A randomized, evaluator-blinded, controlled study of effectiveness and safety of small particle hyaluronic acid plus lidocaine for lip augmentation and perioral rhytides

Dermatol Surg. 2015 Apr;41 Suppl 1:S127-36. doi: 10.1097/DSS.0000000000000199.


Objective: To compare the safety and effectiveness of small particle hyaluronic acid plus lidocaine (SPHAL) versus no treatment for lip augmentation and perioral rhytides.

Methods and materials: Adults scoring 1 (very thin) to 2 (thin) on the Medicis Lip Fullness Scale (MLFS) for upper and lower lips were randomized (3:1) to SPHAL or no treatment. Treatment success was an MLFS increase ≥1 point at Week 8. Secondary end points (MLFS score, independent photographic review, Global Aesthetic Improvement Scale, Wrinkle Assessment Scale for Upper Lip Lines) and safety were assessed throughout.

Results: Statistically significantly more patients were treatment successes with SPHAL (upper lip [80.2% vs 11.9%], lower lip [84.2% vs 18.4%], and upper and lower lips combined [76.1% vs 11.6%]), compared with no treatment (p <.001, all outcomes). Patients treated for both lip augmentation and perioral rhytides were rated as having an aesthetically meaningful improvement in perioral rhytides (p <.001). Most common treatment-emergent adverse events (AEs) included lip bruising, swelling, and pain and were mostly mild and transient in nature, without anticipated device AEs.

Conclusion: Small particle hyaluronic acid plus lidocaine was effective and well tolerated and significantly more effective when both lips and perioral rhytides were treated, with improvement evident up to 6 months after treatment.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Aged
  • Anesthetics, Local / administration & dosage*
  • Anesthetics, Local / adverse effects
  • Contusions / chemically induced
  • Cosmetic Techniques*
  • Edema / chemically induced
  • Female
  • Gels
  • Humans
  • Hyaluronic Acid / administration & dosage*
  • Hyaluronic Acid / adverse effects
  • Injections, Intradermal
  • Lidocaine / administration & dosage*
  • Lidocaine / adverse effects
  • Lip*
  • Male
  • Middle Aged
  • Pain / chemically induced
  • Particle Size
  • Rejuvenation
  • Skin Aging*
  • Young Adult


  • Anesthetics, Local
  • Gels
  • Hyaluronic Acid
  • Lidocaine