While there is an increasing interest among men in cosmetic procedures, there is little research in this area to guide physicians. Experts say that customization is best for tough cases.
There is an increasing interest among men in cosmetic procedures, but to date, there is little research in this area to guide physicians. In fact, one analysis shows that of 17 clinical trials on botulinum toxins for aesthetic indications, only 11 percent of the patients were men.
This is noteworthy because men and women have faces that are structurally different and as such, they may respond differently to botulinum toxin injections, says Derek Jones, M.D., of Skin Care and Laser Physicians, Beverly Hills. Dr. Jones is the lead author of an analysis of Xeomin treatment for glabellar frown lines in men.
The study was presented at the American Society for Dermatologic Surgery meeting in October.
Dr. Derek Jones
“There remains a need for research that addresses how men and women respond differently to aesthetic treatments in order to guide individualization of treatment plans. Because publish data to meet this need are lacking, we are pleased to present this post hoc analysis,” Dr. Jones says.
Despite the lack of clinical studies in men, the use of minimally invasive cosmetic procedures in men continues to grow. In just 10 years between 2006-2016, there was a 50% increase in botulinum toxin injections among men, a 40% increase in minimally invasive procedures and a 230% increase in injectable dermal fillers with hyaluronic acid (HA) and calcium hydroxylapatite (CaHA).
Men and women respond differently
Differences in facial structure may explain why men and women respond dif erently to botulinum toxin injections. Men have more muscle mass in the glabellar area than women. Facial anatomy plays a role as well. Differences in skull shape with bony prominences and vascularization may affect treatment outcomes.
Men generally have different goals than female patients. While men may seek treatment for glabellar frown lines or periorbital puffiness to look less tired in the work place, their objective may not be to achieve a youthful exuberance.
In a post-hoc analysis of randomized, double-blind studies on the treatment of glabellar frown lines in men, Dr. Jones and colleagues reported that, in general, men have lower response rates to botulinum toxin injections used to reduce the appearance of wrinkles. For this reason, researchers say customized treatment plans are important for male patients.
“This data mirrors what I see in my daily practice in botulinum toxin A for male aesthetic patients: Individualized treatment plans for males may require a higher initial dose to achieve similar results to females. Men with strong, hypertrophic glabellar complex do not always adequately respond to FDA-recommended dose of 20 U and these first-time patients may require a touch-up treatment at a two-week follow-up,” Dr. Jones says.
The analysis included data from U.S.-based phase three clinical trials that included 55 men with moderate-tosevere glabellar frown lines. Thirty-four of the men received 20 units of incobotulinumtoxinA (Xeomin/Merz Pharma GmbH) (4 U in 0.1 cc in each of 5 injection sites in the GFL) and 21 received a placebo.
A second European study cited in the presentation included 21 men with moderate to severe glabellar frown lines, 11 of whom received incobotulinumtoxinA for upper facial lines, and 10 received a placebo. The study examined the combined treatment of glabellar frown lines, crow’s feet and horizontal forehead lines.
The Jones analysis showed that after treatment with 20 units of incobotulinumtoxinA for glabellar frown lines in both men and women, men had a lower treatment response rate on both the Facial Wrinkle Scale (FWS) and Merz Aesthetics Scale (MAS). The results were consistent with the European study.
One endpoint in the U.S.-based studies was defined by men and women who achieved a score of zero or one on FWS. Fifty-six percent of men and 81% of women achieved this endpoint at maximum contraction 30 days post treatment.
A second endpoint was defined by the percentage of subjects who achieved at minimum, a single point change on FWS at maximum contraction 30 days post treatment. A high proportion of both men (79%) and women (87%) achieved this endpoint (investigator assessed).
This compares to 65% of men and 75% of women who achieved at minimum of a single point change on a four-point scale at rest (subject assessed).
“A one-point improvement at rest was considered an important indicator for subjects who received an aesthetic benefit that was observable during typical real-world circumstances (ie, without having to fully contract their muscles),” researchers stated in the presentation.
In the European phase three study, which assessed all upper facial lines and GFL at maximum contraction, 55% of men and 84% of women achieved a score of zero or one on MAS for GFL at maximum contraction at 30 days. This compared to 82% of men and 97% of women who achieved at least a one-point change on MAS at maximum contraction.
Similar trends in the differential response to botulinum toxin products between men and women have been observed in separate studies on Botox.
This study was funded and conducted by Merz North America, Inc.
Derek H. Jones, MD; Martina Kerscher, MD; Thorin Geister, MD; Michael A. Hast, MD; Petra Weissenberger, MD. “Effi cacy of Xeomin for the Treatment of Glabellar Frown Lines in Male Subjects: Post-Hoc Analyses from Randomized, Double-Blind Pivotal Studies,” ASDS annual meeting, October 2017.