Efficacy and tolerance of an injectable medical device containing stable hybrid cooperative complexes of high- and low-molecular-weight hyaluronic acid: a monocentric 16 weeks open-label evaluation

Figures & data

Table 1 Materials and instruments employed in the study

Materials	Model/producer/country
Profhilo^®: 2.25 mL non-pyrogenic prefilled syringe, containing 2 mL of 3.2% hyaluronic acid (HA) for intra-dermal use (32 mg H-HA + 32 mg L-HA dissolved in 2 mL of saline-buffered sodium chloride)	IBSA Farmaceutici Italia srl, Italy
Camera 3D	Vectra H1, Canfield, USA
Corneometer	CM825, Courage-Khazaka, Köln, Germany
MoistureMeterD	Delfin Technologies, Kuopio, Finland
Primos compact portable	GFMesstechnik, Teltow, Germany
Optical colorimetry	Chroma meter CR-200 Minolta, Japan
Silicon	liquid Optosil – Heraeus Kulzer, Germany
Catalyst	Universal Activator – Optosil^® – Xantopren^®, Germany
FotoFinderDermoscope	TeachScreen, Germany
Dermal Torque Meter	Dia-Stron Ltd, UK

Abbreviations: 3D, three-dimensional; HA, hyaluronic acid; H-HA, high-molecular-weight HA; L-HA, low-molecular-weight HA.

Figure 1 Reduction in the surface microrelief throughout the study.

Note: *P<0.05 vs T0.

Figure 2 Reduction in the FVLS “cheek volume loss” throughout the study.

Note: *P<0.05 vs T0.
Abbreviation: FVLS, facial volume loss scale.

Figure 3 Reduction in the WSRS “wrinkle severity” throughout the study.

Note: *P<0.05 vs T0.
Abbreviation: WSRS, wrinkle severity rating scale.

Figure 4 Variation from baseline in the skin electrical capacitance.

Note: *P<0.05 vs T0.
Abbreviation: AU, arbitrary unit.

Figure 5 Three-dimensional face volume analysis: increase of volume (cm³) T0 versus T8W and T16W versus T0.

Figure 6 Stacked bar plots of self-assessed efficacy by volunteers at week 16.

Figure 7 Subject 11 (49 years old): (A) T0 Baseline and (B) T8W 8 weeks after the first injection procedure.

Figure 8 Subject 19 (39 years old): (A) T0 Baseline and (B) T8W 8 weeks after the first injection procedure.