Evaluation of the Merz Hand Grading Scale After Calcium

Hydroxylapatite Hand Treatment

Vince Bertucci, MD, FRCPC,* Nowell Solish, MD, FRCPC,* Martin Wong, BA,†
and Michael Howell, PhD‡

BACKGROUND Measurement scales that quickly and rigorously evaluate the effectiveness of filler treatment
in hands are important tools in clinical practice. The Merz Hand Grading Scale (MHGS) is used to grade the
Downloaded from http://journals.lww.com/dermatologicsurgery by BhDMf5ePHKav1zEoum1tQfN4a+kJLhEZgbsIHo4XMi0hCywCX1AWnYQp/IlQrHD3i3D0OdRyi7TvSFl4Cf3VC4/OAVpDDa8KKGKV0Ymy+78= on 03/06/2021

appearance of the dorsal hand. The MHGS has been validated for photographic and live assessment of
the hands.

OBJECTIVE To evaluate the sensitivity of the 5-point MHGS to detect clinically meaningful and aesthetically
pleasing changes in hand appearance after treatment with a calcium hydroxylapatite (CaHA)-based
dermal filler.

METHODS The controlled 4-week study randomized 30 subjects (60 hands) 2:1 to a Treatment group
(treatment at enrollment) or a Control group (treatment at end of study). Effectiveness was evaluated with live
MHGS ratings and photographic assessments with the Global Aesthetic Improvement Scale (GAIS).

RESULTS At Week 4, all Treatment group subjects (20/20) achieved a $1-point improvement on the MHGS
compared with 0/10 (0%) of the Control group (p < .0001). Subjects and treating physicians rated 92.5% (37/40)
and 100% (40/40), respectively, of hands as at least “improved,” using the GAIS.

CONCLUSION The MHGS is an appropriate and validated tool that clinicians can use to counsel patients and
evaluate clinically meaningful and aesthetically pleasing changes after hand treatment with CaHA.

V. Bertucci has been an investigator, speaker, and consultant for Merz North America, Inc. N. Solish has been
an investigator for Merz North America, Inc. M. Wong is used as a Clinical Project Director at Merz North
America, Inc. This study was sponsored by Merz North America, Inc. Editorial assistance was provided by
Meridius Health Communications, Inc. and supported by Merz North America, Inc.

P atients often seek treatment to enhance the

appearance of their hands in addition to their
face, as hands are the second leading indicator of age
after face.1 This is particularly true for individuals
who have undergone facial procedures, as these
patients are often bothered by the discrepancy
between the youthfulness of their face and the aged
appearance of their hands. Common concerns
include irregular surface pigmentation that can be
due to sun exposure, and more prominent
visibility of veins and tendons due to loss of
subcutaneous fat.
Radiesse (Merz North America, Inc., Raleigh, NC), is
an opaque, white-colored injectable dermal filler
composed of calcium hydroxylapatite (CaHA)
microspheres suspended in a gel carrier. CaHA injec-
ted into the dorsum of the hand has been shown to
provide immediate volume correction,2,3 and was
approved in Canada in 2010 for the treatment of
volume loss in the dorsum of the hands. In 2015,
CaHA became the first and only filler to be approved in
the United States to correct volume loss in the dorsum
of the hands.4 Previously, products such as autologous
fat5 and hyaluronic acid6 have been used.7 CaHA is

*Division of Dermatology, University of Toronto, Toronto, Ontario, Canada; †Research and Development, Merz North
America, Inc., San Mateo, California; ‡Meridius Health Communications, Inc., San Diego, California

© 2015 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.
· ·
ISSN: 1076-0512 Dermatol Surg 2015;41:S389–S396 DOI: 10.1097/DSS.0000000000000546

S389

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 MHGS AFTER TREATMENT

also approved for the correction of moderate to severe corresponding to a predetermined randomization
facial wrinkles and folds, including nasolabial folds, sequence. After collection of the required data for the
and is indicated for correction of the signs of facial fat analysis between these 2 groups, the Control group
loss (lipoatrophy) in people with human immunode- was crossed over and received treatment. Treatment
ficiency virus.8 group subjects were followed for 1 month from study
enrollment. Assessments were done at Week 1, Week
Treatment success after a cosmetic procedure can be 2, and Week 4.
measured subjectively with patient satisfaction ques-
tionnaires, or more objectively, with the use of vali- Treatment Protocol
dated clinical assessment scales.9–13 The 5-point
Subjects assigned to the Treatment group were treated
photonumeric Merz Hand Grading Scale (MHGS)
at enrollment with CaHA dermal filler; Control group
was designed as an assessment tool for physicians to
subjects received delayed treatment at Week 4 (after
quickly and reliably evaluate the appearance of the
completion of all effectiveness assessments).
dorsum of the hand. The MHGS has been rigorously
validated for this purpose in photographic and live
Before treatment, 0.26 mL of 2% lidocaine HCl was
assessments.14–18
mixed in-office with each 1.5 mL syringe of CaHA, in
accordance with the mixing procedure described in the
Objective Canadian Radiesse Instructions for Use.8 The final
product had a medium viscosity for dermal fillers, as
The primary objective of this study was to assess the
previously reported.19 Preop instructions included
sensitivity of the validated MHGS to detect clinically
washing of the hands and cleaning the dorsal treatment
meaningful changes in the appearance of the dorsum
areas with antiseptic. There was no preop anesthesia
of the hand after treatment with CaHA. In addition,
administered, other than mixing of CaHA with lido-
this study investigated whether changes on the MHGS
caine. Subjects received injections in the dorsum of both
were clinically meaningful and aesthetically pleasing
hands between the first and fifth metacarpals using
with the use of the GAIS and subject satisfaction
a 27-gauge needle. Skin tenting was performed with the
assessments, respectively.
noninjecting hand to separate the skin from underlying
vasculature and tendons. The volume of CaHA injected
Methods was at the discretion of the treating physician, who
determined the optimal cosmetic result for each hand. A
Subjects multi-bolus technique was used and injections were
given in small boluses of 0.2–0.5 mL per bolus. Each
This prospective, randomized, controlled, 4-week
subject received 1 treatment of no more than 3 mL per
study at 2 Canadian investigational sites enrolled
hand. Subjects were instructed to sit on their hands after
healthy subjects who were candidates for hand treat-
the injection, and ice was applied at the discretion of the
ment. The clinical study was conducted in accordance
treating investigator. The dorsum of the hand was
with applicable regulations inclusive of Institutional
gently massaged until the CaHA was evenly distributed
Review Board (IRB) approval by Veritas IRB Ethics
across the dorsum. After the procedure, subjects were
Committee (Montreal, Canada). Written informed
instructed in appropriate care, which included (1)
consent was obtained from each eligible subject before
application of ice or cool compresses for approximately
enrollment into the study. Subjects between 18 and 65
24 hours, (2) avoiding sun or tanning, or (3) massaging
years of age were assessed for inclusion if both their
the area if palpable nodules become present.
right and left hands had a rating of 2 or 3 on the MHGS
as determined by a masked evaluator.14
Assessments

Once enrolled, subjects were randomized 2:1 to Demographic information for each subject was col-
either the Treatment group or the Control group lected at Baseline. Individual MHGS assessments were

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 BERTUCCI ET AL

made for each hand at Baseline and at Week 2 and 4

TABLE 1. The Global Aesthetic Improvement
visits. Photographs were also taken at Baseline, Week Scale (Narins and Colleagues, 2003)
2, and Week 4 using standardized photography.
Rating Description

The MHGS ratings were made from live assessment of Very much Optimal cosmetic result for the
improved implant in this patient.
subject hands performed by evaluators masked to the
Much improved Marked improvement in appearance
randomization assignments of the subjects. There was from initial condition, but not
1 masked evaluator qualified to perform this task at completely optimal for this patient.
A touch-up would slightly improve
each site. Blinding was maintained by not allowing the result.
raters to observe subjects entering and leaving the Improved Obvious improvement in appearance
room, not allowing conversation between subjects and from initial condition, but a touch-
up or retreatment is indicated.
raters, and properly positioning the hand to be eval-
No change The appearance is essentially the
uated under a custom curtained frame, so that raters same as the original condition.
could not see the subject’s face and upper torso. Worse The appearance is worse than the
original condition.

Before study initiation, masked evaluators were trained

and qualified by the study sponsor to perform live
assessments using the MHGS. Weighted Kappa analysis
was performed to ensure that qualified evaluators
exhibited substantial intrarater and interrater reliability.
The GAIS was used to determine if changes on the
MHGS were clinically and aesthetically meaningful. The
GAIS assessments at Week 2 and Week 4 were photo-to-
photo review ratings performed by the same qualified
evaluators masked to subject randomization assign-
ments. In addition, treating physicians and subjects in
the Treatment group assessed each hand live using the
GAIS at Week 4 relative to pretreatment Baseline pho-
tos. The GAIS ratings are described in Table 1.
To determine whether changes were aesthetically
pleasing, treating physicians and subjects in the
Treatment group also completed physician and subject
satisfaction questionnaires, respectively. For all sub-
ject satisfaction responses, each Treatment group
subject compared their hands during the Week 4 study
visit with pretreatment Baseline photos.
Safety
Adverse events were assessed immediately after treat-
ment and at all subsequent visits by the treating phy-
sician. Subjects in the Treatment group were given
a 30-day Subject Diary and instructed to provide daily
entries to record potential and prespecified adverse
events, including bruising, itching, pain, redness, and
swelling of their hands. Subject diaries were reviewed
at each visit for adverse events. If an adverse event in
the subject diary was also observed by the investigator,
that specific adverse event was counted only once
during the safety analysis.
Safety was also evaluated using a series of real time
hand function tests which assessed range of motion,
sensation, dexterity, and grip and pinch strength. All
subjects (both Treatment and Control groups) were
also evaluated using various real time hand function
testing procedures. Hand function tests were per-
formed after hand photography at Baseline, Week 2,
and Week 4. Results from these hand function tests
will be reported in a separate publication.
Statistical Analysis
To determine sample size, it was assumed that the
Treatment group hands would have a success rate of
60% and the Control hands would have a success rate
of 20%. Using 80% power and a 1-sided significance
level of 0.025, it was determined that 36 hands were
needed in the Treatment group and 18 hands were
needed in the Control group.
Analysis of each individual hand was performed to
determine if the MHGS could detect changes in the
dorsum of the hand 4 weeks after treatment. The
threshold of improvement with the MHGS was a 1-
point improvement. The primary outcome was the

41:12S:DECEMBER SUPPLEMENT 2015 S391

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 MHGS AFTER TREATMENT

number of subjects in the Treatment group achieving Injection Volume

a $1-point improvement in both hands on the MHGS
Mean total injection volume for both hands among all
from Baseline at Week 4, and if the improvement was
treated subjects was 4.5 6 2.0 mL (range 1.7–7.2). The
statistically significant compared with the untreated
mean bolus volume was 0.26 mL and the mean num-
Control group. The level of significance was #0.05
ber of total boluses per subject was 17.5.
using a 2-sided paired t-test. Secondary outcomes were
analyzed in an exploratory and descriptive way, and
Evaluator Merz Hand Grading Scale Training
included effectiveness measured using the GAIS, phy-
and Qualification
sician and subject satisfaction questionnaires, and
hand function tests. The intrarater and interrater agreement analysis for
scale qualification demonstrated that each of the
masked evaluators rated hands consistently when
Results
compared with their own evaluation and when com-
Subject Demographics pared with each other. The masked evaluators were
very consistent within themselves, with intrarater
Of the 41 subjects screened between January 2012 and weighted Kappa values for each of the 2 evaluators to
February 2012, 20 were randomized to the Treatment be 0.97 and 0.85, respectively. High agreement
group and 10 were randomized to the Control group. between the 2 evaluators at the 2 sites was demon-
Of the 11 screen failures, 5 did not receive a hand strated by the interrater weighted Kappa value (0.88).
rating of 2 or 3 on the MHGS, 4 had current or The almost perfect strength of agreement in results of
recurrent inflammation or infection, 1 was unable to the qualification weighted Kappa analysis demon-
meet all study requirements, and 1 had received sys- strated that the masked evaluators were using the
temic steroids within the past 2 months. Overall, 28 MHGS in a consistent and reproducible manner
subjects were treated; 2 subjects in the Control group before the initiation of the study.
declined treatment at Week 4. Treatment results of the
Control group were not required for analysis of the Significant Improvement in MHGS Ratings
primary effectiveness endpoint. Mean (range) age of After CaHA Treatment
subjects was 52 years (37–65). Subjects were pre-
A statistically significant improvement in the MHGS
dominantly female (28/30; 93.3%) and white (27/30;
ratings relative to Baseline was demonstrated in the
90%), and of diverse Fitzpatrick Skin Types (Table 2).
Treatment group compared with the Control group.
At Week 4, each subject (20/20) in the Treatment
TABLE 2. Subject Demographics group achieved a $1-point improvement on the
MHGS compared with 0/10 (0%) of the Control
Enrolled Subjects group (P < .0001) (Figure 1). The mean change (SD) in
(N = 30)
MHGS rating was 21.8 (0.5) for hands in the Treat-
Age, years
ment group versus 0.0 (0.0) for hands in the Control
Mean (Range) 51.5 (37–65)
group at Week 4. Furthermore, there was symmetry of
Gender, n (%)
Female 28 (93.3) improved hand appearance (equal MHGS ratings) in
Male 2 (6.7) 100% of the treated subjects.
Race, n (%)
Caucasian 27 (90.0) Improvement in MHGS Rating After CaHA
Non-Caucasian 3 (10.0) Treatment Corresponds With Improvement in
Fitzpatrick skin type, n (%)
GAIS Rating and Subject Satisfaction
Type I 4 (13.3)
Type II 6 (20.0) GAIS ratings were reported from 3 sources: masked
Type III 17 (56.7)
evaluator assessment, treating physician assessment,
Type IV, V, VI 3 (10.0)
and subject assessment. Masked evaluators performed

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Figure 1. Percent change in Merz Hand Grading Scale
Rating, by the Treatment Group. Percentage of subjects
with $1-point improvement on Merz Hand Grading Scale
(MHGS) score at Week 4. For the MHGS ratings, assess-
ments were performed exclusively by the masked eval-
uators, who were blinded to randomization assignments
of the subjects. Before rating the hands of the subjects, the
masked evaluators (1 per site) were trained and qualified
on the MHGS by sponsor personnel using a protocol
specifically designed for this purpose. Control group, N =
10; treatment group, N = 20.
a photo review for GAIS ratings, and rated 100% (40/
40) of hands as at least “improved” (Figure 2). Sub-
jects and treating physicians compared the appearance
of the hands live at 4 weeks after treatment with
Baseline photographs. Similar to the masked evalua-
tor, the treating physicians rated 100% (40/40) of
hands as at least “improved” on the GAIS (Figure 2).
The vast majority of subjects, 92.5% (37/40) rated
their own hands as at least “improved” (Figure 2),
indicating that subject-reported treatment outcomes
corresponded to the $1-point MHGS improvement as
rated by the masked evaluator in all hands (Figure 1).
Based on the satisfaction questionnaire results, most
subjects in the Treatment group were “Extremely
Satisfied” (13/20; 65%) or “Satisfied” (3/20; 15%).
Treating physicians were also “Extremely Satisfied”
(15/20; 75%) or “Satisfied” (4/20; 20%) with treat-
ment outcomes (Figure 3). In addition, 80% of sub-
jects rated their hands as “Look Much Younger”
(survey on youthfulness of appearance) compared
with those before treatment, and 70% indicated that
they would be “Somewhat Likely” to “Extremely
Likely” to return for future hand treatment (survey on
likelihood to return for future hand treatments).
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BERTUCCI ET AL
Figure 2. Results of Global Aesthetic Improvement Scale
Assessments after CaHA treatment. Aggregate of subject,
physician, and masked evaluator assessments of change
in hand appearance in the Treatment group at Week 4
using the Global Aesthetic Improvement Scale (GAIS). The
masked evaluator GAIS assessments were performed
using subject hand photographs as provided during
poststudy webinars proctored by the sponsor. The treating
physician and Treatment Group subject GAIS assessments
were performed during the Week 4 study visits, comparing
the appearance of Treatment Group subject hands with
Baseline reference hand photographs. The survey con-
sisted of 5 improvement categories: “Very Much
Improved,” “Much Improved,” “Improved,” “No Change,”
and “Worse.” Treatment group, N = 40 hands.
Before and after pictures show typical improvement in
hand appearance 4 weeks after treatment (Figure 4). At
Baseline, each hand was rated 3 on the MHGS by
a masked evaluator. Four weeks after treatment with
a total volume of 4.0 mL of CaHA mixed with lidocaine
for both hands, both hands were rated 1 on the MHGS
by the same masked evaluator. Both the subject and the
treating physician rated the Week 4 images as “Very
Much Improved” on the GAIS compared with Baseline
photos. The masked evaluator rated the Week 4 images
as right hand “Much Improved” and left hand “Very
Much Improved” on the GAIS compared with Baseline
photos. The subject rated her hands as “Look Much
Younger” compared with Baseline photographs.
Safety
Subjects reported 61% (n = 146) of all adverse events
and the treating physicians reported the remaining
39% (n = 95) (Table 3). Most subject-reported adverse
events were of mild or moderate severity and all
resolved within 7 days.
41:12S:DECEMBER SUPPLEMENT 2015 S393
 MHGS AFTER TREATMENT
Figure 3. Satisfaction survey results after calcium
hydroxylapatite treatment. For all subject satisfaction
responses, each Treatment group subject (N = 20) com-
pared their hands during the Week 4 study visit with pre-
treatment Baseline photos. Similarly, treating physicians
compared subject hands during the Week 4 study visit with
Baseline photos. The survey consisted of 6 satisfaction
categories: “Extremely Satisfied,” “Satisfied,” Slightly
Satisfied,” “Slightly Dissatisfied,” “Dissatisfied,” and
“Extremely Dissatisfied.”
The most common adverse event reported was
swelling. All 20 Treatment group subjects experi-
enced swelling for a total of 35 swelling events with
mean duration of approximately 7 days. Swelling
was not related to volume injected (range 1.7–7.2 cc),
and 17% of subject-reported swelling events had
onset >14 days post treatment. Five of 20 subjects
reported “severe” swelling, with 11 of 20 subjects
experiencing a recurrence of swelling >3 days after
the initial resolution. Only 1 of 20 subjects received
intervention for swelling, which consisted of a topical
steroidal treatment prescribed on day 16 with reso-
lution by day 24. No nodules were reported during
the study.
Hand function test results indicated no negative effect
on hand function as a result of CaHA hand treatment.
Results from the hand function tests will be reported in
a separate publication.
CaHA injections were well tolerated for hand treat-
ment with a mean total treatment volume of 4.5 mL.
The majority of adverse events reported in this study
were expected, generally short in duration, and typical
of dermal filler injections.
S394 DERMATOLOGIC SURGERY
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Figure 4. Before and after hand treatment with calcium
hydroxylapatite. Left and right hands of a 65-year-old
subject from the Treatment group shown with corre-
sponding ratings (range: 0–4) from the Merz Hand Grading
Scale (MHGS) before and 4 weeks after calcium hydrox-
ylapatite (CaHA) treatment. At Baseline, both hands rated 3
on the MHGS (“severe loss of fatty tissue; moderate visi-
bility of veins and tendons”) as rated by a masked evalu-
ator. Four weeks after treatment with a total volume of 4.0
mL of CaHA mixed with lidocaine (2.0 mL per hand), both
hands rated 1 on the MHGS (“mild loss of fatty tissue;
slight visibility of veins”) by the same masked evaluator.
GAIS rated as “Very Much Improved” by both the subject
and the treating physician 4 weeks after treatment when
compared with Baseline photographs. In the satisfaction
survey, both the subject and the treating physician were
“extremely satisfied” with the cosmetic results. Four
weeks after treatment, the subject reported that her hands
“look much younger” and that she was “extremely likely”
to return in the future for hand treatments.
Discussion
As the dermal filler market continues to grow, an
increasing number of products and procedures are
available to help patients maintain a youthful facial
appearance. However, many patients who use these
products and treatments are bothered by the fact that
their hands show signs of volume loss, and increased
prominence of veins and tendons. The disparity
between their perceived age based on their face and
that of their hands is one of the reasons why soft tissue
filler treatments of the hand have become increasingly
popular with patients. Over time, the hands may
experience loss of dermal elasticity and atrophy of
subcutaneous tissue, giving them a sunken, often bony
appearance, and resulting in more prominent
appearance of veins and tendons. Until recently there
has been no approved dermal filler option in the
United States. CaHA is the first and only dermal filler
 BERTUCCI ET AL

appearance of the hand. The MHGS can be used to

TABLE 3. Adverse Events Reported in Subject
Diaries or by Treating Investigators Over the initiate a discussion about the possibility of hand
Course of Study treatment, which some patients may not even know
exists, and to explore the range of treatment effects
Adverse Events
that can be expected with CaHA treatment.
Event Reported by Reported by Treating
Type Subjects, N (%) Physicians, N (%)
Conclusion
Swelling 35 (24) 30 (32)
Bruising 29 (20) 19 (20) Restoring volume in subjects with moderate to severe
Redness 27 (18) 16 (17) loss of fat tissue in the dorsum of hands with CaHA is
Pain 26 (18) 19 (20)
well tolerated and produces a statistically significant
Itching 14 (10) 4 (4)
improvement in hand appearance. This randomized,
Other* 15 (10) 7 (7)
Total 146 (100) 95 (100) controlled, single-blind study demonstrates that live
assessment based on the MHGS can objectively detect
*Other events reported by 11 subjects were not serious,
generally short in duration, and nearly all (80%) were “mild” or improvements in hand appearance 4 weeks after
“moderate” in severity. treatment with CaHA. Importantly, the study dem-
onstrates that a $1-point rating change on the MHGS
scale is clinically meaningful and aesthetically pleas-
to be approved in the United States to correct volume ing, providing a clinically valuable tool to physicians
loss in the dorsum of the hands. and patients. In addition to being required to obtain
FDA approval, the MHGS can be used to improve
Previous work validated the MHGS as a tool to communication between physicians and patients,
characterize the appearance of hands based on clinical assisting patients in making informed choices and
and aesthetic signs and symptoms (loss of fatty tissue, assessing changes after treatment. Additionally, the
visibility of veins and tendons) with high intrarater MHGS is a useful tool that may be used to train new
and interrater reliability.14–16 practitioners and to assess the efficacy of soft tissue
filler hand treatments in clinical trials.
These previous studies validated the MHGS as a tool
to quickly and easily measure the effectiveness of
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Address correspondence and reprint requests to: Vince
Bertucci, MD, FRCPC, 8333 Weston Road, Suite 100,
Woodbridge, Ontario L4L 8E2 Canada, or e-mail: vince.
bertucci@utoronto.ca