News: Xandrox15
Regrowth LLC, has recently added an exciting new product to their Xandrox line of hair loss treatment products, called Xandrox15. The active ingredients in Xandrox15 are 15% minoxidil and 5% azeleic acid. Dr. Lee has put together a good Q&A document on Xandrox15, which I have included below.
I have been testing Xandrox15, and using it exclusively for the last month and a half. While typically it makes sense to try a product for 3 or more months before making an assessment of how well it works for you, I have seen enough of a response in a month and a half of use that I can make some preliminary conclusions about it.
Xandrox15 uses ethyl alcohol and glycerin as the vehicle. This has several implications and has made me realize the importance of the vehicle for the delivery of a topical solution. First, you can apply Xandrox15 as you would any other minoxidil containing solution like Rogaine, Kirkland minoxidil solution, or even Xandrox 5% formulations. Xandrox15 is easier to apply than Xandrox 12.5% lotion, which I have used in the past and am still quite fond of. It leaves less residue than 12.5% Xandrox as well. Second, the fact that Xandrox15 contains glycerin instead of propylene glycol means (at least for me) a lot less irritation of the scalp. I always would get an itchiness of the scalp after applying minoxidil formulations that contained propylene glycol, and I just assumed that this went with the territory. My scalp feels a lot better after applying Xandrox15 than even 5% Xandrox. The only potential drawback with the glycerin is that it is quite sticky. So if you have long hair, it may not be a good idea to use Xandrox15 in the day time. I use it in the evenings. However, you can use this stickiness as a sort of styling helper as it feels almost like hairspray when it dries. For those of you whose scalps are sensitive to propylene glycol, Xandrox15 may well be worth checking out. By the way, I have learned that Dr. Lee is willing to make 5% Xandrox using glycerin instead of propylene glycol if you request it.
As for how well Xandrox15 works relative to regular minoxidil (and even 5% Xandrox and 12.5% Xandrox), after only one and a half months of use, I am very pleased with what I have seen so far. I have grown vellous, unpigmented hair up to a centimeter long and up to a centimeter in front of my hair line and temples! I have never seen anything like this, and can only attribute it to the high concentration of minoxidil and better absorption thanks to the vehicle. It will probably take several hair cycles (up to a year or more) before this growth becomes cosmetically significant (if at all). This is the fastest, and most effective growth I have seen in the shortest period of time. I have always been an excellent responder to minoxidil so this is probably a contributing factor to what I am seeing. I will soon be posting new monthly photos of my progress, and will keep using Xandrox15. I wholeheartedly recommend this product.
Here is Dr. Lees Q&A on this product:
Q. What is Xandrox15?
A. Xandrox15 is an exclusive Regrowth, LLC medication for the treatment of alopecia androgenetica, containing 15% minoxidil and 5% azelaic acid by weight. Xandrox15 is available in 125mL bottles. Each mL of Xandrox15 contains 150mg of minoxidil and 50mg of azelaic acid.
Q. Why is Xandrox15 considered to be a breakthrough product?
A. This is the first minoxidil solution in which the base liquid contains a concentration of minoxidil greater than 5%. Minoxidil had been considered to be soluble in alcohol based solutions only to the extent of slightly less than 5%. To make a stable, high concentration minoxidil solution required years of experimentation, research and development. The result has been rewarding. Xandrox15 is a clear, light amber colored, extremely stable solution, containing 15% minoxidil and 5% azelaic acid with a proven efficacy in the treatment of MPB.
Q. Regrowth, LLC already offers a Xandrox 12.5% Lotion. Whats the advantage of a Xandrox15 solution?
A. (1) Convenience. A solution is more convenient to apply to the scalp than a lotion. The tip of the dropper can be placed directly onto the scalp with a minimal amount of solution wasted on coating the hair shafts. Whereas a lotion can be conveniently applied to areas of the scalp with little hair or miniaturized hair, the solution is easily applied anywhere on the scalp, including larger areas of thinning hair.
(2) Stability. Whereas the lotion had a tendency to separate at temperatures above 100o F (38o C), the Xandrox15 solution is stable at subfreezing temperatures to temperatures above 200o F (93o C). There are no problems in regards to keeping the Xandrox15 indoors, outdoors or even in your car.
(3) Efficacy. The hair promoting effects of topical minoxidil are dose related. The additional 2.5% minoxidil concentration combined with the greater absorption of the alcohol based Xandrox15 solution is more effective in recruiting miniaturized hair follicles to mature again and produce a terminal hair shaft.
Q. Is the effectiveness of Xandrox15 superior to Xandrox 12.5% Lotion?
A. It certainly can be. It is well established that the effectiveness of topical minoxidil in treating MPB is dose related. In our test group, patients grew more hair using Xandrox15 in areas where they had been using Xandrox 12.5% Lotion. There appears to be a threshold level of stimulation with minoxidil to which follicles can be recruited to grow terminal hair again. This threshold level will vary considerably among patients depending primarily on their genetic predisposition to MPB and the length of time affected hair follicles have been miniaturized.
Q. Are there any special precautions relating to the 125mLbottles of Xandrox15?
A. Because of the volatility of the ethyl alcohol, the bottle should be tightly capped when the solution is not being used. The solution is extremely stable within a wide range of temperatures and has been tested to be unaffected in the range of 10o to 200o Fahrenheit (-12o to 93o Centigrade) for short exposures. Xandrox15 is best kept at room temperatures.
PHARMACOLOGY
Q. Will Xandrox15 be better absorbed into the dermis of the scalp?
A. Yes. Ethyl alcohol is one of the few substances that freely permeates the skin (the permeability coefficient of ethanol across human skin in 8 x 10 8 mol/cm2) and it carries the minoxidil in with it. The penetration enhancing effects of ethanol play a significant role in minoxidil absorption. The effective absorption of topical minoxidil depends on the vehicle composition. Greater effects are achieved when the fraction of the volatile component increases, especially at ethanol concentrations higher than 50% (and maximizing at 90%).
Q. Why not apply 3mL of the 5% Xandrox instead of using Xandrox15?
A. The amount of minoxidil in 3mL of 5% Xandrox is the same as the amount of minoxidil in 1mL of Xandrox15. However, in terms of absorption and efficacy, you are much better served by the use of Xandrox15 because (1) the 80% alcohol base of the Xandrox15 allows for significantly greater delivery of minoxidil to the follicles where it is needed; (2) With better patient compliance, your chances of reversing hair loss is improved and there is certainly better patient compliance in applying 1 mL of Xandrox15 than there would be in applying 1 mL of 5% Xandrox 3x/day; (3) the cost of 3 mL of 5% Xandrox is more than 1 mL of Xandrox15; and most importantly (4), there is a threshold level at which atrophied hair follicles will respond to minoxidil to produce a terminal hair shaft again. A 15% minoxidil solution is much more likely to recruit hair follicles to grow again than is a 5% minoxidil solution to do so.
In regards to the second active ingredient, most of the total amount of azelaic acid (150mg) in 3mL of 5% Xandrox would be wasted. 50mg of azelaic acid, which is the amount of azelaic acid in 1mL of Xandrox15, is more than sufficient to effectively inhibit DHT synthesis in the scalp.
Q. Does Xandrox15 leave any kind of residual on the scalp when it dries?
A. When the alcohol has absorbed into the scalp, there will be a slight stickiness due to the residual glycerin, minoxidil and azelaic acid. This residual reservoir of minoxidil provides a beneficial source for the continued absorption of minoxidil even after the Xandrox15 has dried on the scalp. If Xandrox15 is only used at night and applied in small amounts, you can minimize the objections to the residual on the scalp, while you are simultaneously maximizing the absorption of minoxidil.
FORMULATION
Q. How much of the base of Xandrox15 is ethyl alcohol?
The base solution consists of 80% ethyl alcohol and 20% glycerin.
Q. Does Xandrox15 have a greasy feel?
A. Since the base is 80% ethyl alcohol, Xandrox15 solution absorbs quickly and does not leave an oily sheen on the scalp. The alcohol/glycerin compound is far superior to the greasy feeling of Rogaine Extra strength and/or the 5% generic minoxidil solutions, which use a 50% propylene glycol, 30% ethyl alcohol, 20% water base.
Q. Why use glycerin instead of the propylene glycol that is used in most minoxidil preparations?
A. A significant number of patients, perhaps as many as 10%, have an adverse skin reaction to propylene glycol. On the other hand, it would be extremely rare to have an adverse reaction to glycerin, which is commonly used in dermatological preparations as a humectant. Humectants attract moisture to ones skin. Glycerin based soaps are offered at exclusive spas and resorts for this very reason.
Q. Why doesnt Regrowth add vitamin B6 and zinc to Xandrox15?
A. Whereas in vitro experiments demonstrate that the addition of vitamin B6 and zinc to azelaic acid allows azelaic acid to be used in smaller quantities to inhibit the synthesis of DHT in the skin, there are absolutely no studies in regards to the absorption dynamics of topical vitamin B6. Exhaustive research and consultations with the pharmacology departments of many universities yielded no information concerning the absorption, efficacy or safety of topical vitamin B6. Without this vital information, it would be irresponsible and irrational to add vitamin B6 to minoxidil/azelaic acid solutions for the treatment of MPB.
There are studies in regards to the use of topical zinc. However, zinc will form insoluble salts when it reacts with minoxidil/azelaic acid, rendering all of the ingredients ineffective.
For these reasons, it was decided to use azelaic acid as a component of all Xandrox formulations in amounts that will be effective in inhibiting the synthesis of DHT in the scalp for more than three standard deviations (>99%) of the patients
Q. Why wasnt retinoic acid added to Xandrox15?
A. Retinoic acid was an important additional ingredient when minoxidil solutions only contained 2% minoxidil (Rogaine). With higher concentration minoxidil solutions, there is no need for retinoic acid, which can have more drawbacks than benefits. Retinoic acid acts as a chemical peel and can cause drying, scaling, redness and irritation of the scalp. Moreover, chronic use of retinoic acid makes the skin more sensitive to sun damage.
Q. Why use azelaic acid instead of other agents to decrease the DHT in the scalp?
A. The first choice of topical treatment for MPB would have been to combine spironolactone and minoxidil in solution. Unfortunately, they arent compatible in the same solution. Other substances such as emu oil, grape seed extract, linoleic acid, green tea, saw palmetto, etc. may decrease DHT in the scalp, but there are no credible studies to prove their value. The pharmacological actions of azelaic acid are well documented and proven with time.
Q. On a forum someone mentioned that azelaic acid had anti-proliferative and cytotoxic properties. Is that true?
A. Anti-proliferative means "it prevents the proliferation of cells." and cytotoxic means "it kills cells." So, the answer to the question is, "Yes! But in a beneficial way." Azelaic acid has an anti-proliferative and cytotoxic action' only on malignant cancer cells and pathogenic bacteria. If you read the cited articles (Exp Dermatol. 1995 Apr;4(2):79-81. Effect of azelaic acid on melanoma cells in culture. Lemic-Stojcevic L, Nias AH, Breathnach AS. ; Anticancer Res. 1990 Nov-Dec;10(6):1599-602. Cytotoxic activity of azelaic acid against human melanoma primary cultures and established cell lines. Zaffaroni N, Villa R, Silvestro L, Sanfilippo O, Silvestrini R.; Biochem Pharmacol. 1985 May 15;34(10):1653-8. Activity of azelaic acid on cultures of lymphoma- and leukemia-derived cell lines, normal resting and stimulated lymphocytes and 3T3 fibroblasts. Picardo M, Passi S, Sirianni MC, Fiorilli M, Russo GD, Cortesi E, Barile G, Breathnach AS, Nazzaro-Porro M) carefully, you will realize that azelaic acid has a demonstrated anti-proliferative and cytotoxic action only on malignant cells and bacteria. In fact, it is this biochemical action that makes it a useful and beneficial medication. There is no evidence to even suggest that azelaic acid is harmful to hair follicle cells. In fact, the opposite is true. Azelaic acid is used to normalize of keratinization and one of the side effects from the use of azelaic acid can be hypertrichosis.
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