FAQs - New Products

Q. What is Xandrox15-PLUS?  
A. Xandrox15-PLUS is an exclusive Regrowth medication for the treatment of alopecia androgenetica, containing 15% minoxidil, 5% azelaic acid and 0.1% finasteride by weight.  Xandrox15-PLUS is available in 125mL bottles.  Each mL of Xandrox15-PLUS contains 150mg of minoxidil, 50mg of azelaic acid and 1mg finasteride.

Q. When will Xandrox15-PLUS be available?
A. June 2008

Q. Why is Xandrox15-PLUS so highly recommended?  
A. This is the first hair growth product that contains 15% minoxidil, azelaic acid and finasteride in solution form.  Xandrox15-PLUS is a clear, light amber colored, extremely stable solution, containing 15% minoxidil, 5% azelaic acid and 0.1% finasteride with a proven efficacy in the treatment of MPB. 

Q. Why did Regrowth decide to add finasteride to the Xandrox15-PLUS product?  
A. The rationale for compounding a 15% Minoxidil, 5% Azelaic Acid and 0.1% Finasteride solution is to produce the single best medication for the treatment of MPB.  The use of a high concentration topical minoxidil, combined with agents that decrease the amount of DHT in the scalp utilizes the two FDA safe and proven modes for treating MPB.

Q. Xandrox15 already contains 5% azelaic acid to decrease DHT in the scalp.  Why add finasteride?  
A. Although topical azelaic acid will prevent the synthesis of DHT in the scalp where it is applied, it does not protect the hair follicles from DHT circulating in the bloodstream.  Finasteride applied topically can and does decrease the serum DHT and, although the 5-alpha reductase enzymes in the scalp is primarily Type I, there are also Type II 5AR's in the scalp that the topically applied finasteride can inactivate.   

Q. Since finasteride inhibits only the Type 1 5-alpha reductase, how do you know that the serum DHT is decreased with the use of topical finasteride? 
A. Independent studies from other researchers (e.g. Rushton and Ramsay in an article in the British Journal of Medicine) have shown that topical finasteride lowers the serum by inhibiting the synthesis of DHT in the prostate. "A 0.05% formulation of topical finasteride was well absorbed and lowered the serum dihydrotestosterone concentration by up to 40%".

Q. Should Xandrox15-PLUS be used by patients who are or who are not taking oral finasteride?  
A. Xandrox15-PLUS can be used as the sole treatment for treating MPB or as a supplement to patients who are already using the oral finasteride, as oral finasteride 1mg/daily lowers the amount of DHT in the scalp by only 38% (Roger S. Rittmaster, M.D. at the American Academy of Dermatology (AAD) meeting in San Francisco, March 2000).

Q. Are there any special precautions relating to the 125mLbottles of Xandrox15-PLUS?  
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 10° to 200° Fahrenheit (-12° to 93° Centigrade) for short exposures.  Xandrox15-PLUS is best kept at room temperatures.

PHARMACOLOGY

Q. How well are the active ingredients of Xandrox15-PLUS absorbed into the dermis of the scalp?  
A. 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 transports the minoxidil, azelaic acid and finasteride with it. The penetration enhancing effects of ethanol play a significant role in minoxidil absorption.  The effective absorption of topical minoxidil and finasteride 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. Does Xandrox15-PLUS 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.  The finasteride is completely absorbed.  This residual reservoir of minoxidil provides a beneficial source for the continued absorption of minoxidil even after the Xandrox15-PLUS has dried on the scalp.   If Xandrox15-PLUS is only used at night and applied in small amounts, you can minimize the objections to the residual matter on the scalp, while you simultaneously maximize the absorption of minoxidil.

FORMULATION

Q. How much of the base of Xandrox15-PLUS is ethyl alcohol??  
A. The base solution consists of 80% ethyl alcohol and 20% glycerin with a trace of phosphoric acid.

Q. Does Xandrox15-PLUS have a ‘greasy’ feel?  
A. Since the base is 80% ethyl alcohol, the Xandrox15-PLUS solution absorbs quickly and does not leave an oily sheen on the scalp.  Many patients like the extra body the glycerin gives to their hair, especially if they comb or brush their hair after the glycerin dries.

Q. Why use glycerin instead of the propylene glycol that is used in most minoxidil preparations?
A. A significant number of patients, as many as 7%, 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 one’s skin. Glycerin based soaps are offered at exclusive spas and resorts for this very reason.  

Q. Why wasn’t retinoic acid added to Xandrox15-PLUS?  
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.

DIRECTIONS FOR USE

Q. How is Xandrox15-PLUS applied to the scalp?  
A. 1mL of Xandrox15-PLUS should be applied to the scalp once daily.  Each bottle of Xandrox15-PLUS is accompanied with a calibrated 1mL medicine dropper that allows the patient to conveniently apply 1mL of Xandrox15-PLUS solution onto the scalp, and an optional dauber.   Dropper: Place the tip of the dropper onto the scalp and squeeze the rubber bulb to release a small amount of Xandrox15-PLUS.  Divide the total 1mL quantity into as many doses as are required to moisten/wet the scalp in all the areas affected by MPB.  The fingertips can be used to spread the liquid within the desired areas or to restrict the flow to other areas.  Wash hands thereafter.      

Q. Is there an alternative method of application other than using a dropper?  
A. Regrowth offers a 2oz. plastic bottle with a custom fitted dauber applicator with protective overcap. Xandrox15-PLUS can be transferred to the applicator bottle and dispensed by simply inverting the dauber and gliding it across the scalp.  It has been established that four side-to-side passes over the scalp approximate 1 mL of dispensed solution. This is, by far, the most convenient way to apply topical minoxidil solutions.  Although the amount being dispensed cannot be precisely calibrated, if only enough liquid is applied to moisten the affected areas, there is minimal chance of utilizing excessive amounts of Xandrox15-PLUS.

Q. Should the scalp be dry or wet when Xandrox15-PLUS is applied? 
A. The scalp can be dry or hydrated, but the scalp should not be wet to the degree of diluting or washing off the minoxidil/azelaic acid/finasteride. 

Q. How soon after applying Xandrox15-PLUS can one shower or shampoo? 
A. For optimal absorption of the minoxidil, azelaic acid and finasteride, allow one hour.  The high concentration of ethyl alcohol in the base allows for rapid absorption of the minoxidil, azelaic acid and finasteride. 

Q. Will wetting the hair for styling purposes affect the efficacy of Xandrox15-PLUS?  
A. No, assuming you are not going to get the scalp so wet that you will wash off the Xandrox15-PLUS.

Q. Will blow-drying the hair affect the efficacy of Xandrox15-PLUS?  
A. It would be advisable to blow-dry the hair before the application of Xandrox15-PLUS.  Otherwise, blow-drying will cause most of the Xandrox15-PLUS to evaporate rather than to absorb.  Applying 1mL of Xandrox15-PLUS to the scalp should not significantly alter the appearance of one’s hairstyle.

Q. What do I do if a precipitate forms in my bottle of Xandrox15-PLUS?  
A. Since the Xandrox15-PLUS is a highly saturated solution of minoxidil, there may be rare occasions when a precipitate will form in the bottle.  If and when this happens, the tightly capped bottle of Xandrox15-PLUS should be placed in a bath of water that has been heated to a gentle simmer, and shaken vigorously.  As long as the bottle of Xandrox15-PLUS is kept tightly capped, it can be kept in heated water until all the minoxidil goes back into solution.

USE WITH OTHER PRODUCTS

Q. Wouldn’t it be more beneficial to use Xandrox15-PLUS twice daily, rather than to alternate its use with a lower concentration minoxidil solution?  
A. Possibly, but it’s neither necessary nor advisable to do so.  The potency of Xandrox15-PLUS in combination with a 5% Xandrox or a 5% Minoxidil solution is usually sufficient to obtain optimal results in treating MPB.  Applying more than 1mg of finasteride does not improve its benefits.

Q. Can Xandrox15-PLUS be used in conjunction with 5% Xandrox?  
A. Yes.  Apply 1mL of either solution once/day.  The applications should be at least 8 hours apart. If nighttime Xandrox solution containing 0.025% retinoic acid is used, it should be applied at night and Xandrox15-PLUS should be applied in the morning.

Q. Can Xandrox15-PLUS be used in conjunction with the 5% Minoxidil Solution?  
A. Yes. Apply 1mL of either solution once/day. The applications should be at least 8 hours apart.  It does not matter which solution is used at any particular time of day.

Q. Should one use the 5% Spironolactone Lotion in conjunction with Xandrox15-PLUS?
A. For most patients, it shouldn’t be necessary.  The azelaic acid and the finasteride in Xandrox15-PLUS should provide adequate reduction of DHT in the scalp.

Q.Should one use Xandrox15-PLUS, if he is already taking oral finasteride?
A. There is no contraindication to doing so.  Oral finasteride 1mg/daily lowers the amount of DHT in the scalp by only 38%, the topical finasteride will lower the scalp DHT even further.

Q. Should a patient initiate treatment for MPB with Xandrox15-PLUS?
A. No.  As a rule, most patients will have a satisfactory response to Xandrox 5% solutions or to the combination of a 5% Minoxidil solution with the use of the 5% Spironolactone Lotion.  If, after at least six months of treatment with either of these regimens, the improvement is not satisfactory, then the patient may want to consider the use of Xandrox15-PLUS on those areas of the scalp with inadequate regrowth of hair.

The second reason why a patient should not begin treatment of MPB with Xandrox15-PLUS is because topical minoxidil can allow hair that is already in the telogen phase to shed before the end of the phase.  Although the hair is replaced with thicker hair shafts, the observation of increased shedding, however temporary, may have a psychologically damaging effect on those patients who are already traumatized by the balding process.

SIDE EFFECTS AND CONTRAINDICATIONS

Q. What is the margin of safety from having systemic effects due to minoxidil when dosing with Xandrox15-PLUS daily?
A. Minoxidil requires a serum concentration of 20 ng/mL to have any hemodynamic or other systemic effect in the human body.  Allowing for the average 1.4% absorption (range 0.3 - 4.5%) of minoxidil from the topical application of 1 mL of Xandrox15-PLUS, there will be a serum concentration of minoxidil of ~4 ng / mL of minoxidil in the serum.  So, there is an estimated 5-fold safety margin from any systemic effects of minoxidil due to the use of Xandrox15-PLUS, when it is used once/day as recommended.  For optimal results, it is suggested that topical minoxidil be applied twice/day.  One dose should be 1mL Xandrox15-PLUS and the second dose, at least 8 hours apart, should be 1mL of the lower concentration Xandrox 5% or 5% Minoxidil.

Q. What are the systemic effects and possible side effects of minoxidil use?
A. Oral minoxidil is used as a medication to lower the blood pressure.  The most common systemic effects associated with oral minoxidil intake are tachycardia (increased heart rate) and orthostatic hypotension (dizziness on standing).  Other side effects may include fluid retention, chest pain and facial edema.  There have been rare reports of pericardial effusion (fluid collection around the heart) with the use of oral minoxidil.

Q. Wouldn’t the amount of alcohol used in Xandrox15-PLUS be harmful?
A. Not at all.  At most, 1mL of Xandrox15-PLUS and 1mL of another minoxidil solution would be applied daily.  The percutaneous absorption from an 80% ethyl alcohol solution would be less than 50mg. By comparison, this is the amount of alcohol in less than 1 mL of wine (10% alcohol by volume).  Skin exposure is not a safety concern.

Q. What should a patient do, if he or she experiences any of the systemic side effects of minoxidil?
A. The patient should immediately cease using all topical solutions, which contain minoxidil.  Side effects should abate within days. Report your side effects immediately to Regrowth (RichardLeeMD@earthlink.net).  Following cessation of the topical application of minoxidil, approximately 95% of systemically absorbed minoxidil is eliminated within four days. 

Q. Are there patients who should avoid using Xandrox15-PLUS?
A. Yes.  Patients with any history of heart disease should not use Xandrox15-PLUS.  Also patients who have a known adverse reaction to minoxidil, azelaic acid or finasteride should avoid using Xandrox15-PLUS.

Herr Doktor Lee forscht weiter, testet neue Medikationen und Techniken und wird diese erhältlich machen, wenn sie wissenschaftlich als sicher und wirksam bestätigt wurden. Währenddessen setzt REGROWTH seine Bemühungen fort, Patienten mit den effektivsten Produkten zu erschwinglichen Preisen zu versorgen.  Xandrox 15 Plus mit Finasteride wird Ende Juni  erscheinen.