High Kissability Marks for Restylane Kysse in New Phase 4 Study

July 14, 2020
High Kissability Marks for Restylane Kysse in New Phase 4 Study image

In a recent first-of-its-kind phase IV, Kissability study for an injectable hyaluronic acid (HA) lip filler, subject satisfaction as well as partner satisfaction were evaluated following treatment with RestylaneKysse. Many consumers report they often keep their lip treatments a secret and have concerns about partner perceptions after injection. In the Kissability study, all subjects (100 percent) and a majority of their partners (90 percent) were satisfied with their lips after Restylane Kyssetreatment, with most partners (73 percent) reporting a more kissable and natural feel.

"The Phase 4 Kissability study helps answer the ongoing question from patients to their aesthetic provider: 'How will my partner react?' The data from this study supports that Restylane Kysse resulted in overwhelmingly positive partner satisfaction with both kissability and appearance," said Dr. Janelle Vega, board-certified dermatologist and paid Galderma consultant in Miami, FL. "The use of XpresHAn Technology in Restylane Kyssehelps patients look more natural when they are smiling, speaking, laughing, and even kissing - right in time for International Kissing Day!"

The Phase 4 Kissability data also found that subjects agreed that their lips had a natural look (96 percent) and that they felt more attractive (87 percent) after treatment with Restylane Kysse. Ninety-eight percent of subjects also reported they were satisfied with the kissability of their lips after treatment.

"The creative and unique approach to this Phase 4 study design has allowed theRestylane brand to distinctively showcase and amplify the data from both the patient and the partner perspectives," says Alisa Lask, General Manager and Vice President of the U.S. Aesthetics Business at Galderma. "The proven global safety profile, combined with the data, support Galderma's plan to establish Restylane Kysse as a leader in the U.S. lip filler market."

All subjects in the Restylane KyssePhase 4 study were over the age of 21, in a steady relationship with a partner for at least 6-months and had the intent to undergo lip augmentation. Completed separately by the subject and their partners, at home, the innovative Kissability Questionnaire explored how satisfied partners were with subjects' lips after injection, and if they were even more kissable. Primary endpoint included subject-assessed Global Aesthetic Improvement Scale (GAIS) at week 8 and secondary endpoints included independent photographic review of naturalness of expression, age, and lip texture, adverse events (AEs), FACE-Q satisfaction with lips (subject) and Kissability questionnaire (between visits). This Phase 4 study was open to people of all races and ethnicities. This has been a critical factor in the design of all of our aesthetic studies since 2016 so that our research is reflective of the world we all live in.

Following FDA approval earlier this year, Restylane Kysseis the latest addition to the Restylane family of HA dermal fillers. The first HA filler specifically indicated for the lips using XpresHAn Technology, RestylaneKysse, is designed to enhance existing beauty through natural-looking volume and Kysse-able softness that lasts for up to 1 year.

With over 40 million treatments worldwide, the portfolio of products helps to smooth facial wrinkles and folds, such as smile lines (Restylane-L, Restylane Refyne, Restylane Defyne and Restylane Lyft with Lidocaine), create fuller and more accentuated lips (Restylane Silk, Restylane-L and RestylaneKysse), and add lift and volume to the cheeks and the back of the hands (RestylaneLyft with Lidocaine).

Galderma is working closely with their aesthetic healthcare provider partners, while following all safe and proper social distancing guidelines, to offer Restylane Kysse in healthcare providers' respective practice locations across the country.

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