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Before Treatment 

What would you like to know about HArmonyCa™ ?

Treatment Process

Having treatment with HArmonyCa™ 

Where can HArmonyCa™ be used?

Are you after a refreshed look that reflects how you feel inside… ? 1−3,*,†,‡,§,¶,**

HArmonyCa™ is designed to address multiple signs of facial ageing in one treatment to help rejuvenate your skin.1,4−7,*,†,††,‡‡

It is proven to create lift and may encourage collagen production in the mid and lower areas of the face.1,*,§§

Could this be the facial harmony you’re looking for?

* Results from a prospective and non-randomised interventional study where HArmonyCa™ was injected in the preauricular region of 15 women. The primary endpoint was 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

‡ Results from a 1-year, prospective, open-label, post-marketing study where HArmonyCa™ and HArmonyCa™ Lidocaine were injected in the midface of 140 patients with moderate to severe midface volume deficit. The primary endpoint was responder status based on EI-assessed MFVDS at Month 1. Secondary endpoints included responder status based on EI-assessed and participant-assessed GAIS, change from baseline on FACE-Q Satisfaction with Cheeks questionnaire and change from baseline on FACE-Q Satisfaction with Facial Appearance questionnaire. The mITT population was all treated participants with non-missing baseline MFVDS score. At Month 1, the MFVDS responder status (a participant with at least 1-grade improvement on the MFVDS based on the EI’s live assessment of midface volume deficit) was 82.8% (95% CI: 75.7%–88.5%) in the mITT population for both treatment groups combined.2,8,9

§ The proportion of patients who were somewhat or very satisfied with how fresh their face looked (measured by FACE-Q) increased from 20.7% at baseline to 76.1% at Month 1. The proportion of patients who were somewhat or very satisfied with how rested their face looked (measured by FACE-Q) increased from 10.7% at baseline to 73.5% at Month 1. Participant self-perception of age (exploratory endpoint) decreased from mean 55.7 years at baseline to 54.5 years at Month 1. At Month 12, the majority of participants were still somewhat or very satisfied in the individual FACE-Q Satisfaction with Facial Appearance questions.2,8

¶ A post-marketing clinical follow up of safety and performance of HArmonyCa™(N=162).3

** Performance evaluation of the late follow-up cohort (N=45) using the 5-point Likert Scale User Satisfaction Questionnaire where a high user satisfaction for overall satisfaction was reported (mean 4.1 out of 5).3

†† 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

‡‡ Vectra® H2 (Canfield Scientific, Inc.) was used to assess skin lift and tightening by measuring the changes in facial tension vector (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

§§ HArmonyCaTM can be injected in the preauricular area in the ascending and descending branches of the jaw.1
 

1.  Urdiales-Gálvez F et al. J Cosmet Dermatol. 2023;22(8):2186–2197.
2.  Allergan Aesthetics. Data on File. M21-787 Responder Rates. REF-125579.
3.  Allergan Aesthetics. Data on File. HArmonyCa™ Lidocaine. Clinical Study Report. July 2022. REF-99624.
4.  Allergan Aesthetics. HArmonyCa™ Lidocaine IFU. M032 V01. 2021.  
5.  Swift A et al. Aesthet Surg J. 2020;sjaa339.
6.  Kahn DM, Shaw RB. Facial Plast Surg. 2010;26:350–355.
7.  Coleman SR, Grover R. Aesthet Surg J. 2006;26:S4-S9.
8.  Allergan Aesthetics. Data on File. M21-787 Introduction, Study Objectives, Endpoints, and Demographics. REF-125574.
9.  Allergan Aesthetics. Data on File. M21-787 Primary Effectiveness and Other Analyses. REF-125577.

Will treatment be painful?

Rest assured: HArmonyCa™ contains lidocaine, which is a local anaesthetic, to help make treatment comfortable.1

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

Post-Treatment

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

How will I feel after treatment with HarmonyCa™?

It's reassuring to know that HarmonyCa™ has been evaluated in clinical studies1-3– and tolerated well without any downtime!1,4,*,†

Any possible short term side effects can include swelling, pain, tenderness and itching  (but these typically resolve within 24–48 hours, and swelling within a week).4,#

If you’re unsure about anything, then do talk to your practitioner, pharmacist or nurse right away.

*Results from a retrospective, non-interventional study assessing the incidence and severity of treatment related side effects in 403 adults treated with HArmonyCa™ Lidocaine at six clinics in Brazil.1

† In a retrospective, non-interventional study (N=403), there were 12 side effects in 11 patients (2.7%) relating to HArmonyCa™ and/or the injection procedure, of these only one was deemed moderate in severity.1

# Please see HArmonyCa™ IFU for the full list of warnings and precautions.4

1. Braz A et al. A Retrospective Analysis Of Safety In Participants Treated With A Hybrid Hyaluronic Acid And Calcium Hydroxyapatite Filler. Poster Presentation. April 2023. Available at: https://abbvie1.outsystemsenterprise.com/GMAEventPublications/Assets.aspx?ConferenceId=581.
2. Allergan Aesthetics. Data on File. HArmonyCa™ Lidocaine. Clinical Study Report. October 2023. REF-99624.
3. Urdiales-Gálvez F et al. J Cosmet Dermatol. 2023;00:1–12.
4. Allergan Aesthetics. HArmonyCa™ Lidocaine IFU. M032 V01. 2021.

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.1

However, these are often mild and typically get better within 24–48 hours, while swelling may take up to a week. Apply an ice pack or cold compress to the treated area to reduce any redness, swelling and irritation – your healthcare practitioner should advise you on your treatment aftercare.1

Do get in touch with your practitioner if you have any concerns post-treatment or if you experience one of these common side-effects that doesn’t get better within the typical timeframe or gets worse, or if you experience any other side effect.1,*

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

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

Is there anything I should avoid doing after HArmonyCa™ treatment?

Your practitioner will talk you through your HArmonyCa™ aftercare, but top tips for the first 24 hours after treatment include: 1,*

• Avoiding strenuous activity1
• Avoiding exposure to sunlight, tanning lamps and extreme weather conditions1
• Using an icepack or cold compresses if your face feels a little tender or looks red1
• Massaging any small bumps if they appear1  

Feel free to ask your practitioner for all the advice you need.

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

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

How quickly can I get back to my everyday activities after treatment?

Everyone’s different, of course, but hopefully you can get back to work and your normal daily activities on the same day after having treatment. Your practitioner should be able to advise you.

What can I expect after my HArmonyCa™ treatment?

HArmonyCa™ is designed to rejuvenate skin by restoring volume, elasticity and firmness.1*,†,§

It’s one treatment with two effects.2 After treatment, your skin may feel firmer and tighter. 1,*,†,‡ But that’s not the only thing to expect … this immediate and visible lifting effect can last up to 6 months!1–3,*,†, ‡,#

Imagine leaving the clinic with potentially immediate results that can get better with time.1,3,*,†,‡,§

* Results from a prospective and non-randomised interventional study where HArmonyCa™ was injected in the preauricular region of 15 women. The primary endpoint was 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 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

‡ 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

# Results from a pre-clinical animal study of HArmonyCa™ with results demonstrated over 12 weeks which showed that HArmonyCa™ led to an instant and sustained lift following injection.3

1. Urdiales-Gálvez F et al. J Cosmet Dermatol. 2023;00:1–12
.2. Allergan Aesthetics. HArmonyCa™ Lidocaine IFU. M032 V01. 2021.
3. Allergan Aesthetics. Data on File. HArmonyCa™ Lidocaine. Lift capacity. October 2023. REF-84448.

Will I be happy with my results with HArmonyCa™? 

It’s sensible to choose an experienced medical practitioner to tailor a treatment plan to your needs and who’s familiar with the HArmonyCa™ injection technique.1,2,4

Patients were highly satisfied with their results after just one treatment session.3,* What’s more, most even said they wanted to repeat treatment!4,†,‡

Want to join the 92% of people seeing improvements in their skin?4,†,§

Ask your practitioner about HArmonyCa™ and facial harmony.

* Results from a single-centre, prospective, quasi-experimental controlled study where HArmonyCaTM was injected in different areas of the face of 15 participants. The Subject Global Aesthetic Improvement Scale was used to assess patients' overall satisfaction at 120 days after the single-session treatment.3

† A post-marketing clinical follow up of safety and performance of HArmonyCa™ (N=162). Significant improvements were reported in treated facial regions.4

‡ Performance evaluation of the early satisfaction cohort (N=62) using the 5-point Likert Scale User Satisfaction Questionnaire where a high user satisfaction for look and feel was reported (mean 3.9 out of 5).4

§ A post-marketing clinical analysis of HArmonyCa™ in which a subset of patients (N=48) evaluated effectiveness of treatment using the Global Aesthetic Improvement Scale (GAIS).4
 

1. Allergan Aesthetics. HArmonyCa™ Lidocaine IFU. M032 V01. 2021
2. Lipko-Godlewska S, et al. J Cosmet Dermatol. 2021;14:169–178
3. Bravo B et al. Plast Reconstr Surg Glob Open. 2023;15(11):1–10. 
4. Allergan Aesthetics. Data on File. HArmonyCa™ Lidocaine. Clinical Study Report. October 2023. REF-99624.

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

If you’re 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 suffer from prolonged bleeding or tissue healing due to medical conditions or medicinal drugs. 
  • If you currently have an infection or inflammation (either acute or chronic) at or near the treatment site.
  • If you have any medical conditions or are taking any medicines which can impair your ability to heal.
  • If you are hypersensitive to lidocaine or other amide-type local anaesthetics or have a condition for which lidocaine is contraindicated.
  • 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. M032 V01. 2021. 

 

UK-HAR-230135 | Date of prep: September 2024

Adverse events should be reported.

Reporting of Side effects:

UK patients: If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can help by reporting side effects directly via the Yellow Card Scheme at https://yellowcard.mhra.gov.uk/ or via the MHRA Yellow Card app, available in the Google Play or Apple App Stores. Adverse events should also be reported to AbbVie at ProductSurveillance_EAME@allergan.com. By reporting side effects, you can help provide more information on the safety of this product.

 

Irish patients: If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via www.hpra.ie.