The U.S. Food and Drug Administration (FDA) has approved Galderma’s Restylane Contour for cheek augmentation and correction of midface contour deficiencies in adults over the age of 21. The new hyaluronic acid (HA) dermal filler features XpresHAn Technology, a manufacturing process which creates a smooth, injectable gel that integrates into the skin for natural, dynamic expression in motion.
The FDA approval of Restylane Contour is supported by data from a randomized, comparator-controlled, multi-center, pivotal Phase 3 study conducted at 15 centers across the United States. The study evaluated 270 patients across two groups over 48 weeks.
Group A compared the effectiveness and safety of Restylane Contour (n=142) versus a control comparator (n=68). Group B compared the injection of Restylane Contour with needle (n=60) and cannula devices (n=60) in the same patient on each side of their face.
Results showed that Restylane Contour is safe and effective for cheek augmentation and the correction of midface contour deficiencies. Patients treated with Restylane Contour required less total volume injected to achieve optimal aesthetic results compared to patients treated with the comparator (4.26 mL versus 4.88 mL, respectively).
In Group A, ≥76% of patients treated with Restylane Contour were “satisfied” with their cheeks compared to ≥73% treated with the comparator across all FACE-Q questions through Week 48. Among patients in Group B, more than 91% were “satisfied” with their cheeks across all FACE-Q questions at all timepoints through Week 48.
The most commonly observed side effects for cheek injection were bruising, redness, swelling, pain, tenderness and itching at the injection site. Most patients (85%) did not experience any adverse events (AEs) related to treatment. There were no severe or late-onset AEs related to Restylane Contour treatment, and 93% of AEs were mild in intensity (53/57), with four moderate AEs of bruising, pain and/or facial pain.
Restylane Contour showed comparable efficacy and safety when injected with needles and cannula devices.
“Cheeks are the cornerstone of the face, and focusing on natural contour and not just volume loss can result in a dynamic expression that amplifies their natural beauty,” said Dr. Leslie Baumann, MD, a board-certified dermatologist in Miami and a lead investigator in the clinical trial of Restylane Contour.
Galderma plans to introduce Restylane Contour in practice locations across the country beginning this summer.