Dataset Information

Safe and Effective Chin Augmentation With the Hyaluronic Acid Injectable Filler, VYC-20L.

ABSTRACT:

Background

VYC-20L is a hyaluronic acid soft tissue filler with lidocaine designed to restore facial volume.

Objective

Evaluate the safety and effectiveness of VYC-20L in patients with chin retrusion.

Materials and methods

Adults with chin retrusion were randomized (3:1) to receive VYC-20L in the chin at study onset (treatment group) or 6 months later (control group). The primary effectiveness end point was ?1-point improvement on the Allergan Chin Retrusion Scale (ACRS) from baseline at Month 6. Safety assessments included injection site responses (ISRs) and adverse events (AEs).

Results

VYC-20L was administered to 192 participants (treatment group, n = 144; control group, n = 48). At Month 6, significantly more participants had an ACRS response in the treatment versus control group (56.3% vs 27.5%; p = .0019). Effectiveness was also demonstrated by the proportion of participants with improved/much improved Global Aesthetic Improvement Scale scores and responses on the FACE-Q Satisfaction with Chin questionnaire and FACE-Q Psychological Wellbeing module. Treatment benefit remained evident at Month 12. Most common ISRs were tenderness (81.1%) and firmness (75.1%). One participant (0.5%) discontinued the study due to 2 treatment-related serious AEs of facial cellulitis and injection site inflammation, both resolved without sequelae.

Conclusion

VYC-20L significantly improved an ACRS response and was generally safe and well tolerated.

SUBMITTER: Beer K

PROVIDER: S-EPMC7752233 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

Safe and Effective Chin Augmentation With the Hyaluronic Acid Injectable Filler, VYC-20L.

Beer Kenneth K Kaufman-Janette Joely J Bank David D Biesman Brian B Dayan Steven S Kim William W Chawla Smita S Schumacher Andrew A

Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.] 20210101 1

<h4>Background</h4>VYC-20L is a hyaluronic acid soft tissue filler with lidocaine designed to restore facial volume.<h4>Objective</h4>Evaluate the safety and effectiveness of VYC-20L in patients with chin retrusion.<h4>Materials and methods</h4>Adults with chin retrusion were randomized (3:1) to receive VYC-20L in the chin at study onset (treatment group) or 6 months later (control group). The primary effectiveness end point was ≥1-point improvement on the Allergan Chin Retrusion Scale (ACRS) fr ...[more]

PMID: 33347003

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Project description:Introduction: The lips and the mouth play an indispensable role in vocalization, mastication and face aesthetics. Various noxious factors may alter and destruct the original structure, and appearance of the lips and the anatomical area surrounding the mouth. The application of hyaluronic acid (HA) may serve as a safe method for lip regeneration. Although a number of studies exist for HA effectiveness and safety, its beneficial effect is not well-established. Aim: The present meta-analysis and systematic review was performed to investigate the effectiveness of HA on lip augmentation. We also investigated the types and nature of adverse effects (AEs) of HA application. Methods: We reported our meta-analysis in accordance with the PRISMA Statement. PROSPERO protocol registration: CRD42018102899. We performed the systematic literature search in CENTRAL, Embase, and MEDLINE. Randomized controlled trials, cohort studies, case series and case reports were included. The untransformed proportion (random-effects, DerSimonian-Laird method) of responder rate to HA injection was calculated. For treatment related AEs descriptive statistics were used. Results: The systematic literature search yielded 32 eligible records for descriptive statistics and 10 records for quantitative synthesis. The results indicated that the overall estimate of responders (percentage of subjects with increased lip fullness by one point or higher) was 91% (ES = 0.91, 95% CI:0.85-0.96) 2 months after injection. The rate of responders was 74% (ES = 0.74, 95% CI:0.66-0.82) and 46% (ES = 0.46, 95% CI:0.28-0.65) after 6 and 12 months, respectively. We included 1,496 participants for estimating the event rates of AEs. The most frequent treatment-related AEs were tenderness (88.8%), injection site swelling (74.3%) and bruising (39.5%). Rare AEs included foreign body granulomas (0.6%), herpes labialis (0.6%) and angioedema (0.3%). Conclusion: Our meta-analysis revealed that lip augmentation with injectable HA is an efficient method for increasing lip fullness for at least up to 6 months after augmentation. Moreover, we found that most AEs of HA treatment were mild or moderate, but a small number of serious adverse effects were also found. In conclusion, further well-designed RCTs are still needed to make the presently available evidence stronger.

Dataset Information

Safe and Effective Chin Augmentation With the Hyaluronic Acid Injectable Filler, VYC-20L.

Background

Objective

Materials and methods

Results

Conclusion

Publications

Safe and Effective Chin Augmentation With the Hyaluronic Acid Injectable Filler, VYC-20L.

Similar Datasets

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