Fractional CO2 laser resurfacing of photoaged facial and non

Transcription

Journal of Cosmetic and Laser Therapy, 2009; 11: 190–201
ORIGINAL ARTICLE
Fractional CO2 laser resurfacing of photoaged facial and non-facial
skin: Histologic and clinical results and side effects
GORDON H. SASAKI, HEATHER M. TRAVIS & BARBARA TUCKER
J Cosmet Laser Ther Downloaded from informahealthcare.com by Emily Hu on 06/16/10
For personal use only.
Sasaki Advanced Aesthetic Medical Center, Pasadena, Ana Tevez, California, USA and Loma Linda University,
Medical Center, Loma Linda, Ana Tevez, California, USA
Abstract
Background: CO2 fractional ablation offers the potential for facial and non-facial skin resurfacing with minimal downtime
and rapid recovery. Objectives: The purpose of this study was (i) to document the average depths and density of adnexal
structures in non-lasered facial and non-facial body skin; (ii) to determine injury in ex vivo human thigh skin with varying fractional laser modes; and (iii) to evaluate the clinical safety and efficacy of treatments. Methods: Histologies were
obtained from non-lasered facial and non-facial skin from 121 patients and from 14 samples of excised lasered thigh
skin. Seventy-one patients were evaluated after varying energy (mJ) and density settings by superficial ablation, deeper
penetration, and combined treatment. Results: Skin thickness and adnexal density in non-lasered skin exhibited variable
ranges: epidermis (47–105 μm); papillary dermis (61–105 μm); reticular dermis (983–1986 μm); hair follicles (2–14/
HPF); sebaceous glands (2–23/HPF); sweat glands (2–7/HPF). Histological studies of samples from human thigh skin
demonstrated that increased fluencies in the superficial, deep and combined mode resulted in predictable deeper levels
of ablations and thermal injury. An increase in density settings results in total ablation of the epidermis. Clinical improvement of rhytids and pigmentations in facial and non-facial skin was proportional to increasing energy and density settings.
Patient assessments and clinical gradings by the Wilcoxon’s test of outcomes correlated with more aggressive settings.
Conclusions: Prior knowledge of normal skin depths and adnexal densities, as well as ex vivo skin laser-injury profiles at
varying fluencies and densities, improve the safety and efficiency of fractional CO2 for photorejuvenation of facial and
non-facial skin.
Key Words: Adnexal densities, carbon dioxide fractional laser, facial and body skin ablation, skin depths
Introduction
Adhering to the principles of selective photothermolysis (1), fractional photothermolysis (2–9) creates a
pattern of spatially precise micro- or macroscopic
epidermal and/or dermal zones of thermal injury that
spares a larger reservoir of surrounding photodamaged skin, resulting in greater safety, predictable
treatment of superficial pigmentations and rhytids,
and a smoother recovery period. In contrast, complete ablative lasering of photodamaged skin by
carbon dioxide and erbium: YAG lasers, which produce an open wound, are often associated with a
protracted uncomfortable healing period and higher
rates of complications, including prolonged erythema, dyschromic changes, demarcation lines,
scarring, milia and infection (10–13).
The first phase of this paper entails a histologic
study of punch biopsies from discarded normal
human skin, obtained during routine aesthetic
or reconstructive procedures, in order to record
their average epidermal/dermal depths and average
number of adnexal structures/high-powered microscopic field. The second phase of this study documents the ablative depths and collateral thermal
profiles, produced by CO2 fractionated laser on
ex vivo human thigh skin, removed from a thighplasty. These histologic findings were used to adjust
the selections of laser parameters in 72 patients,
studied in phase three, to remove superficial lesions,
deeper lesions, or more complex lesions by combining deep and superficial injuries for more effective
and safer outcomes.
Correspondence: Gordon H. Sasaki, Sasaki Advanced Aesthetic Medical Center, 800 S. Fairmount Ave, Suite 319, Pasadena, CA 91105, USA. Fax: 1 626
796 3373. E-mail: [email protected]
(Received 2 April 2009; accepted 13 August 2009)
ISSN 1476-4172 print/ISSN 1476-4180 online © 2009 Informa UK Ltd. (Informa Healthcare, Taylor & Francis AS)
DOI: 10.3109/14764170903356465
Fractional CO2 laser resurfacing of photoaged skin
Materials and methods
Device description
A unique ActiveFX™ scanner and DeepFX™ scanner were used in conjunction with the UltraPulse®
CO2 Laser System (Lumenis Inc., Santa Clara, CA,
USA) to deliver laser energy in fractional modes by
controlling the laser power, beam shape and size,
number of pulses and density.
The UltraPulse® CO2 beam profile is a ‘flat top’shaped pulse that delivers four times more energy per
pulse than a super-pulse-shaped beam, which produces at the beginning of the pulse a burst of energy
that tails off throughout the duration of the pulse. The
UltraPulse® system is also capable of delivering a
power density of 240 W/cm2 that, in turn, provides the
needed optimal fluence up to 18.6 J/cm2 with a pulse
duration of less than l.0 ms. All of these parameters
ensure selective photothermolytic ablation, while
using either a large spot size of 1.3 mm with the
ActiveFX™ scanner or a smaller spot size of 0.12 mm
with the DeepFX™ scanner. In the ActiveFX™ mode,
pulses of 1.3 mm are delivered in a non-sequential,
non-adjacent scan sequence (CoolScan™) of about
30 microthermal zones (MTZ) per centimeter to
allow heat dissipation from adjacent pulses within the
scan, thereby reducing a thermal dwelling effect. In
the DeepFX™ mode, pulses are delivered in circular
patterns from the periphery to the center of the pattern’s shape. Currently, ActiveFX™ is usually selected
for the treatment of fine rhytids and superficial pigmentations. DeepFX™ is used for the management
of moderate/deep rhytids, deeper pigmentations and
scars. For lesions that are mixed in depth, a combined
TotalFX™ treatment first with DeepFX™, followed
immediately by ActiveFX™, provides the potential for
optimal results.
Histologic studies
Phase 1
From 1998 to 2008, 121 patients (24 males, 97
females; age range 43–77 years) consented to have
their discarded normal skin from a variety of aesthetic
191
and reconstructive procedures studied for both skin
thickness and density of adnexal structures. Each
patient signed an informed consent that adhered to
the standard of the IRB Public Health Service, bill
of rights for medical subjects, the Health Insurance
Portability and Accountability Act (HIPAA), and
photography release forms. Six millimeter punch
biopsies from ex vivo human skin were used to characterize the normal skin profile independently by a
pathologist. Samples were fixed in formalin for serial
sectioning and staining with hematoxylin and eosin
in preparation for histologic examination.
Phase 2
Because fluence and density primarily determine the
nature of ablative thermal effects on target tissues, an
investigation was designed to assess the effects that
different levels of energy and degrees of spot overlap
in the ActiveFX™, DeepFX™, and TotalFX™ would
produce on a strip of ex vivo human thigh skin. Table
I summarizes the treatment parameters at each of the
14 designated sites with a constant frequency setting
of 125 Hz. Each 5 × 5 mm treated sample site was
excised, fixed in formalin, and evaluated independently by a pathologist from serial sectioning and
staining with hematoxylin and eosin.
Clinical procedures
Subjects, treatment sites and parameters
The clinical experience was divided into two groups
and is summarized in Table II. In Group 1 (November 2006 to December 2007), 22 patients (19 females,
three males) were treated only in the ActiveFX™
mode either for wrinkles and superficial pigmentations of photoaging or for moderate acne scarring.
Fitzpatrick skin types ranged from I to II (18 Caucasian) and III to IV (four Latin extraction); mean
age was 58.4 years (range 40–83 years). Table III lists
the treatment areas, number of sites, and the mean
fluences, densities, and frequencies delivered to the
involved skin. The DeepFX™ scanner and handpiece
were unavailable for clinical use until January 2008.
Table I. Settings for ActiveFX™, DeepFX™ and TotalFX™ on 14 samples of human thigh skin.
ActiveFX™ treatments
Sample 1
Sample 2
Sample 3
Sample 4
Sample 5
Sample 6
100 mJ
Density 1
125 mJ
Density 1
150 mJ
Density 1
100 mJ
Density 2
100 mJ
Density 3
100 mJ
Density 6
Sample 7
15 mJ
Density 1
Sample 8
20 mJ
Density 1
Sample 9
15 mJ
Density 2
Sample 10
20 mJ
Density 2
Sample 11
15 mJ
Density 1
100 mJ
Density 1
Sample 12
20 mJ
Density 1
100 mJ
Density 1
Sample 13
15 mJ
Density 2
100 mJ
Density 1
Sample 14
20 mJ
Density 2
100 mJ
Density 1
DeepFX™ treatments
TotalFX™ treatments
DeepFX™
ActiveFX™
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G. H. Sasaki et al.
Table II. Clinical experience with TotalFX™, ActiveFX™, and DeepFX™.
Treatment
mode
Group 1 (22 patients)
Group 2 (50 patients)
Total number
of patients
ActiveFX™
ActiveFX™
ActiveFX™
ActiveFX™
TotalFX™
TotalFX™
ActiveFX™
ActiveFX™
16
9
4
3
35
7
7
29
DeepFX™
3
Indications and sites (no. of patients/site)
Wrinkles/pigmentations on forehead, eyelids, nose, face, lips and chin
Wrinkles/pigmentations on neck
Wrinkles/pigmentations on décolletage
Acne scars
Acne and traumatic scars (5), tattoo (1), café-au-lait macule (1)
Wrinkles/pigmentations on neck (21), décolletage (15), shoulder (8),
upper arm (9), forearm (12), hands (12), lower extremity (4)
Syringoma (1), sebaceous adenoma (1), facial scar (1)
In Group 2 (January 2008 to January 2009), a
total of 50 patients (46 females, four males) received
TotalFX™, ActiveFX™, and DeepFX™ treatments
for a variety of lesions including fine and moderate
wrinkles, superficial pigmentations, acne and traumatic scars, syringomas, sebaceous adenomas, caféau-lait macules, and remnants of red pigmentation in
a tattoo previously treated twice with a Q-switched
Nd:YAG 532 nm laser. Fitzpatrick skin types extended
from I to II (47 Caucasians) and III to IV (one Latina,
one Asian); mean age was 56.9 years (range 18–84
years). Table IV summarizes the treatment areas
and settings (energies, densities, and frequencies)
dispensed at each site.
Treatment protocol
Each patient received a complete evaluation and
examination of the areas, including an explanation of
the various available options and a discussion of
expectations. Conditions that should be considered
for contraindicating laser treatment include pregnancy, use of isotretinoin, recent Accutane exposure,
collagen vascular and connective tissue diseases, keloidal disorders, vitiligo history, radiation dermatitis,
and skin malignancies.
If fractional lasering was selected, the patient was
advised about the potential side effects and complica-
Table III. Group 1: ActiveFX™ parameters for treatment sites
(2006–2007).
Parameter settings (mean and range)
Area
Forehead
Eyelids/
periorbital
Face/nose
Lips
and chin
Neck
Décolletage
Acne scars
mJ
Density
Frequency (Hz)
70.7 (50–100)
60.3 (50–70)
1.2 (1–2)
1.0 (1–2)
55.7 (40–75)
55.7 (40–75)
70.2 (50–100)
80.5 (75–100)
1.4 (1–2)
2.0
55.7 (40–75)
75.5 (60–100)
65.3 (50–75)
63.7 (50–75)
87.5 (75–100)
1.2 (1–2)
1.3 (1–2)
2.0
55.7 (40–75)
55.7 (40–75)
87.5 (75–100)
tions including erythema, infection acne eruption,
contact dermatitis, post-inflammatory hyperpigmentation, hypopigmentation, permanent textural changes
and scarring. At the preoperative visit, consents and
standardized photographs with a high-quality color
D70 Nikon digital camera were obtained. An assessment score (0–9) for wrinkle depth and distribution
was assigned to each patient. An estimate of the depth
of skin pigmentation (superficial, deep, mixed levels)
was made by Wood’s lamp analyses. Prophylactic
medications were prescribed that included an antibiotic, antiviral medication, and a mild analgesic. An
aftercare sheet was provided stressing the avoidance
of direct sun exposure, the need for daily tepid showering, and the frequent application of Aquaphor® at
least four times per day until re-epithelialization
occurs.
On the procedure day, the skin was cleansed of
surface oils, debris and makeup. A topical anesthetic
gel (lidocaine/tetracaine 23%/7%) was applied without occlusion for about an hour to one treatment site.
The anesthetic gel was wiped away carefully with
damp gauzes immediately before treatment was begun
on a dry skin surface. For other sites to be treated, the
topical anesthetic gel was applied and then removed
in a serial fashion in order to reduce the chances of
significant transcutaneous absorption that can lead to
pharmacologic side effects. The patient’s eyes were
protected with corneal shields. The staff implemented
complete laser precautions during the entire procedure, including the use of protective eye goggles and
antiviral masks. Some patients benefited from nerve
blocks to the forehead, lower lids and mouth.
Subjects in Group 1 received ActiveFX™ treatments to the forehead, eyelids, nose, face, lips and
chin, neck and décolletage areas, using average settings: 60–80 mJ, densities 1–2, 55–75 Hz, shape 3
and size 6 mm (as summarized in Table III). On the
thinner skin of the eyelids, neck and décolletage, the
parameters were modified to lower settings. In thicker
skin, containing increased concentrations of adnexal
structures (forehead, face and nose), the settings
were increased. Treatment parameters were set at the
193
Table IV. Group 2: TotalFX™, and ActiveFX™ and Deep FX™ parameters for treatment sites (2008–2009).
TotalFX™ parameter settings (mean and range)
DeepFX™
Area (no. of sites)
Forehead
Eyelid/periorbital
Face/nose
Lips and chin
Scars, tattoo and café-au-lait macule
mJ
18.4
15.3
19.2
20.1
20.1
ActiveFX™
Density
(12.5–20)
(12.5–17.5)
(17.5–20)
(17.5–20)
(17.5–20)
1.9
1.3
2.0
2.0
2.06
(1–2)
(1–2)
(1–2)
(1.2)
(1–2)
mJ
125
80
125
125
125
Density
2
1
2–3
3.0
3.0
Frequency (Hz)
125
125
125
125
125
ActiveFX™ parameter setting (mean and range)
ActiveFX™
Neck
Décolletage
Shoulders/upper arms
Forearms
Hands
Lower extremities
mJ
Density
90–100
90–100
90–100
90–100
90–100
90–100
1
1
1
1
1
1
Frequency (Hz)
125
125
125
125
125
125
DeepFX™
Syringomas
Sebaceous adenomas
Facial scar
mJ
Density
17.05
17.5
20.0
3
3
3
highest levels around the lips and chin to improve
the radial lip lines and for acne scars. All patients
were treated with a single pass, utilizing the CoolScan mode and repeat delays between 0.5 and 1.0 s.
An adjustable forced continuous chilling airflow was
used to reduce thermal injury and provide pain management during the entire treatment.
Patients in Group 2, who received TotalFX™, were
treated first with the DeepFX™ to the forehead, eyelids, nose, face, lips and chin, using average energy
settings of 15.5–20.0mJ, densities between 1 and 3,
shape 2 and size 6-7 mm (as summarized in Table IV).
Density 3 was selected for treatment of the nose and
lip lines, depending on the severity of the lines or
irregularities. Higher average settings were selected to
treat the thicker and more adnexal-concentrated skin
of the forehead, face/nose, and lips/chin areas while
lower average settings were used over the thinner skin
of the lateral cheek and eyelids. Immediately thereafter, superficial ablative ActiveFX™ treatments completed the total treatment with higher average settings
than used in 2006–2007: 80–125 mJ, densities 1–2,
frequency 125 Hz, shape 3 and size 6–7 mm. Only
ActiveFX™ treatments (90–100 mJ, density 1, 125
Hz, shape 3, size 7 mm) were used on the neck, décolletage, shoulders/upper arms, forearms, hands and
lower extremities. Only DeepFX™ (17 mJ, density 2)
treatments were employed for the treatment of syringomas, sebaceous adenomas, and facial scars.
Evaluation
Prior to treatment, all proposed areas of treatment
were evaluated by the senior author (GHS) and an
independent member of the office for degrees of wrinkle
lines and pigmentations using a 9-point scale (0 =
none, 1–3 = mild, 4–6 = moderate, and 7–9 = severe)
from standardized photographs. After 3 months, the
effectiveness of treatment of the same wrinkle lines
and pigmentation was assessed from the post-treatment
photographs, utilizing the same scale system. Clinical
scores were then compared using the signed-rank
statistical Wilcoxon’s test. Subjects were asked to
quantify the amount of pain produced during treatments on a 0–9-point scale, in which 0 = no pain and
9 = intolerable pain. Patients also rated their perception of global improvement at least 3 months after
treatment on a quartile grading scale: 0–25% (no or
minimal improvement); 26–50% (fair improvement);
51–75% (good improvement); and 76–100% (excellent
improvement).
Results
Normal histology findings (Table V)
In Group A, skin from the forehead, nose, medial
and lateral cheeks, lips and chin averaged a mean
total depth of 2196 μm, comprised of the epidermis
(105 μm), papillary dermis (105 μm), and reticular
dermis (1986 μm). The adnexal density calculated
from each of these sites averaged high numbers of
hair follicles (14/HPF), sebaceous gland units (23/
HPF), and sweat glands (7/HPF), compared with
those counted from specimens in Groups B and C.
In general, 90% of adnexal structures were observed
in the upper two-thirds of the dermis in all three
groups.
62 μma
(45–80 μmb)
75 μma
(55–95 μmb)
57 μma
(40–75 μmb)
117 μma
(105–130 μmb)
50 μma
(40–60 μmb)
72 μm
115 μma
(98–130 μmb)
75 μma
(64–85 μmb)
70 μma
(58–83 μmb)
25 μma
(20–30 μmb)
40 μma
(30–50 μmb)
47 μm
120 μma
(110–130 μmb)
110 μma
(100–120 μmb)
125 μma
(115–135 μmb)
120 μma
(110–130 μmb)
131 μma
(120–141 μmb)
97 μma
(85–110 μmb)
126 μma
(117–135 μmb)
105 μm
Epidermis
60 μma
(50–70 μmb)
82 μma
(45–120 μmb)
85 μma
(60–110 μmb)
122 μma
(110–135 μmb)
82 μma
(90–110 μmb)
86 μm
115 μma
(110–120 μmb)
71 μma
(57–85 μmb)
60 μma
(40–80 μmb)
40 μma
(30–50 μmb)
45 μma
(30–60 μmb)
61 μm
95 μma
(70–120 μmb)
75 μma
(50–100 μmb)
135 μma
(120–150 μmb)
97 μma
(75–120 μmb)
110 μma
(85–140 μmb)
112 μma
(90–125 μmb)
110 μma
(90–130 μmb)
105 μm
Papillary
dermis
1100 μma
(700–1500 μmb)
800 μma
(600–1000 μmb)
725 μma
(500–950 μmb)
1900 μma
(1700–2100 μmb)
1175 μma
(1050–1300 μmb)
1140 μm
1460 μma
(1120–1800 μmb)
1407 μma
(1115–1700 μmb)
1200 μma
(900–1500 μmb)
437 μma
(375–500 μmb)
412 μma
(300–525 μmb)
983 μm
1700 μma
(1500–200 μmb)
2000 μma
(1700–2500 μmb)
2100 μma
(1500–2700 μmb)
2000 μma
(1500–2500 μmb)
2000 μma
(1500–2200 μmb)
2000 μma
(1500–2300 μmb)
2100 μma
(1500–2500 μmb)
1986 μm
Reticular
dermis
aAverage
1298 μm
1307 μm
2139 μm
867 μm
957 μm
1222 μm
1091 μm
2/HPF
3
1
0
4
3/HPFc
4/HPF
2
3
502 μm
497 μm
2
5
7/HPFc
14/HPF
15
16
14
14
8
22
10/HPFc
Hair
follicles
1330 μm
1552 μm
1690 μm
2209 μm
2336 μm
2209 μm
2241 μm
2217 μm
2360 μm
2185 μm
1915 μm
Total average skin
thickness
HPF = high-powered field.
mean; baverage range; caverage number/HPF (three samplings at 10 × magnification).
Average
Lower extremity (7)
Abdomen (7)
Dorsal hand (5)
Dorsal forearm (9)
Group C
Brachium (5)
Average
Lower eyelid (17)
Low neck /
décolletage (12)
Upper eyelid (19)
Mid-neck (9)
Group B
Upper neck (3)
Average
Chin (7)
Lower lip (6)
Upper lip (11)
Lat. cheek (13)
Med. cheek (19)
Nose (14)
Group A
Forehead (13)
Skin site
(no. of patients)
Table V. Variation in skin depth and density of adnexal structures/HPF in 121 patients.
2/HPF
0
0
0
0
1/HPF
2/HPF
2
1
1
3
5/HPF
23/HPF
31
27
24
11
19
35
11/HPF
Sebaceous
glands
2/HPF
0
0
4
2
6/HPF
2/HPF
0
0
0
2
7/HPF
7/HPF
31
5
3
1
5
1
5/HPF
Sweat
glands
260–1680 μm
275–1300 μm
320–2100 μm
300–800 μm
400–900 μm
275–1200 μm
245–1070 μm
275–500 μm
250–500 μm
250–1250 μm
150–1500 μm
300–1600 μm
386–1321 μm
400–1700 μm
450–1100 μm
400–1300 μm
450–1100 μm
300–1200 μm
300–1750 μm
400–1100 μm
Depth of 90% adnexal
structures
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G. H. Sasaki et al.
In Group B, thinner skin from three levels of the
neck and eyelids exhibited an average mean total
depth of 1091 μm, consisting of the epidermis (47 μm),
papillary dermis (61 μm), and the reticulardermis
(983 μm). In contrast to the findings in Group A, the
density of adnexal structures per high-power field was
lower, consisting of hair follicles (4/HPF), sebaceous
glands (2/HPF) and sweat glands (2/HPF).
In Group C, skin from the brachium, dorsal forearm, dorsal hand, abdomen and lower extremities demonstrated an average mean total depth of 1298 microns,
with contributions from the epidermis (72 μm), papillary dermis (61 μm) and reticular dermis (86 μm). The
density of adnexal structures per high-power field was
similar to that enumerated in Group B previously, with
low counts of hair follicles (2/HPF), sebaceous glands
(2/HPF), and sweat glands (2/HPF).
Histology in ex vivo human thigh skin
Figure 1 depicts typical histologic changes obtained
after ActiveFX™ lasering of excised thigh skin. Samples 1, 2 and 3 were treated with fluences that increased
from 100 mJ, to 125 mJ and to 150mJ. Other parameters of density 1 and frequency 125 Hz were kept
constant in order to evaluate the effects of energy alone
on the specimens. At a setting of 100 mJ, a total penetration depth of 145 μm was observed (ablation of 70
μm, 75 μm of thermal injury). When the setting was
increased to 125 mJ, the total penetration depth
increased to 210 μm (ablation of 100 μm, 110 μm of
thermal injury). At the highest setting of 150 mJ, the
total depth of penetration was measured at 450 μm
(ablation of 150 μm, 300 μm of thermal coagulation).
Figure 2 illustrates a representative finding
observed after ActiveFX™ treatment. Samples 1, 4, 5
195
and 6 were treated with the density settings incrementally advanced from 1 to 6. Since the energy (100 mJ)
and frequency (125 Hz) were kept constant, the total
penetration depth (level of ablation and coagulative
injury) was confined to the papillary dermis. The
interval distances between ablative spots narrowed as
the density increased from 1 to density 3. At density
4 (not shown) and above, injury resulted in a loss of
the ablative columns, simulating findings observed
after full-surface ablative CO2 procedures.
Figure 3 shows characteristic changes seen after
DeepFX™ treatment. Samples 7 and 8 were treated
in the DeepFX™ mode with an increase in fluence
from 15 mJ to 20 mJ, keeping the density at 1. At 15
mJ, the total penetration depth was measured at 700
μm (420 μm of ablation, 280 μm of thermal injury).
The interval distances between ablative spots were
equally spaced apart. At 20 mJ, the total penetration
depth increased to about 1100 μm (660 μm of ablation, 440 μm of thermal injury).
Figure 4 presents typical examples of microscopic
changes in samples 7 and 9, after both received treatments at 15 mJ in the DeepFX™ mode, but at a density
of either 1 or 2. Although the total penetration depth
remained constant between 660 and 750 μm (420–450
μm of ablation, 240–300 μm of thermal injury), the
interval distances between ablative spots narrowed as
the density was increased from 1 to 2. When the fluence
levels were increased from 15 mJ to 20 mJ, as performed
in samples 8 and 10 (not depicted), the total penetration
depth increased from 700–750 μm to 900–1000 μm
(540–720 μm of ablation, 360–480 μm of thermal
injury). As the density changed from 1 (sample 8) to 2
(sample 10), the interval distances between ablative
spots narrowed, but did not approach complete surface
ablation, observed at densities between 4 and 6.
Figure 1. Fluence changes in ablative, thermal, and total micron depths in ex vivo thigh skin after ActiveFX™ treatments (100 mJ, 125 mJ,
and 150 mJ of energy) at density 1 and 125 Hz frequency.
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G. H. Sasaki et al.
Figure 2. Density changes in ex vivo thigh skin after ActiveFX™ treatments (density 1, 2, 3, and 6) at 100 mJ and 125 Hz frequency.
Figure 5 demonstrates the typical histologic
changes that were observed in samples 11 and 12
after TotalFX™ treatment. Sample 11 was treated
initially with DeepFX™ at a fluence of 15 mJ and
at density 1, followed thereafter by ActiveFX™ at
100 mJ, 125 Hz and density 1. Sample 12 was
treated at a higher fluence with the DeepFX™ of
20 mJ, density 1, and then followed with the Active
FX™ at 100 mJ, 125 Hz and density 1. In sample
11, the total penetration depth in the DeepFX™
mode was calculated to be at 800 μm (480 μm of
ablation, 320 μm of thermal injury), while the total
depth of penetration in ActiveFX™ was about 300 μm
(125 μm of ablation, 175 μm of thermal injury).
When the DeepFX™ fluence was increased from
15 mJ to 20 mJ, as in sample 12, the total penetration depth was about 1150 μm (690 μm of ablation,
460 μm of thermal injury), while the identical
ActiveFX™ parameters resulted in a total penetration depth of 275 μm (125 μm of ablation, 150 μm
of thermal injury) within the papillary dermis.
In sample 13 at 15 mJ (not shown), the total penetration depths in the DeepFX™ mode (825 μm)
and in the ActiveFX™ mode (250 μm) were similar
to those observed in sample 11 (15 mJ) because of
identical fluencies. The only observable difference
Figure 3. Fluence changes in ablative, thermal and total micron depths in ex vivo thigh skin after DeepFX™ treatments (15 mJ, 20 mJ)
at density 1.
197
Figure 4. Density changes in ex vivo thigh skin after DeepFX™ treatments (density 1 and 2) at 15 mJ.
was the effect of density changes that produced closer
impact spots at density 2 than found at density l.
In samples 12 and 14 (not shown), the total
penetration depths for the DeepFX™ modes at 20
mJ were similar and ranged between 900 and
1000 μm, as were the total penetration depths (200–
240 μm) in the ActiveFX™ mode because of identical fluencies. As anticipated, interval distances
between ablative spots narrowed as the density
of 1 (sample 12) was increased to a density of 2
(sample 14).
Clinical findings
Twenty-two patients in Group 1 received only
ActiveFX™ treatments with a single pass that
averaged lower fluencies (60–80 mJ), frequencies
(55–75 Hz) and densities (1–2) to all areas of the
visible face, neck and décolletage than did patients
in Group 2. The average mean score for pain (0–9)
during treatment was 3.2, which was reduced to a
score of 1.5 1 hour after the end of the procedure.
Patients reported taking a mild analgesic, such as Tylenol or Motrin for a few days until mild desquamation
Figure 5. Fluence changes in ablative, thermal and total micron depths in ex vivo thigh skin after DeepFX™ (15 mJ, 20 mJ) followed by
identical ActiveFXTM exposures at 100 mJ, 125 Hz frequency and density 1.
198
G. H. Sasaki et al.
and re-epithelialization were completed by the fourth
day. Minimal swelling and punctate crusting disappeared within a week. No scarring, demarcation
lines, infections or hypo-hyperpigmentation were
observed during the 3-month evaluation period.
After 3 months, the score for photoaging of facial
fine–moderate wrinkles and superficial pigmentations improved from 6.4 ± 0.3 at baseline to 4.2 ± 0.4,
statistically significant by the Wilcoxon’s test. In contrast, severe wrinkles in the periorbital and perioral
areas, mature acne scars, and deep pigmentations in
facial skin responded minimally to ActiveFX™ treatments (7.5 ± 0.5 baseline; 6.5 ± 0.2 at 3 months),
and accounted for the majority of fair grading
(26–50%) on the Quartile Grading Scale by the
patients for global improvement. Although patients
rated their response to ActiveFX™ treatments of fine
crêpey lines and superficial pigmentations in the skin
of their necks and décolletage areas as fair–moderate
in global improvement, the evaluators determined a
lower score of improvement from photographic analyses (5.6 ± 0.3 baseline; 3.7 ± 0.6 at 3 months).
Fifty patients in Group 2 were treated with (i)
TotalFX™ facial wrinkles and mixed levels of pigmentations (35 patients), acne and traumatic scars,
ankle tattoo, and shoulder café-au-lait macule (seven
patients); (ii) ActiveFX™ for wrinkles and superficial
pigmentations in the face (seven patients), neck (21
patients), décolletage (15 patients), shoulder (eight
patients), upper arm (9 patients), forearm (12 patients),
hands (12 patients) and lower extremity (four
patients); or (iii) DeepFX™ for syringomas (one
patient) and sebaceous adenomas (one patient), and
a facial scar (one patient).
The average facial DeepFX™ settings selected in
TotalFX™ were 15–20 mJ and densities 2–3 with the
exception of lower treatment parameters for the thinner
eyelid skin (12.5–15 mJ, density 1). The average facial
ActiveFX™ settings in the TotalFX™ mode were higher
(125 mJ, densities 2–3, 125 Hz) than those selected in
patients from Group 1. During combined treatment,
the average pain score was 2–3 during DeepFX™ treatment, but increased to levels of 3–4 with ActiveFX™
treatments superimposed on the DeepFX™-ablated
sites. Patients reported taking stronger analgesics for
3–5 days until desquamation and epithelialization
ended by post-treatment days 9–12. In spite of the
more aggressive combined treatments, no scarring,
demarcation lines, hypo-hyperpigmentations or infections occurred during the 3-month evaluation period.
At the end of 3 months, scores for improvement of
fine–moderate wrinkle lines and superficial–moderately
deep pigmentations improved from a baseline of 6.7 ±
0.3 to 2.3 ± 0.5, which was statistically significant by
the Wilcoxon’s test. The majority of patients’ global
assessment on the Quartile Grading Scale rated their
results as good to excellent (Figure 6).
The use of TotalFX™ treatment at settings of
20 mJ, 125 Hz, and density 2–3 for acne and traumatic
Figure 6. (A) Pre- and (B) 3 months post-treatment of photoaging
with TotalFX™: DeepFX™ (20 mJ, density 2–3) followed by
ActiveFX™ (100 mJ, 125 Hz, density 2) with improvements in
skin texture, wrinkles and pigmentations.
scarring was assessed to have a favorable outcome by
the evaluators ‘s score (7.0 ± 0.6 baseline; 3.3 ± 0.4 at
3 months) and the patient’s global evaluation of good
results (Figure 7). The level of pain experienced during
treatment was not significantly different from those
expressed by patients treated for photoaging in the
TotalFX™ mode. In contrast, TotalFX™ had no
demonstrable effect in modifying the appearance of the
remnants of red pigments with the tattoo, nor of reducing the pigmentation of the café-au-lait macule.
ActiveFX™
The ActiveFX™ treatments in Group 2 differed in two
respects from those treated in Group 1. First, the
parameter settings were increased to higher treatment
levels for almost identical degrees of facial wrinkles and
pigmentations. Second, ActiveFX™ was made available to treat off-facial skin that extended from the neck,
décolletage, and upper and lower extremities. Despite
the more aggressive settings, the average pain score
during treatment was assessed to be about 2.0–2.5 and
reduced to 0–1 an hour after completion of the procedure. Patients reported a transient heating sensation
that responded favorably to the application of cool wet
towels over the treated sites, aided by the continuous
chilling air-flow device. Most patients reported taking
no analgesics during their healing phase of 3–5 days.
Significantly, no scarring, demarcation lines, hypohyperpigmentation or infections were observed during
the entire 3-month post-treatment period. The more
aggressive treatment settings resulted in improved outcomes both in facial and off-facial skin by the evaluators (6.5 ± 0.3 baseline; 2.0 ± 0.4 at 3 months) and
by the patients’ global assessment on the Quartile
Grading Scale of good to excellent (Figures 8–10).
DeepFX™
Only three patients were treated only with the DeepFX™
for elimination of syringomas, sebaceous adenomas and
facial scars at a fluence of 17.5–20 mJ and density of 3.
199
Figure 7. (A, B) Pre- and (C, D) 5 months post-treatment of acne scarring with TotalFX™: DeepFX™ (20 mJ, density 2–3) followed
by ActiveFX™ (100–125 mJ, 125 Hz, density 2–3). Scar softening, textural changes, and pigmentation blending were observed after
3 months.
Improvement in smoothing out facial scars was observed
at these higher settings. There was no beneficial effect
noted on the syringomas or sebaceous adenomas.
Discussion
In 2004, Manstein and colleagues (2) introduced the
concept of fractional photothermolysis that was rapidly
incorporated into new laser resurfacing devices and
bundled with previous advancements such as pulsed
technology and computerized pattern generator (CPG)
scanning. The fractional CO2 UltraPulse® laser represents one of the new innovative devices (14–17) and
differs from its original predecessor in many significant
aspects. The handpieces, software of the CPG, and scan
patterns have been changed to provide both superficial
resurfacing with ActiveFX™ and deeper thermal injury
with DeepFX™, while maintaining the capabilities of
complete ablation (MaxFX™) and of surgical functions
with the first UltraPulse® device. When the effects of
ActiveFX™ are combined with the micro-ablative
features and coagulative columns of DeepFX™, not
only is minimal cumulative injury documented at the
epidermal-papillary levels, but also skin tightening is
observed from a combination of tissue collapse and
collagen shortening.
The study not only confirms that this novel laser
system effectively resurfaces a variety of skin conditions such as rhytids, superficial pigmentations and
scars, but also extends its safety profile in order to
reduce complications and hasten the recovery period.
In contrast, the indications and parameters for successful treatment of melasmas, café-au-lait macules,
tattoos, striae, cellulite, syringomas, and sebaceous
adenomas have yet to be defined.
Conclusion
The nature of the fractionated wound and variation
of penetration depths produced by the ablative and
G. H. Sasaki et al.
200
Figure 8. (A) Pre- and (B) 5 months post-treatment with ActiveFX™ (100–125 mJ, 125 Hz, density 2) with improvement on Visia™
photoanalysis of photoaging (C: spots; D: wrinkles; E: pores; F: texture; G: porphyrin).
thermal injuries by the UltraPulse® CO2 laser, not
only guide patient selection, but also determine facial
or non-facial skin usage, number of passes during a
single treatment period, and the need for multiple
treatments. Non-sequential fractional resurfacing by
the superficial, deep and combined modes can result
in improvements in photodamaged skin and scars.
Histologic and clinical evidence demonstrated the
safety and efficacy of fractional resurfacing of facial
and non-facial skin. Further refinements in patient
selection, laser settings, multiple passes, stacking
pulses, and directional patterns of injury may open
new avenues to improve the safety and efficacy of this
versatile fractional laser system.
Acknowledgements
Margaret Gaston is acknowledged for her excellence in standardizing and analyzing the photographs in the study.
201
Disclosure
Dr Sasaki is a consultant with Lumenis, Inc. The cost
of histologic examinations and interpretations of thigh
specimens in phase 2 of this study by pathologist
Susan Murakami MD was funded by Lumenis, Inc.
References
Figure 9. (A) Pre- and (B) 3 months post-treatment with
ActiveFX™ (100 mJ, 125 Hz, density 2) demonstrating
improvement in skin texture, pigmentations and crêpey lines.
Figure 10. (A) Pre- and (B) 3 months post-treatment with
ActiveFX™ (100 mJ, 125 Hz, density 2) resulting in improvements
in skin texture, pigmentations and crêpey lines.
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Fractional CO2 laser resurfacing of photoaged facial and non

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