Authors: Richard Fried MD Ph.D, W. Phillip Werschler, MD, Judith Cenci, MD, Lauren Sternberg MD, Priya Dhanaraj MD, Dara Tolas MA, Suzanne Withrow MA
Facial volume loss can substantially impact both self-perception of the affected individual and their social/professional interactions and opportunities. Persons who are perceived as more youthful and attractive are rated as nicer, more energetic, healthier, and more likely to be productive than those perceived to be older and unattractive.
The observed facial changes that result from underlying volume loss associated with age and photodamage often produce an older and less attractive appearance. Loss of facial volume often produces a sad, sunken, deflated, dull, tired, and lackluster appearance. These changes can be interpreted as evidence of aging and loss. In addition, some may consciously or subconsciously see these changes as harbingers of their own progressive deterioration and decline. Injection of approved fillers into the upper face, mid face, and lower face can create a more youthful, better rested, and kinder appearance. Randomized controlled trials (RCT’s) demonstrating the effectiveness of injectable fillers in improving emotional and functional status remain scarce.
It’s About Time
A hallmark of hyaluronic acid and calcium hydroxyl appetite filler products is their ability to produce immediately apparent volumetric changes. The recent proliferation of technologically improved hyaluronic fillers has dramatically enhanced the armamentarium available to active clinicians. Claims of anatomic regional superiority and longer duration are enticing. The early days of fillers characterized by “briefly there till completely gone” are being supplanted by “there now, persistently there, and stimulatory for a reasonable period of time.” This is a meaningful step forward; persistence of filler presence with enhancement of collagen production. It can be argued that this represents a true slowing of the facial aging process. Understandably, “filler wars” abound with manufacturers claiming product superiority and battling for dominance in the hands of clinicians.
In contrast to the immediate deposition of hyaluronic acid or calcium hydroxyl appetite, another option exists for enhancement of collagen production and persistence of benefit. Poly-L Lactic Acid is an extremely effective stimulator of collagenases and fibroplasia that produces gradual volumization of the treated areas. While there is apparent immediate volume repletion with PLLA injection, it is mostly from the sterile water and lidocaine commonly used to prepare the product and thus largely dissipates soon within days after injection. The subsequent enhancement in collagen production and facial volumization occur gradually over the 1-3 months following each injection. Optimal correction usually occurs 1-3 months after 3-4 monthly injections of a full vial of PLLA. While the exact dilution of PLLA varies among injectors, 6-7cc’s of sterile water with 2 ccs of lidocaine are frequently reported.
Poly-L-lactic acid (PLLA) is a synthetic, biocompatible, biodegradable polymer. For its use in soft tissue augmentation, it is supplied as a lyophilized powder containing PLLA microparticles, the size and chemical attributes of which are tightly controlled. As a biocompatible material, PLLA generates a desired subclinical inflammatory tissue response that leads to encapsulation of the microparticles, stimulation of host collagen production, and fibroplasia. Over time, the PLLA degrades, the inflammatory response wanes, and host collagen production increases. This response leads to the generation of new volume and structural support that occurs in a gradual, progressive manner, and which can last for years.
Timing is everything; In life, in love, in business, in theatre, and in fillers. More information is needed to assess whether the delayed onset of clinically evident volumization produced by PLLA injection will still deliver patient satisfaction and favorable changes in emotion and function.
Purpose of the present study
A consideration among some clinicians is the “delayed gratification” aspect of poly L-Lactic Acid. While the efficacy, safety, and duration of PLLA injection benefits are well supported by the literature, its mechanism of action as a strong biostimulator that produces gradual tissue augmentation over several months is unique. Many clinicians wonder whether patients will objectively “remember” their baseline appearance and subsequently be satisfied with their ultimate cosmetic outcome. Is the immediate “correction” provided by hyaluronic acid and calcium hydroxyl appetite fillers, available to all who see (including and especially the recipient), a stellar positive or a potential negative? Is it possible that some individuals might be embarrassed or self-conscious about the sudden change in their appearance? Might the gradual changes and equal or better volumization with greater duration produced by PLLA injection produce a more psychologically comfortable transition in appearance with equal or greater satisfaction in outcome?
The goal of this study was to assess the changes in emotional and functional status of subjects treated with 2-4 monthly PLLA injections to the upper, mid, and lower face.
The Study
50 subjects were recruited from 2 community US based dermatology centers (Bucks County Pennsylvania and Spokane, Washington). 50 were eligible and enrolled according to protocol inclusion and exclusion criteria, 49 females and 1 male. 58% of subjects were age 45-60, 33% 60-75, and 8% 35-45. The protocol was approved by a central IRB and full informed consent provided.
Two patient self-report measures were utilized, The Facial Volume Restoration Outcome Questionnaire (Table 1) and the Rosenberg Self Esteem Scale (Table 2). The Facial Volume Restoration Outcome Questionnaire is a 35-item patient self-report Likert scale based instrument. Subjects self-report and self-rate selected areas of their emotional and functional status. The Rosenberg Self Esteem Scale is also a Likert scale based instrument measuring overall self-esteem. Subject self-report measures were completed at baseline and 6 months after their first injection. Facial volume loss was assessed on a 0-4 scale (Table 3) pre-treatment and post-treatment by the principle investigator or a Sub-Investigator.
Subjects were injected monthly with one full diluted vial of PLLA over 3 or 4 consecutive months.
Subjects received 1 full vial of poly L Lactic acid at each treatment visit. The PLLA was reconstituted with 7cc of sterile water and 2cc of lidocaine without epinephrine. The contents of the vial were injected in areas deemed appropriate by the certified injector and agreed upon by the study subject. Approximately 4-6 weeks later, a second vial was reconstituted as above and injected according to the above parameters. Finally, approximately 4-6 weeks later (12-16 weeks after the first injections), subjects were evaluated and a decision was jointly made with the injector regarding whether a third vial was desired and appropriate. All 50 subjects were injected at week 1, 49 subjects were injected at second visit, and 35 were injected at the third visit.
Results
Pre-and post-assessments were completed on 41 subjects. The remaining 9 were lost to follow-up or withdrew and did not complete the post filler instruments or return for investigator evaluation. None failed to return due to known AE’s. Approximately 30% of subjects who completed pre-and post-injection instruments reported increased confidence, increased sense of control, increased productivity, increased comfort with others, feeling more attractive, increased happiness when looking in the mirror, more happiness when their faces were touched, healthier eating, increased contentment, beliefs that they were seen as less stressed by others, they were happier with their bodies, they are exercising more, and that their lives were better. 43% felt more optimistic and 33% felt less anxious (Table 4). The changes in self-esteem self-reported on the Rosenberg scale were very modest but also favorable. IGA of facial volume loss improved from 2.2 at baseline to1.2 at 6-month follow-up assessment (lower score suggesting less volume loss).
Discussion
Injection of PLLA is a safe and effective method for facial volume and contour restoration. A potential “draw-back” or “negative” of PLLA injection is the delay in clinically evident volume repletion. The improvements are gradual as enhanced endogenous collagen production and fibroplasia replenishes volume depleted areas. In the present study, we essentially assessed the following question; “Can patients “be patient”, objectively remembering their previous appearance sufficiently to appreciate the improvements in their appearance provided by their own enhanced collagen production and fibroplasia. The present data suggest that the answer is “yes they can”. Many subjects did indeed perceive favorable emotional and functional improvements at 6 months after their first PLLA injection. Clinicians should consider “growing younger gradually” is a palatable option for patients. More gradual clinical change may evoke fewer comments, questions, and stares while delivering the desired cosmetic, emotional, and functional results. Buttressing and clarifying the data on the emotional and functional benefits of facial volume restoration can further “legitimize” treatment with poly L-Lactic Acid as an effective and meaningful medical procedure. Dissemination of data substantiating that volume restoration is more than simply a vanity intervention can serve as a compelling “recruitment tool” for the growing number of “maturing persons” struggling with the deflation and lackluster appearance that accompany the volume loss associated with aging, medications, stress, and illness.
Perhaps the “slow and steady wins the race” adage remains valid!
Limitations of the study include recognition that the favorable changes reported may not be a direct result of their filler experience and lack of quantification of Likert Scale gradations.
