Safety and Efficacy of Facial Rejuvenation with Small Gel Particle Hyaluronic Acid with Lidocaine and AbobotulinumtoxinA in Post-Chemotherapy Patients: A Phase IV Investigator-initiated Study.

BACKGROUND: Due to advances in detection and treatment, approximately 70 percent of cancer patients are living more than five years after diagnosis. Research indicates that appearance worries are of great concern to cancer survivors impacting their quality of life. This is the first Phase IV investigator-initiated study to investigate the safety and efficacy of facial rejuvenation with small gel particle hyaluronic acid with lidocaine and abobotulinumtoxinA in post-chemotherapy patients.
METHODS: The safety and efficacy of facial rejuvenation with small gel particle hyaluronic acid with lidocaine and abobotulinumtoxinA was assessed in nine post-chemotherapy patients. Efficacy of small gel particle hyaluronic acid with lidocaine and abobotulinumtoxinA was measured at baseline, Week 2, and Week 8, using a wrinkle severity assessment score. Safety and tolerability of both products were assessed throughout the study by monitoring the occurrence of adverse events.
RESULTS: Patients received a mean total of 2.4mL of small gel particle hyaluronic acid with lidocaine in the nasolabial folds and 57.8 Units of abobotulinumtoxinA to glabellar lines at baseline. Additionally, at Week 2, a mean total l.OmL of small gel particle hyaluronic acid with lidocaine was administered to four patients. The mean investigator's wrinkle severity assessment score at baseline was 2.22, indicating mild-to-moderate severity. At each of Weeks 2 and 8, there were significant improvements from baseline in wrinkle severity (p=0.004). Overall, small gel particle hyaluronic acid with lidocaine was well tolerated. Adverse events (i.e., bruising, redness, swelling, pain, tenderness, itching or other adverse events) were localized, self-limiting, and resolved within 1 to 2 days. The only adverse event attributed to abobotulinumtoxinA was soreness and slight tenderness at an injection site reported in one patient.
CONCLUSION: Both study products were well tolerated in post-chemotherapy patients with no significant adverse events. There was a clinically meaningful and statistically significant improvement in wrinkle severity at Week 2 post-administration as compared to baseline. This improvement was maintained in all patients at Week 8.