Minoxidil as a Treatment Option for Crown Hair Loss

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Introduction: As noted in the history of minoxidil, minoxidil is a topical solution that is applied twice a day and rubbed into the scalp and balding areas. It comes in 2 percent and 5 percent (extra strength) formulations and can slow, and/or halt baldness in a majority of patients and has proven to regrow hair in 30 to 85 percent of men, depending on which clinical study you read, and how success is measured. There is also a 2 percent version for women who actually respond better to the medication than men do.(26) Lifetime use of minoxidil is necessary to maintain new hair growth, or hair loss stoppage, thus it requires a firm committment. (Article continues below ad)

How it might work: Doctors and researchers are not entirely sure how minoxidil regrows hair, but they have speculated that minoxidil works by keeping hair follicles in the anagen phase longer by enlarging and regenerating the hair follicle through some mechanism. It had BEEN thought that since it was a vasodilator, it might increase blood flow to the scalp/hair gland, but this theory is no longer being considered since similar blood pressure vasodilator medications do not have the same side effect as minoxidil. According to new studies by L'Oreal, it has been suggested that minoxidil works by activating an enzyme called prostaglandin endoperoxide synthase-1, which helps promote hair growth. (28b)

Efficacy (Effectiveness of Minoxidil, Rogaine Foam)

Who does it work best for?

Minoxidil has mostly been known as a hair loss drug that works best for crown hair loss (vertex).

"Regrowth is more pronounced at the vertex than in the frontal areas and is not noted for at least 4 months. Continuing topical treatment with the drug is necessary indefinitely because discontinuation of treatment produces a rapid reversion to the pretreatment balding pattern." (28)

The younger one is, and the more recent the hair loss, the better the chance minoxidil will work for that patient. "Patients who respond best to this drug are those who have a recent onset of androgenetic alopecia and small areas of hair loss." (28)

Besides working best on the mid-scalp and crown areas, minoxidil is effective in assisting hair transplantion efforts.

"Minoxidil is often more effective in improving hair growth in central areas of the scalp than in frontal areas. It is often effectively used by physician hair restoration specialists to complement hair transplantation, contributing to an appearance of "fullness" in scalp hair." (28)

Minoxidil can also reportedly halt and/or slow hair loss, but it can not win the battle against the aging process forever. Sooner or later, age and genetics will cause even minoxidil treated hair to fall out. However, this might be at a slower rate or with less hair fall than without using minoxidil. Further information about age and effectiveness is detailed in a summary below.

Statistics & Studies:

As stated above, the effectiveness rate of minoxidil in treating hair loss seems to vary with each study. Since one of the first major studies of 2200 participants at 27 testing centers, no other study has been conducted with a similar sample size (number of participants), nor has there been much uniformity in the length of treatment measured which has ranged from 16 to 120 weeks. Quite simply, there is no possible way to look at all the studies conducted since 1985 to present and develop a statistical average of the mild to moderate to changes in new hair growth, or continued hair loss for subject participants. On the official website for Rogaine, rogaine.com, the company claims their new foam delivery system can achieve hair regrowth in 85 percent of male users. "ROGAINE^® Foam regrew hair in 85% of men after 4 months when used twice daily."

This claim of 85 percent is somewhat of a mystery as Rogaine.com doesn't link to it from their website. This leads one to dig through tons of minoxidil studies that are ambiguous in their explanation and results. Even the one study that focuses on 5 percent minoxidil foam failed to give hard statistical numbers and only said it was superior to placebo based foam. Duh. (29)

However, after hours and hours of reading and amateur detective work, I believe I have discovered the jewel to which Rogaine refers to in their claim: "Rogaine Foam regrew hair in 85% of men after 4 months when used twice daily" - claim from their website and advertisements.

The study is actually a post-market study, paid for by Pfizer (just before they sold Rogaine to Johnson and Johnson), and conducted in Germany on both patients and doctors. To be honest, it's actually just one of two studies commissioned by Pfizer. The first is:

1. A one-year observational study with minoxidil 5% solution in Germany: results of independent efficacy evaluation by physicians and patients, (29) (and the second study is):

2. Rapid onset of action of minoxidil 5% topical solution in a 4-month German observational study on both patients and physicians.(31)

Both studies were presented at 62nd Annual Meeting of the American Academy of Dermatology, Feb. 6-11, 2004. in Washington, DC. By March, those findings were published in the Journal of the American Academy of Dermtology, which can not be read unless one registers. Fortunately, the International Society of Hair Restoration ran a story on these new finding and boiled them down into a shortbut informative article at: ISHRS.org/articles/minoxidil-study.html

A chart built from the first test, shows:

One year post-market study on 5 percent topical solution minoxidil on 984 men. Conducted by physicians in Germany.
Funded by Pfizer Group, maker of Rogaine. 2002-2003 (30, 31)

To reach something like 85 percent, we have to add up all the totals in the second row, "Stimulating Hair Regrowth. So we then ad 15.9 + 47.8 + 20.6 = 84.3 percent regrowth of hair. Okay, it's not 85, but it could fit with a margin of error. One thing unclear from this study, conducted in 2002 to 2003, is whether the men were using the new foam based version, or the old liquid spray solution.

Just prior to Upjohn's FDA approval, back in 1988, the company ran an extensive test and trial of 2200 patients through 28 testing centers over 12 months. Approximately 1,833 men completed the study on the 2 percent formulation and researchers found 40 percent of those who completed the 12-month trial were found by researchers to have had ''moderate to dense terminal hair growth.'' Terminal hair is thick-pigmented hair, as opposed to downy nonpigmented hair, called vellus.

The Upjohn study found that younger people grew hair more rapidly than older people, with:

• 54 percent hair regrowth for those under 30.

• 45 percent for those 31 to 34 years-old.

• 41 percent for the 35 to 39 years-old.

• For those aged 40 to 49, about 26 percent were found to have had moderate to dense growth after a year of taking the drug.

In later tests, with the 5 percent formulation, these statistical odds of regrowing hair not just on the crown, but also on the mid-scalp and even the frontal zone areas would improve. (33)

In 2002, researchers compared minoxidil 2 percent with minoxidil 5 percent and concluded:

In men with AGA, 5% topical minoxidil was clearly superior to 2% topical minoxidil and placebo in increasing hair regrowth, and the magnitude of its effect was marked (45% more hair regrowth than 2% topical minoxidil at week 48). Men who used 5% topical minoxidil also had an earlier response to treatment than those who used 2% topical minoxidil. (34)

However, this is a confusing statement. Did 45% of the men grow more hair, or was 45 more hair growth achieved on the 5 percent group as opposed to the 2 percent group, according to hair count?

Outside the realm of crown hair loss (and those with crown hair loss are usually suffering some form of frontal hair loss), a 2003 study that was published revealed that 5 percent minoxidil did show some success in treating frontal hair loss: The report from Dermatology Times: (35)

Includeded 252 balding men all Hamilton-Norwood patterns III-V hair loss. Each man's hair loss was documented and classified at baseline by global photographs of the frontal and vertex scalp areas. The three treatment arms of the study consisted of 139 men using a 5 percent topical minoxidil solution, 142 using a 2 percent topical minoxidil solution, and 71 on vehicle alone (placebo). The men applied 1 mL of solution twice daily to the entire top of the scalp, including the vertex and frontal areas.

Polaroid photographs were taken at baseline and again at weeks 16, 32, and 48. Electronic images of the photographs were evaluated by an independent panel of three blinded, board-certified dermatologists experienced in doing photographic reviews.

The panel members compared each man's photos from weeks 16, 32, and 48 to his baseline photo. They then independently classified the hair growth as "no change," "slight increase," "moderate increase," "great increase," or "slight decrease," "moderate decrease," or "great decrease." At the study's end, the three judges' scores were combined into a final classification for each patient.

Results at 48 weeks (study conclusion) show that visible, photographically evident improvements were seen in the frontal scalp regions of 51 percent of men using 5 percent minoxidil, 42 percent using 2 percent minoxidil, and 13 percent of placebo users. Among these men, moderate to great increases in hair growth were seen in the frontal scalp regions of 19 percent of men using 5 percent minoxidil, 10 percent using 2 percent minoxidil, and 3 percent of placebo users.

"Most patients might think topical minoxidil only works in one part of the scalp," Dr. Olsen said, adding that the current package insert states minoxidil's effectiveness in the vertex region but does not address the frontal region.

"Limitations in terms of claims of efficacy are related to the research methods used. ...patients must understand that the FDA will not allow package-insert claims of hair growth in scalp areas not specifically targeted from the outset of the study. So it may help to explain to men that although minoxidil's efficacy in MPHL was previously shown by hair counts done only in the vertex region, global photographic evidence now proves minoxidil's effectiveness in the frontal region as well.

"Now we have objective evidence that shows minoxidil indeed works in other parts of the scalp, including the frontal area, as shown on global photographs," Dr. Olsen said.

In a small but important 2004 study comparing the efficacy of finasteride over minoxidil in, 80 percent of the patients receiving the 1 mg a day finasteride pill saw increased intensity of hair, while only 51 percent of the rogaine group saw improvement. This test was conducted on a Turkish Army medical school, and consisted of 65 total male patients.(36)

The results of more studies can be viewed here:

Side Effects:

The side effects of minoxidil are mild to non-existent and include dry scalp, itching and dandruff. Minoxidil is extremely dangerous to cats and may cause death. Any contact with between cats and areas that your scalp might touch (pillow, blankets, couch, reclining chair), should be avoided.

Increased Shedding:

When first used, minoxidil has the peculiar effect of increased hair shedding. It actually causes more hair shedding as the mechanism of action sends more hairs from the anagen to the telogen phase. Johnson and Johnson, researchers and dermatologists report this is quite normal and necessary in order for your scalp to make way for new hair growth. Keep in mind that the hairs lost were already headed into the telogen phase.

ROGAINE® stimulates hair follicles to shift from the resting phase to the growth phase. Thus, it is not uncommon to see a temporary increase in shedding during the first 2 weeks using ROGAINE®. This occurs in some people as the new hair pushes out the weak hairs, when the hair follicle shifts into the growth phase. It is very much like losing baby teeth to make room for adult teeth. This increase in shedding is only temporary and should subside within a couple of weeks with continued treatment. Please note, however, if increased shedding continues for longer than 2 weeks, you should consult your doctor to rule out other possible medical problems. (38)

Other Important Notes:

• The shelf life of Rogaine foam is 2 years.

• Women's version of rogaine only comes in 2 percent instead of 5 percent mostly because the 5 percent didn't prove to be that much more effective. Women generally respond better to minoxidil than men.
  
  
• Minoxidil can assist with hair growth and the hair growth cycle before/after hair transplantation. "Based on the surgeons' clinical experience, the use of approved hair regrowth agents in hair transplant patients with viable but suboptimally functioning follicles in the region to be transplanted can increase hair density, speed regrowth in transplanted follicles, and complement the surgical result by slowing down or stopping further hair loss." (37).
  
  
• Super extra strength versions of minoxidil in 6 percent, 12.5, and 15 percent are available online from Regrowth LLC which com.(38b)