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.

Fig. 1.

Chin retrusion responder rates (±95 percent CI) according to the Galderma Chin Retrusion Scale, assessed by blinded evaluator. A responder was defined as a subject with at least a one-point improvement from baseline according to the Galderma Chin Retrusion Scale. HA_RD, hyaluronic acid filler Restylane Defyne. ***p < 0.001 HA_rd versus no-treatment control, Fisher exact test. The 95 percent CI was calculated using the Clopper Pearson method. Observed cases.

Fig. 2.

Proportion of subjects with aesthetic improvement (±95 percent CI), assessed by subjects and treating investigators using the Global Aesthetic Improvement Scale. Improved subjects were defined as subjects recorded as improved, much improved, or very much improved on the seven-grade Global Aesthetic Improvement Scale. The 95 percent CI was calculated using the Clopper-Pearson method. HA_RD, hyaluronic acid filler Restylane Defyne.

Fig. 3.

Representative photographs of male and female subjects before and after injection of Restylane Defyne in the chin. The subject above was injected with 2 ml at initial treatment (1 ml in the pogonion and 1 ml in the surrounding area) and 2 ml at touch-up (1 ml in the pogonion and 1 ml in the surrounding area). The subject in the center was injected with 2 ml at initial treatment (2 ml in the pogonion and 0 ml in the surrounding area) and 1.2 ml at touch-up (0.4 ml in the pogonion and 0.8 ml in the surrounding area). The subject shown below was injected with 2.9 ml at initial treatment (1.8 ml in the pogonion and 1.1 ml in the surrounding area) and 1.8 ml at touch-up (0.8 ml in the pogonion and 1 ml in the surrounding area). (Above) A 52-year-old man on day 1 before injection, with a Galderma Chin Retrusion Scale score of 2 (above, left); at week 12, a Galderma Chin Retrusion Scale score of 0 (above, center); and at week 48, a Galderma Chin Retrusion Scale score of 1 (above, right). (Center) A 22-year-old woman on day 1 before injection, with a Galderma Chin Retrusion Scale score of 2 (center, left); at week 12, with a Galderma Chin Retrusion Scale score of 0 (center, center); and at week 48, with a Galderma Chin Retrusion Scale score of 0 (center, right). (Below) A 44-year-old woman on day 1 before injection, with a Galderma Chin Retrusion Scale score of 2 (below, left); at week 12, with Galderma Chin Retrusion Scale score of 1 (below, center); and at week 48, with a Galderma Chin Retrusion Scale score of 1 (below, right).

Fig. 4.

FACE-Q Satisfaction with Chin scale, individual items: proportion of subjects satisfied with their chin before and after treatment with Restylane Defyne. Satisfied subjects include those who responded “very satisfied” or “somewhat satisfied.”