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S 217 V • I
C © ORIGINAL ARTICLE J D D
SPECIAL TOPIC
Recommendations on the Use of Injectable Poly-L-Lactic Acid
for Skin Laxity in O-Face Areas
Alessandra Haddad MD PhD,ª Antonio Menezes MD, Christine Guarnieri MD,c Daniel Coimbra MD,d
Elina Ribeiro MD,e Juliana Sarubi MD,f Luiz Eduardo Avelar MD,g Maria Paula Del Nero MD,c
Marisa Gonzaga da Cunha MD PhD,h Rosemarie Mazzuco MD,i Cristhine Kamamoto MD PhD,c
Camila Cazerta MDc
ªFederal University of São Paulo, São Paulo, SP, Brazil
bDermatology Private Practice, Rio de Janeiro, Brazil
cDermatologist. Dermatology Private Practice, São Paulo, SP, Brazil
Cosmetic Dermatology at Santa Casa de Misericórdia, Rio de Janeiro, Brazil
eDermatology Private Practice, São Paulo, Campos do Jordão and Taubaté, SP, Brazil
fDermatology Private Practice, Belo Horizonte, MG, Brazil
gPrivate Practice, Belo Horizonte, MG, Brazil
hDermatologist. Faculdade de Medicina do ABC and Hospital Israelita Albert Einstein; Dermatology Private Practice, São Paulo, Brazil
iDermatology Private Practice, Rio Grande do Sul, Brazil
Injectable poly-L-lactic acid (PLLA) is a biodegradable synthetic polymer that stimulates collagen production, leading to gradual volume
restoration. The treatment of sagging skin in body areas is still a big challenge, as there are few aesthetic procedures aiming to improve
it. This article provides recommendations on the use of PLLA in the treatment of skin laxity in off-face areas, as the neck, décolletage,
arms, abdomen, buttocks, and thighs, including the patient selection, product preparation, and injection techniques. The use of PLLA
is a promising method for the treatment of skin laxity in corporal areas, improving body contour and appearance. Further investigation
is needed to better understand the efficacy and durability of PLLA in non-facial indications and to provide the best evidence for optimal
patient outcomes.
J Drugs Dermatol. 2019;18(9):217-223.
ABSTRACT
INTRODUCTION
Aesthetic treatments are becoming increasingly popular
among patients, especially nonsurgical procedures.1
According to statistics from the American Society of
Facial Plastic Surgery (ASAPS), there was a 37.6% increase in
the number of nonsurgical treatments from 2012 to 2017.2 Reju-
venation of non- facial areas is becoming a frequent complaint
in patients who recognize the disparity and stigma that arise
between their treated face and their non-treated body areas.
The biochemical properties of the skin are determined by the
epidermis, dermal collagen and elastin network and subdermal
composition.3,4 The capacity to synthesize collagen is lower in
sun exposed and aged skin than in healthy, young skin. Fibro-
blasts in severely damaged skin (either photoaged, naturally
aged, or both) experience a loss of mechanical tension as a re-
sult of decreased interaction with intact collagen, which in turn
leads to a diminished production of skin macromolecules.5,6
The body mass index (BMI) of the patient, which may be used
as an indicator for tissue composition, has a negative correla-
tion with skin rmness and thickness, and a positive correlation
with energy absorption.4 When patients present with body
sculpting concerns, most often there is both a component of fat
excess and skin laxity, with a decrease in neocollagenesis at -
brous septae and fascial planes level that accounts for changes
that bother them.1 It is important to perform a correct diagnosis
of the involved components in order to select the best candi-
dates for PLLA treatments.
As we age, the cellular turnover rate declines, and skin struc-
ture begins to deteriorate. Age-related skin changes include:
1) Increase in the disorderly arrangement of the collagen ber
network7
2) Decrease in the quantity of broblasts8
3) Decline in collagen production by broblasts8
4) Increase in matrix metalloproteinases levels, the primary
enzymes responsible for degradation of collagen bers8
5) Decreased metabolic activity of the skin9
6) Massive elastosis or deposition of abnormal elastin bers,
exaggerated microvasculature, and collagen degeneration9
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a deep tissue regenerator, providing soft-tissue augmentation
through broblast stimulation. In contrast to temporary, space
occupying replacement llers such as hyaluronic acid, PLLA
has been shown to exert biologic activity by stimulating neocol-
lagenesis.12 Once injected, PLLA induces local and subclinical
inammatory response shortly after application, recruiting
monocytes, macrophages, and broblasts. It is then hydro-
lysed into lactic acid monomers and eliminated; nonetheless,
an increased deposition of collagen produced by broblasts
remains, with the resulting increase in dermal thickness.17 The
results persist for 18-24 months, with some reports stating that
effects can last up to 3 years.12 Over a period of several months,
the particles are degraded into lactate, and exhaled as carbon
dioxide. Given that the PLLA mechanism of action induces a
local and gradual reaction that can lead to recovery of the hy-
podermis and collagen network that were lost during the aging
process, the hypothesis of its use for the treatment of skin sag-
ging in off-face areas was raised.17,18
General Recommendations for Treatment with PLLA
Pre-treatment preparation is important to minimize risks and
unwanted side effects. Patients must be properly informed to
ensure that their expectations are realistic. Written informed
consent must always be obtained, as well as pre-treatment
photographs. A complete medical history is always necessary,
including information about any past experience with cosmetic
treatments, use of anticoagulants, history of recurrent herpes
simplex, and presence of inammatory processes (eg, upper
airways, sinus, dental or any structure related to the area to
be treated) or autoimmune diseases. It should also cover al-
lergic or hypersensitivity reactions to any substance, including
anaesthetics.19
Patients should be instructed not to take any medication that
might increase the risk of bleeding from 10 to 14 days prior
to treatment. Pictures, diameter measures, BMI (body mass
index) and weight are important parameters to be assessed.19
In general, two to three sessions of PLLA injections are required
to reach the desired outcome, depending on the particularities
of each patient: area treated, degree of volume loss, and aging.
The strategy is to carry out the subsequent session 4 to 6 weeks
after the initial injection, as in our experience the onset of the
results in off-face areas occurs later than in facial treatments.19
It is important to note that injectable PLLA is a polymeric device
containing microparticles of PLLA with carboxymethylcellu-
lose and mannitol, which must be reconstituted with 7 to 8 mL
of sterile water for injection.20 The vial should be left hydrat-
ing for 24 to 72 hours before use.21 Topical anaesthetics can
be used depending on the pain threshold of the patient. For
off-face areas, the product should be injected in the supercial
These damaging events promote atrophy of the dermal layer.
The biochemical properties of the skin degenerate, leading
to loss in exibility and more pronounced skin laxity. Skin
viscoelasticity is further diminished by a decrease in glycos-
aminoglycan concentration in the dermal layer.10
Evaluating skin laxity is still a challenge. Objective and subjec-
tive measures are often combined in most studies. Objective
assessments may include digital photographs and 3-dimen-
sional imaging, allowing surface shape to be precisely captured,
giving quantitative volume measurements. Subjectively, the
degree of satisfaction is often asked.11 The Pittsburgh Rating
Scale11 is a validated tool for assessment of contour deformities
after bariatric weight loss and can be applied in preoperative
planning or to evaluate surgical outcomes. However, there is
still a lack of standardization for accurate body laxity classica-
tion in each specic area.
This article provides recommendations for the best use of PLLA
in neck, décolletage, arms, abdomen, buttocks and thighs,
including handling and reconstitution, treatment recommenda-
tions and injection techniques according to the experience of
eleven specialists in the clinical use of PLLA for body skin laxity.
PLLA Mechanism of Ac tion
Injectable soft-tissue augmentation agents have become pop-
ular alternatives to face and body rejuvenation. In contrast
to temporary, space-occupying replacement llers such as
collagen-based and hyaluronic acid products, PLLA has been
demonstrated to gradually promote deposition of collagen via
a biostimulatory response, with therapeutic effects lasting ap-
proximately two years.12
Originally developed and marketed in Europe as New-ll®, PLLA
has been successfully recruited for aesthetic indications since
1999, in over 150,000 clinical cases in more than 30 countries.13
In 2004, the FDA approved its use for rejuvenation of facial con-
tours secondary to lipoatrophy associated with antiretroviral
therapy for HIV infection, marketed as Sculptra®.13 By 2009,
PLLA was FDA-approved for the correction of nasolabial fold
deciencies and other lines and wrinkles.12 However, there are
promising results for the use of PLLA for non-facial volumiza-
tion as well, including the neck, décolletage, arms, abdomen,
buttocks, and thighs.12,13 Although the published experience
is limited, preliminary data and expanding clinical knowledge
suggest that PLLA is a versatile option for treating skin laxity
and contour deciencies of many non-facial areas.14
PLLA is a synthetic polymer of lactic acid derived from the
alpha-hydroxy-acid family, biocompatible and biodegradable
that has been used in medicine for more than three decades.
The diameter of the microparticles is tightly controlled, measur-
ing 40 µm to 63 µm on average.15,16 The product is considered
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lower with age advance.
The product can be used alone or combined with another tech-
niques (eg, radiofrequency) to achieve optimal outcomes in the
treatment of sagging skin.
The authors also consider that clinicians should ensure that
their patients understand the benets of the treatment with
PLLA, and that they should be attentive to other factors in-
volved in the aesthetic appearance of body areas such as body
mass index, localized fat, muscular tone, and gradual response
to treatment.
PLLA in Sagging Body Skin: General Recommendations
According to the authors, PLLA (Sculptra®) can be indicated for
treatment of skin laxity, localized atrophy after liposuction, as
well as old stretch marks and cellulite associated with sagging.
The use of PLLA in breasts, calves and genitals is not recom-
mended, as safety and efcacy data and experience in the
treatment of these areas are unavailable.
Before the treatment, it is important to consider the following
aspects that could interfere with the outcome: skin quality; life-
style, as sun exposure and diet restrictions could lead to lower
responses, more sessions or need of higher total volume and
nutritional supplementation; and menopause, which could po-
tentially decrease collagen production and require a higher
number of treatment sessions.
The authors experience is reconstituting the Sculptra® vial with
8 mL of sterile water for injection (SWFI) with hydration time
between 24 and 72 hours. Just before injection, 2 mL of lido-
caine 2% and 6 mL of SWFI are added to the suspension, giving
a nal dilution of 16 mL. An easy way to carry this out is using
a 20 mL syringe to aspirate the 8 mL of the suspension from
the vial, 2 mL of lidocaine and 6 mL of SWFI. With the help of a
sterile connector, transfer the content to smaller syringes (1 or
3 mL) to perform the injections. Usually, the authors use 1 vial
of PLLA per area equivalent to a A4 page for all non-facial areas
per session.
Massaging the injected area for a few minutes immediately
after injection is recommended. The patients are instructed to
massage the region 2 times a day for 7 days as post-treatment
care. Another post-treatment recommendation includes avoid-
ing physical activity in the rst 24 hours and sun exposure in
case of bruising.
For skin tightening, 2 to 4 sessions of PLLA injection are usually
recommended, with intervals between 30 to 60 days. In most
cases the rst results appear after 30 days.
For treatment maintenance, an additional session every 12 to
subcutaneous plane, avoiding supercial injection.21,22 It should
be noticed that the instructions for use may vary in different
countries.
In order to reduce pain and distress, topical anaesthetics and/
or incorporation of 1 to 2 mL of lidocaine into the product have
been used. Studies and authors’ experience have shown that
incorporation of lidocaine into the product signicantly reduces
pain and discomfort.23,24
One of the dilemmas about the addition of lidocaine solution
is the possibility of patients presenting an allergic reaction to
lidocaine. However, reactions to amide anaesthetics, including
lidocaine, are rare. The incidence of true immunoglobulin E-
mediated lidocaine allergy remains uncertain and is presumed
to be very low.23,24
After treatment with injectable PLLA, massage is an integral
component of the injection procedure and post-treatment
care.13 Physicians should massage the treated area immedi-
ately after injection to evenly distribute the product, during
approximately ve minutes to assure proper dispersion, op-
timize results and avoid nodule formation.13,24 According to
Ballin et al,24 treatment sessions should be scheduled four to six
weeks apart so that adequate time elapses to observe volume
enhancement and three treatment sessions are often required
to reach full correction. Patients may apply topical products a
few hours after treatment.25
Regarding the longevity of PLLA, a review of the literature fo-
cused on patient satisfaction and effect duration by Palm and
Goldman26 concluded a longevity of at least two years fol-
lowing injection and high patient satisfaction, especially with
continued treatment.
Recommendations for Nonfacial Use of PLL A
In 2017, eleven dermatologists with wide experience using PLLA
discussed the best practices for injectable use of PLLA in body
skin laxity. This paper presents treatment recommendations for
PLLA in non-facial areas, including patient selection, product
preparation and injection techniques in regions such as neck,
décolletage, arms, abdomen, buttocks, and thighs.
According to the clinical practice of the authors, fewer patients
search for aesthetic body treatments in comparison to facial re-
juvenation. The most frequent complaints for non-facial areas
are: skin sagging, cellulite, localized fat, stretch marks, scars
and décolletage/neck wrinkles.
The experts consider that the volume of PLLA to be applied
and the number of sessions needed vary according to age
and degree of sagging. The best outcomes are seen in patients
younger than 60 years old, as treatment response tends to be
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18 months is recommended, depending on the degree of laxity.
Table 1 presents the general recommendations and treatment
plan for use of PLLA (Sculptra®) in nonfacial areas.
PLLA in the Treatment of Skin Laxity in O ff-Face Areas: Prac-
tical Recommendations for Injections
Photographic documentation throughout the process is very
important, given its gradual results over several months. The
patient should be photographed in different positions and the
areas to be treated should be marked in the standing position.
Skin antisepsis with 2% alcoholic chlorhexidine is recommend-
ed. Topical anaesthetics should be applied 30 minutes before
injection.
According to our experience, injection of 0.05 to 0.1 mL of this
nal volume of Sculptra® per cm2 in the subcutaneous plane is
recommended. Supercial injection must be avoided. The areas
can be treated with linear threading using a 26½ G needle (fan-
ning or cross-hatching techniques) or fanning technique with
a 22–23G 50 mm cannula, which has the advantage of fewer
needle sticks. Caution is required to avoid multiple deposits at
the apex of the fan entry point.
Detailed recommendations for PLLA injection techniques to
treat skin sagging in different body areas are discussed below.
TABLE 2 summarizes these recommendations.
In the neck, the treatment area should be extended close to the
clavicle for better results, as shown in Figure 1. Regarding injec-
tion technique, 0.05–0.1 mL/cm2 can be applied with cannula or
needle in fanning or linear threading.
Décolletage injections can be applied with 0.05–0.1 mL/cm2 with
cannula or needle, in fanning or linear threading, as show in
Figure 2.
For arm treatment, selecting patients whose skin laxity is
more prominent than the fat component is important, and the
best outcomes are achieved when the whole circumference is
treated, as observed in Figure 3. Regarding injection technique,
0.05–0.1 mL/cm2 can be applied with cannula or needle in fan-
ning or linear threading, as show in Figure 4.
In the abdominal area, injections should be placed radially
around the umbilicus, using 0.05–0.1 mL/cm2 in fanning or
short linear threading technique with cannula or needle (Figure
5). Figure 6 and 7 present results of PLLA application in patients
with sagging skin in the abdominal region.
In the gluteal region, the product should be applied preferen-
tially in the superior and lateral quadrants of the buttocks, to
TABLE 2.
Recommendations on the Use of PLLA (Sculptra®) in Off-face Areas
Neck 0.05-0.1 mL*/cm2Cannula or needle Fanning or linear threading Treat also the supraclavicular area
Décolletage 0.05-0.1 mL*/cm2Cannula or needle Fanning or linear threading --
Arms 0.05-0.1mL*/cm2Cannula or needle Fanning or linear threading Treat the whole circumference
Abdomen 0.05-0.1mL*/cm2Cannula or needle Fanning or short linear threading --
Buttocks 0.05-0.1mL*/cm2Cannula or needle Fanning or linear threading --
Thighs 0.05-0.1mL*/cm2Cannula or needle Fanning or linear threading Treat completely
*Final Sculptra® volume: 16 mL
TABLE 1.
General Recommendations for Use of PLLA (Sculptra®) in Nonfacial
Areas
PLLA in off-face indications
Skin laxity, localized atrophy after liposuction, old stretch marks or
cellulite associated with accidity
PLLA not recommended in the following areas
Breasts, calves and genitals
Predictive positive factors for treatment
Younger than 60 years old
Balanced diet
Body Mass Index up to 25
Non-smoker
Moderate and regular physical activity
Absence of localized fat in the area to be treated
Reconstitution/Dilution
Diluent Volume 8 mL of sterile water
for injection (SWFI)
Hydration Time 24-72 hours
Final Injection Volume 16 mL
Treatment plan
PLLA quantity
Approximately 1 vial
per area equivalent to
a A4 page
Number of sessions 2-4 sessions
Interval 30-60 days
Maintenance Every 12-18 months
Post-injection recommendations
Massage
If bruising occurs, avoid
physical activity and sun
exposure in the rst 24h
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FIGURE 2. Techniques for application of PLLA on the décolletage in
linear (A) or fanning (B) threading.
FIGURE 4. Techniques for application of PLLA on the arms in linear (A)
or fanning (B) threading.
FIGURE 5. Techniques for application of PLLA in the abdominal area in
short linear (A) or fanning (B) threading.
FIGURE 3. Arms of a 72-year-old woman before (A) and 3 months
after (B) 2 monthly sessions (1 vial per session) of PLLA (Sculptra®).
Note the improved appearance of the skin. Courtesy of Juliana
Sarubi, MD.
FIGURE 1. Linear threading technique for application of PLLA in the
neck with needle (A) or fanning with cannula (B).
FIGURE 7. Abdomen of a 59-year-old woman before (A) and 4 months
after (B) 3 monthly sessions (1 vial per session) of PLLA (Sculptra®).
Improvement of the skin laxity. Courtesy of Juliana Sarubi, MD.
FIGURE 8. Techniques for application of PLLA on the buttocks in linear
threading (A) or fanning (B).
(A) (B) (A) (B)
(A) (B)
FIGURE 6. Abdomen of a 43-year-old woman, with localized lipoatrophy
post liposuction and skin laxity, before (A) and 45 days after (B) the
injection of 1 vial of PLLA (Sculptra®). Courtesy of Rosemarie Mazzuco,
MD.
(A) (B)
(A) (B)
(A) (B)
(A) (B)
(A) (B)
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favour lifting effect and contour improvement. Regarding tech-
niques, 0.05–0.1 mL/cm2 can be applied with needle or cannula
in fanning or linear threading (Figure 8). Stretch marks and cel-
lulite associated with sagging can be reduced with application
of PLLA as show in Figures 9 and 10.
Figure 8: Techniques for application of PLLA on the buttocks in
linear threading (A) or fanning (B).
Anterior and medial regions of the thighs should be treated to
achieve the best results (Figure 11). Regarding injection tech-
nique, 0.05–0.1 mL/cm2 of PLLA can be applied with cannula
or needle, in fanning or linear threading, as show in Figure 12.
CONCLUSION
Preliminary data and evolving clinical experience have demon-
strated that Sculptra® (PLLA) is a versatile option for treating
skin laxity in different areas of the body due to its unique mecha-
nism of action, gradually promoting collagen deposition via a
biostimulatory response. In our experience, Sculptra® provides
efcient and safe results, improving skin rmness and appear-
ance. Further prospective clinical studies are needed to provide
data on its duration when used in body areas and deepen our
understanding of this promising and exciting treatment.
DISCLOSURES
Dr Cazerta is a former employee of Galderma Brasil and is a ad-
visor for Galderma Brasil. Dr Kamamoto is a medical consultant
of Galderma. Drs Haddad, Guarnieri, Sarubi, Avelar, Del Nero,
Cunha, Mazzuco, Menezes, Coimbra, and Ribeiro have been
speakers and advisors for Galderma Brazil.
FIGURE 9. Buttocks of woman before (A and C) and 3 months after (B
and D) the first treatment. Two treatment sessions with PLLA (Sculptra®)
were carried out, with 1 vial per session. Notice the improved
appearance of skin laxity, stretch marks and cellulite. Courtesy of
Marisa Gonzaga, MD.
FIGURE 10. 34-year-old woman before (A) and after (B) treatment at
rest and with gluteal contraction, before (C) and 4 months after (D) 3
monthly sessions (1 vial per session) with PLLA (Sculptra®). Courtesy
of Juliana Sarubi, MD.
FIGURE 11. Thighs of a 49-year-old woman with skin laxity and cellulitis
before (A) and 2 months after (B) 1 session with 1.5 vial of PLLA
(Sculptra®). Courtesy of Rosemarie Mazzuco, MD.
FIGURE 12. Techniques for application of PLLA in the thighs in linear
threading (A) or fanning (B).
(A) (B)
(A) (B)
(C) (D)
(A) (B)
(A) (B)
(C) (D)
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ACKNOWLEDGMENTS
The authors thank Camila Cazerta, MD, and Samanta Nunes for
editorial assistance.
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AUT H OR COR R ESPOND E NCE
Camila Cazerta MD
E-mail:................……......................... camicazerta@gmail.com