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Calcium Hydroxylapatite Dermal Filler for Treatment of Dorsal Hand Volume Loss: Results From a 12-Month, Multicenter, Randomized, Blinded Trial

Authors:
  • Tennessee Clinical Research Center
  • Westlake Dermatology Clinical Research Center

Abstract and Figures

Background: Calcium hydroxylapatite (CaHA) microspheres suspended in a carrier gel is an opaque dermal filler that has been used to provide immediate volume correction in the dorsal hands. Objective: To assess the safety and effectiveness of CaHA for the correction of volume loss in the hands up to 12 months. Materials and methods: This multicenter, controlled, single-blind study (NCT01832090) included 114 subjects randomized 3:1 to CaHA treatment and untreated control groups. Effectiveness was assessed by blinded investigators using the validated Merz Hand Grading Scale (MHGS). Subject-reported improvement was assessed using the Global Aesthetic Improvement Scale. Effects of treatment on hand function were also assessed. Results: A total of 75% of subjects achieved ≥1-point improvement on the MHGS (p < .0001) at 3 months (primary end point); this response was generally maintained through 12 months. Proportions of subjects reporting improvement ranged from 98% (3 months) to 86% (12 months). There were no clinically significant differences between control and CaHA-treated subjects in any hand function measure. Adverse events were generally expected, minor, short-lived, injection-related, and similar to those observed in previous CaHA clinical studies. Conclusion: Treatment with CaHA results in significant improvement in the appearance of the dorsal hand and is well tolerated.
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Calcium Hydroxylapatite Dermal Filler for Treatment of
Dorsal Hand Volume Loss: Results From a 12-Month,
Multicenter, Randomized, Blinded Trial
Mitchel P. Goldman, MD,* Amir Moradi, MD,
Michael H. Gold, MD,
Daniel P. Friedmann, MD,* Kaveh Alizadeh, MD,
x
Jeffrey M. Adelglass, MD,
k
and Bruce E. Katz, MD
BACKGROUND Calcium hydroxylapatite (CaHA) microspheres suspended in a carrier gel is an opaque der-
mal filler that has been used to provide immediate volume correction in the dorsal hands.
OBJECTIVE To assess the safety and effectiveness of CaHA for the correction of volume loss in the hands up
to 12 months.
MATERIALS AND METHODS This multicenter, controlled, single-blind study (NCT01832090) included 114 sub-
jects randomized 3:1 to CaHA treatment and untreated control groups. Effectiveness was assessed by blinded
investigators using the validated Merz Hand Grading Scale (MHGS). Subject-reported improvement was assessed
using the Global Aesthetic Improvement Scale. Effects of treatment on hand function were also assessed.
RESULTS A total of 75% of subjects achieved $1-point improvement on the MHGS (p<.0001)at3months
(primary end point); this response was generally maintained through 12 months. Proportions of subjects reporting
improvement ranged from 98% (3 months) to 86% (12 months). There were no clinically significant differences
between control and CaHA-treated subjects in any hand function measure. Adverse events were generally
expected, minor, short-lived, injection-related, and similar to those observed in previous CaHA clinical studies.
CONCLUSION Treatment with CaHA results in significant improvement in the appearance of the dorsal hand
and is well tolerated.
Sponsored by Merz North America, Inc. All authors have been investigators and/or consultants for Merz North
America, Inc.
The appearance of the hands is considered
a leading indicator of age.
1,2
Over time, the hands
experience a loss of dermal elasticity and atrophy of
subcutaneous tissue, resulting in an overall volume
loss and increased visibility of veins and tendons.
3
Successful treatment strategies have included the
injection of dermal llers and adipose tissue to correct
the resulting volume loss in the dorsum of the hands, as
well as removal of hand veins through sclerotherapy or
phlebectomy.
4,5
Calcium hydroxylapatite (CaHA)
microspheres suspended in a carrier gel has been used
to effectively restore volume in the dorsal hands.
68
Calcium hydroxylapatite was rst approved by the
United States Food and Drug Administration (FDA) in
2006, for the correction of moderate to severe facial
wrinkles and folds such as nasolabial folds and for the
restoration and/or correction of the signs of facial fat loss
*Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc., San Diego, California;
Private Practice, Vista,
California;
Tennessee Clincal Research Center, Nashville, Tennessee;
x
Cosmo Plastic Surgery, Great Neck, New
York;
k
Texas Pharmaceutical Research LP/Research Across America, Plano, Texas;
Juva Skin and Laser Center, New
York, New York
Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided
in the full text and PDF versions of this article on the journals Web site (www.dermatologicsurgery.org).
© 2017 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.
ISSN: 1076-0512 ·Dermatol Surg 2017;0:19·DOI: 10.1097/DSS.0000000000001203
1
© 2017 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
(lipoatrophy) in people with human immunodeciency
virus. Calcium hydroxylapatite has been approved for
hand augmentation in the European Union since 2003
and in Canada since 2010, and CaHA received a similar
approval for use in the hands from the FDA in 2015.
9
It is
the rst and currently only dermal ller approved by the
FDA to correct volume loss in the hands.
Calcium hydroxylapatite is an opaque, white-colored
dermal ller that provides an immediate volume cor-
rection, and its opacity may also help to mask the
bluish tint associated with visible veins in the hands.
8
Studies on the physical properties of CaHA have
reported high-complex viscosity and a high and elastic
modulus (G9),
2
resulting in predictable performance as
aller. Overall, the properties of CaHA make it well-
suited for volume correction in the hands.
The objective of this study was to assess the safety and
effectiveness of CaHA for the correction of volume loss
in the hands up to 12 months after treatment. An
additional component of this study (and a requirement
for FDA approval of CaHA for use in the hands) was to
assess the effects of CaHA treatment on hand function
using a comprehensive battery of validated tests.
Materials and Methods
Study Design
This was a prospective, randomized, masked, con-
trolled study (ClinicalTrials.gov identication number:
NCT01832090) including 114 subjects at 6 investiga-
tional sites in the United States (Figure 1). Eighty-ve
subjects were randomized to a treatment group
(immediate treatment), and 29 subjects were random-
ized to a control group (delayed treatment) that was
untreated through 3 months after enrolment. After
collection of the required data for the analysis between
these 2 groups at Month 3, the control group was
crossed over and received an initial injection of CaHA
treatment. All subjects were eligible for an optional
retreatment 6 months after their initial treatment,
which enabled assessment of safety after retreatment.
Subjects were followed through 12 months from study
enrolment, with follow-up visits occurring at 1 week
and 2 weeks, and then monthly thereafter.
The clinical study was conducted in accordance with
21CFR812: Investigational Device Exemptions. The
study was approved by an accredited, central institu-
tional review board (IRB) before initiation (New
England Institutional Review Board, Newton, MA).
Each study site was individually approved for partic-
ipation in the study by the IRB. All subjects provided
written informed consent before enrolment.
Subjects and Treatments Administered
Male and female subjects $18 years of age were
required to have a rating of 2 or 3 for both hands on the
validated Merz Hand Grading Scale (MHGS)
1012
to
be eligible for enrolment. Subjects were excluded if
they had any previous surgery or treatment with
Figure 1. Study design.
CALCIUM HYDROXYLAPATITE FOR HANDS
DERMATOLOGIC SURGERY2
© 2017 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
injected dermal llers or adipose tissue in the dorsum
of the hands, or had recent dermal resurfacing or
noninvasive skin tightening procedures (past 6 months
before treatment), or used topical treatments in the
hands (e.g., wrinkle creams, corticosteroids, pig-
menting agents) within the 2 weeks before treatment.
Before injection, each 1.5-mL syringe of CaHA was
manually mixed with 0.26 mL of 2% lidocaine HCl.
Subjects received injections of CaHA in the dorsum of
both hands (dened as the space bound laterally
between the rst and fth metacarpals, proximally by
the dorsal wrist crease, and distally by the meta-
carpophalangeal joints) using a 27-gauge needle.
Before injection, the skin was tentedat the injection
site by grasping the skin between the thumb and
forenger of the noninjecting hand and lifting to sep-
arate it from the vascular and tendinous structures of
the dorsum of the hand. The needle was then advanced
between the subcutaneous layer and the supercial
fascia. Injections started between the second and
fourth metacarpals (Figure 2), and the number of
injection points and were left to the discretion of the
treating investigator. The injector also determined
total injection volume (up to a maximum of 3.0 mL of
CaHA injected per hand), which was administered
using small individual boluses (0.10.5 mL). Gentle
distribution of product was used after the injections.
Assessments and End Points
The primary effectiveness end point was the proportion
of subjects with an improvement of $1 point on the
MHGS in both hands at 3 months in the immediate
treatment group compared with the control group.
Merz Hand Grading Scale assessments were performed
by a live, masked evaluator who was blinded to subject
randomization. Secondary effectiveness end points
included change from baseline in MGHS score and
subject-reported changes on the 5-point Global Aes-
thetic Improvement Scale (GAIS)
13
compared with
baseline. Global Aesthetic Improvement Scale ratings
included Very Much Improved,”“Much Improved,
Improved,”“No Change,and Worse.
Safety and adverse events (AEs) were at each visit by
the investigators; between follow-up visits, AEs were
recorded by subjects using a 30-day diary. A series of
validated, real-time hand function tests were also
completed at baseline and at 3 months to evaluate any
clinically signicant changes in function in the
immediate treatment group compared with untreated
controls. At 12 months, hand function data were
collected in all subjects to evaluate possible longer-
term effects of CaHA treatment. Finger and thumb
exion and extension were assessed using a Jamar
nger goniometer,
14,15
and dexterity was evaluated
using the Functional Dexterity Test (See Supple-
mental Digital Content, Figure 1, http://links.lww.
com/DSS/A73).
16
Grip strength and pinch strength
were assessed using a Jamar hydraulic hand dyna-
mometer and Jamar hydraulic pinch gauge, respec-
tively (See Supplemental Digital Content,Figure1,
http://links.lww.com/DSS/A73).
17
Statistical Analyses
Descriptive summaries of continuous data are pre-
sented as number of observations, mean, SD,
median, minimum, and maximum values. Categorical
data were summarized using frequency counts and
percentages. Statistical hypothesis testing for the pri-
mary end point was conducted using Fisher Exact
Test. For secondary effectiveness variables, statistical
signicance was assessed using Fisher Exact Test or
Figure 2. Areas of the hands treated during the procedure.
GOLDMAN ET AL
0:0:MONTH 2017 3
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Wilcoxon RankSum Test. Statistical signicance was
declared if the one-sided p-value of a Fisher Exact Test
or Wilcoxon Test was #.025.
Results
Subjects and Treatments Administered
A total of 114 subjects were enrolled the study and were
randomized 3:1 to an immediate treatment group (n=
85) or delayed-treatment group (n= 29); 113 subjects
(99%) remained in the study through the 3-month visit.
One subject (control group) withdrew during this period
because of an injury unrelated to the study. Two addi-
tional subjects were withdrawn between Months 3 and
12 because of inability to comply with the study visit
schedule. The mean age of the subjects was 53.3 years,
and most were women (95.6%) and Caucasian (76.3%).
Subject demographics are summarized in Table 1.
For the initial injection (N= 113 subjects; 226 hands),
a mean volume of 2.6 mL CaHA was used in each
hand. Among the 78 subjects (156 hands) who
requested the optional retreatment at 6 months,
a mean volume of 1.6 mL CaHA was injected in each
hand.
Improvement on the Merz Hand Grading Scale
The primary effectiveness end point of the study was
met with 75.3% of treated subjects demonstrating an
improvement of $1 point on the MHGS at 3 months,
compared with 3.4% of subjects in the control group
(p< .0001) (Figure 3). The proportion of hands
achieving a $1-point improvement on the MHGS at 3
months was also signicantly higher for the treatment
group compared with the control group (77.1% vs
5.2%; p< .0001). The mean MHGS improvement for
the treatment group was signicantly greater than the
control group (1.1 points vs 0.1 points; p< .0001) at 3
months. Representative before-and-after photographs
of subjects with a 1-point improvement on the MHGS
can be found in both Figures 4 and 5, the latter of
which illustrates the improvement observed in a 79-
year-old African American woman (the oldest subject
TABLE 1. Subject Demographics
CaHA
(N = 85)
Control
(N = 29)
Mean age, yr (range) 52.8 (26–75) 54.8 (34–79)
Female, % 95.3 96.6
Race, %
Caucasian 77.6 72.4
African American 3.5 10.3
Hispanic 14.1 10.3
Other 4.7 6.8
Fitzpatrick score, %
I 3.5 0
II 52.9 37.9
III 22.4 37.9
IV 15.3 13.8
V 4.7 6.9
VI 1.2 3.4
MHGS score
Mean 2.6 2.6
2 44% 40%
3 56% 60%
CaHA, calcium hydroxylapatite; MHGS, Merz Hand Grading
scale.
Figure 3. Subjects achieving $1-point improvement on the Merz Hand Grading Scale (MHGS) in both hands at 3 months.
CALCIUM HYDROXYLAPATITE FOR HANDS
DERMATOLOGIC SURGERY4
© 2017 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
enrolled in the study). A 2-point improvement on the
MHGS is illustrated for reference by the before-and-
after photographs in Figure 6.
Durability of improvement on the MHGS was
demonstrated over the 12 month duration of the
study. Among the immediate treatment group sub-
jects who received a single treatment, the pro-
portions of hands maintaining a $1-point
improvement on the MHGS ranged from 73.9% at 6
months posttreatment to 71.7% at 12 months
posttreatment (Figure 7). When including
delayed-treatment group subjects who crossed over
at Month 3 postenrolment, the proportions of
hands demonstrating durable improvement after a
single treatment were similar (Figure 7). As expec-
ted, a somewhat higher proportion of subjects who
received retreatment at Month 6 postenrolment
achieved a $1-point improvement on the
MHGS: 82.1% of subjects at 3 months and
88.5% of subjects at 6 months after the second
injection.
Subject-Reported Improvement on the Global
Aesthetic Improvement Scale
Nearly all treated hands (97.6%) were rated at least
Improvedby subjects at 3 months (Figure 8).
Improvement on the GAIS was generally maintained
over the course of the study: 93.4% and 86.4% of all
treated hands were considered at least Improved
at 6 months and 12 months posttreatment, respec-
tively (Figure 8). Among subjects who opted to
receive retreatment, 98.7% and 95.1% of hands
Figure 4. Representative before (top) and after (bottom) photographs showing a 51-year-old Caucasian woman with
a 1-point improvement in the Merz Hand Grading Scale (MHGS) at 3 months. Injection volume, MHGS scores, and subject-
assessed Global Aesthetic Improvement Scale (GAIS) rating noted in the accompanying tables.
Figure 5. Representative before (top) and after (bottom) photographs showing a 79-year-old African American woman with
a 1-point improvement in the Merz Hand Grading Scale (MHGS) at 3 months. Injection volume, MHGS scores, and subject-
assessed Global Aesthetic Improvement Scale (GAIS) rating noted in the accompanying tables.
GOLDMAN ET AL
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were improved at 3 and 6 months after retreatment,
respectively. No hands were rated as being worse
compared with baseline at any point during the
study.
Safety and Hand Function
Adverse events reported were generally expected and
typical of other CaHA studies,
68
and most events
were mild or moderate in severity. The most common
AEs were swelling, pain, redness, and bruising
(Table 2), and nearly all events (96.4%) occurred
within the rst 2 weeks of treatment. A signicantly
higher proportion of subjects who received injection
volumes greater than the mean injection volume (2.6
mL) reported bruising, compared with those who
received injection volumes less than the mean (84.6%
vs 65.6%; p= .03).
No new or unexpected AEs were observed among
those opting for retreatment. Subjects who received
retreatment reported a lower incidence of bruising,
swelling, redness, pain, and itching when compared
with initial treatment. Interventions were not needed
for >98% of AEs, and all resolved without sequelae.
The mean duration of observed AEs was 8.19 days,
and 89% resolved within 14 days. There were no
treatment-related serious AEs. Seven subjects (6.2%)
experienced nodules, including 2 after initial treat-
ment and 5 after retreatment. All cases of nodules were
rated mildin severity and were isolated to 1 study
site. No more than 1 nodule was present on the dorsum
of each hand, and hand function was not affected. A
representative photograph of one of the nodules is
shown in Figure 9.
Results of the validated real-time hand function tests
demonstrated that hand function was not clinically
affected by CaHA treatment. At 3 months, changes in
exion and extension angles for the ngers and thumb,
functional dexterity measurements, and grip strength
were all similar between the treatment group and
untreated control group. No clinically signicant
changes in any hand function assessment were
observed between 3 months (when all control subjects
received initial treatment) and 12 months. Complete
Figure 6. Representative before (top) and after (bottom) photographs showing a 50-year-old Caucasian woman with
a 2-point improvement in the Merz Hand Grading Scale (MHGS) at 3 months. Injection volume, MHGS scores, and subject-
assessed Global Aesthetic Improvement Scale (GAIS) rating noted in the accompanying tables.
TABLE 2. Summary of Adverse Events Through
12 Months
Adverse Event
Subjects With Event at 12
Months, n (%)* (N = 113)
Bruising 82 (72.6)
Swelling 112 (99.1)
Redness 92 (81.4)
Itching 52 (46.0)
Pain 104 (92.0)
Hematoma 1 (0.9)
Nodule 7 (6.2)
Difficulty
performing
activities
54 (47.8)
Loss of sensation 17 (15.0)
*Counts and percentages include subjects who received
optional retreatment at 6 months (N= 78).
CALCIUM HYDROXYLAPATITE FOR HANDS
DERMATOLOGIC SURGERY6
© 2017 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
hand function test results are summarized in the Sup-
plemental Digital Content, Figures 16, http://links.
lww.com/DSS/A73.
Discussion
Results of this study showed that a single treatment with
CaHA is associated with statistically signicant
improvement in the appearance of hands as assessed
using the MHGS by masked, live evaluators. This result
was concordant with subject-reported improvement
using the GAIS. A key nding of the study was the
observed durability of CaHA treatment effectiveness;
similar MHGS results were maintained through 12
months postenrolment after a single treatment. In
addition, the proportion of all treated hands rated as
improved remained >85% through the end of the study.
Although an optional second treatment was offered at 6
months, there was only a nominal corresponding
increase in MHGS improvement and subject-reported
improvement and among those who chose this option.
The optional second treatment was primarily included
to enable assessment of retreatment safety, which
revealed no new or unexpected AEs.
Calcium hydroxylapatite is the currently the only der-
mal ller approved by the FDA for use in the hands;
however, the use of other dermal llers such as hyalur-
onic acid (HA) and poly-L-lactic acid (PLLA) for volume
correction in the hands has been reported over the last
Figure 7. Proportions of hands maintaining $1-point improvement on the Merz Hand Grading Scale (MHGS) after initial
treatment.
GOLDMAN ET AL
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© 2017 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
10 years.
4,5,1822
Although treatment of the hands with
PLLA can provide aesthetic benets with durability
lasting >1 year, multiple treatment sessions with high
dilutions of product may be required,
4
and some pro-
viders avoid use of PLLA in the hands because of the
potential for complications.
21,22
Studies on HA llers in
the hands also show that subjects may achieve marked
aesthetic improvements after treatment.
1820
However,
HA llers may not exhibit the same durability as CaHA
in the hands; only one of the available studies on HA
llers (an open-label study) showed that aesthetic out-
comes were maintained through 12 months,
20
whereas
a second HA study showed a marked decline in aesthetic
outcomes after 6 months.
18
Safety in this study was generally favorable through all
follow-up visits, with no serious AEs. Most AEs were
related to the injection procedure and were mild to
moderate in severity. Subjects who received retreatment
reported a lower incidence of injection-related AEs,
which may have been related to the lower injection vol-
ume used during the second treatment. Incidence of
bruising during the initial treatment was also shown to
be correlated with injection volume.Theoverallsafety
prole was complemented by hand function analyses
using a battery of validated, objective tests. Range of
motion of all ngers and the thumb, functional dexterity,
and grip strength, were all unaffected by CaHA treat-
ment over the 12 month duration of the study. Pre-
sentation of such a comprehensive set of objective
functional analyses in subjects receiving dermal ller
treatments in the hands is unprecedented in the literature.
As is the case for all injectable llers, use of proper
injection technique and knowledge of anatomy are
also important for optimizing outcomes and satisfac-
tion, as well as avoiding AEs. To maximize subject
comfort and aesthetic outcomes in this study, small
boluses of material (0.20.5 mL) were applied slowly
with continuous even pressure followed by gentle
distribution of product after injection. Nodules were
observed at 1 site in the study, which used a more
vigorous postinjection massage technique. To
decrease the risk of AEs such as nodules, it is recom-
mended that the dorsum of the hand be massaged
gently as the patient makes a st. To facilitate gentle
spread of the injected CaHA, the patient may sit on
their hands (while covered in sterile gauze) to warm
and soften the material; use of lubicricant (e.g., ultra-
sound gel) may also help the gentle spread of material.
Overall, the techniques used in this study were con-
sistent with both the CaHA instructions for use
9
and
another recent study that reported favorable aesthetic
outcomes and high levels of subject satisfaction after
CaHA treatment in the hands.
10
Figure 8. Subject-assessed ratings on the Global Aesthetic Improvement Scale.
Figure 9. Reported nodule with onset at Day 54 after retreat-
ment. A white box shows the area where the 2 mm nodule
was observed. All nodules observed in the study were mild,
resolved without sequelae, and did not require intervention.
CALCIUM HYDROXYLAPATITE FOR HANDS
DERMATOLOGIC SURGERY8
© 2017 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
The ndings from this multicenter, controlled, single-
blind pivotalstudy support and extend the observations
from previousclinical studies
68
on the effectiveness and
safety of CaHA use in the hands. A single treatment
with CaHA provided immediate volume correction in
the dorsum of the hands with durable results lasting up
to 12 months.
Acknowledgments The authors express their sincere
appreciation to Martin Wong (formerly of Merz
North America, Inc.) for his direction in the execution
of the study and to Steven L Moran, MD for critically
reviewing the data in this article. The authors also
thank David J Howell, PhD for early assistance with
the article outline and Michael Hast, PhD (Merz
North America, Inc.) for editorial assistance.
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Address correspondence and reprint requests to: Mitchel P.
Goldman, MD, Dermatology Cosmetic Laser Medical
Associates of La Jolla, Inc., 9339 Genesee Avenue, Suite 300,
San Diego, CA 92121, or e-mail: mgoldman@clderm.com
GOLDMAN ET AL
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© 2017 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
... Soft tissue loss and appearance of hands are strong indicators of age [10]. Atrophy of soft tissue and dermal elasticity is specifically noticeable on the dorsal hands of an individual [10]. ...
... Soft tissue loss and appearance of hands are strong indicators of age [10]. Atrophy of soft tissue and dermal elasticity is specifically noticeable on the dorsal hands of an individual [10]. To treat the loss of volume, injection of dermal fillers and adipose tissue have been utilized with success [10]. ...
... Atrophy of soft tissue and dermal elasticity is specifically noticeable on the dorsal hands of an individual [10]. To treat the loss of volume, injection of dermal fillers and adipose tissue have been utilized with success [10]. Here, a 67-year-old woman, FST II, presented with significant atrophy of subcutaneous tissue in her hands. ...
Article
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Introduction Real‐world experience using an allograft adipose matrix (AAM) (Renuva) is presented as a series of seven cases demonstrating successful use of the matrix by nine expert cosmetic physicians across the United States. AAM is donated tissue that is aseptically processed without terminal irradiation into a transplantable adipose matrix that functions as a natural, versatile, and nonimmunogenic cushioning and volume‐restoring tissue. When injected, the adipose matrix is replaced with the body's own fat cells and provides the cellular scaffold required for volume restoration and retention. Methods Nine expert dermatologists were selected to share and discuss real‐world patient cases using AAM. The experts discussed a variety of cases and selected 7 cases that demonstrated successful, novel use of AAM to present in this manuscript. Results Experts agreed that the novel AAM is an easy‐to‐use, effective, and safe alternative to traditional fillers and fat grafting. Conclusion The use of the AAM is recommended for the face, hands, and other adipose tissue‐containing parts of the body. The presented real‐world cases provide guidance on how to identify ideal candidates to ensure optimal volume restoration results.
... The aesthetic effectiveness of CaHA has been investigated in several clinical trials and observational studies that report various degrees of improvement in aesthetic scales [5][6][7][8][9] and levels of patient satisfaction [10][11][12][13][14][15]. The majority of available studies reported a comparison between the aesthetic effects of CaHA following injection versus the baseline values [7,[14][15][16][17][18][19][20][21][22], and there are limited comparative clinical data on efficacy of CaHA relative to other categories of existing fillers [5,[23][24][25][26][27][28]. ...
... The mean age of the participants was 50.2 years old, with a standard deviation of 3.93. Among 13 included studies, 8 investigated the effect of CaHA injection on facial areas [5,8,12,27,28,[37][38][39] and 5 studies on the dorsum of hands [23][24][25][26]40]. The median of follow-up was 26 weeks (from 4 to 48 weeks) and the sample size ranged between 10 to 194 participants. ...
... The median of follow-up was 26 weeks (from 4 to 48 weeks) and the sample size ranged between 10 to 194 participants. Four studies were designed as either split-face or hands [5,8,26,38] and the remaining as parallel clinical trials [12,[23][24][25]27,28,37,39,40]. In studies focused on facial areas, the comparison treatments of five studies were different types of hyaluronic acids, human-based collagen, poly-L-lactic acid, cross-linked polyacrylamide and fat fillers [5,27,28,38,39]. ...
Article
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Background: This study aimed to systematically review and summarize the available controlled clinical trials on the effectiveness of calcium hydroxylapatite (CaHA) in terms of aesthetic outcomes, skin-aging-related outcomes, and patient/investigator satisfaction. Methods: We included controlled clinical trials involving at least 10 human adults that examined the effects of CaHA on aesthetic and skin-aging-related outcomes and satisfaction. Due to the high heterogeneity among the included studies, only a qualitative analysis is provided. Results: Out of 2935 relevant references, 13 studies were included, of which 8 studies focused on facial areas and 5 on dorsum of hand. CaHA injection was associated with enhancements in global aesthetic improvement scale, whether applied in facial regions or on the dorsum of hands. The findings suggested high patients’ satisfaction following CaHA when applied to facial areas. Studies highlighted improvements in hand grading scales and a reduction in facial wrinkles. Conclusions: Current evidence suggests that CaHA injections improve aesthetic results, including facial areas, such as nasolabial folds and jawline, and hands, with high levels of satisfaction. Considering the methodological limitations and heterogeneous comparisons groups, additional controlled clinical trials would contribute to a better understanding of the applications and advantages offered by CaHA.
... needle, the volume is injected at three to five insertion sites of the dorsal hand, until a nodule is raised [30]. The injection techniques that can be used are serial puncture with a needle, fanning technique using a cannula or microdroplets technique with a needle [32,37]. ...
Article
Full-text available
Background The demand for aesthetic procedures aimed at restoring and preserving a youthful appearance is growing. While numerous non‐surgical facial rejuvenation techniques are available, there is a need for a comprehensive review of clinic‐based procedures targeting non‐facial body parts. Aims This review aims to describe and evaluate clinic‐based techniques for rejuvenating the neck, chest, and hands, focusing on various types of fillers and other non‐invasive procedures. Methods In this first part of this review, we conducted an extensive literature review on PubMed, reporting the effectiveness of different fillers, detailing their preparation, required volume per area, injection methods, durability, and any associated side effects. We also discuss the use of mesotherapy, microneedling, chemical peeling, and Profhilo in these specific body areas. Conclusion The review synthesizes the latest data on the effectiveness and safety of these procedures, highlighting the advancements in filler technology and the growing popularity of non‐invasive techniques for body rejuvenation. This article serves as a valuable resource for practitioners and patients interested in non‐surgical body rejuvenation, providing insights into the best practices.
... Moreover, the current study offers a significant long-term evaluation, compared to similar trials [1]. One study in particular included a larger sample size (114 patients), however, over a follow-up period of 12 months [24]. The method of manually mixing Radiesse® with a lidocaine solution prior to injection was approved by the FDA in 2009 and is well documented to significantly reduce pain during treatment [15,25]. ...
Article
Full-text available
Introduction: Hand rejuvenation treatment is in high demand in cosmetic medicine. Radiesse®, a commercially available formulation of calcium hydroxylapatite (CaHA), is safe, biocompatible, and provides long-lasting results. Objective: The study aimed to retrospectively evaluate the efficacy and safety of the presented formulation of Radiesse® and its injection procedure. Methods: The hands of 58 women were treated employing Radiesse® diluted with lidocaine. The treatment was performed using a blunt cannula following the proximal-to-distal fanning technique at two entry points on the dorsum of the hands. The patients received 1-4 treatments over a follow-up period of up to five years. Results: The hands of 58 females were evaluated using the Merz Hand Grading Scale (MHGS) and treated with the presented CaHA formulation. After the first treatment, 55 patients (94.8%) achieved a 1-point improvement, and 19 patients (32.8%) did not receive further treatment, being satisfied with the results. The remaining 39 women (67.2%) received 2-4 follow-up treatments. At the end of the treatment(s), 46 women (79%) achieved a final improvement of one point, and 12 women (21%) a final improvement of two points. Three minor adverse events were registered. Conclusions: Radiesse® diluted with lidocaine is an excellent choice for hand rejuvenation. The formulation and technique proved to be safe and efficient. In our experience, a blunt cannula should be employed for optimal vein correction. The treatment was highly satisfying, although planning a second treatment during the 1-month follow-up visit is recommended to best achieve long-lasting results.
... Several products, such as calcium hydroxyapatite and hyaluronic acid fillers, are FDA-cleared for hand rejuvenation. [1][2][3][4][5][6] Although these fillers address the volume loss component, they do not address pigmentary changes, such as lentigines. [7][8][9][10] Lentigines can be effectively treated with chemical peels, which resurface the superficial portion of the epidermis to remove undesirable pigment, thereby addressing extrinsic signs of photoaging. ...
Article
BACKGROUND Improving the appearance of lentigines on the hands is a key component to hand rejuvenation. Soft tissue fillers revolumize hands, but do not address pigmentary changes. OBJECTIVE: This study investigated the effiacy of a 15% trichloroacetic acid (TCA) + 3% glycolic acid (GA) combination peel in improvement of appearance of hand lentigines. METHODS A prospective evaluator-blinded, split-hand study was performed using a 15% TCA + 3% GA peel to treat patients with hand lentigines. Subjects received a total of 3 treatments at 4-week intervals on 1 hand, with the other hand serving as an untreated control. Final photographs were taken 12 weeks after the last treatment. Two blinded board-certified dermatologists graded improvement in hand lentigines using a 5-point scale. RESULTS Eighteen of 20 patients completed the study (90%). The mean age was 64.4 years (SE 1.6, range 51–71). The mean pain scores were 3.8 (SE 0.4) on a 10-point scale (1 = no pain, 10 = extremely painful). Blinded evaluators correctly identified the after-treatment photographs in 16 patients (88%). Physician and patient-graded mean improvement of lentigines was significant for treated versus control hands ( p < .01). No adverse events were noted. CONCLUSION A series of three 15% TCA + 3% GA peels are effective and safe in the treatment of hand lentigines.
Article
Hand rejuvenation addresses aging-related changes such as subcutaneous fat loss, skin degradation, and photodamage. Autologous fat transfer (AFT) has emerged as a promising treatment, offering durable volume augmentation and regenerative effects. This study aims to systematically review the evidence on the techniques, outcomes, and complications of AFT for hand rejuvenation. A systematic review was conducted following the PRISMA guidelines, searching databases such as MEDLINE, SCOPUS, DOAJ, and PUBMED from inception to April 2024. Inclusion criteria were studies reporting on hand rejuvenation using fat grafting, including randomized clinical trials, observational studies, case reports, and case series. Data extraction and risk of bias assessment were performed independently by multiple reviewers blindly. Eleven studies published between 2001 and 2019 were included, comprising 303 patients with a strong female predominance. Study designs varied, with three randomized clinical trials, seven case series, and one prospective study. High satisfaction rates were consistently reported, with complications being generally infrequent and minor. Various fat grafting techniques were employed, with manual aspiration being the predominant fat harvesting method. Follow-up periods ranged from 5 to 38 months, facilitating thorough evaluation of treatment outcomes. AFT for hand rejuvenation is effective and safe, offering high patient satisfaction and minimal complications. Long-term fat retention and regenerative effects of adipose-derived stem cells contribute to success. However, fat graft resorption may require multiple treatments. Future research should standardize assessment tools, volumetrically measure graft resorption, and conduct high-quality trials to optimize protocols. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.
Article
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Background Many studies assess aesthetic effectiveness of calcium hydroxylapatite (CaHA), with single-group designs as the most frequently applied designs in practice. This study systematically reviewed CaHA’s effectiveness for aesthetic purposes among these studies. Methods A comprehensive search was conducted across 5 bibliographic databases. Single-group studies with at least 10 human adults were included. Summary measures of patients satisfaction and global aesthetic improvement scores were combined using the generalized linear mixed model. This systematic review adhered to the PRISMA reporting standards. Results Of 3131 records, 46 single-group studies, majority focused on facial areas (n = 32), were included for final qualitative analysis. A total number of 27 studies were included in the meta-analysis. Findings of the meta-analysis showed that 98% (95% confidence interval [CI], 91%–99%; I ² , 0.0%) of patients were satisfied with the injection results in the facial area and 90% (95% CI, 67%–97%, I ² , 35%) in other treated body areas. Also, patients reported 89% (95% CI, 76%–96%; I ² , 65%) improvement on the global aesthetic improvement scale in facial areas and 94% (95% CI, 75%–99%; I ² , 0.0%) in other treated regions. Similarly, investigators reported global aesthetic improvement in 92% of patients (95% CI, 33%–100%; I ² , 92%) in facial areas and 95% (95% CI, 1%–100%; I ² , 89%) in other treated areas. Conclusions Our findings showed aesthetic improvements and satisfaction following CaHA injections in both facial and nonfacial areas. However, studies focusing on nonfacial regions are limited. We recommend more rigorously designed trials to better understand CaHA’s clinical effects.
Chapter
Demand for hand rejuvenation is on the rise. Hands are one of the foremost herald to aging (secondary only to the face). Two of the most prominent markers of an aged hand are prominent deep structures (such as veins and tendons) and areas of discoloration on the dorsum of the hand. These can all be effectively addressed with hand rejuvenation procedures; these include topical agents, chemical peels, laser therapy, dermal fillers, fat grafting, and a combination of modalities.
Article
Hand aging is a prevalent concern characterized by the atrophy of local soft tissues and increased visibility of vessels and tendons. Hyaluronic acid (HA) and calcium hydroxyapatite (CaHA) are well-established treatments for addressing this issue. While hybrid filler containing HA and CaHA has been proposed for facial rejuvenation, studies investigating its efficacy for hand rejuvenation are lacking. This study aims to assess the safety and efficacy of a premixed hybrid filler containing calcium hydroxyapatite (CaHA) and hyaluronic acid (HA) for hand rejuvenation. A prospective, double-blind, controlled trial was conducted. The control arm (CA) received conventional subdermal treatment with CaHA at a 1:1 dilution. The intervention arm (IA) underwent hybrid treatment, consisting of CaHA at a 1:1 dilution combined with 1 ml of low-density HA. Evaluation was performed subjectively using the Global Aesthetic Improvement Scale (GAIS) and the Manchester Hand Grading System (MHGS), and objectively using cutometry, corneometry, and ultrasound. Both the CA and the IA exhibited high rates of patient satisfaction and satisfaction as assessed by blinded evaluators. Although numerical superiority was observed in the IA, no statistical difference was found between the two groups. Significant improvements in hydration, elasticity, and skin thickness were observed in both arms, with no discernible difference between them. Greater ultrasound echogenicity was noted in the IA, which, as indicated by existing literature, may suggest enhanced biostimulation. No adverse effects were reported in either arm. Premixed filler containing HA and CaHA for hand rejuvenation appears to be a safe and effective approach. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.
Article
A filler composed of calcium hydroxylapatite and carboxymethylcellulose gel (CaHA/CMC) has been shown to possess biostimulatory and skin‐tightening properties that have been applied not just to the face but also to the body to boost rejuvenation. Recently, evidence and recommendations for CaHA/CMC treatment of the face have been provided, but they are still lacking in terms of body treatment. This article aims to perform a systematic review of the literature on CaHA/CMC applications on the body and provide evidence from the literature. Currently, the only FDA‐approved indication on the body is treating the hands and a recent European Union Medical Device Regulation approval has been released for decolletage treatment. The application of hyperdilutions on the neck, feet, arms, thighs, abdomen, and other body parts has been proven to provide a skin‐tightening effect. However, despite their wide use with a good safety profile in clinical practice, recent trends and guidelines of diluted and hyperdiluted CaHA/CMC have yet to be supported by randomized controlled trials.
Article
Full-text available
Aging of the hands results from both natural processes and chronic ultraviolet light exposure. Together, these cause textural and pigmentary changes, excess skin laxity, rhytides, and soft tissue atrophy that presents as prominent bones and tendons with easily visible veins. Many options are available for the reversal of these changes. Photoaging can be improved with chemical peels and light-based treatments (such as Q-switched lasers), resurfacing lasers, intense pulsed light, and photodynamic therapy. Soft tissue atrophy can be corrected with autologous fat, nonanimal stabilized hyaluronic acid, calcium hydroxylapatite, and poly-L lactic acid injections. The literature shows that these treatments have favorable outcomes for most patients; but in order to reduce known complications, it is important to understand the proper use and limitations of each modality.
Article
Author Information *Dermatology and Laser Center, White Plains, New York †Frederic S. Brandt Dermatology & Assoc., Coral Gables, Florida ‡Skin Study Center, Broomall, Pennsylvania §Lorenc Aesthetic Plastic Surgery, New York ¶Lasky Clinic, Beverly Hills, California **Therapeutics Inc., La Jolla, California Address correspondence and reprint requests to: Rhoda S. Narins, MD, 222 Westchester Avenue Ste. 300, White Plains, New York, NY 10604, or e-mail: rsnmd@worldnet.att.net Acknowledgment The authors thank Stephen Baker, MD, FACS (Clinical Instructor Plastic Surgery, Volunteer Clinical Faculty, University of Miami School of Medicine), Doris J. Day, MD (Department of Dermatology, New York University Medical Center), Andrew Frankel, MD (Division of Head and Neck Surgery, University of California at Los Angeles, Los Angeles, CA), Scott Gottlieb, MD (Department of Dermatology, Hospital of the University of Pennsylvania, Philadelphia, PA), Curt M. Littler, MD (SHARP Rees-Stealy Medical Group Inc., San Diego, CA), and Richard W. Swift, MD (Department of Plastic Surgery, Manhattan Eye, Ear and Throat Hospital, New York) for their contribution as evaluating investigators in this study.
Article
Hand rejuvenation is an increasingly requested procedure in dermatology. Dorsal hand augmentation with soft tissue filler is one aspect of hand rejuvenation. Calcium hydroxyapatite is FDA approved for this purpose, while at the present time other filler products are utilized but are considered off-label for dorsal hand augmentation. This article reviews the relevant anatomy, the general and filler-specific techniques commonly employed, and potential complications that may arise. J Drugs Dermatol. 2016;15(7):809-815.
Book
This illustrated text and reference emphasizes the fundamentals of hand therapy for both specialists and non-specialists who encounter clients with hand issues. It provides a consistent format with tips and guidelines for hand therapy treatment. Coverage includes hand anatomy, key terms and concepts, and the evaluation process. A focus on professional issues includes clients with functional somatic syndromes and challenging behavior, client-therapist rapport, and the roles of therapy assistants. Providing many case studies, this text helps therapists think critically about clients individual needs. Emphasizes the development of clinical reasoning skills, describing the components of the evaluation process and addressing how to decide what to evaluate. Covers a broad array of common diagnoses seen in hand therapy, including shoulder and elbow disorders, peripheral nerve problems, wrist and hand fractures, tendonitis and tendonosis, finger sprains and deformities, tendon injuries, arthritis, burns, infections, ganglion cysts, stiffness, Dupuytrens, and pediatric and geriatric hand problems. Diagnostic-specific information and treatment guidelines follow a consistent format: Overview Diagnosis and pathology Timelines and healing Anatomy Treatment (non-operative and/or operative) Questions to ask the doctor What to say to clients Evaluation tips Diagnosis-specific information that affects clinical reasoning Tips from the field Precautions and concerns Role of therapy assistants Case examples Offers topics to use as mental prompts when working in the clinical setting: Questions to ask the doctor What to say to clients Tips from the field Precautions and concerns Over 400 illustrations in the text and on the CD demonstrate important concepts. Case studies in the common diagnoses chapters demonstrate the use of clinical reasoning and highlight the human side of each client encounter. Clinical pearls and precautions share advice from the author and contributors, learned from years of clinical experience. Describes the role of the therapy assistant with the client, showing how the therapy assistant may be included in the therapy process. Glossary includes key terms from the text, offering easy access to definitions of key terms. CD provides samples of hand therapy exercises and clinical forms that may be used with clients.
Article
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 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.
Article
Background: The Merz Hand Grading Scale (MHGS) is a 5-point scale used to grade appearance of the dorsum of the hand. The MHGS has been previously validated for assessment of photographed hands but not for live assessment. Objective: The purpose of this randomized, blinded study was to validate the MHGS for live assessment of the hands in the clinical setting. Methods: Three physician raters completed a scale qualification program that included MHGS training, ratings of standardized hand photographs, and statistical analysis for reliability. Eighty-four subjects (28 males, 30% Fitzpatrick skin Types IV-VI, mean age of 42 years), randomized to 2 live assessment sessions for independent and blinded observation of dorsa of their right hands, completed the study. Results: Overall MHGS intrarater weighted Kappa value was 0.74 (0.68-0.79 [CI 95%]). First- and second-time hand-rating agreement scores ranged from 64% to 75%. Interrater weighed Kappa values ranged from 0.59 to 0.71, representing between-rater paired results of each combination of raters. Conclusion: High-weighted Kappa values and agreements demonstrate that consistency at different time points can be achieved individually and by different raters for live assessments. The MHGS is a suitable instrument for live assessment in the clinical setting.
Article
In this evaluator-blind, placebo-controlled study, microinjections of stabilized hyaluronic acid (HA) gel for rejuvenation of aging hands were evaluated. Patients received three injections of 1.0 ml HA gel (20 mg/ml HA) in the dorsum of one hand and 1.0 ml saline in the other, over 3 months (M). Treatments were compared up to M03; comparisons with Day 1 (D01) were made up to M05 and M12 (extension study). Efficacy was evaluated by patients and investigators using the Global Aesthetic Improvement Scale (GAIS). Self-assessment questionnaires, biomechanical measurements, and adverse events (AEs) were analyzed. Thirty women (mean age: 53 years) provided data up to M05. At M03, HA gel treatment improved hand skin condition in all patients versus D01, according to the GAIS; improvements were sustained to M12. Mean patient scores at M01-M03 were significantly higher for HA gel than for saline ( P <0.05). Self-assessment questionnaire grades up to M03 were generally significantly better for HA gel versus saline ( P <0.05); grades were maintained to M12. Statistically significant improvements with HA gel in hydration and elasticity was demonstrated at M03, compared with D01 and saline ( P <0.05), and in terms of skin roughness versus D01. Maximum roughness ( P <0.05) and waviness ( P <0.01) were significantly improved versus saline. All AEs were mild and anticipated, with no serious AEs. Overall, HA gel injections were generally well tolerated and efficacious for rejuvenation of aging hands compared with saline. Sustained improvements at 12 months compared with baseline indicate that efficacy could be maintained long term. J Drugs Dermatol. 2015;14(3):288-295.
Article
Hand rejuvenation aims to restore volume and produce smooth, elastic skin. A combined treatment has been proposed: Juvéderm Ultra® 3 for filling and smoothing the skin and Juvéderm® Hydrate to rehydrate and restore skin quality. Twenty physicians enrolled 99 subjects (i.e., 198 hands). At the first visit, hands were injected with Juvéderm Ultra® 3. At the second visit (day 15) hands were treated with Juvéderm® Hydrate. A final assessment was made at day 30. Ninety-eight percent of subjects were female (mean age=60.3 years). Mean volumes injected were 1.02 ml Juvéderm Ultra® 3 per hand at day 0 and 0.91 ml Juvéderm® Hydrate per hand at day 15. Mean grading on the Hand Aging Scale was 3.18 preinjection, which decreased to 1.73 on study completion (p<0.0001). Injections were rated as "very easy/easy" in 99.4 and 98.9% of cases for Juvéderm Ultra® 3 and Juvéderm® Hydrate, respectively. Most physicians found both products "very easy/easy" to massage. Physician evaluation based on the Global Aesthetic Improvement Scale (GAIS) showed that the proportion of "very much/much improved" was significantly higher at days 15 and 30 compared to baseline (63.7 and 70.3 vs. 41.8%). Patient GAIS scores showed that the proportion of "much improved" was significantly higher at day 30 than at day 15 (53.1 vs. 43.9%). Over 94% of physicians and approximately 90% of subjects would recommend treatment. The adverse event rate was 8.2 %, including edema, hematoma, redness, and pain. Combined Juvéderm Ultra® 3 and Juvéderm® Hydrate treatment is effective and safe for rejuvenating the aging hand. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors at www.springer.com/00266.
Article
The aged hand is characterized by cutaneous and dermal atrophy, with deep intermetacarpal spaces, prominent bones and tendons, and bulging reticular veins. Epidermal changes include solar lentigines, seborrheic keratoses, actinic keratoses, skin laxity, rhytides, tactile roughness, and telangiectasia. A Medline search was performed on hand rejuvenation from 1989 to 2011, and results are summarized. Practical applications of these procedures are also discussed. Reports of injectable hyaluronic acid, calcium hydroxylapatite, poly-L-lactic acid, autologous fat transfer, vein treatment, and chemical peels, along with lasers and light sources such as Q-switched laser, intense pulsed light, photodynamic therapy, nonablative resurfacing lasers, and ablative resurfacing lasers, in the rejuvenation of hands were found. Review of the literature revealed options for minimally invasive treatment for rejuvenation of the skin and volume restoration of the dorsal hand. These treatments include injectables and fat transfer for volume restoration; sclerotherapy or vein ablation for dorsal hand vein treatment; and chemical peels, lasers, light, and energies for the treatment of epidermal and dermal changes.