Presidential Greeting - American Society for Laser Medicine and ...

22 American Society for Laser Medicine and Surgery Abstracts
to remodel deeper reticular dermis and hypodermis without
increased risk of epidermal injury side effects. Additional clinical
evaluations are warranted.
#69
SIDE EFFECTS AND RISKS ASSOCIATED WITH
CRYOLIPOLYSIS
Nazanin Saedi, Jeffrey Dover, Micheal Kaminer,
Christopher Zachary
SkinCare Physicians, Chestnut Hill, MA; University of California,
Irvine, CA
Background: Cryolipolysis, the non-invasive destruction of fat
cells by controlled cooling of a targeted treatment area, has been
shown to be safe and effective in several clinical trials. During the
initial clinical studies involving 341 patients, common side effects
included discomfort during treatment, followed by numbness,
bruising, and soreness/aching. During the first year of clinical use,
thousands of patients have been treated, allowing for more
thorough evaluation of adverse events.
Study: Data were collected from three sources: clinical trials in
which we (JD and MK) participated as investigators, side effects
reported to the manufacturer, and the authors’ clinical experience
using the CoolSculpting procedure.
Results: The most commonly reported side effects included
discomfort during treatment, numbness and tingling lasting an
average of 3.6 weeks, bruising, and erythema which was present
in most cases and lasted only minutes. Vasovagal symptoms
during the treatment were very uncommon. Discomfort during
the procedure could be mitigated by reducing vacuum pressure,
adjusting applicator placement, and through proper patient
selection. Several less common side effects, not encountered
during the original clinical studies, occurred in the first year of
commercial use during which over 30,000 treatments were
performed. These include severe pain, skin sensitivity, and skin
changes. Severe pain during and after the procedure was rare
(0.03%), and pain medications were not consistently effective.
This pain was self-limiting, resolving over a few weeks. The
incidence of first or second degree burns and transient pigment
changes were low (0.01%).
Conclusion: The side effects and risks associated with
cryolipolysis are transient and generally mild. The most
significant side effects are rare and include severe pain, skin
sensitivity, and skin changes, all of which appear to fully resolve
spontaneously.
#70
COMPARISON OF LASER-ASSISTED LIPOLYSIS
AND LIPOSUCTION: HISTOLOGY AND
SPLIT-BODY CLINICAL RESULTS
Robert Weiss, Jeffrey Angobaldo, Sean Doherty,
Brooke Seckel
Maryland Laser, Skin and Vein Institute Baltimore, MD;
Renaissance Plastic Surgery, Plano, TX; Boston Plastic Surgery
Associates, Concord, MA
Background: Laser-assisted lipolysis (LAL) supplements
liposuction (SAL) with laser heating of fat and connective tissue.
The two procedures are compared histologically and clinically in
multiple-site, split-body studies.
Study: Two subjects underwent split-body fat-removal
procedures for arms, thighs, back and flanks with follow-ups to 3
months. Photographs and physician self-assessments were
collected to 3 months. Suction cups were applied to sites with
200 mmHg vacuum pressure to measure the amount of drawn
skin. Two subjects were tattooed and underwent split-body
treatment followed by abdominoplasty 3 and 6 months later.
Clinical endpoint for LAL was 458C temperature 3 mm below the
skin. Localized hardness developed in one subject who did not
massage post-op. A fifth subject underwent abdominoplasty 9
months post-LAL.
Results: The LAL-treated side had smoother contours, less
bruising and 10–20% less vacuum-drawn skin than the
liposuction-only side. Skin contraction increased with time to 20–
30% vertical and 5–15% horizontal at 3 months on both sides. The
local hardness was not palpable ex vivo but was sectioned and
analyzed histologically (H&E). Contour irregularities on the SALtreated
sites were greater than on the LAL-treated side, one
subject requested revisions to the SAL-side. The irregularities
were most pronounced 1 month post-op but still visible at 3
months. Fibrotic tissue was easily identified 9 months post-LAL
presumably coincident with the aspiration cannula and/or the
laser fiber. No adhesion of the dermis to underlying fascia was
found.
Conclusion: The results suggest that a laser adjunct to
liposuction can decrease bruising, improve contours and reduce
skin laxity compared with suction-assisted liposuction. Histology
supports the view that thermally altered adipose connective
tissue can affect skin laxity. Additional multi-site studies are
warranted.
#71
A 24-WEEK CONTROLLED TRIAL TO ASSESS THE
EFFECTS OF AN INTENSE ULTRASOUND
TREATMENT ON LOWER FACE SKIN LAXITY
USING A NOVEL 3-D SELF-POSITIONING LASER
SCANNER
Daniel Barolet, Mathieu Auclair, Francois Barolet,
Virginie C. Barolet, Isabelle Lussier
McGill University Montreal, Canada; RoseLab Skin Optics
Research Laboratory, Montreal, Canada
Background: IUS exposure appears to be safe and effective to
treat skin laxity of the lower face. The novel 3D laser scanner is a
promising method for quantitative measurements of the lower
face following IUS treatment. Further trials to advance
therapeutic applications of this innovative approach are
warranted.
Study: This was 24-week single blinded randomized controlled
clinical study. Twenty-four healthy adults (42- to 65-year old) with
skin laxity of the lower face participated in this trial, and received
either one IUS treatment to the nasolabial folds, jowls, and
submental areas, or served as controls (2:1). Change in skin
morphology, measured by a 3D self-positioning handheld laser
scanner (VIUscan TM ), was determined by computing the ratio of
the target areas that underwent a variation of 1 mm.
Additional efficacy assessments included blinded clinical
impression of change based on digital photographs, subject
assessments of pain and discomfort, treatment satisfaction, and
adverse reactions.
Results: Statistical significant differences in skin topographical
changes between the IUS-treated and control subjects were
observed for the submental and jowls areas at week 12 and week
24, and for nasolabial folds, at week 24 (P < 0.05). Clinical
impression of change revealed that the majority of treated