Efficacy and safety of a new hyaluronic acid dermal filler in the treatment of moderate nasolabial folds: 6-month interim results of a randomized, evaluator-blinded, intra-individual comparison study.

Abstract

BACKGROUND:

Hyaluronic acid (HA) fillers such as Restylane(®) are frequently used for the correction of facial soft tissue defects.

OBJECTIVE:

To compare the efficacy and safety of a novel HA filler, Emervel(®) Classic, with those of Restylane in the treatment of moderate nasolabial folds.

METHODS:

This was a split-face, randomized and evaluator-blinded comparison study. Subjects were randomized to receive an injection of Emervel Classic or Restylane on their left or right side. Efficacy was evaluated based on the change in Wrinkle Severity Rating Score (WSRS) from baseline. Local tolerability was assessed based on subject diary, which recorded the severity of erythema, oedema/swelling, bruising, pain/tenderness and pruritus during the first 3 weeks after injection.

RESULTS:

The interim results 6 months after injection are reported. At week 24, the mean improvement in WSRS from baseline was 0.83 ± 0.51 for Emervel Classic, similar to that for Restylane (0.90 ± 0.57). A similar volume of both fillers was injected. Most local tolerability events were mild and transient. Erythema, oedema/swelling and pain/tenderness were significantly less severe and disappeared faster with Emervel Classic than with Restylane (at least p < 0.05).

CONCLUSION:

Emervel Classic provides similar efficacy and better overall local tolerability compared with Restylane 6 months after treatment of moderate nasolabial folds.

• Authors: Berthold Rzany, Christiane Bayerl, Isaac Bodokh, Dominique Boineau, Thomas Dirschka, Catherine Queille-Roussel, Michael Sebastian, Boris Sommer, Michel Poncet, Mohammed Guennoun, Maurizio Podda
• Journal: Journal of cosmetic and laser therapy : official publication of the European Society for Laser Dermatology (J Cosmet Laser Ther) Vol. 13 Issue 3 Pg. 107-12 (Jun 2011) ISSN: 1476-4180 [Electronic] England
• PMID: 21609212 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial)

Chemical References

• Hyaluronic Acid
• Restylane

Topics

• Adult
• Cosmetic Techniques (adverse effects)
• Female
• Humans
• Hyaluronic Acid (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
• Male
• Middle Aged
• Single-Blind Method
• Skin Aging (drug effects)