A Split-Face Study of the Effects of a Stabilized Hyaluronic Acid-Based Gel of Nonanimal Origin for Facial Skin Rejuvenation Using a Stamp-Type Multineedle Injector: A Randomized Clinical Trial

Plast Reconstr Surg. 2016 Mar;137(3):809-816. doi: 10.1097/01.prs.0000480686.68275.60.

Abstract

Background: The mid-dermal injection of stabilized hyaluronic acid-based gel of nonanimal origin has been shown to be an effective method for skin rejuvenation. The previous manual technique, using a prefilled syringe, made it difficult to precisely control the injection into the mid-dermal layers and to achieve an even distribution of gel across the area. This single-center, evaluator-blinded, prospective, split-face, randomized controlled trial investigated the efficacy and safety of nonanimal stabilized hyaluronic acid using a stamp-type electronic multineedle injector.

Methods: Twenty-five patients (aged 27 to 59 years) were recruited into this study. Each participant submitted to a single treatment with a nonanimal stabilized hyaluronic acid injection to one side of the lower cheek. The skin hydration, melanin content, erythema, and elasticity of both cheeks were evaluated at each follow-up visit, at 1, 2, 4, 8, and 12 weeks after treatment.

Results: Stratum corneum hydration was significantly improved after injection. Although no significant improvement was observed at 1 week after treatment, the Corneometer readings for the treated side were significantly higher than those for the untreated the side after the 2-, 4-, 8-, and 12-week treatment visits. Skin elasticity was also significantly improved during the study. The injection had no significant effect on the melanin and erythema indices throughout the follow-up period. The treatment was well tolerated, and no serious adverse events were reported.

Conclusions: Nonanimal stabilized hyaluronic acid treatment resulted in improved hydration and elasticity of the facial skin. The specialized stamp-type electronic multineedle injector enables the hyaluronic acid filler to rejuvenate the skin effectively and safely.

Clinical question/level of evidence: Therapeutic, II.

Trial registration: ClinicalTrials.gov NCT02312154.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Biocompatible Materials / administration & dosage
  • Dermal Fillers / administration & dosage*
  • Equipment Design
  • Esthetics
  • Humans
  • Hyaluronic Acid / administration & dosage*
  • Injections, Intradermal / instrumentation*
  • Middle Aged
  • Patient Satisfaction / statistics & numerical data*
  • Prospective Studies
  • Reference Values
  • Rejuvenation / physiology
  • Single-Blind Method
  • Skin Aging / drug effects*
  • Statistics, Nonparametric
  • Syringes*
  • Treatment Outcome

Substances

  • Biocompatible Materials
  • Dermal Fillers
  • Hyaluronic Acid

Associated data

  • ClinicalTrials.gov/NCT02312154