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COMBINED THERAPIES
5% XANDROX SOLUTIONS
XANDROX 12.5% LOTION


INCLUDING PACKAGE INSERTS

Updated: 5-8-99

The currently accepted state-of-the-art medical treatment for male pattern baldness is the concurrent use of high-concentration topical minoxidil, retinoic acid and daily doses of an anti-androgen such as topical spironolactone, topical azelaic acid or oral finasteride (Propecia). One of the most convincing reports using this combination of medications was reported from Walter Reed Army Hospital and is reproduced in totality in Additional Journal Reports. There have also been numerous enthusiastic reports in the popular press in regards to the effectiveness of this new approach to male pattern baldness. It is exciting to realize that balding is now a choice, rather than a fate.

At the REGROWTH Hair Treatment Centers, we have been utilizing 1ml of high concentration minoxidil solutions applied twice daily and recommending the addition of .025% retinoic acid in the nighttime application. Having been convinced of the safety and efficacy of finasteride from the Phase III clinical trials by Merck & Co., Inc., we are also dispensing 1mg of finasteride for daily use, and more recently, introduced 2% spironolactone solution and azelaic acid (Xandrox). The results have been profoundly satisfying for the majority of the patients. Hair growth rated 'good' to 'excellent' has been reported in 70 to 75 percent of the nearly 6000 patients who are using these combinations of medications.

In a simplified schema, the finasteride and spironolactone decrease the amount of dihydrotestosterone (DHT) in the scalp, allowing the hair follicles to mature closer to their normal size, and the minoxidil promotes hair growth. Topical minoxidil is dose dependant and the higher the concentration, the more effective it is in promoting hair growth. The retinoic acid acts as a chemical 'peel' and allows for greater penetration of the scalp. Spironolactone in topical form acts like 1 mg. finasteride in oral form to reduce the action of DHT on the follicles. The spironolactone, however, has none of the potential side effects associated with finasteride. Topical 5% minoxidil has been successfully combined with azelaic acid in a single solution (Xandrox) to provide simultaneous inhibition of DHT as well as stimulation to hair growth.

Since we deal exclusively with hair loss problems, we carefully evaluate all products purported to grow hair. There have always been numerous claims of substances and procedures to grow hair. Some may have real value, but there has not been sufficient testing under clinical situations for us to recommend their use. What we promise to our patients is to make available only those treatments that are safe, efficacious and have proven medical benefits.

We are actively engaged in developing even more effective therapies, combining hair growth stimulants, anti-androgens and anti-inflammatory agents.

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From: Richard Lee, M.D.

Ladies and Gentlemen:

Thank you for your interest in our website. I am very happy to announce that as of 30 September '98, REGROWTH has made available newly formulated solutions, utilizing the only two FDA approved methods for treating pattern baldness: minoxidil and agents that prevent enzymatic conversion of testosterone to dihydrotestosterone (DHT).

REGROWTH is dispensing a new, proven, effective, affordable and exclusive topical solution that integrates the best pharmacologic properties of minoxidil and azelaic acid. The addition of betamethasone valerate is included unless otherwise requested. The product is known as Xandrox and is formulated both with and without retinoic acid to allow for daytime and nighttime use. Minoxidil is dissolved into the solution at the highest possible concentration at 5% to maximize its stimulus to hair growth. Azelaic acid, also at a 5% concentration, will inhibit virtually all (>98%) the 5-alpha reductase in the areas of the scalp to which it is applied, preventing any local formation of DHT. Betamethasone valerate is a potent anti-inflammatory and counteracts any potential irritation to the scalp due to any of the components of the Xandrox base solution. Xandrox topical solutions are dispensed in 3 oz. Bottles containing at least 65mL of medication and are accompanied by a calibrated medicine dropper and/or a fine mist sprayer for ease of application.

Details concerning the pharmacologic properties of minoxidil and azelaic acid and betamethasone valerate and of Xandrox solutions have been posted on this website along with contraindications, warnings, recommended use and dosage. There are also many additional FAQ's that may be of interest.

Our current 5% minoxidil solutions have been reformulated to include optional prescription 0.025% betamethasone valerate, and their price is competitive with Rogaine Extra Strength 5% minoxidil solution. The 2% spironolactone solutions can be ordered as a separate product.

April 30, 1999, REGROWTH, LLC introduced a 12.5% minoxidil lotion, also containing 5% azelaic acid and an absorption enhancer, benzyl niccotinate. Since the results of minoxidil are dose-dependent, a 12.5% minoxidil lotion will be much more effective than a 5% solution. Recent refinements in compounding have resulted in a lotion which leaves no residue or odor with apparent complete absorption. It is suggested that the 12.5% lotion be used in conjunction with 5% Xandrox solutions, and that the lotion be applied sparingly ONLY to areas of apparent thinning directly after the application of 5% Xandrox.

The introduction of Xandrox as well as the less expensive prescription 5% minoxidil solutions, Xandrox 12.5% minoxidil lotion with 5% azelaic acid, and separate 2% spironolactone solutions gives REGROWTH patients a wide latitude of choices in their treatment for the prevention and reversal of pattern alopecia.

Sincerely,

Richard Lee, M.D.

Chief Consulting Physician

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5% XANDROX SOLUTIONS


5% XANDROX SOLUTIONS CONTAIN 5% MINOXIDIL AND
5% AZELAIC ACID WITH OPTIONAL 0.025% RETINOIC ACID
AND OPTIONAL 0.025% BETAMETHASONE VALERATE.

(Complete Package Insert)



Minoxidil 5%

Description: Minoxidil topical solution is a non-specific hair growth stimulant. Minoxidil appears as a white or off-white, odorless crystalline solid that is soluble in water to the extent of approximately 2 mg/mL, but more readily soluble in propylene glycol or ethanol. The chemical name for minoxidil is 2, 4-pyrimidinediamine, 6-(1-piperinedinyl)-, 3-oxide (MW= 209.25). Xandrox topical solutions contain 50 mg minoxidil per milliliter.



Clinical Pharmacology: Minoxidil topical solutions stimulate hair growth in individuals with androgenetic alopecia, expressed in males as thinning or the hair at the vertex, crown, temporal and/or frontal areas and in females usually as diffuse hair loss or thinning in the frontoparietal areas. The mechanism by which minoxidil stimulates hair growth is not known but is thought to have a direct effect on the hair follicle to sustain the anagen phase of the hair cycle. It has also been shown to have a vasodilatory effect on the scalp. Minoxidil is a direct acting peripheral arterial dilator that reduces blood pressure by decreasing peripheral vascular resistance.



In placebo controlled trials involving over 3500 male patients given topical minoxidil for 4 months (longer treatment was given after the placebo group was discontinued) and in over 300 female patients given topical minoxidil for eight months, the typical systemic effects of oral minoxidil (weight gain, edema, tachycardia, fall in blood pressure, and their more serious consequences) were not seen more frequently in patients given topical minoxidil than in those given topical placebo. The mean changes from baseline in weight, heart rate, and blood pressure in the treated and placebo groups were similar, and the number of patients experiencing significant changes, such as blood pressure decrease of 15 mmHg or more diastolic or 30 mmHg or more systolic, a heart rate increase of 15 beats/minute or more, or weight gain of at least 5 pounds, was also similar.



The failure to detect evidence of systemic effects during treatment with topical minoxidil reflects the poor absorption of topical minoxidil, which averages about 1.4% (range 0.3 to 4.5%) from normal intact scalp, and was about 2% in the hypertensive patient, whose scalps were shaved. Since it requires 20 ng / mL of serum to have any systemic effects in the human body and allowing for an average absorption rate of 1.4%, there remains a greater than 16-fold safety margin in the use of 5% topical minoxidil.



Following cessation of topical dosing of minoxidil, approximately 95% of systemically absorbed minoxidil is eliminated within four days. Minoxidil and its metabolites are excreted principally in the urine.



Indications and Usage: Xandrox topical solutions are indicated for the treatment of alopecia androgenetica in men and women. At least four months of twice daily application are usually required before evidence of hair growth can be expected. Even in patients for whom topical minoxidil does not seem effective for restoring hair loss, for most patients it will prevent further thinning and loss due to alopecia androgenetica.



Contraindications: Topical minoxidil is contraindicated in those with a hypersensitivity to any of the components of the preparation.



Warnings: Although extensive use of topical minoxidil has not revealed evidence that enough minoxidil is absorbed to have systemic effects, greater absorption or individual variability or sensitivity could theoretically cause a systemic effect. If systemic effects were to occur, patients with underlying heart disease would be at particular risk. Minoxidil could also have additive effects with other therapies in patients being treated for hypertension.



Drug Interactions: There are no known drug interactions associated with the use of a topical minoxidil solution.



Adverse Reactions: In placebo controlled trials, the rate of adverse reactions were no more common, other than dermatologic events such as irritation and allergic dermatitis.



Overdosage: There are no known cases of