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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

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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.

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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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Authors and Affiliations

  1. Department of Surgery “P.Valdoni”, UOC of Plastic Surgery, Sapienza University of Rome, Policlinico Umberto I, Rome, Italy

    Pasquale Fino, Marco Toscani & Nicolò Scuderi

  2. Plastic Surgery Unit, Sapienza University of Rome, Sant’Andrea, Rome, Italy

    Francesca Romana Grippaudo

  3. Clinical Research Department, Fidia Farmaceutici S.p.A., Abano Terme, Padua, Italy

    Nicola Giordan

  4. Department of Plastic, Reconstructive and Aesthetic Surgery, University of Rome La Sapienza, Policlinico Umberto I, Via dei Quinzi, 5, Interno 21, 00175, Rome, Italy

    Pasquale Fino

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  1. Pasquale Fino
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  2. Marco Toscani
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  3. Francesca Romana Grippaudo
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  4. Nicola Giordan
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  5. Nicolò Scuderi
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Correspondence to Pasquale Fino.

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Fino, P., Toscani, M., Grippaudo, F.R. et al. 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. Aesth Plast Surg 43, 470–479 (2019). https://doi.org/10.1007/s00266-018-1284-x

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  • DOI: https://doi.org/10.1007/s00266-018-1284-x

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