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 language | English |
|---|---|
| Pages (from-to) | 507-514 |
| Number of pages | 8 |
| Journal | Giornale Italiano di Dermatologia e Venereologia |
| Volume | 151 |
| Issue number | 5 |
| Publication status | Published - 2016 |
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Keywords
- Dermal fillers
- Hyaluronic acid
- Nasolabial fold
ASJC Scopus subject areas
- Medicine(all)
- Dermatology
Cite this
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. / Cameli, Norma; Mariano, Maria; Serio, Mirko; Berardesca, Enzo.
In: Giornale Italiano di Dermatologia e Venereologia, Vol. 151, No. 5, 2016, p. 507-514.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Clinical and instrumental evaluation of a cross-linked hyaluronic acid filler dermal injection
T2 - Effects on nasolabial folds skin biophysical parameters and augmentation from a single-dose, monocentric, open-label trial
AU - Cameli, Norma
AU - Mariano, Maria
AU - Serio, Mirko
AU - Berardesca, Enzo
PY - 2016
Y1 - 2016
N2 - 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.
AB - 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.
KW - Dermal fillers
KW - Hyaluronic acid
KW - Nasolabial fold
UR - http://www.scopus.com/inward/record.url?scp=84987846899&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84987846899&partnerID=8YFLogxK
M3 - Article
AN - SCOPUS:84987846899
VL - 151
SP - 507
EP - 514
JO - Minerva dermatologica
JF - Minerva dermatologica
SN - 0392-0488
IS - 5
ER -