Systematic Review of Clinical Trials of Small‐ and Large‐Gel‐Particle Hyaluronic Acid Injectable Fillers for Aesthetic Soft Tissue Augmentation

Background Hyaluronic acid (HA) is the most frequently injected filler for soft tissue augmentation in the United States. Objective To systematically review published evidence for aesthetic use of small‐ and large‐gel‐particle HA. Methods and Materials Clinical data on anatomic area, level of eviden...

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Bibliographic Details
Published in:Dermatologic surgery 2013-02, Vol.39 (2), p.205-231
Main Authors: Cohen, Joel L., Dayan, Steven H., Brandt, Fredric S., Nelson, Diane B., Axford‐Gatley, Robert A., Theisen, Michael J., Narins, Rhoda S.
Format: Article
Language:English
Subjects:
Clinical Trials as Topic
Cosmetic Techniques
Gels
Humans
Hyaluronic Acid - administration & dosage
Hyaluronic Acid - chemistry
Particle Size
Skin Aging - drug effects
Treatment Outcome
Viscosupplements - administration & dosage
Viscosupplements - chemistry
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Summary:Background Hyaluronic acid (HA) is the most frequently injected filler for soft tissue augmentation in the United States. Objective To systematically review published evidence for aesthetic use of small‐ and large‐gel‐particle HA. Methods and Materials Clinical data on anatomic area, level of evidence, patient population, trial design, endpoints, efficacy, and safety were extracted from PubMed. Results Fifty‐three primary clinical reports were analyzed. The highest‐quality efficacy evidence was for the nasolabial folds (NLFs), with 10 randomized, blind, split‐face, comparative trials. Several randomized, blind trials supported treatment of the glabella, lips, and hands. Lower‐level evidence (from studies with nonrandomized, open‐label, or retrospective designs) was recorded for the nasojugal folds (tear troughs), upper eyelids, nose, infraorbital hollows, oral commissures, marionette lines, perioral rhytides, temples, and cheeks. Common adverse events (AEs) across anatomic areas were pain, bruising, swelling, and redness. Serious AEs were uncommon (8 events in 8 patients of 4,605 total patients) and were considered to be unrelated (7 events) or probably unrelated (1 event) to treatment. Conclusion The efficacy and safety of small‐ and large‐gel‐particle HA are well established for NLFs; evidence for the glabella, lips, and hands is more limited. Preliminary reports in other anatomic regions suggest efficacy without major complications.
ISSN:1076-0512
1524-4725
DOI:10.1111/dsu.12036