Beyond the Vertex
Objective evidence shows minoxidil's frontal-scalp performance
Mar 1, 2003
Dermatology Times

Patient at baseline (left) and 48 weeks posttreatment with 5 percent topical minoxidil. (Photographs courtesy of Elise Olsen, M.D.)
Durham, N.C. -- Objective evidence now shows that topical minoxidil (Rogaine) is effective in frontal areas of the scalp, and not just in the vertex area in male-pattern hair loss (MPHL).

"This drug works in all areas of the balding scalp," said Elise Olsen, M.D., professor of medicine, division of dermatology, Duke University Medical Center, Durham, N.C.

Dr. Olsen and colleagues have gathered data from a review of global photographs of men with MPHL treated with two different concentrations of topical minoxidil.

Dr. Olsen explained that previous research using target area hair counts had shown minoxidil to be effective in the vertex area of the scalp. Now the use of global photographs shows minoxidil's effectiveness in treating frontal-area hair loss as well.

"Using global photographs to look at the frontal area treated with minoxidil had not been done previously," she said.

The researchers set out to document hair growth with minoxidil applied in the frontal region of the scalp -- the area where men are keenly aware of their hair loss every time they look in the mirror.

Of note are the visible improvements seen in the frontal areas after just 16 weeks of treatment.

"As early as 16 weeks, you could separate out each of the treatment groups [from placebo]. Most hair growth promoters don't work that quickly to see a response so early on," she said.

The multicenter, double-blind, placebo-controlled study evaluated a total of 252 balding men. All had 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." She said 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.

Dr. Olsen has no financial interest in minoxidil, but has been a principal investigator on topical minoxidil-related MPHL trials in the past and is a consultant for Pharmacia.