger bottles.

Because the contents of the bottles are that of a lotion and not a solution, there is no leak-proof seal affixed to the necks of these bottles like there is with the 5% Xandrox solution.

Q. This sure sounds like a marketing ploy to fool the patient into believing he/she is getting more than what he/she has paid for.

A. Not at all. It's a matter of practicality. Our products are shipped all over the world, often in unpressurized cargo bays of airplanes. We must protect against expansion and contraction. In fact, the bottles ALWAYS contain more than the labeled 125 mL or 30 mL stated on the labels. Patients NEVER get less than stated. All patients are rewarded with much, much more than they have paid for.... in many ways.

*After the 12.5% Xandrox lotion was introduced, Xandrox 15% solution was introduced.  It is even more effective than 12.5% Xandrox lotion, and actually cost slightly less than the 12.5% Xandrox lotion.  Patients are encouraged to switch to the more effective Xandrox 15% solution.