What you need to know about HArmonyCa™

Before Treatment 

What do you need to know about HArmonyCa™ before treatment 

* 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.10

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. M049 V02/P01/Mar2023

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

11. Urdiales-Gálvez F, et al. J Cosmet Dermatol. 2023. doi: 10.1111/jocd.15706.

Treatment

Having treatment with HArmonyCa™

What areas of the face can I get treated with HArmonyCa™?

HArmonyCa™ can be used across various areas of your face including your cheek and jawline areas.1,2 During your consultation with your healthcare practitioner you will be able to discuss your concerns and treatment goals. Your healthcare practitioner will then create a treatment plan based on your needs and advise you on what you should do before and after your treatment with HArmonyCa™.1,3

1. Allergan Aesthetics. HArmonyCa™ Lidocaine IFU. M049 V02/P01/Mar2023

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.

Will the treatment be painful?

HArmonyCa™ contains lidocaine, a mild local anaesthetic, to make your treatment more comfortable. Your healthcare practitioner will assess your needs for pain management and apply, if necessary, the appropriate form of anaesthetic. They may also apply ice to the injection site to reduce swelling.1

1 Allergan Aesthetics. HArmonyCa™ Lidocaine IFU. M049 V02/P01/Mar2023

Post Treatment

Do's and don'ts after treatment with HArmonyCa™ 

Is HarmonyCa™ well tolerated?

HArmonyCa™ is well tolerated, with a low risk-benefit profile.*1 But as with any product, you may experience some short term side effects such as swelling, pain, tenderness and itching.†2

If you experience any common side effects which doesn’t resolve within the typical time frame or which worsens, or any other adverse event you should promptly report it to the attending medical practitioner.2

*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, August 2022.

2. Allergan Aesthetics. HArmonyCa™ Lidocaine IFU. M049 V02/P01/Mar2023

Are there any side effects associated with HArmonyCa™? 

As with other injectable treatments, the most common side effects following injection with HArmonyCa™ include redness, swelling, pain, tenderness and itching. These are often mild and typically get better within 24–48 hours, while swelling may take up to a week to completely resolve. You may wish to apply an ice pack or cold compresses to the treated area as per your healthcare practitioner's instructions post-treatment in order to reduce redness, swelling and irritation.1

You should promptly report the attending medical practitioner about:1

  • Any common side effect which doesn’t resolve within the typical time frame or which worsens.
  • Any other side effect.

 

1 Allergan Aesthetics. HArmonyCa™ Lidocaine IFU. M049 V02/P01/Mar2023

Is there anything I should avoid doing after my treatment?

Your healthcare practitioner will inform you to avoid strenuous activity, exposure to sunlight and tanning lamps or extreme weather conditions for 24 hours post- treatment in order to reduce redness, swelling and irritation. You may wish to apply an ice pack or cold compresses to the treated area as per your healthcare practitioner's instructions post-treatment in order to reduce redness, swelling and irritation.1

You should allow at least 4 weeks between ultra-sound based treatments, laser or peeling treatments and use of this product.*1

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

1. Allergan Aesthetics. HArmonyCa™ Lidocaine IFU. M049 V02/P01/Mar2023

How quickly can I return to my everyday activities after treatment? 

During your consultation, you will be advised when it is suitable for you to resume everyday activities after treatment. Normally, you will need to wait 24 hours after your treatment with HArmonyCa™ before doing high- intensity exercise or activities. Common side effects usually resolve within 24 to 48 hours, and any swelling should resolve in under a week.*1

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

1. Allergan Aesthetics. HArmonyCa™ Lidocaine IFU. M049 V02/P01/Mar2023

What can I expect after my HArmonyCa™ treatment?

HArmonyCa™ gave patients the benefits of a visible lift that lasts and sustained collagen stimulation from the inside out*,†,‡,1

HArmonyCa™ rejuvenated the skin for a youthful look by restoring volume, elasticity and firmness, with an increased facial volume 48 hours after treatment, with effects gradually building over a 6-month period.*,†,#,1 Results may vary.

*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. doi: 10.1111/jocd.15706.

Will I be happy with my results with HArmonyCa™? 

To ensure you have a good treatment experience choose an experienced medical practitioner that will create a treatment plan tailored to your needs and is familiar with the injection technique for HArmonyCa™.1,2

Calcium hydroxyapatite, which is contained in HArmonyCa™, restores balance by improving facial asymmetries and appearance.3 Over 90% of HArmonyCa™ users reported that they felt an improvement of general appearance of facial areas treated with HArmonyCa™.*‡4 Results may vary.

*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. M049 V02/P01/Mar2023

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. HArmonyCa™ Lidocaine, August 2022.

5. Urdiales-Gálvez F, et al. J Cosmet Dermatol. 2023. doi: 10.1111/jocd.15706.

Are there any conditions that should prevent me from using HarmonyCa™? 

If you are affected by any of the following, or another condition that may make HArmonyCa™ unsuitable, your healthcare practitioner would consider another treatment to meet your needs:*1

• If you have a known sensitivity to any of the product components (including steroids) or history of anaphylactic reactions and/or multiple severe allergies
• If you suffer from skin disease or abnormal skin conditions, or are susceptible to keloid formation, hypertrophic scarring or developing inflammatory skin conditions
• If you currently have an infection or inflammation (either acute or chronic) at or near the area you wish to be treated
• If you have any medical conditions or are taking any medicines which can impair your ability to heal
• If you are breastfeeding or pregnant
• If you are below the age of 18

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

1. Allergan Aesthetics. HArmonyCa™ Lidocaine IFU. M049 V02/P01/Mar2023.