New independent studies demonstrate that PCL filler offers greater longevity and volumisation 2 year

By Sinclair / 09 May 2023

Two new independent studies demonstrate that Ellansé, Sinclair’s first bio-stimulating dermal filler, offers significant longevity indicative of powerful and neocollagenesis induced by the PCL gel, as well as a sustained volumising action two years’ post-treatment.

The first study, Objective Assessment of the Long-Term Volumising Action of a Polycaprolactone-based Filler*, conducted retrospectively on nine female subjects aged 35-45-years old, investigated the volumising effect and longevity of Ellansé via 3D measurement.

All subjects receiving filler injections were pre-treated with an infraorbital anesthetic nerve block, with Ellansé then injected onto the supra-periosteal plane in the malar area on both sides of the face with a 22Gx50 mm blunt-tipped cannula.

Assessment was made pre- and post-treatment using the Vectra system (Canfield –USA). Standardized full-face 2D and 3D digital surface images were taken for each of the nine subjects at baseline and then at two time points, one year and two years after injection.

The effects of the treatment were observed at one and two years.

The study proved and concluded:

• Ellansé was shown to have a sustained volumising effect at two years, with clear evidence of increase in volume of between 50% and 150% over the baseline, over and above the volume injected in all the cases studied. The study ruled the effect was indicative of significant neocollagenesis induced by the PCL
• There was significant augmentation induced by Ellansé-S over and above the volume of filler initially injected indicated a strong stimulation of Type 1 collagen
• The significant volume augmentation could only be explained by the powerful neo-collagenesis induced by the PCL microspheres
• Of the three collagen-stimulating agents, only PCL and PLLA have been consistently shown to have long-term, clinical efficacy, whereas CaHA shows greater discrepancies in the literature regarding the duration of the clinical effect, from only six to 24 months with several studies demonstrating limited clinical efficacy with the filler.

A second study, Objective Evaluation of the Longevity of A Calcium Hydroxylapatite -based Filler**, comprised a retrospective chart analysis of four female Caucasian subjects aged 28-50 years. As in the previous study, all received filler injections – this time using CaHA filler - following pre-treatment with an infraorbital anesthetic nerve block.

Assessment was again carried out pre- and post-treatment using the Vectra system (Canfield –USA). Full-face 2D and 3D digital surface images were taken for each of the four subjects at baseline and then at three months and five months years after injection.

The study concluded that Calcium Hydroxylapatite soft tissue filler is a proven biostimulant. However, objective volume assessments performed with the Canfield Vectra 3D analysis system showed that the volume augmentation with the filler is not sustained; on the contrary, a significant decline was seen within five months of injection.

Ellansé, from Sinclair’s pioneering dermal filler portfolio, is comprised of a unique and patented composition – 70% Carboxymethyl Cellulose (CMC) based gel carrier and 30% PolyCaproLactone (PCL) microspheres. PCL is biodegradable and bio-resorbable and is naturally hydrolysed into CO2 and H2O by the body. CMC is from non-animal, human or bacterial sources and is not cross-linked to avoid potentially related toxicity. This unique composition allows for immediate correction by the CMC, followed by stimulation of the body’s own collagen with the PCL.

Ellansé contains a bio-absorbable medical polymer called PolyCaproLactone (PCL). When the polymer microspheres suspended in filler gel are absorbed by the body, a reaction is triggered causing the body to regenerate its own Type 1 repair collagen.

The Ellansé range is available in two versions, which is only available to trained medical aesthetics clinicians, and allows them to customise their treatments for the face. It can be placed at different depths within the sub-dermal layers of the skin, meaning it can be used for facial line improvement, to fill and correct wrinkles and folds, and volumise, contour and sculpt the face. Another benefit Ellansé treatment is the improvement in skin quality as a result of the freshly generated collagen; it has been successfully used to ameliorate atrophic scars and deep acne pits, which can have a strong psycho-social impact.

The full publications are available to view on the Sinclair College website.

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