Model Image 25

REFERENCES

Not an actual patient.

1/2 - J.Fares. A prospective study of evaluation of the results achieved with the application of PERFECTHA® Subskin, a new gel of hyaluronic acid non animal origin for malar and mental enhancement.

3 - Park KY1, Kim HK, Kim BJ. Comparative study of hyaluronic acid fillers by in vitro and in vivo testing. J Eur Acad Dermatol Venereol. 2014 May;28(5):565-8.

Cell toxicity was tested on fibroblast cell line. Cell viability was assessed neat and in 1/2 and 1/4 dilutions using 0.2g/ml HA filler.

4 - Koenig B., Analysis of IL-8 inducing potential from human effector cells. Evaluation of inflammatory potential of Perfectha product line by measurement of IL-8 release from adherent macrophages.

Study Report, MMD, August 2020.

5 - Post Market Data from July 2012 to August 2020.

6 - Talarico S. et al. Evaluation of the safety and efficacy of a new filler with hyaluronic acid for the treatment of nasolabial folds and lip contour; Surg. Cosmet. Dermatol.2010;2(2):83-6.

7 - Park KY1, Kim HK, Kim BJ. Comparative study of hyaluronic acid fillers by in vitro and in vivo testing. J Eur Acad Dermatol Venereol. 2014 May;28(5):565-8.

8 - Da Costa et al. Durability of Three Different Types of Hyaluronic Acid Fillers in Skin: Are There Differences Among Biphasic, Monophasic Monodensified, and Monophasic Polydensified Products?; Aesthet. Surg. J. 2016, 1-9.

9 - Internal data - Evaluation and comparison study of the G’ rheological properties of PERFECTHA® with the main competitors HA-based dermal fillers. This study was conducted internally on a TA Instruments DHR-2 rheometer with a 25mm parallel-plate geometry.Frequency sweep tests were performed on samples between 0.1 and 100 rad/s at a 1% strain in order to match the gels Newtonian Plateau and using plate-plate geometry.

10 - Internal Data: Material: Brookfield Texturometer CT3-4500 with a TA51 probe. Extrusion speed: 12mm/s over distance of 15mm.

INDICATION:

The EU approved intended use is: Ellansé (a Poly-ɛ-caprolactone-based dermal filler) is an injectable implant, indicated for subdermal implantation in the face for the lasting correction of wrinkles and facial aging signs or conditions.

INDICATION:

The EU approved intended use is: Ellansé (a Poly-ɛ-caprolactone-based dermal filler) is an injectable implant, indicated for subdermal implantation in the face for the lasting correction of wrinkles and facial aging signs or conditions.

Important Safety Considerations:

Like all procedures of this type there is a possibility of adverse events, although not everybody experiences them. These adverse events include but are not limited to infection, minimal acute inflammatory tissue reaction (redness, swelling, rash, oedema, erythema, lumps/nodules etc.), pain (which may be temporary or persistent in nature), transient haematoma or bruising.

Other potential adverse events include

- Injection related reactions, include itching, discoloration or tenderness may occur at the site of the injection. These usually resolve spontaneously within several days after the injection.

- As with any implant material possible adverse reactions that may occur include, but are not limited to the following: hypersensitivity, allergic reactions, inflammation, infection, fistula formation, haematoma, seroma, extrusion, induration formation, inadequate healing, skin discoloration, oedema, contusions/bruises, ecchymosis, inadequate or excessive augmentation, loss of correction, interference with local circulation if injected into a blood vessel resulting in vessel laceration, occlusion, embolism, infarction, and abscess at implant site which may result in induration and/or scar formation.

- Rare but serious adverse events associated with the intravascular injection of soft tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage, leading to stroke, skin necrosis, damage to underlying facial structures, nausea and vomiting, lack of ocular movement, significant skin changes, ptosis, exotropia and neurological complications.

- Adverse events, other than mentioned above, could occur as can be with any medical intervention.

All (potential) adverse side effects and incidents should be reported immediately to the Sinclair Pharma Corporate Safety Group: quality@sinclairpharma.com