Today, Medicis announced FDA clearance for Restylane injectable gel to be used in lip augmentation.
As one of the world’s most popular wrinkle fillers, Restylane has been used for years to treat moderate to severe facial wrinkles and folds. The new FDA clearance will include indications for lip enhancement in patients over 21.
New Restylane packaging will include the new indication and clinical results that studied the lip augmentation procedure. Medicis is reportedly planning to incorporate the clinical study in their training and promotional materials.
Medicis CEO Jonah Shacknai commented:
“We are pleased with the FDA’s decision to expand the Restylane label to include lip augmentation. This marks another significant milestone for Restylane, now the first and only hyaluronic acid dermal filler approved in the United States for lip augmentation. We were very encouraged by the compelling data from the robust pivotal clinical study, showing effectiveness for up to six months, with a clear majority of eligible subjects opting for retreatment at six months. We believe physicians and their patients will appreciate the unique gel particle structure of Restylane and its ability to create fullness in the lips for up to six months.”
Multi Center Study Evaluates Restylane Lip Augmentation
To evaluate Restylane for lip augmentation, researchers carried out a randomized, evaluator-blinded, no-treatment-as-a-control, multi-center study of 180 patients. Subjects randomized to Restylane treatment at the beginning of the study were retreated at six months, and subjects randomized to no treatment received their first Restylane treatment at six months.
The study measured safety through use of:
- Adverse events that were reported during the study
- Patient diaries kept for two weeks after Restylane lip augmentation
- Nine lip safety assessments performed at various intervals throughout the 7-month study
The Medicis Lip Fullness Scale™
The Medicis Lip Fullness scale is an innovative, 5-point measurement tool that evaluates the effectiveness of lip augmentation. To design the scale, they collaborated closely with the FDA and clinicians during the validation process.
A blinded lip evaluator, physician and photo reviewer all measured effectiveness of Restylane lip augmentation for the upper and lower lip. They also employed the GAIS – Global Aesthetic Improvement Scale. Researchers measured effectiveness for seven months. In addition, three independent physicians performed photo evaluations after the study.
The Results: Research showed that Restylane lip augmentation is well tolerated and effective for up to 6 months. Adverse events were not serious, and included pain, swelling, tenderness, bruising and erythema. 80 percent of patients chose to be treated again after 6 months.