Facial volume loss, resulting from aging, disease or hereditary conditions may lead to dramatic changes in appearance. The use of fillers injection for superficial (lip fillers) and deep (Check augmentation) soft tissue augmentation is one of the four main interventions, commonly used for the aging face, which include resurfacing, red raping, relaxing and replacement.
Upper and lower lips injection have an important role in face aesthetic perception. The ‘ideal lip’ is a full lip, with a well-defined vermilion border. Furthermore, the correct balance between the upper and lower lips is important from an aesthetic point of view. Aesthetic standards vary across cultures and over time, but at present, full, well-defined lips are the ideal in Western cultures.
A variety of suitable materials for soft tissue augmentation exists. Natural fillers, such as collagen, hyaluronic acid (HA) (Juvederm) and calcium hydroxylapatite, are synthesised or derived from biologic materials. Synthetic fillers may be permanent, such as acrylates and silicone, or biodegradable, such as poly-L-lactic acid.
HA fillers is currently the main active material for lip augmentation and lip injection; it is used in various procedures including increasing the overall volume of the lip or enhancing the vermilion border and sculpting and accentuating lip.
HA is a polysaccharide (specifically a glycosaminoglycan that is formed from repeating D-glucuronic acid and D-N-acetylglucosamine disaccharide units) found naturally in the dermis. Its ability to bind water helps in hydration and provides skin turgor.
HA fillers injection are formed from either bacterial based or animal-based substances. In 2004, these fillers got the Food and Drug Administration (FDA) permission for use in tissue augmentation and at this time, there are twelve FDA approved HA fillers used in the USA.
Several open-label reports or randomised, no treatment – controlled studies, have described the effectiveness of HA in lip injection augmentation. However, there are different HA products on the market, and the process of development in the product is still continued.
This report presents the results of Phase II, before – after designed pilot study, which assesses the safety, efficacy and longevity of a new Juvederm filler injection with synthetic origin for upper lip injection augmentation.
HA filler tested in our study (a cross-linked HA with synthetic origin) showed to be effective for upper lip injection augmentation, according to the improvement of the MLFS scoring and as well as by the IGA in weeks 2, 12 and 24 after treatment.
Multiple assessment methods were used in this study to confirm the benefit of a HA product injection for lip augmentation. Grading by the investigator, volunteers’ satisfaction and independent review of photographs taken during the study by a blinded evaluator, all showed the significant effect of this HA soft tissue filler.
MLFS is 5-point scale that has been validated for measurement of lip fullness and observations suggest that its reported changes are clinically meaningful and aesthetically visible. Additionally using MLFS is very common in lip augmentation assessment studies.
Evaluation of MLFS scores, 12 weeks after treatment showed improvement in 70% of volunteers. This result is numerically lower than seen in similar studies performed by Glogau et al.,Eccleston and Murphy and also Solish and Swift; where the percentage of responders were between 85% to 95%.
The findings of response to treatment rate 24 weeks after treatment support the results reported in Eccleston and Murphy study (80%) as well as Glogau et al.(70%), and seems more impressive than results reported by Fagien et al.; where improvement in MLFS reported in 56% of volunteers.
No statistical difference was found in response to treatment rate between follow-up visits in 2, 12 and 24 weeks after treatment. This is a sign of persistence of the effect of the tested product up to 24 weeks after treatment (P = 0.83). This durability compares favorably with avian lip fillers injection products which produce results that last between 4 and 6 months and markedly better than collagen products (animal and human) with an average durability of 3 months.
According to the data from the IGA, the efficacy and durability of the tested lip filler injection were scored between 3 and 4 which represent improved and much- improved scores. This assessment matches almost well with the blinded evaluator’s assessments, in which 70–80% of subjects were rated as improved at 2, 12 and 24 weeks.
Higher values of effectiveness were reported by the investigators in study conducted by Klein; where 100% improvement reported in week 12, and 84% in week 24 after filler injection The difference may be due to different scales of measurement in two studies; since Klein used Global Aesthetic Improvement Scale (GAIS) to report the investigator opinion about the effectiveness and persistence of the filler.
Treatment for lip injection augmentation in this study was almost safe and well tolerated. The safety assessments for lip injection augmentation are defined based on a set of outcomes, including normal lip texture, firmness, and symmetry, preserving the natural movements, function and sensation of the lips and also no mass formation in treated site. Almost all of the mentioned outcomes have been achieved in this study and no severe side effects or significant asymmetries were noted during the trial. Only one subject had lump formation that lasted until the end of the study.
The majority of reported complications were anticipated such as pain and bruising and were mild in severity, and generally resolved within 5 days. The time of resolution of these events in a similar report was almost 2 weeks after lip filler injection.
The subjects were almost satisfied with their lip improvement (average VAS = 6.8 in week 24). Although in some trials, GAIS has been used to assess patient’s satisfaction from an aesthetic point of view; we prefer to use visual analogue scale (VAS) as an alternative tool for this purpose. VAS is reported as a good measurement tool to evaluate volunteers’ subjective aesthetic evaluation besides, it is more easy to understand and less confusing for volunteers in compare with GAIS.
This was an open-label study and one of the most important limitations was the lack of control group. The design of this study did not permit us to omit the placebo effect. It should be considered that this setting is a common design for studies of dermal fillers in the lips, especially in case of initial and pilot studies. In addition, to compensate this limitation, our assessment methods designed in a way to have the minimum subjective findings (only in case of volunteers’ satisfaction scoring).
Although, the small population of study subjects might limit any clinically meaningful conclusion from the data, yet as a pilot study, the results showed that the tested HA filler provided a beneficial, durable treatment for the upper lip augmentation with a good safety profile.
Do not hesitate to contact us for a free consultation about lip fillers. We over stress-free six-month payment plan upon approval.
This post is a citation and a copy of an article by Kashani et al., entitled “Assessment of the Efficacy and Safety of Hyaluronic Acid Gel Injection in the Restoration of Fullness of the Upper Lips” published in the Journal of cutaneous and aesthetic surgery.