Clinical and instrumental evaluation of a cross-linked hyaluronic acid filler dermal injection

Effects on nasolabial folds skin biophysical parameters and augmentation from a single-dose, monocentric, open-label trial

Norma Cameli, Maria Mariano, Mirko Serio, Enzo Berardesca

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Background: When a hyaluronic acid dermal device to fill soft tissues is chosen, efficacy, safety and durability are key concerns. This is an open-label prospective study to instrumentally evaluate the effects of HA filler dermal injection on nasolabial folds skin biophysical parameters and augmentation. Methods: A single Italian site treated female subjects aged 40-55, for nasolabial folds, with a single standardized injection. The outcome was evaluated with objective quantitative measurements after 90 (T1) and 180 days (T2) from the injection comparing to baseline (T0) by means of Corneometer (skin hydration measurement), Cutometer (skin elasticity measurement), and Visioface devices for digital and UV computerized image analysis. Secondary endpoints were safety assessment, subject investigator satisfaction with the intervention. Assessment of aesthetic results included photographic documentation. Results: The computerized image analysis confirmed the clinical assessment showing statistically significant reduction in nasolabial folds both at T1 and T2. Visioface® indexes showed a marked and statistical significant response. An excellent profile of satisfaction of the product at T2 from investigators and patients was recorded. Skin hydration and elasticity did not show significant changes. Conclusions: In our study, a standardized HA filler dermal injection on nasolabial folds did not influence skin biophysical parameters such as skin hydration and elasticity. Nasolabial folds showed a persistent and significative response at T2 confirmed by instrumental evaluation. The tolerability and safety profile of the product was excellent.

Original languageEnglish
Pages (from-to)507-514
Number of pages8
JournalGiornale Italiano di Dermatologia e Venereologia
Volume151
Issue number5
Publication statusPublished - 2016

Fingerprint

Nasolabial Fold
Hyaluronic Acid
Skin
Injections
Elasticity
Safety
Research Personnel
Equipment and Supplies
Dermal Fillers
Esthetics
Documentation
Prospective Studies

Keywords

  • Dermal fillers
  • Hyaluronic acid
  • Nasolabial fold

ASJC Scopus subject areas

  • Medicine(all)
  • Dermatology

Cite this

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title = "Clinical and instrumental evaluation of a cross-linked hyaluronic acid filler dermal injection: Effects on nasolabial folds skin biophysical parameters and augmentation from a single-dose, monocentric, open-label trial",
abstract = "Background: When a hyaluronic acid dermal device to fill soft tissues is chosen, efficacy, safety and durability are key concerns. This is an open-label prospective study to instrumentally evaluate the effects of HA filler dermal injection on nasolabial folds skin biophysical parameters and augmentation. Methods: A single Italian site treated female subjects aged 40-55, for nasolabial folds, with a single standardized injection. The outcome was evaluated with objective quantitative measurements after 90 (T1) and 180 days (T2) from the injection comparing to baseline (T0) by means of Corneometer (skin hydration measurement), Cutometer (skin elasticity measurement), and Visioface devices for digital and UV computerized image analysis. Secondary endpoints were safety assessment, subject investigator satisfaction with the intervention. Assessment of aesthetic results included photographic documentation. Results: The computerized image analysis confirmed the clinical assessment showing statistically significant reduction in nasolabial folds both at T1 and T2. Visioface{\circledR} indexes showed a marked and statistical significant response. An excellent profile of satisfaction of the product at T2 from investigators and patients was recorded. Skin hydration and elasticity did not show significant changes. Conclusions: In our study, a standardized HA filler dermal injection on nasolabial folds did not influence skin biophysical parameters such as skin hydration and elasticity. Nasolabial folds showed a persistent and significative response at T2 confirmed by instrumental evaluation. The tolerability and safety profile of the product was excellent.",
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T2 - Effects on nasolabial folds skin biophysical parameters and augmentation from a single-dose, monocentric, open-label trial

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AU - Mariano, Maria

AU - Serio, Mirko

AU - Berardesca, Enzo

PY - 2016

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