CED

Clinical dermatology • Original article

Clinical and Experimental Dermatology

Efficacy and safety of injection with poly-L-lactic acid comparedwith hyaluronic acid for correction of nasolabial fold: arandomized, evaluator-blinded, comparative study
M. Y. Hyun,1 Y. Lee,1 Y. A. No,1 K. H. Yoo,2 M. N. Kim,1 C. K. Hong,1 S. E. Chang,3 C. H. Won3 and
B. J. Kim1
1
Department of Dermatology, Chung-Ang University College of Medicine, Seoul, South Korea; 2Department of Dermatology, Catholic Kwandong University International ST.Mary’s Hospital, Incheon, South Korea; and 3Department of Dermatology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea

doi:10.1111/ced.12499

Summary

Background. Hyaluronic acid (HA) fillers and poly-L-lactic acid (PLA) fillers are
frequently used to correct facial wrinkles.
Aim. To compare the efficacy and safety of a novel injectable poly-L-lactic acid
(PLA) filler and a well-studied biphasic HA filler for the treatment of moderate tosevere nasolabial folds.
Methods. In this multicentre, randomized, evaluator-blinded, comparative study,
subjects were randomized for injections with PLA or HA into both nasolabial folds.
Efficacy was determined by calculating the change in Wrinkle Severity Rating Scale(WSRS) relative to baseline. Local safety was assessed by reported adverse events.
Results. At week 24, mean improvement in WSRS from baseline was 2.09  0.68
for the PLA side and 1.54  0.65 for the HA side. Both injections were well tolerated, and the adverse reactions were mild and transient in most cases.
Conclusions. PLA provides noninferior efficacy compared with HA 6 months after
being used to treat moderate to severe nasolabial folds.

Introduction
Volumetric deficiencies are increasingly recognized asa major component of the ageing process, which has
led to a paradigm shift in the therapeutic approach
to facial rejuvenation. To correct volume loss, soft-tissue augmentation with fillers is a widely accepted
treatment. Over the past decade, the use of injectablefillers has steadily increased.1 Fillers are preparedfrom a range of materials, including autologous
Correspondence: Dr Beom Joon Kim, Department of Dermatology,
Chung-Ang University Hospital, 224-1 Heukseok-dong, Dongjak-gu, Seoul
156-755, Korea
E-mail: beomjoon@unitel.co.kr
Conflict of interest: the authors declare that they have no conflicts ofinterest.
CHW and BJK contributed equally to this manuscript and should beconsidered joint first authors.
Accepted for publication 8 May 2014ª 2014 British Association of Dermatologists

implants, collagens, hyaluronic acid (HA), andbiosynthetic polymers such as calcium hydroxylapatite, poly-L-lactic acid (PLA) and polymethyl
methacrylate.
PLA is a biodegradable and bioabsorbable aliphatic
polyester produced by carbohydrate fermentation ofcorn dextrose,2 and was first synthesized by Frenchchemists in 1952.3 Each PLA molecule is relatively
heavy (140 kDa), 2–50 lm in size and irregularly
crystalline-shaped, all of which contribute to its slow
physiological absorption. The half-life of L-polylactides is estimated at 31 days, with total absorption occurring by 18 months.4 PLA has beenused for years in resorbable surgical materials,
such as sutures, plates and screws, and in membranes for guided tissue regeneration in periodontal
surgery.5
Injectable PLA is a biostimulator rather than a traditional filler, which provides immediate volumetric

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Efficacy and safety of PLA compared with HLA for correction of nasolabial fold  M. Y. Hyun et al.

improvement.6 It was approved by the US Food andDrug Administration (FDA) for human immunodeficiency virus (HIV)-related facial atrophy in August
2004, and has also been used extensively in an
off-label capacity to correct non-HIV-related facial volume loss.7 As a biostimulator, PLA promotes volumization through the production of collagen andvascularization of existing collagen.8 Its mechanism ofvolumetric expansion is related to a foreign-body giantcell reaction that occurs several weeks to months after
injection. In addition, the collagen production that
occurs as the product degrades produces the observed
volume changes and aesthetic benefit.7
Many studies have evaluated the efficacy of injectable PLA, but no study has compared the efficacies of
injectable PLA and other procedures to improve nasolabial folds. In the present multicentre, randomized,
patient- and evaluator-blinded, comparative study, weevaluated the efficacy and safety of a novel PLA filler
for the treatment of moderate to severe nasolabial
folds, and compared its efficacy and safety with that ofa commercially available and well-studied HA filler. To
our knowledge, this is the first study to investigate thesubjective efficacy of injectable PLA and to compare itagainst an existing injectable HA product.

tion while participating in the study. Subjects who
had undergone laser or chemical skin resurfacing,
botulinum toxin injections, facelift procedures, or tissue augmentation in the nasolabial folds during theprevious 24 weeks were excluded.
Materials and injection technique

The study was reviewed and approved by the institutional review board of Chung-Ang University Hospitaland Asan Medical Center, and performed in accordance with the principles of the Declaration of Helsinki
and Korean Good Clinical Practice, and with local regulatory requirements. All subjects provided written
informed consent prior to study participation.

AestheFill (REGEN Biotech, Inc., Seoul, Korea) is aninjectable PLA product that was recently developed forvarious types of soft tissue augmentation. Restylane
was the first injectable HA filler to be registered in theUSA, and is the most widely used and well-studied filler for treatment of nasolabial folds. Its efficacy andsafety have been investigated extensively.9–12
Restylane (Q-Med, Uppsala, Sweden) is a transparent gel consisting of 20 mg/mL HA dispersed in aphysiological saline solution (pH 7.0). AestheFill ispackaged as a sterile, freeze-dried preparation in a clear
glass vial. We diluted 100 mg of PLA powder with
0.7 mL of saline solution 10 min before injection.
At the initial treatment visit (week 0), subjects
were randomized using a computer-generated code
to receive injections of one of the products in bothnasolabial folds. A eutectic mixture of lidocane 2.5%
and prilocaine 2.5% (EMLA; AstraZeneca, S€
odert€
alje,
Sweden) was applied topically 1 h before injection.
With the subject in an upright position, the products
were injected into the junction of the subcutaneousand deep dermal planes, using a linear-threading
technique. Preparations of both products were
injected using a disposable 1.0 mL syringe with asterilized 0.5-inch 27G needle. The TAs were given
instructions to fully correct the nasolabial defects,
but not to overcorrect them.

Patient selection

Assessment

This randomized, patient-blinded and evaluating assessor (EA)-blinded, treating assessor (TA)-open, comparative study was conducted at two medical centres:
Asan Medical Center and Chung-Ang University Medical Center, in Korea. For study inclusion, healthy
male and female adult outpatients older than
20 years were required to have moderate to severe
nasolabial folds [Wrinkle Severity Rating Scale(WSRS) score of 3 or 4) that were approximately symmetrical, as judged by the TAs at each centre. The
subjects had to be willing to refrain from other facial
cosmetic procedures during the study period. Womenof childbearing age were required to have a negative
urine pregnancy test, and to use reliable contracep-

Response to the initial injections of PLA and HA wasevaluated at 2 weeks, and if deemed necessary by the
EAs, a repeat treatment (touch-up) was performed by
the TAs. The material injected for the touch-up was
identical to that used for the initial treatment.
The visual appearance of each nasolabial fold wasassessed at each visit by the EAs and TAs, using thefive-point WSRS at 0, 8, 16 and 24 weeks. The degreeof overall improvement in the appearance of the nasolabial folds was determined at 8, 16 and 24 weeks by
the TAs and the subjects, using the Global Aesthetic
Improvement Scale (GAIS) (3 = very much improved,
2 = much improved, 1 = improved, 0 = no change,
and 1 = worse).

Methods

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Clinical and Experimental Dermatology (2015) 40, pp129–135ª 2014 British Association of Dermatologists

Efficacy and safety of PLA compared with HLA for correction of nasolabial fold  M. Y. Hyun et al.

Safety assessment

At each follow-up visit, the subjects were asked about
adverse events (AEs), and the TAs examined the injection sites for erythema, swelling, induration, pruritus,
irritation, mass, haematoma, pain and dryness. Invisible subcutaneous papules (< 5 mm) and visible or protruding nodules can develop after an injection of PLA.
Statistical analysis

The primary efficacy endpoint was the WSRS scoreassessed by the EAs at week 24. The one-sided 97.5%
confidence interval of the mean between-treatment difference (PLA minus HA) was calculated, and noninferiority was declared if the lower limit of the interval
was > 0.29. A margin of 0.29 was chosen based on
published results showing a mean between-treatment
difference (previous control minus HA) of approximately
0.58 in the mean improvement in WSRS at week 24.13
The secondary efficacy endpoints were (i) EA- andTA-assessed WSRS scores at weeks 8, 16 and 24; (ii)TA- and patient-assessed GAIS at weeks 8, 16 and 24;
and (iii) proportion of subjects with an improvementof ≥ 1 grade in the EA- and TA-assessed WSRS scoresfrom retreatment to week 24. Mixed model for
repeated measures] was used to analyze secondary
endpoints (i) and (ii), while McNemar test and an odds
ratio were used to analyze secondary endpoint (iii).
The statistical tests for secondary efficacy endpoints
were two-sided, and P < 5% was considered statistically significant.
Finally, we analyzed the correlation between efficacy
and age by the Pearson correlation coefficient method.
Both the PLA and HA groups were divided into four
subgroups according to treatment method and mean
age to compare the effects of each subgroup using
paired t-test.

Results
Demographics

In total, 58 subjects completed the follow-up at
24 weeks; 30 subjects (3 men, 27 women) in the PLA
group and 28 subjects (4 men, 24 women) in the HA
group. The age (mean  SD) was 51.9  6.9 years(range 37–64) in PLA group and 52.6  6.7 years(38–66) in the HA group. The subgroups were divided
according to age as above or below 52 years of age.
In the PLA group, 14 subjects were aged < 52 years
and 16 subjects were aged > 52 years, while in theª 2014 British Association of Dermatologists

Table 1 Characteristics of patients.
GroupsPatients, nSex, n (%)
Male
FemaleAge, years
Mean  SD (range)
Subgroups≤ 52 years> 52 years

PLA (Aesthefill)

HA (Restylane)3028

3 (10)
27 (90)4 (14)
24 (86)51.9  6.9 (37–64)

52.6  6.7 (38–66)

14 (47)16 (53)

13 (46)15 (54)

HA, hyaluronic acid; PLA, poly-L-lactic acid.

HA group, these numbers were 13 and 15, respectively (Table 1).

Skin assessment

At week 24, the mean WSRS score, as determined by
the EAs, was 1.37  0.56 and 2.00  0.79 for the
PLA and HA groups, respectively (Fig. 1a). The lower
limit of the one-sided 97.5% CI was 0.34, which waswell above the pre-defined margin for noninferiority( 0.58), indicating that the efficacy of PLA at week
24 was comparable with that of HA.
Before the first treatment, the mean WSRS score, as
determined by the EAs, was 3.47  0.51 (Fig. 1a).
These WSRS scores had improved at the follow-up visits at 8, 16 and 24 weeks by at least one grade inboth groups, but the PLA group was slightly superior
to HA group at all three follow-up points. Statisticallysignificant differences were observed at weeks 8, 16
and 24 (P < 0.05). In terms of the TA-assessed WSRS
score, the PLA group was also slightly superior to the
HA group at weeks 16 and 24, but there were no significant differences at any time-point (Fig. 1b).
In terms of the GAIS assessed by the subjects, PLA
was considered more efficacious than HA at every follow-up visit (Fig. 2a). In terms of the GAIS assessed by
the TAs, PLA was significantly better than HA atevery follow-up visit (Fig. 2b). There was no statistically significant difference between the two GAIS
assessments at any visit.
At week 24, PLA was associated with a higher proportion of subjects with an improvement of ≥ 1 gradein the EA-assessed WSRS scores relative to the pretreatment value (100% for PLA vs. 85.7% for HA).
This was also true for the TA-assessed WSRS scores(93.3% vs. 75.0%). However, neither of these differences was statistically significant. Serial photographic

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Efficacy and safety of PLA compared with HLA for correction of nasolabial fold  M. Y. Hyun et al.

(a)

(b)

Figure 1 Wrinkle Severity Rating Scale (WSRS) scores over a 24-week period after the initial treatment (week 0) with poly-L-lactic (PLA;

Aesthefill) and hyaluronic acid (HA; Restylane). (a,b) WSRS scores assessed by (a) the evaluating assessors and (b) the treating assessors.
*P < 0.05.

(a)

(b)

Figure 2 Global Aesthetic Improvement Scale (GAIS) scores at 8, 16 and 24 weeks. The poly-L-lactic (PLA; Aesthefill) side was associ-ated with higher GAIS scores at all follow-up visits, but there was no statistically significant difference between the PLA and hyaluronic
acid (HA; Restylane) sides. (a,b) GAIS scores assessed by (a) patients and (b) treating assessors.

images of the nasolabial folds before and after treatment with PLA and HA are presented in Fig. 3.
Pearson correlation coefficient did not reveal any
statistically significant results. In the comparison of
improved WSRS scores from baseline (week 0)
between subgroups, there were statistical differences
between patients younger and older than 52 years(Table 2). In the subgroup aged > 52 years, the HAtreated group was significantly more improved than
the PLA-treated group at weeks 8, 16 and 24 for
the EA-assessed WSRS, and at week 16 and 24 forthe TA-assessed WSRS (Fig. 4), indicating that HA
may be a better choice for older patients.

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Clinical and Experimental Dermatology (2015) 40, pp129–135

Adverse events

There were three patients with AEs related to local
injection site responses, who had discoloration, nodules and vesicles, respectively, but there was no erythema, irritation, haematoma, induration, swelling,
warmth, dryness or pain at the injection site in any ofthe patients. AEs occurred only in the PLA group andresolved without sequelae. The self-limiting nature andthe short duration of the local reactions suggest thatthey were generally caused during the procedure
rather than being product-related events or hypersensitivity responses.

ª 2014 British Association of Dermatologists

Efficacy and safety of PLA compared with HLA for correction of nasolabial fold  M. Y. Hyun et al.

Figure 3 Photographic images of nasolabial folds of representative patients over time. Aesthefill is poly-L-lactic (PLA) and Restylane ishyaluronic acid.

Table 2 Comparison of improved Wrinkle Severity Rating Scale scores from week 0 in of each subgroup.
Evaluating assessor

Testing assessor

Compared group

8 weeks

16 weeks

24 weeks

8 weeks

16 weeks

24 weeks

PLA ≤ 52 vs. PLA > 52
HA ≤ 52 vs. HA > 52
PLA ≤ 52 vs. HA ≤ 52
PLA > 52 vs. HA > 52

0.984
0.836
0.182
0.008*

0.085
0.762
0.344
0.004*

0.249
0.968
0.628
0.004*

0.164
0.621
0.947
0.090

0.565
0.309
0.534
0.013*

0.408
0.255
0.933
0.044*≤ 52, Age under 52 years; > 52, age over 52 years; PLA, poly-L-lactic acid (Aesthefill) treated group; HA, hyaluronic acid (Restylane). *P < 0.05.

(a)

(b)

Figure 4 Improvement in Wrinkle Severity Rating Scale (WSRS) scores over a 24-week period from the initial treatment (week 0) with

poly-L-lactic acid (PLA; Aesthefill) and hyaluronic acid (HA; Restylane) in subgroups aged > 52 years. (a,b) WSRS scores assessed by(a) the evaluating assessors and (b) the treating assessors. *P < 0.05.

ª 2014 British Association of Dermatologists

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No serious AEs or infections were reported, and no
subjects discontinued treatment because of an AE.

Discussion
The precise mechanism of action that produces theplumping effects of injected PLA has not been fully
elucidated, but it appears to be related to both host
response and gradual degradation of the material.5
Biological responses to PLA implants are histologicallycharacterized by a classic foreign-body granuloma.2 At
3 months after subcutaneous injection, PLA microspheres are surrounded by macrophages, lymphocytes
and giant cells in a fibrous tissue capsule, consisting
mostly of collagen.14 At 6 months, the microparticles
become porous and deformed, and at 9 months, there
is no evidence of residual polymers or surrounding
fibrosis.4,14 Thus, although increased numbers offibroblasts and collagen fibres are deposited as thepolymers degrade,8 the bulking effect of injected PLA
appears to depend primarily on the host response.15,16
Collagen production usually starts within 6–8 weeks
after injection,17 with type 1 collagen continuing toform for up to 9–12 months after the final treatment.8
The ‘intended’ foreign-body inflammatory response,dermal fibroplasia and slow PLA microsphere degradation each contribute in varying degrees to the longterm clinical effects, which may be evident for up to
2 years.2,5,15,18,19 This relative longevity contrasts
with other temporary fillers, such as bovine/humancollagen and HA.
PLA particles start to be reabsorbed around
6 months after injection and have disappeared by
9 months.20 Polylactides are metabolized along a similar metabolic pathway to that of lactate/pyruvate.21
Subcutaneous metabolism of PLA does not affectplasma lactate.22,23 Tissue-implanted PLA is consideredbioresorbable because it disappears as a result of enzymatic and nonenzymatic hydrolysis, which includes
extracellular hydrolysis, ester cleavage and the catalytic effects of the lactic acid monomers.3 Macrophages
phagocytize the lactic acid derivatives, and lactic acidenters the tricarboxylic acid cycle, then it is metabolized
and subsequently eliminated from the body as carbon
dioxide and water.8 In a study conducted using 14Clabelled PLA implants, it was concluded that lactic acidis eliminated through respiration as carbon dioxide.21
The only specific AE of PLA injection was nodule
formation. Small, palpable, inconspicuous, subcutaneous nodules, as well as visible nodules, can result
from uneven distribution, superficial placement or
improper reconstitution of the product.24 In our study,

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only one subject reported an invisible mass-like lesion
at the PLA injection site, and this resolved spontaneously within 1 month. Because the occurrence rate ofvisible or invisible nodules induced by PLA injection
was very low, and either resolved spontaneously or
were treated by subcision, nodules are not likely to be
major factors in treatment selection.
PLA was found to be as effective as HA in treating
moderate to severe nasolabial folds, as the efficacies ofboth products, as measured by mean WSRS score, werecomparable for all follow-up visits. PLA was superior interms of the proportion of subjects whose WSRS scores
had improved by at least one grade at week 24, andwas found to be consistently comparable to HA in termsof the GAIS assessed by the subjects at every study visit.
However, our data showed interesting results in older
subjects (> 52 years of age). When efficacy was compared in the total number of subjects, the results in the
PLA group were better than in the HA group. However,when compared only between the subgroups of patients
aged >52 years, the HA group had superior results. One
possible reason is that there is a different mechanism
behind the improvement of nasolabial folds between
injectable PLA and HA. As mentioned above, PLA
causes tissue augmentation by inducing a foreign-bodyinflammatory response and dermal fibroplasia. The
immune response and collagen production are weakerin older than in younger adults because of the ageing
process. For this reason, the soft tissue augmentationinduced by PLA was lower in the older than in theyounger patients, and this was similar in the HA subgroups.

Conclusion
The present comparative study showed that PLA is
noninferior to HA in correcting moderate to severe
nasolabial folds, and appears to have superior efficacy to HA in younger patients, in contrast to theresults shown in older patients. Therefore, PLA may
be a good choice for correcting nasolabial folds inyounger patients. This study is the first study toinvestigate the subjective efficacy of PLA comparedwith HA filler.

What’s already known about this topic?
● HA and injectable PLA fillers provide immedi-

ate volumetric improvement, and are frequently
used for the correction of facial soft-tissue defects.

ª 2014 British Association of Dermatologists

Efficacy and safety of PLA compared with HLA for correction of nasolabial fold  M. Y. Hyun et al.

What does this study add?
● Injectable PLA can produce a result compara-

ble with HLA fillers for the correction ofnasolabial folds, and can be a good choice forsuch a treatment.

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