Anandamida

Download as pdf or txt
Download as pdf or txt
You are on page 1of 9

A Multicenter Pivotal Study to Evaluate Tissue

Stabilized—Guided Subcision Using the Cellfina Device


for the Treatment of Cellulite With 3-Year Follow-up
Michael S. Kaminer, MD,* William P. Coleman, III, MD,† Robert A. Weiss, MD,‡
Deanne M. Robinson, MD,x and Jody Grossman, BA, MT, CCRAk

BACKGROUND Cellulite is a common female cosmetic concern for which no single treatment option had
been proven effective over the long term. A novel tissue stabilized-guided subsicion system (TS-GS system)
has demonstrated significant reduction in the appearance of cellulite after treatment.

OBJECTIVE The objective of this extended follow-up period was to assess the effectiveness of TS-GS out to 3
years after initial treatment.

PATIENTS AND METHODS After completing an open-label, multicenter, pivotal study, 45 subjects were
followed for an extended period of up to 3 years after receiving a single treatment using the TS-GS system.
Treatment areas were photographed prior to the procedure and at multiple time points post-treatment
throughout the 3 years. In this open-label study, subjects served as their own controls. Effectiveness was
assessed based on blinded independent physician panel assessments of improvement from baseline using
a cellulite severity scale. Subject aesthetic improvement and patient-reported satisfaction were also collected.

RESULTS The results of this trial supported Food and Drug Administration clearance of the device for the
long-term reduction in the appearance of cellulite following TS-GS.

CONCLUSION These data further demonstrate the safety and efficacy of this treatment with no reduction in
treatment benefits out to 3 years.

This study was sponsored by Cabochon Aesthetics, Inc., Menlo Park, CA, prior to acquisition by Merz North
America, Inc., Raleigh, NC. All authors except J. Grossman have been consultants and/or investigators for Merz
North America, Inc. J. Grossman is an employee of Merz North America, Inc.

C ellulite refers to the dimpled appearance of skin


and is estimated to occur in up to 95% of
postpubertal females.1 Although seen by the medical
The etiology of cellulite is believed to be attributed pri-
marily to the subcutaneous tissue structure in women and
to fat cell volume secondarily.5,6 Based on magnetic res-
community as a normal, nonmedical condition, the onance imaging study results in women, cellulite depres-
appearance of cellulite in persons affected is a significant sions are associated with underlying thick fibrous
cosmetic concern,1 and has been associated with septae,5,6 generally running perpendicular to the skin.4
significant social stigma adversely affecting self-esteem.2 The fibrous septae tether the dermis to underlying fascia
Several factors that reportedly contribute to cellulite resulting in dermal depressions and a dimpled appearance
include, among others, gender (predominantly females), of the skin where the tethers are attached,6 as depicted in
age (postpubertal), genetic predisposition, thickened Figure 1. Evidence also exists suggesting that skin laxity
fibrous septae, enlarged fat lobules, stress, hormonal contributes to the appearance of cellulite, and may pro-
imbalance, and decreased dermal collagen.1,3,4 vide support to the tenet that cellulite worsens with age.5

*Skincare Physicians, Chestnut Hill, Massachusetts; †Coleman Cosmetic and Dermatologic Surgery Center, Metairie,
Louisiana; ‡Maryland Laser Skin and Vein Institute, Hunt Valley, Maryland; xConnecticut Dermatology Group, Milford,
Connecticut; kUlthera, Inc., Mesa, Arizona

© 2017 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.
· ·
ISSN: 1076-0512 Dermatol Surg 2017;0:1–9 DOI: 10.1097/DSS.0000000000001218

© 2017 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
CELLFINA 3-YEAR FOLLOW-UP

device, minimally invasive or invasive procedure for


contouring or cellulite on the buttocks or thighs since
their 12-month study follow-up visit; used skin care
products (e.g., creams) for improvement in cellulite
within 1 month prior to the follow-up visit.

Materials and Treatment

The TS-GS system was designed with a unique


vacuum-assisted tissue capture platform to allow for
Figure 1. Subcutaneous structure of the skin. precise control of treatment depth and area of release.
A vacuum chamber is used with two guidance plat-
A novel tissue stabilized-guided subsicion (TS-GS)
forms to lift and fix tissue for controlled local anes-
system (Cellfina System; Merz North America, Inc.,
thesia infiltration, followed by depth-controlled tissue
Raleigh, NC) has been shown to reduce the appear-
release. The mechanical action of the single-use
ance of cellulite safely and effectively,1 and is Food and
microblade assembly, which is attached to a motor
Drug Administration (FDA)-cleared for long-term
module and moved through predefined paths in the
improvement in the appearance of cellulite in the
guidance platform, creates precise tissue (and thus
buttocks and thigh areas of adult females (reference
septae) release areas within the tissue at the user-
IFU). The TS-GS system provides precise control of
selected depths, at either 6 or 10 mm depth.
treatment depth and area of tissue (fibrous septae)
release using a unique vacuum-assisted design.
Dimpled areas of the buttocks and/or thighs targeted
for tissue release were marked. Tissue release was then
We recently reported significant reduction in cellulite
completed in all marked areas using the TS-GS system.
severity and improvement in the appearance of cellu-
All treated areas were cleaned and bandaged and
lite at 1 year following a single treatment session in 47
subjects were instructed to wear compression gar-
subjects with moderate to severe cellulite. All subjects
ments for up to 14 days post-treatment.
treated in the pivotal study were evaluated for partic-
ipation in an extension phase for up to 3 years. The
Study Design
objective of this extension phase was to assess long-
term results. We report herein for the first time, the This nonrandomized, open-label pivotal study protocol
3-years results following a single treatment session. conformed to the ethical guidelines of the 1975 Decla-
ration of Helsinki, was approved by an Independent
Patients and Methods Human Research Review Committee (New England
Institutional Review Board; Newton, MA), met all
After completing an open-label, multicenter, pivotal applicable requirements for ISO 14155 Clinical Investi-
study, 45 subjects completed the extended period of up to gation of Medical Devices for Human Subjects, First
3 years after receiving a single treatment using the TS-GS Edition 2011, was approved by the FDA (IDE G120116),
system. The main inclusion criteria for the pivotal study and was registered on ClinicalTrials.gov under identifier
were females with moderate or severe cellulite on the NCT01671839. Three participating study sites treated
buttocks or thighs. Detailed inclusion and exclusion 55 subjects. Subjects served as their own controls and
criteria for the pivotal study have been previously pub- returned for follow-up visits at 3 and 14 days; 1, 3, and 6
lished.1 The extension phase of the study included the months; and 1, 2, and 3 years following TS-GS treatment.
following additional inclusion criteria: understood and
accepted the obligation not to try or receive any other
Efficacy and Safety Assessment
cellulite treatments through the 3-year follow-up. Addi-
tional study extension exclusion criteria included: having Follow-up efficacy assessments included professionally
undergone an injected drug, energy-based obtained photographs of the treated areas following

2 DERMATOLOGIC SURGERY

© 2017 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
KAMINER ET AL

a consistent, standardized, photography protocol Subjects with incorrectly identified before and after
from baseline through 3 years post-treatment. photographs were excluded from the PP analysis. Best-
Overall study success and demonstration of a safe and case and worse-case imputation scenarios were also
clinically significant improvement in the appearance utilized. In the best-case scenario, subjects were
of cellulite in the treated subjects was evaluated imputed with last available observation carried for-
based on meeting primary and powered secondary ward, implying that the outcome was not changed at
endpoints. the 3-year evaluation. For the worst-case analysis, CSS
change from baseline at 3 years was imputed with the
The primary endpoint defined in the pivotal study was worst possible outcome values.
subjects with an average of $1 point reduction from
baseline in cellulite severity, as assessed by a panel of Cellulite Severity Scale change from baseline at 3 years
three independent physician evaluators (plastic/cos- was adjusted for investigational site, subject age, race,
metic surgeons or dermatologists) comparing pre- skin type, baseline BMI, and percent of body weight
treatment and 3-month and 1-year post-treatment change from baseline (at 3 years) as covariates.
photographs, using a 0 to 5 point Cellulite Severity Adjusted CSS change from baseline at 3 years was
Scale (CSS). A CSS following a simplified scoring reported along with 1-sided 97.5% confidence limit.
methodology was developed and validated for use in Longitudinal analysis of the CC population was con-
this study and is reported separately.7 ducted for the powered secondary effectiveness end-
points for comparison of the 3 years results.
The powered secondary endpoint was defined as
improvement of one grade or more in severity (none, Rate of correct selection of blinded photographs by
mild, moderate, severe) in >60% of treated subjects as independent physician assessment of subject photo-
determined by independent physician evaluator assess- graphs taken before and 3 years following treatment
ment of pretreatment and post-treatment photographs. was presented as a percent with 95% exact binomial
During the extension period of the study, these endpoints confidence interval. Individual physician average rates
were also evaluated out to 3 years post-treatment. were tabulated along with the average study rate.

Other secondary endpoints included independent Improvement in appearance according to a GAIS by


physician evaluator assessment of aesthetic improve- independent physician assessment of subject pho-
ment based on a comparison of pretreatment and post- tographs taken before and 3 years following treat-
treatment photographs using a Global Aesthetic ment was presented as percent of subjects in each
Improvement Scale (GAIS). improvement category with 95% exact binomial
confidence interval.
To evaluate safety, subjects were assessed for the
occurrence of adverse events at each follow-up visit. Individual subject assessment of the degree of satis-
The primary safety endpoint was freedom from the faction with the appearance of their cellulite before
occurrence of device- and/or treatment-related serious and 3 years following treatment was reported as per-
adverse events. cent of subjects in each satisfaction category. Subject
rates were reported along with 95% exact binomial
confidence intervals.
Statistical Analysis

Analysis of the powered secondary endpoints was based


Results
on the complete case (CC) population defined as all
subjects who received treatment and completed the 3 Of the 55 subjects who participated in the pivotal
years follow-up visit. Sensitivity analyses of the powered study,1 all subjects returned for the 3-month follow-up
effectiveness endpoints were also generated on a per- visit, and 50 subjects completed the main period and
protocol (PP) analysis and considered supportive. entered the extension period. A total of 45 subjects

0:0:MONTH 2017 3

© 2017 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
CELLFINA 3-YEAR FOLLOW-UP

TABLE 1. Primary Efficacy Endpoint: Cellulite Severity Reduction From Baseline After Treatment*

Baseline 3 mo, N = 55 Change Significance, p


Mean (SD) 3.4 (0.8) 1.2 (0.9) 22.1 (0.7) < .0001
Median (min, max) 3.0 (1.0, 5.0) 1.0 (0.0, 4.0) 22 (24.0, 0.00)

Baseline 1 yrs, N = 50 Change Significance, p


Mean (SD) 3.4 (0.8) 1.5 (0.8) 22.0 (0.8) < .0001
Median (min, max) 3.0 (1.0, 5.0) 1.0 (0.0, 3.0) 22.0 (24.0, 0.0)

Baseline 2 yrs, N = 52 Change Significance, p


Mean (SD) 3.3 (0.9) 1.3 (1.0) 22.0 (0.8) < .0001
Median (min, max) 3.0 (1.0, 5.0) 1.0 (0.0, 4.0) 22.0 (24.0, 0.0)

Baseline 3 yrs, N = 45 Change Significance, p


Mean (SD) 3.2 (1.0) 1.2 (0.9) 22.0 (1.0) < .0001
Median (min, max) 3.0 (0.0, 5.0) 1.0 (0.0, 3.0) 22.0 (24.0, 1.0)

*Complete case population.


SD, standard deviation.

completed the 3-year extension period. Subjects were publications.7 Interim 2-year results have been
encouraged to maintain a stable weight, the same reported (accepted for publication and in press,
lifestyle (diet, hydration, exercise), and refrain from Dermatologic Surgery). Of note, at 3 years post-
the use of any creams, lotions or other modalities that treatment, 47% (21/45) of subjects had a weight gain
could be used to improve the appearance of cellulite or from baseline of greater than 5 pounds (range 5.2–
affect the color of their skin (spray tanning products) 60.0 pounds, avg 19.9), 13% had a weight gain of less
for the duration of the study. Each data point was than or equal to 5 pounds (range 0.4–5 pounds, avg
assessed at each follow-up study visit. 3.1), 4% (2/45) maintained their baseline weight to 3
years post-treatment, 18% (8/45) had a weight loss of
The primary and secondary endpoint data through less than or equal to 5 pounds (range 1–4.6 pounds
1 year follow-up have also been presented in previous lost, avg 2.7), and 18% (8/45) had a weight loss of

Figure 2. Cellulite severity scale (CSS) reduction from baseline after treatment.

4 DERMATOLOGIC SURGERY

© 2017 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
KAMINER ET AL

Figure 3. Physician global aesthetic improvement scores (GAIS).

more than 5 pounds (range 6–32.0 pounds lost, avg period. At 3 years, 41 of 45 subjects (91.1%, meeting the
15) from baseline. 95% lower confidence limit of 81.6%) improved
$1point in Cellulite Severity Grade.
Efficacy: Independent Physician
Panel Assessment Physician GAIS assessments of photographs taken
before and 3 years after treatment are summarized in
The effectiveness of treatment persisted through the
Table 2 and Figure 3. As seen at the previous annual
3-year follow-up period. In the CC population, a mean
assessments, all subjects (45/45, 100%) were deter-
(SD) $2.0 (1.0) point decrease in pretreatment CSS
mined to have noticeable improvement; 56% were
score was maintained at 3-year follow-up (N = 45;
characterized as having much improvement or better.
p < .0001), as summarized in Table 1 and Figure 2. The
powered secondary effectiveness endpoint of one grade
Efficacy: Patient Satisfaction
or more improvement in Cellulite Severity Grade (none,
mild, moderate, severe) in >60% of treated subjects, as Subject satisfaction was 93% compared to baseline at
determined by independent physician assessment of 3 years demonstrating no subject-perceived decrease
subject photographs taken before and 3 years following in efficacy over time. Subject satisfaction results are
treatment, was maintained at the 3-year follow-up shown in Table 3 and Figure 4. Subject photographic

TABLE 2. Physician Global Aesthetic Improvement Scale Scores*

3 mo, N = 55, 1 yr, N = 50, 2 yrs, N = 52, 3 yrs, N = 45,


N (%) N (%) N (%) N (%)
Very much improved 6 (10.9) 10 (20.0) 4 (7.7) 4 (8.9)
Much improved 35 (63.6) 26 (52.0) 23 (44.2) 21 (46.7)
Improved 13 (23.6) 14 (28.0) 25 (48.1) 20 (44.4)
No change 1 (1.8) 0 (0.0) 0 (0.0) 0 (0.0)
Worse 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)

*Very much improved: Optimal cosmetic result in the treated areas for this subject; Much improved: Marked or significant improvement
in appearance of the treated areas from the initial condition; Improved: Noticeable improvement in appearance of the treated areas from
the initial condition but more subtle in magnitude; No change: The appearance of the treated areas is essentially the same as the original
condition; Worse: The appearance of the treated areas is worse than the original condition.

0:0:MONTH 2017 5

© 2017 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
CELLFINA 3-YEAR FOLLOW-UP

TABLE 3. Subject Satisfaction

Baseline 14 d 1 mo 3 mo 6 mo 1 yr 2 yrs 3 yrs


Rating, N (%) (N = 55) (N = 54) (N = 54) (N = 55) (N = 52) (N = 50) (N = 52) (N = 45)
Very satisfied 0 (0.0) 12 (22.2) 13 (24.1) 21 (38.2) 21 (40.4) 23 (46.0) 24 (46.2) 19 (42.2)
Satisfied 0 (0.0) 25 (46.3) 30 (55.6) 26 (47.3) 25 (48.1) 24 (48.0) 26 (50.0) 23 (51.1)
Neutral 0 (0.0) 16 (29.6) 9 (16.7) 7 (12.7) 4 (7.7) 3 (6.0) 2 (3.8) 3 (6.7)
Unsatisfied 27 (49.1) 1 (1.9) 2 (3.7) 1 (1.8) 2 (3.8) 0 (0.0) 0 (0.0) 0 (0.0)
Very unsatisfied 28 (50.9) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)

panels are provided in Figures 5–8, which document study designed to capture real-world clinical practi-
the maintenance of treatment results for up to 3 years. ces of physicians who treat cellulite. Fifty-three (53)
Table 4 provides subject-specific summaries. patients at eight study sites received treatment of their
cellulite using the TS-GS system, according to the
Pain Assessment/Safety physicians’ standard of care.

There were no reports of pain, treatment effects, or


Data generated from the registry study (n = 53) dem-
adverse events at the 3-year follow-up.
onstrated consistency with data in this pivotal study
(n = 55) in treatment time, tissue release, patient-reported
treatment-related pain, and GAIS assessment. Average
Discussion
times for anesthesia administration and tissue release in
In this extension period of up to 3 years, significant the pivotal study were 24 and 18 minutes, respectively,
reduction in cellulite severity and sustained compared to 25 and 21 minutes in the registry study.
improvement in the appearance of cellulite following
a single treatment session was demonstrated in Pivotal study patients had an average 13 (maximum
patients with moderate to severe cellulite. These 25) cellulite dimples released. In the registry study,
results are in alignment with observational data on subjects who received treatment on the buttock only
the real-life clinical use of the TS-GS system from (n = 7) had an average 18 (maximum 30) sites released,
a Registry Study. The registry study was a pro- subjects who received treatment on the buttock and
spective, multicenter, nonrandomized, observational thigh (n = 43) had an average 24 (maximum 47) sites

Figure 4. Subject satisfaction.

6 DERMATOLOGIC SURGERY

© 2017 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
KAMINER ET AL

Figure 5. Sample subject photos before treatment (left) Figure 7. Sample subject photos before treatment (left)
and after 3 years (right). and after 3 years (right).

released, and subjects who received treatment on the namely releasing with the device in a vertical orienta-
thigh only (n = 3) had an average 21 (maximum 25) tion whenever possible, avoiding treatment of the
sites released. “banana roll” buttock area right under the gluteal
crease, and treating very deep dimples at a 10 mm
In pivotal study patients, 86% and 14% of dimples depth. An additional optimized treatment strategy is
were released at 6 and 10 mm depths, respectively. In use of the partial release which is used in approxi-
the registry study, 60% of patients had all buttock mately 90% of dimples treated. With a partial release,
dimples released at 6 mm depth only, and 40% of the smallest but adequate portion of the dimple or
patients were treated with a combination of both depression is captured and released, avoiding treat-
depths. Thigh dimples were released at 6 mm, 10 mm, ment or release of “normal” or unaffected tissue.
and a combination of both depths in 89%, 2%, and
9% of patients, respectively. Patient-reported treatment-related pain averaged 4.5
out of 10 during anesthesia administration, and 3.4
In both trials, the vast majority of dimples were during tissue release in the pivotal study. Comparable
released at 6 mm depth. In instances of 2 dimples in average pain scores reported in the registry trial were
very close proximity where releasing two contiguous 4.5 and 1.7 during anesthesia administration and tis-
sites should be avoided, a strategy of releasing 1 dim- sue release, respectively.
ple at 6 mm depth and 1 at 10 mm depth was followed
to mitigate the potential for seromas. Smaller dimples Registry study patients were followed to 6 months
were treated by completing a partial release when post-treatment, and physician GAIS scores were
deemed appropriate.7 Since commercial release of the obtained showing 96% of patients rated as improved,
TS-GS system, continued experience with the device much improved, or very much improved. These data
has led to further optimization of treatment strategies, align very closely with the pivotal study data where

Figure 6. Sample subject photos before treatment (left) Figure 8. Sample subject photos before treatment (left)
and after 3 years (right). and after 3 years (right).

0:0:MONTH 2017 7

© 2017 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
CELLFINA 3-YEAR FOLLOW-UP

TABLE 4. Figures 5 to 8 Subject-Specific Summaries

Figure 5 Figure 6
Age: 46; BMI: 23.7; baseline weight: 151 lbs Age: 49; BMI: 23.7; baseline weight: 156 lbs
Weight change from baseline to 3 yrs: 28 lbs Weight change from baseline to 3 yrs: +29 lbs
Fitzpatrick skin type: 3 Fitzpatrick skin type: 5
No. of released sites: 11 (8 buttock, 3 thigh) No. of released sites: 15 (9 buttock, 6 thigh)
Complete releases: 3 (all buttock) Complete releases: 4 (all buttock)
Partial releases: 8 (buttock and thigh) Partial releases: 11 (buttock and thigh)
Treatment depth: A combination of 6 mm (9) Treatment depth: A combination of 6 mm (14) and
and 10 mm (2, buttock) 10 mm (1, buttock)
Release template: A combination of rectangle (9) Release template: A combination of rectangle (13) and
and teardrop (2) teardrop (2)

Figure 7 Figure 8
Age: 30; BMI: 24.0; baseline weight: 142 lbs Age: 28; BMI: 24.0; baseline weight: 125 lbs
Weight change from baseline to 3 yrs: +21 lbs Weight change from baseline to 3 yrs: 220 lbs
Fitzpatrick skin type: 3 Fitzpatrick skin type: 3
No. of released sites: 21 (11 buttock, 10 thigh) No. of released sites: 14 (9 buttock, 5 thigh)
Complete releases: 8 (all buttock) Complete releases: 3 (all buttock)
Partial releases: 13 (buttock and thigh) Partial releases: 11 (buttock and thigh)
Treatment depth: A combination of 6 mm (17) Treatment depth: A combination of 6 mm (11) and
and 10 mm (4, buttock) 10 mm (3, buttock)
Release template: A combination of rectangle (19) Release template: A combination of rectangle (13) and
and teardrop (2) teardrop (1)

BMI, body mass index.

98.1% of subjects were assessed as improved, much a comparison. In a recent comprehensive literature
improved, or very much improved at 3 months post- review of cellulite treatments conducted by Zerini and
treatment, increasing and maintaining at 100% at 1, 2, colleagues,9 in which the majority of publications were
and 3 years follow-up. dated 2010 to 2013, it was concluded that no effective
and long-term treatments for cellulite reduction had been
Current treatments for cellulite include injectable and well established. Available noninvasive devices (e.g.,
topical products, oral supplements, mesotherapy, and mechanical massage, lasers, light sources, radiofrequency
massage.7,8 Noninvasive devices that generally target the devices), and nondevice treatments of cellulite appear to
fat cells include mechanical massage, low-level, light- provide only minor, short-term improvements in the
energy therapy, that is, lasers, intense pulse light, radio- appearance of cellulite, and/or may require multiple
frequency, and infrared light.8 Surgical options that target treatment sessions, and are not single treatment options
the fibrous septa include laser-assisted or manual Sub- requiring combination use to maximize benefit.7,9
cision and liposuction.5 Using the surgical approaches,
the depth and specific area of fibrous septae release are The results of this multicenter study demonstrate that
variable and dependent on physician technique which a single treatment session with a novel TS-GS system is
can lead to inconsistent outcomes.7,8 Treatment of larger a safe and effective treatment for long-term, 3-year
areas is also difficult and time-consuming. improvement in the appearance of cellulite on the
thighs and buttocks with no loss of benefit observed.
Limitations of the extension period include the lack These long-term data support the FDA clearance of the
of a comparison group; however, lack of an effective device for this long-term reduction in the appearance
and long-term treatment option has precluded such of cellulite following TS-GS.

8 DERMATOLOGIC SURGERY

© 2017 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
KAMINER ET AL

Acknowledgments The authors thank professional 3. Byun SY, Kwon SH, Heo SH, Shim JS, et al. Efficacy of slimming cream
containing 3.5% water-soluble caffeine and xanthenes for the treatment
photographers Tanya Dueri and Laura Dunphy for of cellulite: clinical study and literature review. Ann Dermatol 2015;27:
their work in developing the photographic 243–9.

methods and photography for the study; 4. Hexsel D, Abreu M, Rodrigues Y, Soirefmann M, et al. Side-by-side
comparison of areas with and without cellulite depressions using
Drs. Daniel Mills, Howard Sofen and Paul magnetic resonance imaging. Dermatol Surg 2009;35:1–7.
Yamauchi who provided independent physician 5. Hexsel D, Mazzuco R. Cellulite. In: Tosti A, Hexsel D, editors. Update in
assessment of blinded pretreatment and post- Cosmetic Dermatology. Berlin Heidelberg: Springer-Verlag; 2013:21–32.

treatment photographs; registry study investigators 6. Hexsel D, Soirefmann M. Cosmeceuticals for cellulite. Semin Cutan Med
Surg 2011;30:167–70.
Drs. Roy Geronemus, Suzanne Kilmer, Tina Alster,
7. Kaminer MS, Coleman WP III, Weiss RA, Robinson DM, et al.
Jeremy Green, Joel Cohen, and Simeon Wall; and Multicenter pivotal study of vacuum-assisted precise tissue release for the
Dr. Oksana Kozlova who provided the statistical treatment of cellulite. Dermatol Surg 2015;41:336–47.

plan and analysis. 8. DiBernardo BE, Sasaki GH, Katz BE, Hunstad JP, et al. A multicenter
study for cellulite treatment using a 1440-nd:YAGWavelength laser with
side-firing fiber. Aesthet Surg J 2016;36:9.

References 9. Zerini I, Sisti A, Cuomo R, Ciappi S, et al. Cellulite treatment:


a comprehensive literature review. J Cosmet Dermatol 2015;14:16.
1. Dupont E, Journet M, Oula ML, Gomez J, et al. An integral topical gel
for cellulite reduction: results from a double-blind, randomized, placebo-
controlled evaluation of efficacy. Clin Cosmet Investig Dermatol 2014;7: Address correspondence and reprint requests to: Michael S.
73–88.
Kaminer, MD, Skincare Physicians, 1244 Boylston Street,
2. Sainio EL, Rantanen T, Kanerva L. Ingredients and safety of cellulite Suite 103, Chestnut Hill, MA 02467, or e-mail:
creams. Eur J Dermatol 2000;10:596–603. [email protected]

0:0:MONTH 2017 9

© 2017 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.

You might also like