The first prospective study evaluating a comprehensive approach to multimodal facial aesthetic treatment shows that combining fillers, neuromodulators and topical agents can achieve significant subjective, objective and psychological improvements, said investigators at The Cosmetic Bootcamp (CBC) 2017. The research provides compelling data that should help both clinically and in patient consultations, they added.
The HARMONY study evaluated the overall impact and psychological benefits of multimodal injectable and topical treatments including Juvederm Voluma XC, Juvederm Ultra XC, Juvederm Ultra Plus XC (all hyaluronic acid/HA, Allergan), Botox Cosmetic (onabotulinum toxin A, Allergan) and Latisse (bimatoprost, Allergan).
“We do this all the time in our practices,” says study co-author Vic Narurkar, M.D. “We often start patients on one treatment, then lead them to another as needed. But never has this been looked at in a prospective fashion — when you do what we like to call panfacial rejuvenation with aesthetic injectables.” He is founder and director of the Bay Area Laser Institute, chairman of dermatology at California Pacific Medical Center, San Francisco, and a CBC co-founder and director.
Study co-author Ava Shamban, M.D., says dermatologists know anecdotally the physical and emotional boost that combination aesthetic treatments can bring, but this study shows that what we do in practice leads to people feeling significantly better about themselves with real established social and psychological benefits. Dr. Shamban is a Santa Monica, Calif.-based dermatologist in private practice.
Investigators at 10 U.S. sites enrolled 100 patients (including 96 females) between ages 35 and 65 years who had never had botulinum toxin therapy of any serotype, or prescription eyelash products, prior facial plastic surgery, permanent or semipermanent fillers, laser resurfacing of the face or neck, or mesotherapy. Patients also had to refrain from off-protocol facial treatments (such as chemical peels) during the study.
At the baseline visit investigators performed filler injections in the midface and perioral areas and instructed patients to apply one drop of Latisse (bimatoprost, Allergan) per eyelid nightly for 17 weeks. At day 14 investigators touched up filler treatments as needed. Investigators injected up to 4 cc of Juvederm Voluma total, and up to 6 cc of Juvederm Ultra or Juvederm Ultra Plus, per patient. At three months patients underwent onabotulinum toxin A injections (up to 20 or 24 units for the glabella and crow’s feet, respectively), followed by an evaluation visit at month four. Additionally, patients assessed their own results using a new age appraisal visual analog scale.
The study’s primary endpoint was change in FACE-Q Satisfaction with Facial Appearance Overall scores from baseline to month four. The FACE-Q is “a validated instrument that consists of independently functioning scales measuring symptoms and concepts that are important to facial aesthetic patients,” Dr. Narurkar says.
The proportion of patients treated in four or five facial areas was 83%. Between baseline and month four; mean overall FACE-Q score rose 31.7 points (p<0.0001).2
Among secondary endpoints, “psychological well-being improved dramatically,” from a mean FACE-Q of 61 at baseline to 82 at month four (p<0.0001). Regarding self-confidence, patients reported that after treatment they felt more comfortable in social, dating and business situations. Additionally, “people perceived themselves as looking 4.6 years younger on average. A significant portion said they looked six years younger.”
While it’s impossible for aesthetic treatments to literally reverse aging, “we can look the very best for our age” with aesthetic treatments.
In terms of Cohen’s effect, HARMONY facial enhancement results scored significantly higher than those of breast enhancement and just below those of hip replacement.
“That’s very significant because people think that doing (aesthetic) treatments is frivolous. It’s directly tied to wellness,” she says.
The study’s biggest surprise is the impact factor of panfacial global rejuvenation, according to Dr. Narurkar.
“Many times what we do is trivialized. Now we have this validated measure” of the impact that global aesthetic rejuvenation can have on a person’s well-being, he says.
“Even though the study size was fairly small, the results are significant in terms of both the injection approach and results,” Dr. Shamban said.
In a female patient, for example, Dr. Shamban says that reducing the “background noise” of lines and wrinkles allowed the patient’s signature feature to shine, her eyes.
“Her lines and wrinkles aren’t completely gone, but she got a relatively decent brow lift from the toxin. Her cheek lines and everything looks better,” she says.