Restylane Kysse: Soft, Natural, Kissable, Long-lasting Lip Filler
Restylane Kysse debuts as the newest hyaluronic acid filler on the U.S. Market
I’m proud to share information on Restylane Kysse, the latest of the Restylane XpresHAn technology HA fillers that offers long-lasting, flexible and natural results for lip enhancement that are long-lasting. Restylane Kysse is also FDA-approved to treat upper lip lines.
I was fortunate to act as one of the 14 U.S. physicians that participated as injectors and clinical investigators in the the phase III clinical trial. The safety and effectiveness of Restylane Kysse in this lip filler study led to FDA-approval of Restylane Kysse in April 2020.
I recently shared with Allure Magazine some of the benefits of the newest hyaluronic acid lip filler to hit the U.S. market. Its long-lasting duration, natural appearance and ability to integrate into the lip seamlessly, and low incidence of side effects including minimal swelling are just some of its benefits.
I have included in this blog entry many of the Restylane Kysse subjects I personally injected and treated as a part of this trial so you can view the natural and structural support that this filler offers.
My early experience with Restylane Kysse began over 2 years ago. As a clinical investigator, I was one of only a handful of physicians in the U.S. to inject Kysse and gain our first American experience with the product. Restylane Kysse has an outstanding safety profile. It has been approved for use as a hyaluronic acid filler for lip augmentation in both Europe and Canada prior to U.S. approval.
In this blog entry, I would like to share some of our findings from the phase III clinical trial that Art of Skin MD participated in. I served as the injecting physician, and our talented Registered Nurse, Jessica Scott, BSN, RN, helped as a blinded evaluator for our study subjects. We have gained valuable insight ahead of most of the nation that allows us to deliver superior results with Restylane Kysse right from the start of FDA-approval.
What is different about Restylane Kysse compared to other lip fillers?
There are several distinct differences that make Restylane Kysse unique from other fillers on the market, including other products in the Restylane portfolio. Restylane Kysse is manufactured using XpresHAn technology. This proprietary method of cross-linking individual strands of hyaluronic acids imparts durability, softness, and flexibility. Restylane Kysse, like Defyne and Refyne (other fillers with XpresHAn technology), integrate well into the soft tissues following placement. This means that results look great in still photos and selfies, but they also look natural with facial expression and on video.
Restylane Kysse was studied for 48 weeks following injection in our phase III clinical trial. Due to its formulation, it is a longer-lasting filler. It has an FDA-approved duration longer than other lip fillers. Eight weeks after lip injection, 98% of treating physicians and 96% of patients noticed a significant improvement in their lips.
At 24 weeks, results are consistently impressive: 86% of treating physicians and 88% of patients noticed a significant enhancement of their lips. At the conclusion of the study (48 weeks after injection), 67% of treating investigators (physician injectors like me) and 78% of the treated patients saw a significant improvement still in both their upper and lower lips.
Restylane Kysse requires less product for a similar result in lips
In the pivotal clinical FDA trial, Restylane Kysse was compared to another lip filler, Juvederm Volbella. In this study, it was examined whether Restylane Kysse was inferior to Juvederm Volbella. It was not. In the clinical trial, it was found that 20% less Restylane Kysse was used than Volbella to achieve a similar level of lip fullness.
Volbella is a great choice for hydration of lips, and reviving lips that have great structure but just need a bit of improvement. Restylane Kysse is a more robust filler. Therefore, it is not surprising that it provided supportive filling with less product to achieve increases in lip fullness.
Restylane Kysse has few side effects following placement
In the FDA trial, the majority of Restylane Kysse lip injection patients experienced no side effects. Specifically, 61% of Kysse patients had not adverse events. The vast majority of Kysse patients that did experience side effects had mild adverse events, typically bruising or a temporary feeling of the product that resolved with time.
The incidence of mild side effects with Restylane Kysse was similar to Volbella. Swelling, like with Volbella, tends to be mild in nature and allows patients a quick return to work and daily activities.
Restylane Kysse Study: Patient and Partner Satisfaction with Lips
In addition to the Restylane Kysse pivotal noninferiority clinical trial that compared it to Volbella, a second study was conducted. The second Restylane Kysse study is a phase IV post-marketing study. It examined subject satisfaction in the aesthetic improvement of their lips following treatment with Restylane Kysse. Additionally, this unique study is the first to ask partners how they feel about lip enhancement. Husbands/wives, boyfriends/girlfriends, and partners provided feedback on how natural and kissable their partner’s lips were following Restylane Kysse treatment.
High Patient Satisfaction After Restylane Kysse Treatment
In the phase IV study, subject satisfaction was measured to see how satisfied patients themselves were with lip treatment using Restylane Kysse. In surveys that followed treatment, 98% of patients treated with Restylane Kysse were satisfied to very satisfied with the kissability of their lips. Importantly, 96% of patients felt their lips were natural to very natural following lip enhancement with Restylane Kysse. Lastly, 87% of treated subjects felt more attractive following Restylane Kysse injection to their lips.
Partners to the study patients were also asked to weigh in on the results. They found Kysse treated lips to feel natural and more kissable in 73% of cases.
Lip Expression, Texture, and Redness with Restylane Kysse
In this study, an independent physician reviewer rated how the subjects’ lips looked in various positions and facial expressions following treatment with Restylane Kysse. The vast majority, 80% of the treated subjects, were rated to have maintained natural expression following lip treatment.
The appearance of the treated lips were also evaluated. In terms of lip appearance, 77% of treated patients were rated as having improved lip texture. A rosy glow is considered an attractive feature to lips. In this Kysse study, the degree of lip redness following lip injection increased to statistically significant values.
Kysse and Tell: A summary of results
Restylane Kysse is the newest Restylane product crafted specifically for the lips. It is already approved in multiple countries including Canada and countries in the EU. The clinical study demonstrated the ability of Restylane Kysse to provide beautiful, full lips with a relatively small amount of product.
Restylane Kysse is long-lasting, with results that last and are FDA-approved for almost one full year. The aesthetic improvements achieved in lip patients left them satisfied. Further studies have demonstrated measurable improvements in lip smoothness, fine lines, and rosiness to the lips. Partners are also pleased with the results following lip treatment with Restylane Kysse.
For more information on expert lip injection in San Diego with hyaluronic acid fillers such as Restylane Kysse, contact Art of Skin MD at 858.792.7546 or email [email protected]