שאלות ותשובות

*Results from a pre-clinical animal study of HArmonyCa™ with lidocaine, with results demonstrated over 8 weeks.⁵

† Results from a pre-clinical animal study of HArmonyCa™ with lidocaine, with results demonstrated over 12 weeks.²

1 Segal T, et al. 2014 – Post marketing study of safety and efficacy of Crystalys, a calcium hydroxyapatite based filler for facial soft tissue augmentation. Available at: https://www.luminera.com/wp-content/uploads/2019/02/Post- marketing-study-Crystalys.pdf. Accessed July 2023.

2 Park S, et al. Ann Dermatol. 2014;26:357–362.

3 Gonzaga da Cunha M, et al. Surg Cosmet Dermatol. 2020;12:109–117.

4 Zerbinati N, Calligaro A. Clin Cosmet Investig Dermatol. 2018;11:29–35.

5 Allergan Aesthetics. Data on File. HArmonyCa™ Lidocaine INT- HAR2150040. Collagen stimulation. Jul 2021. 

6  Aguirre-Cruz G et al. Antioxidants (Basel) 2020; 9.

7  Salwowska NM et al. J Cosmet Dermatol 2016; 15:520–526.

8 Lowe NJ, Lowe P. Dermatol Ther (Heidelb). 2012; 2(1):14

9 Allergan Aesthetics. HArmonyCa™ Lidocaine IFU. M032 V01. 2021.

10 Allergan Aesthetics. Data on File. HArmonyCa™ Lidocaine INT-HAR2150036. Lift capacity. Jul 2021.

1 Allergan Aesthetics. HArmonyCa™ Lidocaine IFU. M032 V01. 2021.  

2 Urdiales-Gálvez F, et al. J Cosmet Dermatol. 2023. doi: 10.1111/jocd.

3 Lipko-Godlewska S, et al. J Cosmet Dermatol. 2021;14:169–178. 

1 Allergan Aesthetics. HArmonyCa™ Lidocaine IFU. M032 V01. 2021.

*In a post-marketing clinical analysis of HArmonyCa™ (N=162), conducted in Israel, one unrelated serious side effect was reported and one side effect required medical intervention due to material migration into the lips and over correction.¹

† Please see HArmonyCa IFU for the full list of side effects, contraindications, warnings and precautions.²

1 Allergan Aesthetics. Data on File. HArmonyCa™ Lidocaine. Clinical Study Report. July 2022.

2 Allergan Aesthetics. HArmonyCa™ Lidocaine IFU. M032 V01. 2021. 

1 Allergan Aesthetics. HArmonyCa™ Lidocaine IFU. M032 V01. 2021. 

* Please see HArmonyCa™ IFU for the full list of warnings and precautions.¹

1. Allergan Aesthetics. HArmonyCa™ Lidocaine IFU. M032 V01. 2021. 

* Please see HArmonyCa™ IFU for the full list of side effects, contraindications, warnings and precautions.¹

1. Allergan Aesthetics. HArmonyCa™ Lidocaine IFU. M032 V01. 2021. 

*Results from a prospective and non-randomised interventional study where HArmonyCa™ was injected in the preauricular region of 15 women. The primary endpoint were the volumetric changes at Day 180. Secondary endpoints included changes in facial tension vectors, time to filler tissue integration and safety profile.¹

†Ultrasound and elastography examinations were performed using the Samsung HT 30 ultrasound machine and the ElastoScan HS30/XH30 respectively (Samsung Healthcare Global). When compared to baseline, an increase in density, viscoelasticity, and firmness of the tissue was observed at 60 days and then confirmed at 90 days after treatment. At 180 days after treatment an increase in collagen in the treated areas was confirmed.¹

‡Vectra® H2 (Canfield Scientific, Inc.) was used to assess skin lift and tightening by measuring the changes in facial tension vectors (FTV) at 60, 90, and 180 days after treatment. As compared to pre-treatment values, FTV significantly increased at all timepoints with a median (interquartile-range) increased by 2.2 (1.6– 2.2) mm and 2.0 (1.7–2.2) mm in the right and left side, respectively p < 0.0001 each, 180 days after treatment.¹

#Vectra® H2 (Canfield Scientific, Inc.) was used to assess volumetric changes, with a median (interquartile-range) volume increased by 2.1 (1.9–2.3) cc and 2.1 (1.8–2.2) cc in the right-and left-side, respectively, p<0.0001 each at Day 180.1

1.Urdiales-Gálvez F et al., J Cosmet Dermatol. 2023;00:1–12.

*A post marketing clinical follow up of safety and performance of HArmonyCa™ (N=162).⁵

†Performance evaluation using the Lemperle Scale.⁵
1 Allergan Aesthetics. HArmonyCa™ Lidocaine IFU. M032 V01. 2021. 2 Lipko-Godlewska S, et al. J Cosmet Dermatol. 2021;14:169–178

3 Segal T, et al. 2014 – Post marketing study of safety and efficacy of Crystalys, a calcium hydroxyapatite based filler for facial soft tissue augmentation. Available at: https://www.luminera.com/wp-content/uploads/ 2019/02/Post-marketing-study-Crystalys.pdf. Accessed July 2023.

4 Allergan Aesthetics. Data on File. INT-HAR-2150007. HArmonyCa™ Lidocaine. Clinical Study Report. March 2021. 

* Please see HArmonyCa™ IFU for the full list of side effects, contraindications, warnings and precautions.¹

1. Allergan Aesthetics. HArmonyCa™ Lidocaine IFU. M032 V01. 2021.