A Randomized Trial to Assess Effectiveness and Safety of a Hyaluronic Acid Filler for Chin Augmentation and Correction of Chin Retrusion

Abstract

Background: The chin is important for facial appearance, affecting overall balance and harmony of the face. The purpose of this study was to evaluate effectiveness of the hyaluronic acid filler Restylane Defyne for chin augmentation and correction of chin retrusion versus a no-treatment control. Methods: Male and female subjects, aged 22 years or older, with mild to moderate chin retrusion, were randomized 3:1 to the hyaluronic acid filler Restylane Defyne (n = 107) or no treatment (n = 33). Assessments included live, blinded evaluations on a validated chin retrusion scale (Galderma Chin Retrusion Scale), aesthetic improvement (Global Aesthetic Improvement Scale), subject-reported FACE-Q Satisfaction with Chin, and safety follow-up. Results: Galderma Chin Retrusion Scale responder rate (≥1 grade improvement) was higher for the hyaluronic acid filler Restylane Defyne (81 percent) than for control (6 percent) (p < 0.001) at week 12, and remained higher at week 48 (74 percent versus 11 percent; p < 0.001). Aesthetic improvement rates were high throughout the study as reported by investigators (≥96 percent) and subjects (≥85 percent). Subject satisfaction was higher in the hyaluronic acid filler Restylane Defyne group than in the control group at week 12 (p < 0.001). In the individual FACE-Q scale items, 87 to 98 percent of subjects were satisfied at week 12. Treatment-related adverse events were mild to moderate. Conclusions: The hyaluronic acid filler Restylane Defyne was safe and effective for augmentation of the chin region to improve the chin profile and associated with high aesthetic improvement and subject satisfaction. Effectiveness was sustained throughout 48 weeks. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Chin Augmentation and Treatment of Chin Retrusion with a Flexible Hyaluronic Acid Filler in Asian Subjects: A Randomized, Controlled, Evaluator-Blinded Study

“…The endpoints and definitions used were comparable to our study (i.e., GCRS responder rate was also ≥ 1-grade improvement). In terms of baseline severity, Marcus et al [ 5 ] presented that 63% of patients in the HA DEF group in the US study had moderate retrusion, which was comparable to 65% in this study (Table 1 ).…”

“…The assessment scale used to measure chin retrusion in this study was the validated 4-point GCRS designed to measure a clinically relevant improvement. This scale has also been used in a previous US study (Marcus et al ) [ 5 ] using the same HA product, HA DEF , and was therefore considered the most appropriate choice for confirming the effectiveness in this additional population.…”

“…In the prior mentioned US study (Marcus et al ) [ 5 ], HA DEF was evaluated using a randomized, evaluator-blinded, no-treatment control design for 48 weeks in adults with mild-to-moderate chin retrusion with similar outcomes as in the present study. The endpoints and definitions used were comparable to our study (i.e., GCRS responder rate was also ≥ 1-grade improvement).…”

“…HA DEF is approved in China for treatment of nasolabial folds since 2021, and recently (2023) also received the extended approval to include injection into the chin. The product is approved in the USA for use in the chin since 2021 [ 4 ], following demonstration of effective and safe use of HA DEF for the chin indication in a US population [ 5 ]. HA DEF is designed with OBT™/XpresHAn™ technology that enables distributed integration into the tissue and provides flexible support and contour enhancement.…”

Adverse Events Reported From Hyaluronic Acid Dermal Filler Injections to the Facial Region: A Systematic Review and Meta-Analysis

“…Lastly, hardly any RCTs or CTs that focused on the chin or glabella region could not be found that met our inclusion criteria; these facial areas were thus not included due to limited data. The RCTs that did include the chin or glabella region did not report the same adverse events as our included studies, thus would not allow us to run an effective analysis [ 54 - 55 ].…”