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.