History & Philosophy
When we convinced our founder/owner, Dr. Richard Lee, to re-write the History and Philosophy section of the revamped REGROWTH, LLC website, his modesty did not allow him to mention that he had been elected into the Phi Beta Kappa honor society or that he graduated magna cum laude from the University of Pittsburgh with B.S. and M.D. degrees and subsequent residency training at U.C.L.A. As admirable as these accomplishments may be, we admire him even more for his honesty, integrity and genuine concern for his patients. These qualities have kept REGROWTH, LLC in the forefront of medical practices established for the treatment of male pattern baldness.
-Employees of REGROWTH, LLC - October 2007
It’s almost beyond comprehension to think that Regrowth, LLC was established over 20 years ago. Time really does fly. Twenty years ago, the medical establishment in the United States never even considered male pattern baldness (MPB) to be a medical disorder and any thoughts of treating the condition was met with scorn and ridicule, even though MPB had a medical moniker…alopecia androgenetica.
I was 47 years old in 1996 and the balding spot at the vertex of my scalp was becoming increasingly prominent. I would have been resigned to simply allow the balding proceed along its natural course had not a brother-in-law, a physician in Canada, suggested I try Rogaine®) 2% Minoxidil Solution, which had recently been approved by the Canadian Federal Drug Administration.
After four months of use, it was apparent that the hair loss at the vertex had pretty much stopped. A wispy growth of fine hairs covered the formerly balding area. The treatment could hardly be considered a resounding success, but for someone experiencing the balding process, it was gratifying and exciting to know that finally there was a scientifically proven, safe treatment for MPB, even though of limited efficaciousness.
In fact, I was so happy with even the limited results that I volunteered (gratis) to be the consulting physician for a clinic that my neighbor and I set up in the Los Angeles area of California. Consequently, REGROWTH was incorporated in 1987 with the intention of providing 2% minoxidil solutions at the lowest possible prices and at the greatest convenience for our patients. The basic concept upon which REGROWTH was established was simple; no doctor’s fee for consultation, minimum prices and maximum convenience. It was to be a medical business, practiced with professionalism, and an empathetic regard for all of the patients.
The most densely populated portion of Los Angeles was selected for the first REGROWTH office, which opened in 1986 prior to the US FDA approval for 2% minoxidil solution and which was located in a small enclosed mall with heavy foot traffic. Perhaps because of its location, word got out that 2% minoxidil solutions would soon be available at a fraction of the price being charged at pharmacies at a time when 2% minoxidil solutions had to be custom compounded.
Because demand was so high and so intense and because Rogaine®) was not yet available in the U.S., REGROWTH supplied patients with the components and paraphernalia to produce their own 2% minoxidil solutions from prescription 10mg tablets of minoxidil. The instant demand for 2% minoxidil kits required setting up branch offices in the adjacent Orange and San Bernardino counties. All three offices were very busy, but on the very day the U.S. FDA approved Upjohn’s 2% minoxidil solution (Rogaine®)) as treatment for male pattern baldness, the Upjohn Company filed suit against REGROWTH for "inducement to patent infringement" (showing others how to compound minoxidil solutions). A quick settlement was reached in which REGROWTH could sell only Rogaine®) 2% minoxidil until the Upjohn Company’s patents on minoxidil solutions expired on 13 February 1996. Although REGROWTH's sales volume of Rogaine®) had been high, the profit margin on the sale of Rogaine®) 2% minoxidil was marginal, necessitating the consolidation of the practice into the original Los Angeles office and instituting a one-time-only $20 doctor’s consultation fee. Since there are rarely any side effects from the use of topical minoxidil, there were no compulsory follow-up visits. The fee and policy have never changed. A mail order program was established to service the patients for whom the location of the Los Angeles office was inconvenient.
In the nine years during which REGROWTH was restricted to prescribing and selling only Rogaine®, I did a great deal of research on minoxidil solutions and other medications for pattern baldness. It had already been well documented in the medical literature that minoxidil solutions in higher concentrations were more effective and just as safe as 2% minoxidil solutions for treating MPB. Other articles suggested that topical minoxidil used in conjunction with retinoic acid (Retin A®) might improve the treatment results.
For various physical and chemical reasons, compounding a suitable 5% minoxidil solution was more complicated than had been anticipated. It required many months of experimentation and a lengthy collaboration with a University of California Berkeley-affiliated pharmacologist to produce a stable, non-oxidizing, non-greasy-feeling, 5% minoxidil solution. The REGROWTH 5% Minoxidil Solution differs from Rogaine®) XS (5% minoxidil) and the OTC (over the counter) generic 5% minoxidil solutions by having a higher proportion of ethyl alcohol and a lower percentage of propylene glycol in the base. This change allowed for improved absorption of minoxidil and a decreased ‘greasiness’ of the solution. Unlike Rogaine®) XS or OTC 5% minoxidil solutions, our solutions are made on demand, so the increased amounts of propylene glycol are not necessary to extend the shelf life. These REGROWTH 5% minoxidil solutions have been made available both with and without 0.025% retinoic acid.
When Proscar® was made available for the treatment of benign prostatic enlargement, sporadic reports began to appear in medical journals of an interesting side effect of orally administered finasteride, i.e. some men reported an improvement of the hair on their scalp. It was a serendipitous, but very opportune finding. Further research and studies confirmed the role of DHT (dihydrotestosterone) in the pathophysiology of MPB. Not until I could be personally convinced of its safety and effectiveness did REGROWTH begin to recommend and prescribe finasteride to our patients. Beginning in March 1997, I began taking quartered tablets of Proscar® (5mg finasteride tablets) and to my pleasant surprise, grew thicker, more mature hair at the vertex. At age 58, this was quite unexpected. In December 1996 Merck & Co. filed an application with the FDA for approval of a 1mg daily dose of finasteride and on 19 December 1997, Propecia® was approved by the US FDA.
Although oral finasteride has proven to be a real breakthrough in the treatment of MPB, especially when used in conjunction with minoxidil solutions, many patients did not like the idea of enduring systemic effects from ingesting the medication. And all patients were justifiably concerned about the potential side effects associated with finasteride and the as yet unknown long-term effects. As such, REGROWTH has done extensive research to find effective and safe topical anti-androgens. There are two outstanding medications that are effective and safe: spironolactone and azelaic acid. These are both extensively tested and US FDA approved medications that have been in use for many years. Spironolactone is an excellent anti-androgen and works well to regrow hair by reducing the DHT in the scalp, but it had two negative properties. It has an inherently offensive odor and it can degrade rapidly. Again, I engaged the services of the same biochemist-pharmacologist who helped with the minoxidil base solution to solve these problems. After many months of research and development, the problems have been satisfactorily resolved. Our 2% spironolactone solutions are available in 2 ounce bottles with dabber tops and a 5% Spironolactone Lotion is available in 2-ounce jars. Unfortunately, minoxidil and spironolactone cannot be compounded into the same base, because within hours these medications interact chemically and degrade both of these active ingredients.
Xandrox was introduced in July 1998 and was a breakthrough product for the medical treatment of MPB. It was developed with the knowledge that the hair promoting action of minoxidil combined with the anti-androgen of azelaic acid would have potent, additive effects in combating male pattern baldness. Xandrox utilized and incorporated the only two proven safe and effective means to successfully treat MPB; i.e. the growth stimulating property of topical minoxidil and a medication to decrease the amounts of DHT in the scalp.
Xandrox combines in a single solution 5% minoxidil and 5% azelaic acid to provide the patient with simultaneous inhibition of DHT and stimulation to hair growth. On 30 April 99, Xandrox 12.5% lotion was introduced as a supplement to the use of Xandrox 5% solutions to treat those areas of the scalp that were not responding well to other therapies.
Another major REGROWTH accomplishment in the treatment of MPB was the formulation of alcohol-based solutions with minoxidil concentrations significantly higher than 5%. REGROWTH has a patent pending (U.S. utility application serial number 10/764,005, titled “Topical Solutions Comprising High Concentrations of Piperidinopyrimidine Derivatives and Methods of Use Thereof) for this compounding technique.
This innovative compounding technique allowed REGROWTH to introduce Xandrox15 in September 2003. The active ingredients of Xandrox15 include 15% minoxidil and 5% azelaic acid in an alcohol based solution. Xandrox15 is the single, most potent medical product for the treatment of MPB.
In response to a demand for a high concentration minoxidil solution for patients who were using finasteride or topical spironolactone to decrease the DHT levels in the scalp, REGROWTH introduced a 12.5% Minoxidil Solution in December 2006.
Many of the minoxidil solutions are available with and without the addition of retinoic acid (Retin-A®).
When scientific studies proved the value of a ketoconazole shampoo to reduce the amounts of DHT in the scalp, REGROWTH offered Treatment Shampoo (2% ketoconazole/3% salicylic acid) in March 2002.
Along with the array of medications for the treatment of MPB, REGROWTH takes pride in being responsive to the needs and questions of our patients. For the many patients who have untoward reactions to propylene glycol, we make minoxidil solutions, which substitute non-allergenic humectants. For patients who desired a more convenient method for applying topical solutions, we offer a dabber-top plastic bottle. For patients who requested retinoic acid solutions, we offer a 0.025% retinoic acid solution and a 0.050% retinoic acid solution, which were introduced in March 1997.
REGROWTH is organized and operates as a private medical practice. We take great efforts to be responsive to our patients’ needs and questions. Consultations are carefully reviewed prior to any suggestions for treatment. On a daily basis, scores of questions are individually and privately answered by email. Your concerns are our concerns as well.
I remain active in research and in evaluating and testing any promising new medications and techniques for the treatment of MPB and I hope to make them available if and when they are scientifically proven safe and efficacious. Meanwhile, REGROWTH will continue to supply our patients with the most effective products at the most affordable prices.
Richard Lee, M.D.
Hairs looking at you, kid!