Ellansé™ Monography
Product information gathered by
Luis C. Casavantes, MD., and Palmira Morales, MD.
November 2023.
Ellansé™, launched in 2009, is a brand of dermal filler used for different clinical indications like aging face (facial rejuvenation) and volume restoration of diverse body areas, including the penis (nonsurgical phalloplasty).
Ellansé™ is manufactured by AQTIS Medical BV (Sinclair Pharma) in the Netherlands.
What is Ellansé™?
Ellansé™ is a long-term injectable implant with breakthrough technology made of polycaprolactone (PCL) microspheres, a synthetic polymer suspended in a gel of carboxymethylcellulose (CMC), glycerin, and buffered saline solution.
The content of PCL/CMC in Ellansé™ is 30/70%.
Ellansé™ is a sterile, single-use, latex-free, non-pyrogenic, bioresorbable, non-permanent injectable implant; it is a stand-alone device that should not be combined with any other device to meet its intended purpose.
The product is easy to inject using a 27G needle or micro-cannula.
Ellansé™ is available as a box containing two individually packed, pre-filled, ready-to-use, 1 ml. syringes and four individually sealed sterile 27G needles.
The two main indications of Ellansé™ are:
1. Correction of signs of aging, such as wrinkles, fine lines, and loss of facial volume in areas such as cheeks, temples, and jawline.
2. Penile volume augmentation
Ellansé™ is known for its unique properties, distinguishing it from most other dermal fillers; its main characteristics include:
1. Stimulation of new collagen in the area of injection. This collagen stimulation helps to improve skin elasticity and firmness, contributing to a more youthful appearance.
2. Long-lasting results: One of the notable features of Ellansé™ is its duration of effect. While many dermal fillers provide either permanent or temporary results, Ellansé™ can last longer, typically more than four years, due to the collagen-building effects and the low rate of absorption of PCL.
3. Gradual and natural results: Ellansé™'s effects develop gradually, creating a more natural-looking outcome than other fillers. This progressive enhancement allows patients to achieve and maintain their desired results over time.
4. Different formulations: There are two varieties of Ellansé™, classified according to their longevity: Ellansé™ S, whose effect lasts for 18+ months, and Ellansé™ L, which lasts for 24+ months; its longevity depends on the chain length of PCL. The choice of formulation depends on the individual patient's needs and the desired treatment area. The vast majority of phalloplasty patients opt for Ellansé™ M.
Mechanism of Action
The PCL filler induces the formation of collagen type-III and type-I at an early stage (measured at nine months) and later predominantly collagen type-I, which deposits around the PCL microspheres (measured at 21 months). Human biopsies have demonstrated that PCL also stimulates the formation of new elastin fibers and capillaries.
The body naturally hydrolyses PCL into carbon monoxide and water, leaving residual collagen type-I and type-III, which extends the life of the additional volume beyond the life of the PCL microspheres.
The turnover rate of collagen can vary with age, genetics, and overall health. In general, collagen turnover rates tend to slow down as people age. Younger individuals may have a faster collagen turnover rate, contributing to skin's elasticity and youthful appearance.
As published by Kim, PCL particle size was mathematically calculated for four years in an in vivo biopsy study. Until three years after the injection, PCL particles remained smooth, and their diameter persisted at 95.47%, showing phase-I isovolemic degradation. Four years after the injection, particles decreased in size and became very rough, showing phase-II bulk degradation. The author concluded that Ellansé™-M's longevity was longer than four years.
There isn't a specific "time cycle" for the turnover of collagen that applies universally, as it varies between tissues and individuals.
Factors that influence collagen turnover include:
1. Age: Collagen turnover tends to decrease with age, leading to reduced production and increased degradation.
2. Genetics: Genetics can affect how collagen is synthesized and replaced in the body.
3. Environmental factors: Sun exposure, smoking, and other environmental factors can accelerate collagen breakdown and affect the turnover rate.
4. Health and diet: Your overall health and diet can impact collagen production and turnover. A balanced diet rich in essential nutrients can support collagen production.
5. Lifestyle factors: Exercise and physical activity can also influence collagen turnover, stimulating collagen production.
In vitro trials have demonstrated that the presence of ascorbate (Vitamine C) enhances the production of collagen by the native fibroblasts.
Safety and Side Effects
A review of adverse effects of Ellansé™ as a facial filler from 2009 to 2022 showed that the event rate was 0.0462% (or one event in every 2,165 syringes used). They include nodules, hardness, infection, swelling, and bruising [1].
There are no documented side effects for patients who underwent nonsurgical phalloplasty with Ellansé™ because, to this date, this indication continues to be off-label. Further clinical trials are necessary to establish its safety and efficacy.
Bibliography
Christen MO, Vercesi F. Polycaprolactone: how a well-known and futuristic polymer has become an innovative collagen-stimulator in aesthetics. Clin Cosmet and Investig Dermatol 2020; 13:31-48.
Oh H, Lee S, Na J. Comparative evaluation of physical characteristics and preclinical data of a novel monodisperse polycaprolactone microspheres filler. Aest Plas Surg 2022; 46:225-226.
Kim J. Isovolemic degradation of polycaprolactone particles and calculation of their original size from human biopsy. Plast Reconstr Surg Glob Open 2020; 8(6):e2866.
Middelkoop E, de Vries H, Ruufs L, et al. Adherence, proliferation and collagen turnover by human fibroblasts seeded into different types of collagen sponges. Cell and Tissue Research 1995; 280;447-453.
Zhao H, Ren R, Bao S, et al. Efficacy and safety of polycaprolactone in treating nasolabial folds: A prospective, multicenter, and randomized controlled trial. Facial Plas Surg 2023; 39(3):300-306.