Skinfill Carbonium: new product for the treatment of deep wrinkles... remodelling Dr. Vannini Fulvio

Skinfill Carbonium: new product for the treatment of deep wrinkles and face contour
remodelling
Dr. Vannini Fulvio
Aesthetic medicine
aples
Abstract
A tissue augmentation product, based on cross-linked hyaluronic acid (HA), has been evaluated by
Promoitalia Group S.p.A.’s scientific department in Naples, which has cooperated with various
Italian research centers.
The study involved 80 patients treated with one to two injections during a follow-up period of 7
months from September 2007 until April 2008. The treatment was completed when skin was
levelled following one or two injections. No serious or permanent adverse reactions were noted
during the test period.
Introduction
Aging skin is a challenge to every aesthetic therapist. Besides treatment with different cosmetic
procedures, more profound wrinkles and folds of the face need more effective correction through
tissue augmentation. For a long period of time products based on bovine collagen have been used.
However, these products have been found to be sensitizing, short lasting, and also a potential source
for the transmittance of certain viral diseases. To this date, a wide variety of other materials have
been tested and used for the restoration of depressed contour deformities, for example silicone, and
most recently, cross-linked versions of hyaluronic acid ( HA) (1,2,3,4,5,6,7,12).
HA is a natural polymer with extraordinary biological compatibility. The substance is a constituent
of all connective tissues in both humans and most other vertebrates and is biodegradable. Because
of these favourable properties, the demand all over the world for HA based products in the practice
of tissue augmentation of the aging skin is rising (1). However, the intradermal durability of a nonmodified HA preparation needs to be cross-linked in order to fulfil the demand for a long lasting
product.
Until today, commercial preparations of HA have not all been proven to have the properties of an
optimal substance, such as pronounced tissue augmentation, transparency, non-toxicity, ease of
injection and a long lasting intradermal durability combined with biodegradability. Most
importantly, if the HA preparation is not highly purified, it can be potentially sensitizing to some
individuals.
Objective
The primary objective of this limited study was to investigate the safety an efficacy, during and
after the injection, of the cross-linked HA preparation, named Skinfill Carbonium, when injected
intradermally to correct wrinkles, folds and increase the fullness of the lips.
Material and method
For this study, a volume of 1.6 to 3.2 ml of Skinfill Carbonium was used. Skinfill Carbonium is a
sterile, non-pyrogenic, viscoelastic implant based on cross-linked HA. It is a clear, colorless and
transparent gel packaged in a disposable syringe with a volume of 1.6 ml. Each box contains two
syringes. The product is manufactured by cross-linking the glucoseamino-glucan molecule of HA
using BDDE (1,4-butanediol diglycidyl ether 0.06 µg/ml), to get a product with a HA concentration
of 10 mg/ml.
The result is a polymer with a molecular network that resides in the intracellular matrix of the skin
for 6 to 12 months. Skinfill Carbonium is a product by Promoitalia Group spa.
In the present study, the product was implanted through needles of 27 Gauge ½” (0.4x13 mm). The
injections were made intradermally using the linear threading technique. In cases of a remaining
defect, the same procedure was repeated until the entire wrinkle or deformity was treated
sufficiently. In most cases one to two syringes were used for every treated patient.
Patients
A total of 80 patients (100% females) participated in the study. Depending on the severity of the
wrinkle and fold due to the age or the condition of the skin, some of the patients received a followup treatment two to three weeks after the initial treatment. The facial areas treated for these patients
were limited to the glabellar lines, nasolabial folds, mouth angle wrinkles, cheeks, chin, upper lip
and forehead giving a total of seven different facial areas treated.
All patients were monitored for at least half an hour after the treatment in order to detect any
occurrence of e.g. erythema, swelling, redness, itching, pain or tenderness. Any noticeable adverse
event was carefully documented and followed up.
Results
Efficacy
The three main parameters used for determining the results and the efficacy of the treatment were:
1. The degree of correction
2. The physician’s estimation of the degree of improvement, and
3. The patient’s assessment of the degree of improvement.
In accordance with the above-mentioned parameters, the study shows that the product fulfilled the
expected degree of correction, as evaluated by the physician, as well as the patient’s self-assessment
of the degree of improvement. The combined evaluation showed that the product immediately filled
out and lifted the wrinkles.
Safety
In a very small number of the treated patients there were minor injection-related reactions, as could
be expected from the sensitizing study (13).
Reactions related to an actual injection of the product were seen in a total of 2 cases (out of a total
of 80). One case was an 81-year-old woman with very deep, over – folding wrinkles, who was
treated once with only injection. In this case no improvement was noticeable. The other case was a
lip enhancement treatment where the effect had disappeared after two to three weeks. No reactions
or adverse events were found to be related to the actual implant of the product.
The results described above could indicate that the use of this specific cross-linked HA preparation
is not to be considered a risk to the patients.
Discussion
Generally, materials used for intradermal implantation, mainly in the facial area, have differed
widely over time. Because the skin is under constant transformation due to aging and other factors,
permanent implants have shown to not be suitable or desirable for dermal correction, since these
types of products will not degrade. In some cases, the injected product has migrated from the treated
area, thus creating a lateral augmentation in a way that the wrinkle has been increased instead of
being reduced. Other adverse events have been reported related to degradable materials, for
example, for products deriving from bovine collagen (7, 11).
The preparation used in this particular study is based on non-bacterial, natural HA, a substance that
has several advantages compared to products based on bacterial HA.
HA based products have already, in their non cross-linked form as an implant, been used for more
than 30 years and in millions of individuals with a high efficacy and safety track record.
The critical properties in relation to a HA based dermal filler is the source of the material and also
the method of cross-linking of the preparation in order to prolong the durability of the implanted
product. To ensure that the results given are the best possible, and to minimize any risk for adverse
events, a non- bacterial and natural form of HA, deriving from rooster combs, has been chosen for
the preparation used in this study. This HA has then been cross-linked using a low degree of BDDE
(1,4-butanediol diglycidyl ether), a chemical cross-linking agent commonly used for dermal filler
products based on HA. The product is then sterilized using steam sterilization. Furthermore, the
roosters used for the preparation of this product are raised in selected farms. Seen the origin of the
HA, it has a very high molecular weight compared to HA deriving from bacterial origin. Bacterial
origin HA has a molecular weight that ranges from 1 000 000 to 2 500 000 Dalton (Low Molecular
Weight, LMW) whereas HA deriving from rooster combs has a High Molecular Weight (HMW)
equal 5 500 000 Daltons. It is thanks to this fact that the product has a high viscosity in spite of the
low concentration of HA (10 mg/ml).
Another characteristic of the product in object is the Easy-Flow technology, which means that a
filler with an elevated molecular weight would have a higher shear thinning compared to those of
bacterial origin with a lower molecular weight. Shear thinning means that a non-Newtonian fluid
has the ability to transform its own state, from solid to liquid and vice versa; this is exactly what the
Skinfill Carbonium product does meaning that it has elevated manageability and plasticity. The
former thanks to the elevated product adaptation during the passage through the syringe and the
latter due to the excellent adaptation in the dermis with immediate recovery of its viscosity and
filling of the depression.
The resulting product is a formation of intermolecular bonds of high viscosity with a high
viscoelasticity and elasticity. Furthermore, the low cross-linking level means that the final product
is similar to the natural occurring HA found in the human tissue, and is as such very well tolerated
by the human skin cells and tissues (9, 10).
Conclusions
The results from the study shows that the examined product, used with the described injection
technique, serves its purpose as a dermal filler to be used for corrections of wrinkles, folds and lip
in an efficient and safe manner. It also has the advantage of being similar to the natural occurring
HA present in the human body.
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