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Randomized Double-Blind Controlled Study on the Safety and Efficacy of a Novel Injectable Cross-linked Hyaluronic Gel for the Correction of Moderate-to-Severe Nasolabial Wrinkles

  • Pasquale FinoEmail author
  • Marco Toscani
  • Francesca Romana Grippaudo
  • Nicola Giordan
  • Nicolò Scuderi
Original Article Non-Surgical Aesthetic
  • 31 Downloads

Abstract

Introduction

The current study compares two hyaluronic acid fillers, Ial System Duo and Belotero Basic/Balance, for the treatment of wrinkles.

Materials and Methods

This is a single-center, double-blind randomized controlled study. Inclusion criteria consisted of subjects with bilateral nasolabial wrinkles. Each subject was treated with both products: One was applied on the right side and the other on the left side of the face. The quantity of product injected and any problems or local reactions (erythema, edema, pain or itching) were recorded and reassessed at 3 and 6 months and then monthly until complete absorption of the product. The Wrinkle Severity Rating Scale (WSRS) and the Global Aesthetic Improvement Scale (GAIS) were used for the assessment, as well as an ultrasound measurement of the skin thickness.

Results

Complete data were available for 59 subjects. At 3 and 6 months, both products showed improvement in the WSRS and GAIS score in the areas treated compared to pre-treatment assessments, although no significant differences were observed between them. No resulting significant differences were observed on skin thickness among the two products, which were completely reabsorbed in 285 ± 34 days (Ial System Duo) and 277 ± 34 days (Belotero Basic/Balance; Student’s t test: p = 0.2181). No significant differences were observed with regard to the subject’s satisfaction and adverse events.

Conclusions

The Ial System Duo achieves long-term permanence (more than 9 months confirmed by ultrasound) in correction of moderate and severe wrinkles, similar to Belotero Basic/Balance. Both products showed a high safety profile and a high degree of subject and physician satisfaction.

Level of Evidence II

This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

Keywords

Skin wrinkles Fillers Esthetic surgery 

Notes

Acknowledgements

All authors hereby declare not to have any potential conflict of interests and not to have received funding for this work from any of the following organisations: National Institutes of Health (NIH); Wellcome Trust; Howard Hughes Medical Institute (HHMI); and other(s). Each author participated sufficiently in the work to take public responsibility for the content.

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature and International Society of Aesthetic Plastic Surgery 2019

Authors and Affiliations

  • Pasquale Fino
    • 1
    • 4
    Email author
  • Marco Toscani
    • 1
  • Francesca Romana Grippaudo
    • 2
  • Nicola Giordan
    • 3
  • Nicolò Scuderi
    • 1
  1. 1.Department of Surgery “P.Valdoni”, UOC of Plastic SurgerySapienza University of Rome, Policlinico Umberto IRomeItaly
  2. 2.Plastic Surgery UnitSapienza University of Rome, Sant’AndreaRomeItaly
  3. 3.Clinical Research DepartmentFidia Farmaceutici S.p.A.Abano Terme, PaduaItaly
  4. 4.Department of Plastic, Reconstructive and Aesthetic SurgeryUniversity of Rome La Sapienza, Policlinico Umberto IRomeItaly

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