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The HARMONY study puts objective data behind the aesthetic and psychological improvements delivered by a panfacial approach to facial rejuvenation. It’s also the first study to use video analysis, and online photo ratings from a representative sample of Americans, as outcome measures.
A 59-year-old female shown before (left) and four months after (right) the following treatments: Juvéderm Ultra XC (1.9 cc) in the nasolabial folds; Juvéderm Ultra XC (0.1 cc) in the perioral lines; Juvéderm Ultra Plus XC (1.2 cc) in the marionette lines; Juvéderm Ultra Plus XC (0.8 cc) in the oral commissures; Juvéderm Voluma XC (3.0 cc) in the midface; Botox Cosmetic (20 units) in glabellar lines, (24 units) in crow's feet; Latisse 0.03% (one drop to eyelid margin daily). Photos: Allergan
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).
Dr. Narurkar“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.
Dr. Shamban“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.
Dr. Narurkar says that he considers actual filler volumes used to be the single most important study finding. It was important to inject real-world filler volumes and “not the amounts you often see on podium or in clinical trials to get Grade 1 or 2 improvement, but still on-label usage.”
In the midface investigators used an average of three Voluma syringes per patient; and in the lower face, four syringes of Juvederm Ultra or Ultra Plus. For the glabella and crow’s feet, they used 20 to 24 units of Botox, respectively.
“Interestingly, the lowest volumes were used in the submalar area, which is different from the initial pivotal Voluma trial,” he says.
Although all treatment centers achieved significant FACE-Q improvements, blinded investigators compared results of the two top-performing centers versus the two lowest-performing centers to formulate treatment recommendations. In this analysis, Dr. Narurkar says, investigators observed similarities for most demographic and baseline characteristics.
“However, higher-performing sites exhibited greater improvement across all measures - whether it be satisfaction with appearance, aging appearance, social confidence or self-perception of age,” he says.
The differential between mean scores of the highest versus lowest performers ranged from 16% (subject’s global aesthetic improvement) to 103% (aging appearance appraisal).
The highest-performing sites also achieved the best results in all filler-related outcomes, he adds. In the HARMONY study the sites that achieved the highest patient satisfaction ratings used the lowest Voluma volumes, and the highest volumes of Juvederm Ultra and Ultra Plus XC. In the midface, top-performing sites used 2.7 cc of Voluma total, versus 2.9 cc total for the lowest-performing sites.
“As we have matured Voluma into our practice, we are using one to two syringes at most,” Dr. Narurkar says. “This again validates what we do in the real world versus the original pivotal clinical trials. We’ve shifted away from over-volumizing and contouring the face.”
Dr. Shamban adds that the study corroborates her clinical experience: “People really like to have their nasolabial folds treated.”
For an objective viewpoint, investigators created an online forum in which 2,000 everyday Americans used a nine-point scale to rate individual participants’ baseline and post-treatment photos in terms of characteristics such as attractiveness, successfulness, healthiness and approachability.
“The sample was weighted to represent the demographics of the U.S. population, which means that all ethnicities were represented. The objective was to evaluate how social perception of each HARMONY subject is impacted following panfacial treatment. It’s the first time this has ever been done in an aesthetic trial,” Dr. Narurkar said.
The online evaluators also judged which of two paired images expressed more of qualities such as attractiveness, friendliness and healthiness. People make such snap judgments constantly, Dr. Narurkar says. Quantifying these social impressions can result in more efficient use of filler products in individual facial areas. “And the magnitude of the observed benefit was extremely high,” he adds.
“This is the first time ever that a published, peer-reviewed trial has been done showing what happens at rest and in motion when you inject both toxins and fillers to the face,” Dr. Narurkar said.Patients had to make various facial expressions: smiling, frowning and grimacing, while being videotaped with standardized lighting and positioning. Based on video analysis, panfacial rejuvenation with fillers and neuromodulators provides very natural results.
“We do this intuitively in our practice – it’s realistic volumes,” evaluated both at rest and in motion, he says.
“The animation videos are especially helping me because I use them now in my toolbox. People often don’t know what they’re going to look like” after several combined procedures, Dr. Narurkar said. “There’s a fear of looking unnatural, of looking ‘done.’ I use all these different expressions - grimacing, smiling, frowning - to let them know they’re going to look like themselves. That’s a huge issue in doing panfacial injectables.”
Panelist Mary P. Lupo, M.D., says that it’s no shock to see that the more treatments patients undergo in proper combination, “the better they look and feel. But it’s great to have a scientific, peer-reviewed publication that proves to patients that we’re not just ‘selling’ them when dermatologists recommend specific aesthetic treatments.” Dr. Lupo is a New Orleans-based dermatologist in private practice and a co-founder of CBC.
In counseling patients, physiicans often share their opinion based on observational experience without offering insight from published research. The publication of this study may change that appoach. “With data now supporting conclusions dermatologists have long held anecdotally, we can say, ‘Look at the study, it showed that when you use all these products in combination, people not only felt better about themselves subjectively, but objectively, people also thought they looked better.” Dr. Lupo said.
Drs. Narurkar and Shamban advise dermatologists to monitor the ongoing stream of publications that will be based on HARMONY data.
“I encourage you to follow it because it’s directly relevant to how dermatologists and other core aesthetic physicians practice,” Dr. Shamban said.
The HARMONY study was sponsored by Allergan.
1. Klassen AF, Cano SJ, Scott A, Snell L, Pusic AL. Measuring patient-reported outcomes in facial aesthetic patients: development of the FACE-Q. Facial Plast Surg. 2010;26(4):303-9.
2. Allergan. Data on file.