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Experimental and Clinical Efficacy of Two Hyaluronic Acid-based Compounds of Different Cross-Linkage and Composition in the Rejuvenation of the Skin

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ABSTRACT

Background

In the field of aesthetic medicine there is an increasing demand for safe and effective hyaluronic acid (HA) fillers to counteract the aging process.

Methods and Aims

We designed a study to evaluate the safety and histological biocompatibility of Aliaxin® Global Performance, a cross-linked HA filler and Viscoderm® Skinkò E, a product composed of non-cross-linked HA and a complex including vitamins, antioxidants, amino acids and minerals injected into the skin of guinea pigs. Then, we translated our findings into the clinical setting, administering a combination of these compounds to patients seeking a facial rejuvenation procedure targeting moderate-to-severe wrinkles affecting the nasolabial folds.

Results

The animal study showed that the two compounds did not induce any significant inflammatory reactions and increased collagen and elastic fibers in the skin. In the clinical setting, injection of Aliaxin® Global Performance, followed by Viscoderm® Skinkò E, resulted in a higher improvement in nasolabial fold hydration, trans-epidermal water loss and wrinkle aesthetic appearance, if compared with a protocol based on Aliaxin® Global Performance alone.

Conclusion

In summary, we show evidence on the safety and mechanism underlying two new HA-based compounds of different cross-linkage and composition, proposing that they can be safely used in combination in patients seeking facial rejuvenation procedures with long-lasting efficacy.

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Abbreviations

Aliaxin® GP:

Aliaxin® Global Performance

BDDE:

1,4-Butanediol diglycidyl ether

CLHA:

Cross-linked HA

HA:

Hyaluronic acid

HE:

Hematoxylin and eosin

HPF:

High-power field

N:

Newton

NCLHA:

Non-cross-linked HA

PBS:

Phosphate buffered saline

PWBC:

Polymorphonuclear white blood cells

SEM:

Standard error of the mean

TEWL:

Trans-epidermal water loss

TGF-β:

Transforming growth factor beta

Viscoderm® SE:

Viscoderm® Skinkò E

WSRS:

Wrinkle severity rating scale

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ACKNOWLEDGMENTS AND DISCLOSURES

This article was not supported by grants. JCMM acknowledges CONACyT for membership.

TI, JCM, AC and BP contributed equally to every part of this work including design and conduction of clinical and experimental studies as well as statistical analysis and drafting of the article.

The authors certify that there is no conflict of interest with any financial organization regarding the material discussed in the manuscript. We thank IBSA Farmaceutici Italia for the donation of Viscoderm® Skinko’ E and Aliaxin® Global Performance.

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Authors and Affiliations

  1. School of Biomedical Sciences, University of Leeds, Mount Preston Street, Garstang building, Leeds, LS2 9JT, UK

    Tommaso Iannitti

  2. Poliambulatorio del Secondo Parere, Modena, Italy

    Tommaso Iannitti, Alessandro Coacci & Beniamino Palmieri

  3. Centro de Investigación en Reproducción Animal, CINVESTAV, Tlaxcala AP 62, CP, 90000, Mexico

    Julio César Morales-Medina

  4. Department of General Surgery and Surgical Specialties, University of Modena and Reggio Emilia Medical School, Surgical Clinic, Modena, Italy

    Alessandro Coacci & Beniamino Palmieri

Authors
  1. Tommaso Iannitti
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  2. Julio César Morales-Medina
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  3. Alessandro Coacci
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  4. Beniamino Palmieri
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Correspondence to Tommaso Iannitti.

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Iannitti, T., Morales-Medina, J.C., Coacci, A. et al. Experimental and Clinical Efficacy of Two Hyaluronic Acid-based Compounds of Different Cross-Linkage and Composition in the Rejuvenation of the Skin. Pharm Res 33, 2879–2890 (2016). https://doi.org/10.1007/s11095-014-1354-y

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  • DOI: https://doi.org/10.1007/s11095-014-1354-y

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