Correction of Temporal Wasting using Calcium Hydroxylapatite with Integral Lidocaine:

Accepted Article an Underused Procedure for Enhancing Overall Facial Appearance

Running head: Correction of Temporal Wasting using CaHA(+)

Sheila C. Barbarino, M.D., FACS

1Barbarino Surgical Arts, Austin, TX, USA.

Correspondence:

Barbarino Surgical Arts at Kalologie 360 Spa

Cosmetic & Reconstructive Surgery
1100 S. Lamar Blvd, Ste 2120
Austin, TX 78704
Cell phone: 215 518 3385
E-mail: sheila.barbarino@gmail.com

ORCID ID: 0000-0002-8367-8663

Disclosure information:

Dr Barbarino is a paid consultant and speaker for Merz, Alastin, Allergan, Lumenis, Skinceuticals,
Sinclair Pharmaceuticals and Syneron/Candela.

This article has been accepted for publication and undergone full peer review but has not been
through the copyediting, typesetting, pagination and proofreading process, which may lead to
differences between this version and the Version of Record. Please cite this article as doi:
10.1111/JOCD.13505
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Accepted Article
Article type : Original Contribution

Correction of Temporal Wasting using Calcium Hydroxylapatite with Integral Lidocaine:

an Underused Procedure for Enhancing Overall Facial Appearance

Running head: Correction of Temporal Wasting using CaHA(+)

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Accepted Article
Abstract

Aim: To assess physician and subject awareness of the impact of temporal hollowing
on appearance, and evaluate treatment satisfaction following injection of calcium
hydroxylapatite with integral Lidocaine (CaHA(+)).

Methods: Subjects with temporal depression grade ≥2 on a validated Temple Hollowing

Scale were recruited. CaHA(+) was injected supraperiosteally using a bolus technique.
Photographs were taken prior to treatment and 30 days and graded by three evaluating
physicians using the Global Aesthetic Improvement Scale (GAIS) and temple hollowing
scale. The same physicians estimated subjects age before and after treatment.
Photographs were graded by patients as part of a satisfaction questionnaire.

Results: The study enrolled 10 subjects aged 32 to 68 years old. Physician GAIS
scores of subject appearance at 1 month were rated as ‘very much improved’ in 80%
and ‘much improved’ in 20% of subjects. Temple hollows were graded as 1 after
treatment in 90% of subjects. Following blinded review of patients’ true ages, estimates
for subjects’ perceived age were on average 4 years younger than their actual age.
Most subjects had not been aware of temple hollowing prior to treatment, but 9 out of 10
were very to extremely satisfied with results and all were willing to repeat treatment. No
treatment complications were observed.

Conclusions: Treatment of the temple area can have a dramatic aesthetic effect and
should not be neglected when addressing facial rejuvenation. CaHA(+) is an effective
and well-tolerated product for use in the temple area and is associated with a high
degree of subject and physician satisfaction.

Key words: Calcium hydroxylapatite; facial rejuvenation; lidocaine; temple area; aging.

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Accepted Article
Introduction

The temple area is comprised of the deep and superficial temporal fat pads and the
temporalis muscle. It provides support to the periorbital area and lateral brow, and
should appear relatively flat with the slightest hint of concavity, neither too full nor too
indented. In the aging face, skeletal changes resulting from altered bone disposition and
resorption, combined with depletion and/or displacement of the temporal fat pads and
reduced subcutaneous support from collagen and elastin, can lead to volume loss in the
temple area.1 It may also occur in younger individuals as a result of a genetic
underdevelopment of temporal fullness. Without the support of the temporal fat pads
and the temporalis muscle, the face takes on an hourglass shape with a bony
appearance to the outer part of the eye socket causing a person to look more aged and
tired, and can signal uncertainty, concern or distress.2 A secondary effect is the loss of
support to the eyebrows, leading to lateral brow ptosis and the eyes appearing smaller.3
Despite the contributions of sunken temples to an aged facial appearance, this area is
commonly overlooked by both patients and physicians in upper facial rejuvenation.4
Most patients do not realize that temporal concavity can contribute to their looking older
and more tired than their true biological age or that a treatment for this area even exists.
It is therefore up to the provider to inform patients of the potential of this underused
procedure for facial rejuvenation.

The contours of the temple area can be easily restored with injection of soft tissue fillers
or implants to replace this volume. Several reports with hyaluronic acid fillers show that
smoothing the upper facial area by restoring volume to the temporal hollow improves
eyebrow positioning and results in significant aesthetic improvement as well as high
patient satisfaction.5–7 Some physicians use poly-L-lactic-acid (PLLA) for a gradual
restoration of volume in this area,8 while others prefer a more permanent solution with
the use of a surgically-placed silicone implant.9 Calcium hydroxylapatite (CaHA;
Radiesse®, Merz North America, Inc., Raleigh, NC, USA) is an effective filler for facial
soft-tissue augmentation and is associated with a high and well-established, long-term
safety profile.9 An important characteristic of CaHA, and the reason why the author

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Accepted Article
prefers this product for the temple area, is that it achieves its effects by a combination of
an immediate volumizing effect and long-term collagen stimulation for durable aesthetic
results without the requirement for surgery. Indeed, one of the first indications of CaHA
was for restoration and/or correction of the signs of lipoatrophy in people with human
immunodeficiency virus.11 In 2015, Radiesse® (+) Lidocaine with the convenience of
integral 0.3% lidocaine (CaHA (+)) received US FDA approval, and in 2016 the product
received a CE mark and became available to physicians in Europe. To date, the author
is aware of only one study that has specifically assessed the efficacy and safety of
CaHA (+) for correcting volume loss in the temporal area.12 The aim of the current study
was to highlight to both physicians and patients the impact that this subtle and under-
used procedure can have on a patient’s overall facial appearance using CaHA (+) as
the soft tissue filler.

Methods

Individuals between the ages of 35–65 years presenting to a private aesthetic surgery
practice for a facial rejuvenation procedure in whom the treating physician noted a
depression in the temple area were asked if they would consider treatment to this area
and were screened for suitability. Subjects were required to have a grade of at least 2
on the validated Allergan Temple Hollowing scale.13 Subjects were not eligible for
treatment if they had undergone any other dermal filler or surgical treatment to the
temporal area in the last 2 years, if they had current active local or systemic skin
disease that could affect wound healing, or excessive scarring in the area of treatment.
Pregnant or breast-feeding women, or those planning a pregnancy were also excluded.
All participants were required to show willingness and ability to comply with protocol
requirements including returning for a follow-up visit and abstaining from any other
procedures in the treated area throughout the study. All subjects provided signed
informed consent to the procedure and to the subsequent use of identifiable
photographs for scientific purposes. This study adhered to the tenets of the Declaration
of Helsinki as amended in 2008 and was compliant with the Health Insurance Portability

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Accepted Article
and Accountability Act (HIPAA), which ensures protection of individually identifiable
health information, unless consented by the patient.

The study comprised two visits over a 30-day period. At visit 1, the area for filler
placement was identified by seating the patient in an upright position and asking them to
open and close their mouth. Using a white pencil the physician outlined the temporal
hollow. An upper mark was placed at the top of the area and a separate mark at the
lowest point of the hollow. The deepest point is generally found midway between these
two marks. CaHA with integral 0.3% Lidocaine (CaHA (+) 1.5 ml syringe) was injected
at the supraperiosteal level using a 25 gauge Outer Diameter (O.D.) to 27 gauge Inner
Diameter (I.D.) needle. This was placed perpendicular to the skin and advanced slowly
until contact with bone was felt with the needle tip. The investigator then proceeded with
slow injection of several small boluses of 0.05 ml CaHA (+). The number of insertion
sites was dependent on the amount of temporal volume depletion. The author’s
preferred technique is to start from the highest point of the temporal area and work
down, typically performing multiple needle insertion sites to cover the deficient area.
Injections were followed by mild massage to ensure that the product was evenly
dispersed, and ice packs were applied for 10 minutes to reduce the risk of bruising and
swelling. Photographs were obtained at baseline and at Visit 2, 30 days later, using
standardized patient positioning and lighting.

In addition to live assessment by the treating physician, three other facial plastic
surgeons evaluated each patient’s before and after photographs and assessed
improvement using a five category Global Aesthetic Improvement Scale (GAIS) as: very
much improved, much improved, improved, no change, or worse. At Visit 2, patients
were also assessed using the Allergan Temple Hollowing scale. At the beginning of the
study, the three non-treating physicians were asked how important they felt it was to
treat the temporal area when performing facial aesthetic procedures (not important,
mildly important, very important and extremely important), and how often they
recommended temporal filling to their patients (rarely, sometimes, frequently, always).
After viewing the post-treatment photographs, the same physicians were asked how
likely they would be to recommend temporal filling in the future, and to estimate the

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 subjects’ age in both the before and after photographs (the physicians were unaware of
Accepted Article
the true age of the patients).

A patient satisfaction questionnaire was also undertaken at Visit 2 during which patients
were shown their baseline and 30-day photographs and asked to respond ‘Yes’ or ‘No’
to the following questions: would you be willing to repeat this treatment; were you
concerned by your temple area prior to treatment; and did you realize your temple area
required improvement? In addition, subjects were asked to rate their satisfaction with
the treatment using a 5-point scale from 1=very unsatisfied to 5=very satisfied.

Adverse events were documented throughout the study.

Results

The study enrolled 10 subjects (8 women and 2 men) ranging in age from 32–68 years
old, none of whom had had previous treatment in the temporal area. All subjects
attended both visits. The total volume of CaHA (+) injected ranged from 1–3 syringes
(1.5–4.5 ml) depending on the severity of temporal wasting.

Prior to treatment 3 subjects were rated as grade 2 on the validated temporal hollowing
scale, 5 were rated as grade 3 and 2 were rated as grade 4. One month after treatment,
9 out of 10 subjects were rated as grade 1 indicating a flat temple with no depression,
and one subject who was rated grade 4 before treatment had improved to grade 2
(shallow depression or concavity with minimal volume loss). Physician scores of
subjects’ appearance according to GAIS 1 month after CaHA (+) treatment were rated
as ‘very much improved’ in 80% of patients, and ‘much improved’ in 20% patients.
Figure 1 shows images of subjects before and after treatment of their temples with
CaHA (+).

All three evaluating facial plastic surgeons rated filling of the temporal area as mildly
important at the beginning of the study and reported that they only rarely (two surgeons)
or sometimes (1 surgeon) recommended temporal filling to their patients. After viewing
the before and after photos of the 10 subjects, all three surgeons reported that CaHA
(+) treatment of the temporal area had a much greater impact on overall upper face

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Accepted Article
improvement than they had previously believed, and all stated that they would be much
more likely to recommend a filler for this area in the future.

The same surgeons reviewed the before and after photos of the 10 patients without
knowing the subjects’ true age. All gave age estimates in the post-treatment photos that
were on average 4 years younger than the subjects’ actual age, and in some subjects
as much as 7 years younger.

The patient survey results revealed that 8 subjects had not been concerned by their
temple area prior to treatment and 9 out of 10 had not realized that it needed
improvement or that it was even an area that could be treated (Figure 2). After
observing their results, however, 6 subjects were extremely satisfied, 3 subjects were
very satisfied and 1 was satisfied with the results of CaHA (+) treatment to their temple
area. Furthermore, all 10 patients reported they would be willing and would want to
repeat the treatment when the filler dissipated.

Treatment to the temple area was well tolerated, and no complications were observed.
Mild bruising was reported by five patients and resolved within 1 week. Three patients
reported mild tenderness on chewing that resolved in 1-2 days.

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Accepted Article
Discussion

CaHA with integral lidocaine is an effective, well-tolerated, long-lasting filler for

correction of temple hollows in subjects with age-related volume loss as well as in
younger subjects with a volume deficit in this area. Many patients overlook loss of
volume at the temples, unaware of the effects it can have on their facial contours and
overall aesthetic appearance. Physicians also often neglect the temple area, as was
evident in the current study, focusing instead on more obvious signs of aging such as
cheek hollows and major frown lines. However, the temples are the link between the
upper and mid face and lack of continuity between these facial areas may only serve to
emphasize a more aged, less aesthetically pleasing appearance. A magnetic resonance
imaging (MRI) study that quantified and compared facial soft tissue loss over time
showed that the most dramatic changes in temporal soft tissue deterioration occur
between the ages of 30 and 60 with mean thickness of subcutaneous tissue in the
temporal area decreasing from 12.3 mm to 8.9 mm.14 Treatment of the temple area
should therefore form part of a physician’s patient consultation when discussing facial
improvement and rejuvenation in any age group.

After treatment of the temples with CaHA (+) the appearance of all subjects was rated
with GAIS as ‘much improved’ to ‘very much improved’ by the physicians, and all stated
that the results they observed would make them more likely to recommend treating this
area in the future. Furthermore, when evaluated with a validated temple hollowing scale,
9 out of 10 subjects were rated as grade 1 after treatment, indicating a flat temple with
no depression. Following assessment of subjects’ before and after photographs by the
same independent group of facial plastic surgeons unaware of the subjects’ true age,
subjects’ perceived age after treatment was noted as younger than their actual age for
all subjects.

Due to the subjective nature of cosmetic improvements, outcomes measured from a

patient’s point of view are important in aesthetic medicine.15 Eight out of 10 subjects had
not been aware of their temple hollowing at the start of the study, but 9 out of 10 were
very to extremely satisfied with the treatment result at the 30-day follow-up visit. In

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Accepted Article
addition, all subjects reported that they would be willing to repeat the treatment. These
findings complement those from a recent study by Juhász et al who observed significant
improvement in the appearance of the temple area for up to 12 months following
treatment of 20 subjects with CaHA (+) using either a bolus or serial puncture injection
technique.12 The mean age of subjects in the current study was 45 compared with 63.5
years in the Juhász study and therefore illustrates that temporal injection of CaHA (+)
also benefits younger subjects in whom temporal volume may be underdeveloped for
congenital reasons.

CaHA with added lidocaine retains a similar rheologic profile to CaHA alone,16 but
creates a smoother product that is ideal for thinner skinned areas of the face such as
the temples. In this study, CaHA (+) was not associated with any adverse events other
than mild bruising and tenderness, which resolved within 1 week of treatment.
Nevertheless, there are several important nerves and vascular structures in the
temporal area that must be avoided including the superficial temporal,
zygomaticotemporal and the deep temporal arteries as well as the frontal branches of
the facial nerve. Arteries and veins are located in superficial layers of tissue as well as
in the deeper layers and many have connections to ocular arteries. For example, the
superficial temporal artery has connections to the supraorbital artery, which is a branch
of the ophthalmic artery, and the anterior deep temporal artery anastomoses with the
zygomatico-temporal artery, which also connects to the ophthalmic artery circulation. To
reduce the risk of intravascular penetration, injections should be performed slowly, with
low plunger pressure and in small aliquots. Aspiration should not be relied on as it may
give a false sense of security.17 Detailed anatomic knowledge is therefore required
before attempting injections in this area.

Injection of CaHA/CaHA (+) to restore volume to the temples is currently an off-label

procedure in the US (although approved in Europe) and few papers document its use in
this area.12,18 However, off-label uses of dermal fillers are commonly practiced by
physicians in consultation with patients and continue to expand the potential uses of
available fillers. The documentation and sharing of these results and injection

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Accepted Article
techniques is essential for the development of safe and effective treatment protocols as
well as satisfied patients with great results.

Conclusion

Volume restoration is very successful at improving and restoring youthful contours, but
subjects and physicians rarely consider how replacing lost volume to the temple area
can result in improvements in facial appearance. Most patients are not even aware that
this is an option for aesthetic improvement. The use of CaHA (+) to replace volume in
the temple area is an effective technique for both young and older subjects and is
associated with a high level of patient satisfaction as well as a reduction in perceived
subject age.

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Accepted Article
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Figure 1. Photos taken before and 30 days after treatment with calcium hydroxylapatite
with integral lidocaine for temporal hollows in younger and older subjects.
Before After

Before After

Before After

Figure 2. Subject satisfaction results.

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Accepted Article Did not realize temple area needed
9
improvement

Was not concerned by temple area prior to

8
treatment

Physician suggested temporal correction 10

Patient was satisfied with temple correction 9.5

Willing to repeat treatment 10

0 2 4 6 8 10

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