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from renewable sources and has been commercially onset of the trial was 2.9 mm without the presence of
available as Sculptra/Fill® (Sanofi Aventis, Paris, France). underlying facial fat. The increases in Cutaneous thickness
It is injected into either the deep dermis or subcutaneous increased at weeks 6, 24, 48, 72 and 96 to 5.1, 6.4, 7.2,
layer and immediately fills the space, restoring facial fat 7.2 and 6.8 mm, respectively. Minimal and localized edema
[42]
loss. Once injected, the material creates immediate was observed in most patients but resolved spontaneously
volumization secondary to the properties associated with within 48 h. Fifteen out of fifty patients developed minimal
[50]
the product’s microparticles. [43,44] However, the volumization ecchymosis which resolved within 3 days. Patients were
effect disappears within a few months as the microparticles compliant with their injections despite the side effects; the
degrade and the material is metabolized, resulting in dermal feasibility of using PLA for facial lipoatrophy treatment was
[43]
[51]
fibroplasia. This degradation results in the formation of clearly demonstrated. Moyle et al. conducted an open
connective tissue or neocollagenesis. [43,45] It is important to label study to evaluate the effect of immediate vs. delayed
understand that PLA is a bio-stimulatory agent which benefits PLA injections for 24 weeks. Patients in the immediate
[46]
from the host system. The results associated with this treatment group received PLA treatments on day 1, as well
product therefore are not immediate and are instead gradual, as 2 and 4 weeks after the initial treatment. Patients in the
lasting for at least 2 years. [45,47] It is approved in Europe for delayed treatment group received PLA injections at weeks
the treatment of scars and wrinkles, and in the United States 12, 14, and 16. The study was limited to three injections
[51]
for the treatment of facial lipoatrophy in patients diagnosed per side and found similar improvements in 24 patients by
with human immunodeficiency virus (HIV) lipodystrophy both subjective assessment and ultrasound. Interestingly,
[51]
syndrome. The injection technique is of crucial importance by week 12, patients in the immediate treatment group
given the risk of papule and nodule formation. [43,45,48] This scored significantly higher on the visual analogue scale and
product is overall very advantageous because it provides had lower levels of anxiety than their delayed treatment
volume restoration while simultaneously increasing the counterparts. Overall, it was concluded that PLA injection
[51]
dermal thickness. [45,47] Other advantages include reduced remained efficacious for more than 18 weeks. [51]
safety concerns because it provides temporary results, and
its very good risk-benefit profile in both HIV+ and cosmetic Although many studies have examined the safety of PLA,
patients. [42] its use is continually refined. [46-48,51] While the above studies
investigated the optimal treatment times and methods
PLA was first approved for use in Europe in 1999. of application, additional studies have been conducted
[52]
Subsequently, many studies have been performed to regarding injection in the periorbital and perioral regions,
[53]
determine the best method for use and the potential benefits. the use of conservative injection volumes , and appropriate
[44]
A preclinical study was conducted in 1993 by Gogolewski et al. dilution volumes. [53,54]
in which PLA solids were implanted into mice. There were
no signs of abscess formation, acute inflammatory response, Calcium hydroxylapatite
or cytotoxic effects at the site of implantation. Another CaHA and its derivatives are naturally found in human
[55]
study was conducted with 300 patients who underwent bone and dental enamel. Due to the structural similarity
treatment with PLA between 1999 and 2004. In total, 819 of the CaHA to the mineral portion of bone and its
injections were administered for treatment of the nasolabial composition of calcium and phosphate ions, it is very
folds, labiomental creases, temples, upper lip, cheeks, chin, biocompatible and therefore does not require skin testing.
and marionette lines. Improvements were noted in most Radiesse® (Bioform Medical, Inc., San Mateo, CA, USA)
patients with effects lasting for 12-24 months. Ten percent consists of CaHA microspheres suspended in an aqueous
[49]
of patients who received treatments between 1999 and 2002 carboxymethylcellulose gel carrier and is primarily used
reported subcutaneous papules, which lasted for 12-24 months for the correction of moderate to severe wrinkles and folds
[1]
and resolved without further intervention. Papules can also and volumization of facial soft-tissue. It is also used for
be treated with intralesional triamcinolone (10 mg/mL) and/or correction of facial lipoatrophy secondary to the human
intralesional 5-fluorouracil with resolution within 3 months. immunodeficiency virus. The microspheres present in
[1]
Since 2002, the reported rate of granuloma formation is Radiesse® are thought to act as a scaffold for new collagen
less than 1%. This low rate is attributed to pre-treatment of formation. CaHA microspheres (25-45 μm in diameter)
PLA with 3 mL of sterile water 36-48 h prior to treatment, are suspended in a carboxymethylcellulose gel carrier in
followed by adding 2 mL of 1% lidocaine immediately prior to a ratio of 30% microspheres to 70% gel by volume. The
[56]
injection. This creates a dilution of 5 mL, whereas previously gel base helps to evenly distribute the microspheres at the
3 mL of sterile water only was added 2-12 h prior to use. injection site, providing immediate volume restoration.
[56]
Injection was administered into subcutaneous fat instead of After the gel degrades in 2-3 months, the microspheres
the deep dermis. promote the formation of new tissue formation by collagen
[57]
deposition. Results typically last for 12-18 months [58-60]
[50]
A study was conducted by Valantin et al. in 2003 evaluating leaving behind calcium and phosphate ions after undergoing
[57]
50 patients who received four sets at day 0 and 2 mL, 4 mL, the phagocytosis process by the macrophages. A study
[57]
6 mL, maximum 4 mL of PLA per cheek, monitored for 96 conducted by Marmur et al. evaluated the histologic and
weeks with valuations at 6 weeks, 24 weeks, 48 weeks, 72 electron microscopic structural changes observed following
weeks and 96 weeks. Substantial improvement of at least CaHA injection at 1 and 6 months. Standard light microscopy
40% in cutaneous thickness from baseline was demonstrated imaging of tissue specimens at 1 month post-injection
in over 40% of patients. Total cutaneous thickness at the demonstrated no inflammatory cell response or fibrosis,
Plast Aesthet Res || Vol 3 || Mar 23, 2016 79