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Light emitting diode‐red light for reduction of post‐surgical scarring: Results from a dose‐ranging, split‐face, randomized controlled trial



Background Scarring has significant aesthetic and functional consequences for patients. A need exists for anti‐scarring therapeutics. Light emitting diode‐red light (LED‐RL) has been shown to modulate skin fibrosis. Objective Evaluate the safety and efficacy of LED‐RL to reduce post‐operative scarring. Methods CURES (Cutaneous Understanding of Red‐light Efficacy on Scarring) was a randomized, mock‐controlled, single‐blind, dose‐ranging, split‐face phase II clinical trial. Starting one week post‐surgery, patients received LED‐RL irradiation and temperature‐controlled mock therapy to incision sites at fluences of 160 J/cm², 320 J/cm², or 480 J/cm², triweekly for three weeks. Efficacy was assessed at 1, 3, and 6‐12 months. The primary endpoint was difference in scar pliability between LED‐RL‐treated and control sites. Secondary outcomes included Patient and Observer Scar Assessment Scale, collagen and water concentration, and adverse events. Results There were no significant differences in scar pliability between treated and control scars. At certain fluences, treated scars showed greater improvements in observer rating and scar pliability, reflected by greater reductions in induration, from baseline to 6 months compared to control scars. Treatment‐site adverse events included blistering (n=2) and swelling (n=1), which were mild and resolved without sequelae. Conclusions LED‐RL phototherapy is safe in the early postoperative period and may reduce scarring. This article is protected by copyright. All rights reserved.
Light emitting diode-red light for reduction of post-surgical
scarring: Results from a dose-ranging, split-face,
randomized controlled trial
Alana Kurtti
| Julie K. Nguyen
| Jeremy Weedon
| Andrew Mamalis
Yi Lai
| Natasha Masub
| Amaris Geisler
| Daniel M. Siegel
Jared R. Jagdeo
Rutgers Robert Wood Johnson Medical
School, Piscataway, New Jersey
Dermatology Service, VA New York
Harbor Healthcare System, Brooklyn,
New York
Department of Dermatology, SUNY
Downstate Medical Center, Brooklyn,
New York
Office of the SVP for Research, SUNY
Downstate Health Sciences University,
Brooklyn, New York
Department of Dermatology, The
Permanente Medical Group, Modesto,
Jared R. Jagdeo, Department of
Dermatology, SUNY Downstate Health
Sciences University, 450 Clarkson Avenue
MSC 46, Brooklyn, NY 11203, USA.
Funding information
National Institute of General Medical
Sciences of the National Institutes of
Health, Grant/Award Number:
Scarring has significant esthetic and functional consequences
for patients. A need exists for anti-scarring therapeutics.
Light emitting diode-red light (LED-RL) has been shown to
modulate skin fibrosis. The aim of this study is to evaluate
the safety and efficacy of LED-RL to reduce post-operative
scarring. Cutaneous Understanding of Red-light Efficacy on
Scarring was a randomized, mock-controlled, single-blind,
dose-ranging, split-face phase II clinical trial. Starting 1 week
post-surgery, patients received LED-RL irradiation and
temperature-controlled mock therapy to incision sites at
fluences of 160, 320 or 480 J/cm
, triweekly for 3 weeks. Efficacy was assessed
at 1, 3 and 612 months. The primary endpoint was difference in scar pliability
between LED-RL-treated and control sites. Secondary outcomes included
Patient and Observer Scar Assessment Scale, collagen and water concentration,
and adverse events. There were no significant differences in scar pliability
between treated and control scars. At certain fluences, treated scars showed
greater improvements in observer rating and scar pliability, reflected by greater
reductions in induration, from baseline to 6 months compared to control scars.
Treatment-site adverse events included blistering (n = 2) and swelling (n = 1),
which were mild and resolved without sequelae. LED-RL phototherapy is safe
in the early postoperative period and may reduce scarring.
Abbreviations: AE, adverse event; CURES, Cutaneous Understanding
of Red-light Efficacy on Scarring; DV, dependent variable; LED, light
emitting diode; LED-RL, light emitting diode-red light; POSAS, Patient
and Observer Scar Assessment Scale; STARS, Safety Trial Assessing
Red-light on Skin.
Received: 26 February 2021 Revised: 19 March 2021 Accepted: 29 March 2021
DOI: 10.1002/jbio.202100073
This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any
medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
© 2021 The Authors. Journal of Biophotonics published by Wiley-VCH GmbH.
J. Biophotonics. 2021;e2747. 1of12
low level light therapy, phototherapy, scarring, wound healing
Scar tissue formation is a natural consequence of wound
healing after injury to the skin, and outcomes can range
from faint scarring to aberrant scarring such as hypertro-
phic scars and keloids [1, 2]. Scar prevention is a key con-
sideration in postoperative wound management, as
scarring has significant esthetic and functional conse-
quences for patients [3, 4]. The understanding of the
molecular biology of wound healing is still evolving, and
many strategies exist to prevent and treat scarring [58].
Skin fibrosis is an abnormal wound healing response fol-
lowing tissue damage (e.g., burns, surgery, trauma), char-
acterized by excessive fibroblast proliferation and
collagen deposition in the dermis, which may manifest
clinically as scar hypertrophy [912]. Skin fibrosis is a sig-
nificant global health problem with an estimated inci-
dence of greater than 100 million persons affected per
year in the developed world [13, 14]. Cutaneous scars
have a profoundly negative impact on patients' quality of
life due to associated pain and pruritus, functional
impairment, cosmetic disfigurement, and psychosocial
distress [13, 15, 16].
There is great research interest and consumer
demand for therapeutic modalities that prevent, reduce,
or remove scars, as evidenced by an estimated $12 billion
annual market for scar treatment in the United States
[17]. Despite the substantial socioeconomic burden asso-
ciated with skin fibrosis, there are few effective and dura-
ble anti-scarring therapeutics available, making scar
treatment a major unmet medical need [1820]. Further-
more, current scar management strategies may be inva-
sive, cause undesirable side effects, or lack high-level
evidence to support their use [18]. Therefore, it is impor-
tant to research and develop novel approaches to treat
and prevent skin fibrosis.
Visible light (400700 nm) is ubiquitous in the envi-
ronment and comprises 44% of total solar energy, yet its
cutaneous biologic effects have not been fully elucidated
[21, 22]. Visible light therapy delivered by light emitting
diode (LED) devices is a therapeutic modality of increas-
ing clinical importance in dermatology, as different wave-
lengths can alter skin physiology and provide benefits
such as in wound healing and skin rejuvenation [2325].
Due to the significant advances in LED technology in
recent years, LED phototherapy has become a valuable
and effective treatment for a wide variety of medical and
esthetic conditions [26]. In 2018, members of the
American Society for Dermatologic Surgery performed
3.49 million procedures using lasers, lights, and energy-
based devices [27]. Furthermore, LED devices are com-
mercially available and have U.S. Food and Drug Admin-
istration (FDA) clearance for various dermatologic
conditions including acne and photoaging [25, 28]. Red
light (630-700 nm) has the deepest tissue penetration
depth of the visible light colors, reaching the entirety of
the dermis where skin fibrosis occurs [24, 29, 30].
Recently published clinical observations indicate that red
light in combination with other modalities, such as pho-
tosensitizers for photodynamic therapy, can decrease skin
fibrosis [3133].
According to our in vitro data, light emitting diode-
red light (LED-RL) at high fluences (defined as equal to
or greater than 160 J/cm
) can exert anti-fibrotic cutane-
ous effects by decreasing the proliferation, collagen pro-
duction, and migration speed of human skin fibroblasts
[3437]. Prior to our studies on the anti-fibrotic proper-
ties of LED-RL, limited data existed regarding red light
photobiomodulation of dermal fibroblasts. In two
phase I, dose escalation, randomized controlled trials
(Safety Trial Assessing Red-light on Skin [STARS 1 and
STARS 2], n = 115), we evaluated the safety and tolera-
bility of LED-RL administered at fluences up to
640 J/cm
on normal skin [38]. Adverse events (AEs)
included treatment-site erythema, hyperpigmentation,
and blistering, all of which were mild and resolved with-
out permanent sequelae [38]. We concluded that LED-RL
is safe up to 480 J/cm
and may exert differential cutane-
ous effects depending on race and ethnicity, with darker
skin being more photosensitive [38].
This report describes findings from Cutaneous Under-
standing of Red-light Efficacy on Scarring, a phase II ran-
domized controlled trial designed to evaluate the safety
and efficacy of LED-RL treatment on fresh post-surgical
scars (National Clinical Trials identifier NCT03795116,
registered 20 December 2018).
2.1 |Study design
This randomized, temperature-matched mock therapy-
controlled, single-blind, dose-ranging, split-face phase II
clinical trial was conducted at SUNY Downstate between
18 April 2019 and 26 October 2020. The study protocol
was approved by an institutional review board and previ-
ously published [39]. The study was performed in accor-
dance with the Declaration of Helsinki and Good Clinical
Practice. All patients provided written informed consent.
Refer to Figure 1 for a schematic of the study design.
2.2 |Patients
Eligible patients were adults (age 18 years) who
planned to undergo elective minimal incision facelift sur-
gery with the same surgeon. Patients were screened
according to the inclusion and exclusion criteria
(Table 1). Prior to enrollment, a screening photosensitiv-
ity test was conducted; the patient was exposed to LED-
RL for 20 minutes on the non-dominant upper forearm,
and evaluated 24 hours later for evidence of photosensi-
tivity (e.g., persistent erythema, rash, pain) [40].
2.3 |Treatment
Starting 1 week after surgery (postoperative days 7 to
10), patients received LED-RL irradiation and mock
therapy to the periauricular skin (i.e., sites of the
surgical incisions). The treatment side (right face vs
left face) was randomized, with the untreated side
receiving temperature-matched mock therapy. The
fluence range was based on published reports of LED-
RL maximum recommended starting dose and the
maximum tolerated dose in our phase I studies [28,
31, 32]. Treatment sessions were administered in-
office triweekly for 3 weeks. Patients were randomly
assigned to three treatment groups via block
1. Group 1 (Low dose): LED-RL 160 J/cm
and mock
phototherapy30 minutes
2. Group 2 (Medium dose): LED-RL 320 J/cm
and mock
phototherapy60 minutes
3. Group 3 (High dose): LED-RL 480 J/cm
and mock
phototherapy90 minutes
The treatment devices were positioned in close contact
with the skin (within 10 mm), held in place via a custom-
designed headset (Figure 2). Patients were blinded to the
LED-RL treated side, as the treatment areas were outside
of the range of view. For the entire duration of the study,
patients were asked to avoid scar treatments (e.g., topical
medications, intralesional corticosteroids, laser therapy),
FIGURE 1 Schematic of study
design for the Cutaneous
Understanding of Red-light Efficacy
on Scarring (CURES) trial
excluding topical agents recommended for routine post-
operative wound care.
2.4 |Treatment devices
The LED-RL source was the Omnilux handheld LED sys-
tem (GlobalMed Technologies, Glen Ellen, CA, USA),
FDA-cleared for the treatment of periorbital rhytides [40,
41]. The LED-RL treatment device emitted visible red
light (633 ± 6 nm) at a power density of 360.2 W/m
room temperature and a distance of 10 mm from the skin
surface [40, 42]. The mock treatment device simulated
the LED-RL treatment device (i.e., had the same physical
components and thermal output) but did not emit red
light [38]. The use of mock phototherapy controlled for
environmental factors that may affect wound healing,
such as ambient light and temperature [35].
2.5 |Assessments and outcomes
2.5.1 |Efficacy
Assessments were conducted at baseline (i.e., at the first
treatment session) and at follow-up visits at approxi-
mately 1, 3 and 612 months post-surgery. While patients
were originally scheduled for a final 6-month follow-up
visit, due to the COVID-19 pandemic, many patients
were required to delay their final visit. The primary end-
point was the difference in quantitative scar pliability
between the LED-RL-treated and control scars. Skin
induration, which reflects scar pliability, was measured
by an indentation instrument, the SkinFibroMeter
(Delfin Technologies, Kuopio, Finland) at the midpoint
of width and length of each scar [4345].
Secondary outcome measures included the Patient
and Observer Scar Assessment Scale (POSAS) and quan-
titative measurements of collagen and moisture. The
tion with the patient. The two subscales of the POSAS
TABLE 1 Eligibility criteria for the CURES trial
Inclusion criteria Exclusion criteria
Provision of written
informed consent for all
study procedures
Stated willingness to
comply with all study
procedures and
availability for the
duration of the study
Suitable candidate for
elective mini-facelift
Pass a screening
photosensitivity test
Current use of any
Light-sensitive conditions
Diabetes mellitus
Systemic lupus
Current tobacco use
History of bleeding or
coagulation disorder
Lax skin associated with
genetic disorders
Open wounds on the face
or neck
Fibrotic skin disease, pre-
existing scar(s), or other
skin conditions affecting
the periauricular skin
History of surgery or
procedure involving or
affecting the periauricular
skin within the past
6 months (e.g., prior
facelift, fillers, laser
Tattoos that cover the
proposed treatment sites on
the periauricular skin
Any other medical
condition(s) that could be
compromised by exposure
to the proposed treatment
Abbreviation: CURES, Cutaneous Understanding of Red-light Efficacy on
FIGURE 2 Custom-designed headset containing an light
emitting diode-red light (LED-RL) treatment device and mock
phototherapy device on opposing sides
each consist of six items rated from 1 to 10, where 1 is
normal skinand 10 is the worst imaginable scar.
The observer evaluated scar vascularity, pigmentation,
thickness, relief, pliability, and surface area while the
patient assessed pain, itching, color, stiffness, thickness
and irregularity. The Dermo spectroscopy probe
(Connected Physics, Orsay, France) was used to mea-
sure collagen and water concentration in the dermis.
Hydration of keratinocytes has been associated with
reductions in collagen secretion and restoration of the
barrier function of skin, helping reduce scar formation
[46, 47].
2.5.2 |Safety
Treatment sessions were monitored for the occurrence of
safety concerns and AEs, as reported by the patient or
observed by the research team. Patients recorded AEs
during the 3 week treatment period in a home diary.
Common expected post-treatment effects, including
warmth, erythema and edema, were not considered AEs
unless they were prolonged (i.e., lasting more than
24 hours) [38].
2.5.3 |Statistical analysis
This clinical trial was designed to be a preliminary study
to obtain estimates of feasibility and outcome variability.
We estimated that a difference of 15% in scar pliability
would be clinically meaningful, based on the minimum
decrease in fibroblast number in response to LED-RL
irradiation in vitro [34]. A sample size of 30 patients
(with the split-face, intra-individual comparison design)
allowed for an estimate of the variance in scar pliability
change in this population.
SAS version 9.4 statistical package (SAS Institute,
Cary, NC, USA) was used for intention-to-treat analysis
and per-protocol analysis. Each primary outcome was
used as a dependent variable (DV) in mixed linear
models. Fixed factors in each model were treatment
group, whether treated, side of face (left vs right), and
time (three follow-up assessments). Baseline score was
introduced as a scored covariate. Tests of interaction
among fixed factors were conducted, and the utility of
polynomial terms in the baseline DV investigated. DV
scores were power-transformed to remove skew of model
3.1 |Patient demographics
A total of 30 patients were enrolled and received at least
one treatment session. All patients were female, mostly
non-Hispanic Caucasian (63.3%), and the mean age was
54.1 years (Table 2). Most patients (n = 20, [66.7%]) com-
pleted the study per-protocol (i.e., received all nine treat-
ment sessions). The most common reasons for study
discontinuation were loss to follow-up (n = 2, [6.7%])
and personal reasons (n = 4, [13.3%]).
3.2 |Safety and tolerability
During the entire study period, no serious AEs were
reported. All patients experienced warmth during treat-
ment sessions and reported bilateral post-treatment
TABLE 2 Baseline demographics of patients
Characteristic Total (n = 30)
Group 1 LED-RL
160 J/cm
(n = 10)
Group 2 LED-RL
320 J/cm
(n = 10)
Group 3 LED-RL
480 J/cm
(n = 10)
Age, years 54.1 (7.5) 53.7 (8.2) 52.4 (7.2) 56.3 (7.4)
Female 30 (100) 30 (100) 30 (100) 30 (100)
Male —— — —
Race and ethnicity
White non-Hispanic 19 (63.3) 5 (50) 6 (60) 8 (80)
White Hispanic 6 (20) 2 (20) 3 (30) 1 (10)
Black or African American 4 (13.3) 2 (20) 1 (0) 1 (10)
Two or more races 1 (3.3) 1 (10) ——
Note: Age is presented as mean (SD). Categorical variables are presented as n (%).
erythema, which resolved within 24 hours. Treatment-
site AEs occurred in three patients (10%): two incidences
of localized bulla formation on the LED-RL-treated side
and one incidence of localized facial swelling. There were
no discontinuations due to AEs.
3.3 |Efficacy
3.3.1 |Skin induration (SkinFibroMeter)
No significant differences were detected between treatment
and control in the three groups at 6 months. However, the
scars treated with a medium LED-RL dose (group 2), had
lower induration values at 6 months compared to the con-
trol, reflecting greater scar pliability on the treatment side
(0.02 vs 0.03). In addition, the scars treated with low and
medium LED-RL doses (groups 1 and 2) showed greater
improvements in scar pliability from baseline to 6 months
compared to the control scars. The low dose-treated scars
(group 1) showed a 62.5% decrease in induration from
baseline to 6 months compared to a 40.0% decrease for the
control scars (Figure 3A). The medium dose-treated scars
(group 2) showed a 77.8% decrease in induration from
baseline to 6 months compared to 50.0% decrease for the
control scars (Figure 3B). Detailed primary outcome results
are displayed in Table 3.
3.3.2 |POSAS-patient rating
At 6 months, the high dose-treated scars (group 3) had
better (lower) total PSAS scores compared to the control
scars (13.0 vs 17.0), while the low and medium dose-
treated scars (groups 1 and 2) had worse patient ratings
compared to the control scars (12 vs 10.5 and 23 vs
18, respectively). Both the treated and control scars in all
three groups showed improvement in patient ratings
from baseline to 6 months. Detailed secondary outcome
results are displayed in Table 4.
3.3.3 |POSAS-observer rating
At 6 months, the low and medium dose-treated scars
(groups 1 and 2) had more favorable (lower) total OSAS
scores on the treatment side compared to the control side
(9.0 vs 12.5 and 8.0 vs 14.0, respectively), while the high
dose-treated scars (group 3) had a slightly worse observer
rating on the treatment side compared to the control side
(13.0 vs 12.0). The low and medium dose-treated scars
(groups 1 and 2) showed greater improvements in
observer rating from baseline to 6 months compared to
the control scars. The low dose-treated scars (group 1)
showed a 45.5% improvement from baseline to 6 months
compared to 24.2% for the control scars (Figure 4A). The
medium dose-treated scars (group 2) showed a 57.9%
improvement from baseline to 6 months compared to no
improvement for the control scars (Figure 4B). Refer to
Figure 5 for comparative clinical photos.
3.3.4 |Collagen
Both the treatment and control sides of all three groups
showed increases in collagen from baseline to 6 months,
as expected in wound healing. The medium and high
dose-treated scars (groups 2 and 3) had lower collagen
compared to the control scars at 6 months (60.0 vs 61.0
and 56.7 and 59.3, respectively), a favorable outcome for
FIGURE 3 The low and medium dose-treated scars in (groups
1 and 2) showed greater improvements in scar pliability compared
to the control scars. A, In group 1 (low dose), the treated scars
showed a 62.5% decrease in induration from baseline to 6 months
compared to a 40.0% decrease for the control scars. B, In group
2 (medium dose), the treated scars showed a 77.8% decrease in
induration from baseline to 6 months compared to a 50.0% decrease
for the control scars
the treatment side as excess collagen in scar tissue is asso-
ciated with worse healing.
3.3.5 |Moisture
At 6 months, there were negligible differences in water
concentration between treatment and control in all three
3.3.6 |Patient satisfaction
70.8% of patients reported they are likely or very likely to
recommend the LED-RL treatment to a friend. 62.5% of
patients reported they are likely or very likely to use this
treatment again after a procedure that may produce
a scar.
To our knowledge, no clinical trials have evaluated the
safety and efficacy of red light for the treatment or pre-
vention of cutaneous scarring. As in vitro data show that
LED-RL can attenuate profibrotic cellular processes that
contribute to skin fibrosis, LED-RL is a promising strat-
egy to minimize scar formation after surgery [34, 35]. In
this study, LED-RL phototherapy was initiated within
1 week post-surgery, coinciding with the early prolifera-
tion phase of wound healing, to help answer important
questions about the impact of intervention time on final
scar outcomes [4850]. While no statistically significant
difference in primary outcome between treatment and
control were detected, LED-RL therapy demonstrated
improvements in multiple endpoints. The low and
medium dose-treated scars (groups 1 and 2) showed
greater improvements in scar pliability compared to the
control as demonstrated by the larger reductions in skin
induration over the study period. In addition, lower col-
lagen levels (groups 2 and 3) were measured on the
treated side at 6 months. Greater improvements in
observer ratings on the low and medium dose-treated
scars (groups 1 and 2) compared to the control were also
noted. Interestingly, the 6-month observer and patient
ratings favored opposite sides for each of the three treat-
ment groups. This discordance highlights that scar out-
comes are subject to interpretation and what one person
A dose-ranging study design was implemented as
the safety of LED-RL phototherapy in a facelift scar
model may differ from the safety in normal skin. For
example, LED-RL fluences determined to be safe in
normal forearm skin (the treatment site in STARS
1 and STARS 2) may have different effects on the face,
as physiological properties of skin vary depending on
anatomic location [51, 52]. Thus, the maximum toler-
ated dose established in our phase I studies served as
the upper limit of treatment dose in this study. We
now demonstrated that LED-RL therapy can be safely
used on fresh surgical wounds on facial skin. No seri-
ous AEs were reported, and the few non-serious AEs
reported were temporary and resolved without sequelae.
Patients expressed high satisfaction with the treatment
as the majority reported that they are likely or very
likely to use the treatment again and recommend the
treatment to a friend.
TABLE 3 Results of primary endpoint
Treatment group
Treatment or
control side Time point Median
Percent change
([baseline6 month]/baseline)
SkinFibroMeter (N) Group 1 Treatment Baseline 0.08 #62.5
6 month 0.03
Control Baseline 0.05 #40.0
6 month 0.03
Group 2 Treatment Baseline 0.09 #77.8
6 month 0.02
Control Baseline 0.06 #50.0
6 month 0.03
Group 3 Treatment Baseline 0.06 #50.0
6 month 0.03
Control Baseline 0.07 #71.4
6 month 0.02
TABLE 4 Results of secondary endpoints
or control
point Median
Percent change
([baseline6 month]/
POSAS- Patient Rating Group 1 Treatment Baseline 36.0 #66.7
6 month 12.0
Control Baseline 37.0 #71.6
6 month 10.5
Group 2 Treatment Baseline 32.0 #28.1
6 month 23.0
Control Baseline 30.5 #41.0
6 month 18.0
Group 3 Treatment Baseline 26.5 #50.9
6 month 13.0
Control Baseline 28.5 #40.4
6 month 17.0
POSAS- Observer
Group 1 Treatment Baseline 16.5 #45.5
6 month 9.0
Control Baseline 16.5 #24.2
6 month 12.5
Group 2 Treatment Baseline 19.0 #57.9
6 month 8.0
Control Baseline 14.0 0
6 month 14.0
Group 3 Treatment Baseline 18.0 #27.8
6 month 13.0
Control Baseline 16.5 #27.3
6 month 12.0
Collagen Group 1 Treatment Baseline 48.7 "17.0
6 month 57.0
Control Baseline 52.0 "8.7
6 month 56.5
Group 2 Treatment Baseline 51.0 "17.6
6 month 60.0
Control Baseline 50.5 "20.8
6 month 61.0
Group 3 Treatment Baseline 47.7 "18.9
6 month 56.7
Control Baseline 52.5 "13.0
6 month 59.3
Moisture (%) Group 1 Treatment Baseline 63.0 #0.8
6 month 62.5
Control Baseline 65.3 #6.3
6 month 61.2
Group 2 Treatment Baseline 60.7 "4.9
This study's methodology offered several advantages
compared to other clinical trials that evaluate scar man-
agement strategies. The split-face study design allowed
each patient to serve as their own control, such that com-
parisons of clinical efficacy between treated and control
scars are within-patient (i.e., intra-individual). Therefore,
any measured changes in scar characteristics can be
attributed to the treatment, eliminating the confounding
factor of inter-individual differences in wound healing. It
is important to note that in the prospective evaluation of
scar reduction therapy, it is assumed that if left
untreated, the bilateral facelift incisions would heal with
identical scars. Furthermore, the treated side of the face
was randomized to account for possible differences in
skin quality (e.g., asymmetry of sun exposure in automo-
bile drivers) [53]. Lastly, this study employed both objec-
tive and subjective outcome measures. The use of
quantitative measurements allowed detection of mechan-
ical skin properties changes not easily appreciated with
subjective assessment of skin appearance.
This study had several limitations. There was a bias in
age toward middle-aged and elderly individuals, as these
are the typical facelift patients [54, 55]. Increased age is
associated with reduced collagen turnover due to a
decrease in fibroblast collagen synthesis, which may affect
the penetration and cutaneous effects of LED-RL [56, 57].
Furthermore, since cell turnover is a major contributor to
the development of scar tissue in a healing wound, elderly
individuals tend to have better outcomes for scar cosmesis
and are less susceptible to pathologic scarring [5861]. The
majority of observer ratings reflected very subtle scarring,
with over 70% of the scar characteristics (vascularity, pig-
mentation, etc.) rated between 1 and 3 out of 10. Because
the majority of patients had minimal scarring, it was diffi-
cult to detect differences between the treated and control
scars. A greater number of treatment sessions over
TABLE 4 (Continued)
or control
point Median
Percent change
([baseline6 month]/
6 month 63.7
Control Baseline 62.7 "0.5
6 month 63.0
Group 3 Treatment Baseline 63.2 #1.9
6 month 62.0
Control Baseline 66.2 #3.3
6 month 64.0
FIGURE 4 The low and medium dose-treated scars in (groups
1 and 2) showed greater improvements in observer rating from
baseline to 6 months compared to the control scars. A, In Group
1 (low dose), the treated scars showed a 45.5% improvement from
baseline to 6 months compared to 24.2% for the control scar. B, In
Group 2 (medium dose), the treated scars showed a 57.9%
improvement from baseline to 6 months compared to no
improvement for the control scars
additional weeks to months may have also correlated with
greater differences between treated and control scars.
Additionally, the thermal output of the mock device may
have improved the appearance of the control scars. Lastly,
while patients were blinded to the treatment side, they
commonly reported greater sensation of warmth during
treatment and greater degree of post-treatment erythema
on the LED-RL-treated side.
Given the complexity of wound healing and the
many potential confounding variables, it is challenging
to devise and conduct robust clinical trials evaluating
scar therapies. Studies are often limited by small sam-
ple sizes, subjective assessment tools, and well-healing
scars that make it difficult to detect differences
between treated and control scars. For instance, sev-
eral systematic reviews have concluded that silicone
gel significantly improves scar outcomes. However, in
a randomized double-blind placebo-controlled clinical
trial including 12 patients, no statistically significant
difference between scars treated with silicone gel and
scars treated with a placebo after direct brow lift sur-
gery were detected [62]. The researchers believed that
because brow lift scars tend to heal well and not form
hypertrophic scars, it was difficult to detect differences
between the treated and control scars. Better scar out-
comes, albeit non-significantly, were observed on the
treated side and perhaps the silicone gel would have
had greater effects on hypertrophy-prone scars. Our
study faced similar challenges as the facelift scars were
logic scarring. Thus, the improvements observed on
the LED-RL treated side, while not statistically signifi-
cant compared to the control, should not be
With LED-RL therapy showing great promise, the
modality warrants further evaluation in a high-powered
study with a larger sample size. Because all doses dis-
played excellent tolerability and conferred improvements
in multiple endpoints, all three doses merit further
assessment in a phase III study. To mimic real-world
practice, home-use LED-RL devices should be evaluated.
Lastly, the effects of LED-RL therapy on hypertrophy-
prone scars should also be investigated.
There is a large unmet need for innovative therapeutic
strategies to prevent cutaneous scarring after surgery.
Despite the substantial healthcare burden of skin fibrosis,
there is no gold standardor universally effective scar
therapy, and current treatment options have limited clin-
ical efficacy and durability [8, 18, 63]. This study demon-
strates that LED-RL phototherapy can be safely used in
the early postoperative period on facial skin and may
reduce post-surgical scarring, as shown by improved scar
cosmesis of the treated sites. Future studies may extend
beyond scar prevention and investigate the use of LED-
RL to treat existing scars.
Dr. Jared Jagdeo and Dr. Daniel Siegel are on the Scien-
tific Advisory Board for Global Med Tech. Dr. Jared
Jagdeo also serves as a consultant for Global Med Tech.
The other authors have no conflict of interests to declare.
Alana Kurtti, BS and Julie K. Nguyen, MD should be con-
sidered joint first author.
The data that support the findings of this study are avail-
able from the corresponding author upon reasonable
Daniel M. Siegel
Jared R. Jagdeo
FIGURE 5 Control scar
compared to low dose light emitting
diode-red light (LED-RL)-treated
scar (group 1) at 6-month visit
10 of 12 KURTTI ET AL.
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How to cite this article: Kurtti A, Nguyen JK,
Weedon J, et al. Light emitting diode-red light for
reduction of post-surgical scarring: Results from a
dose-ranging, split-face, randomized controlled
trial. J. Biophotonics. 2021;e2747.
12 of 12 KURTTI ET AL.
... In this context, fluorescent light energy (FLE) is a biophotonic platform offering a unique approach to dermatology, aesthetic medicine, and wound care [8,10,14]. To generate FLE, chromophores translate light energy into a low-energy fluorescence emission. ...
... Regarding its bioactivities on the skin, spirulina can repair the signs of early skin aging, can exert a tightening effect, stimulate the synthesis of collagen, prevent the formation of stria, and reduce the formation of wrinkles [16]. The spirulina extracts have high nutraceutical and cosmetic value due to their content in biologically important chemical constituents, including provitamins, minerals, proteins, polyunsaturated fatty acids, phenolic acids, tocopherols, and unique pigments such as chlorophylls, phycobilins, and β-carotene [6][7][8][9][10][11][12][13][14][15][16][17][18]. The phytocomplex of spirulina, due to the presence of chlorophylls, phycobilins, and β-carotene chromophores, can generate hyperpulsed FLE when illuminated with yellow-red light (590-630 nm) and re-emit it through the Stoke shift physical mechanism of fluorescence within the red and near-infrared (NIR) spectra, with high potential for beneficial effects on skin tissues. ...
... High-resolution digital photographs taken by VISIA ® (Canfield Imaging Systems, NJ, USA) were used to provide an objective measurement, using standard incandescent, cross-polarized, and ultraviolet light settings [5,14]. Assessments of the number of wrinkles, skin surface spots, texture, pores, ultraviolet (UV) spots, porphyrins, red areas, and brown spots on the skin were taken at baseline/T0, before the fifth treatment (approx. ...
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This study, for the first time, evaluated the safety and efficacy of a new natural-based topical gel containing a spirulina extract. This photoconverter gel generates fluorescent light energy (FLE) via a red LED light device, which is proven to be effective for age control of facial skin. This was a one-centre, observational, uncontrolled pilot trial. Eight healthy female subjects aged 35 to 65 years old, with Fitzpatrick skin types II–V were recruited. The duration of the study was five treatment sessions of one treatment every seven days, with a final follow-up at one month after the last treatment session. The images and the related data were acquired with the SONY® Mod. DSCRX10M3, the Canfield VISIA Facial Imaging System®, and QUANTIFICARE 3D® analysis. Patient compliance was excellent (100%) and the treatment was described as warm and pleasant by the patients. After 30 days, VISIA parameters such as wrinkles, texture, red areas, and Trueskin Age® had improved. The safety and efficacy of the FLE treatment assessed in this trial were achieved for overall rejuvenation of facial skin, focusing on wrinkles evaluated via the specific VISIA algorithms.
... Controlling temperature is essential as increased heat (40°C and above) may independently lead to decreased cell viability, increased ROS generation, G 1 cell cycle arrest, membrane denaturation, and coagulative necrosis (15,(67)(68)(69)(70). 450 J/cm 2 RL (650-nm) has been shown to cause membrane protein denaturation in red blood cells (70). Three human studies by our research team tested the safety of LED RL in patients, and fluences of 320-480 J/cm 2 (treatment duration of 1-1.5 hours) caused occasional erythema and blistering, respectively, in patients without the use of a cooling device (71,72). In mice, fluences up to 2560 J/cm 2 of RL with air-conditioning did not induce erythema, blistering, or ulceration in non-tumor mouse skin. ...
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Background Total annual cancer rates have decreased due to improved treatment and prevention. However, the incidence of melanoma is rising, and not all patients respond to immune and targeted approaches. Therefore, we sought to determine the efficacy of red light (RL) phototherapy in preclinical models of melanoma. Methods Melanoma cells (A375, B16F10, MNT-1) were irradiated with RL. Melanoma proliferation, apoptosis, oxidative stress, and p53 phosphorylation were measured in vitro . In C57BL/6 mice, phototherapy safety, B16F10 tumor growth, and immunocyte infiltration were assessed following RL. Results In vitro , 640 J/cm ² RL decreased cellular proliferation without increasing apoptosis, while 1280 J/cm ² increased apoptosis. RL increased intracellular reactive oxygen species generation and p53 phosphorylation. In animal models, 2560 J/cm ² RL significantly prevented melanoma growth and increased the expression of CD103+ dendritic cells. 1280 and 1920 J/cm ² RL decreased tumor volume, but not significantly. RL did not cause skin inflammation or erythema in normal skin. Conclusion RL represents a potentially safe and effective melanoma therapeutic. RL prevented tumor growth and increased the expression of immune markers, such as CD103, that are associated with favorable melanoma outcomes. Further research is needed to determine the optimal clinical treatment regimen for melanoma using RL.
... However, based on the clinical observations from PBM treatments of scars and fibrosis, there appears to be an even more tantalizing opportunity in conditions with increased TGF-b1, such as cardiac hypertrophy, pulmonary fibrosis, atherosclerosis, and aging, among others. 40,[65][66][67][68][69][70][71] In these scenarios, activation of a large pool of latent TGF-b1 may potentially sequester (ligand trap) and exhaust its levels resulting in overall inhibition. This approach would be similar to current treatments of elevated TGF-levels such as in b-thalassemia, and preeclampsia. ...
Objective: The central role of the TGF-β pathway in embryonic development, immune responses, tissue healing, and malignancies is well established. Prior attempts with small molecules, peptides, and regulatory RNAs have failed mainly due to off-target effects in clinical studies. This review outlines the evidence for selectively activating the endogenous, latent transforming growth factor (TGF)-β1 with photobiomodulation (PBM) treatments. Background: Light treatments play a central role in current-directed energy therapeutics in medicine. Therapeutic use of low-dose light treatments has been noted since the 1960s. However, the breadth of treatments and inconsistencies with clinical outcomes have led to much skepticism. This can be primarily attributed to a lack of understanding of the fundamental light-tissue interactions and optimization of clinical treatment protocols. Methods: Recent advances in molecular mechanisms and improved biophotonic device technologies have led to a resurgence of interest in this field. Results: Over the past two decades, our work has focused on outlining a direct molecular mechanism involving PBM-generated redox-mediated activation of endogenous latent TGF-β1. Conclusions: Despite its critical roles in these processes, the complexity and cross talk in this potent growth factor signaling network have prevented the development of directed targeted therapeutics. PBM treatments offer a novel therapeutic and discovery tool in this aspect, especially with the growing evidence for its roles in cancer immunotherapy and stem cell biology.
Full-text available
Entre muitas das dificuldades que as mulheres enfrentam ao amamentar, como os sintomas de dor nas mamas, estão os relacionados ao ingurgitamento mamário, que associado à fissura mamilar poderá acarretar uma interrupção precoce do aleitamento materno exclusivo. Para evitar a ocorrência do desmame precoce, existem estratégias de tratamento que de acordo com as eficácias podem servir para cicatrização dessas mamas feridas. O objetivo traçado neste artigo foi analisar, por meio de revisão integrativa, a eficácia das estratégias de tratamento para cicatrização de fissura mamilar no ingurgitamento mamário. Para a elaboração desta revisão integrativa, os estudos foram pesquisados nas bases de dados: Cochrane Library, National Library of Medicine (PubMed), Scientific Electronic Library Online (SCIELO). A busca foi realizada nos meses de agosto a novembro de 2021 e de abril a junho de 2022, a partir seguintes descritores (indexados nos Descritores em Ciências da Saúde - DECS): breast feeding, light therapy, terapia a laser, leite materno, lanolina, traumas utilizando os operadores booleanos and, or. Foram incluídos estudos com os seguintes critérios: ensaios clínicos, randomizados e controlados, internacionais e nacionais que estivessem em inglês e português, completos e gratuitos e com a data de publicação dos últimos 10 anos completos (2011-2021). Foram encontrados sete estudos, que dentre estes, foram selecionados quatro que evidenciaram diferentes formas de tratamento e suas condições, levando em consideração a eficácia. Dentre os tratamentos debatidos para cicatrização dos traumas mamilares, não foi possível afirmar positivamente as eficácias pelo fato da discordância observada entre as informações dos estudos analisados.
Full-text available
Background: Skin fibrosis is a significant global health problem that affects over 100 million people annually and has a profoundly negative impact on quality of life. Characterized by excessive fibroblast proliferation and collagen deposition, skin fibrosis underlies a wide spectrum of dermatologic conditions ranging from pathologic scars secondary to injury (e.g., burns, surgery, trauma) to immune-mediated diseases. Effective anti-scarring therapeutics remain an unmet need, underscoring the importance of developing novel approaches to treat and prevent skin fibrosis. Our in vitro data show that light emitting diode-red light (LED-RL) can modulate key cellular and molecular processes involved in skin fibrosis. In two phase I clinical trials (STARS 1 and STARS 2), we demonstrated the safety and tolerability of LED-RL at fluences of 160 J/cm2 up to 480 J/cm2 on normal human skin. Methods/design: CURES (Cutaneous Understanding of Red-light Efficacy on Scarring) is a dose-ranging, randomized, parallel group, split-face, single-blind, mock-controlled phase II study to evaluate the efficacy of LED-RL to limit post-surgical skin fibrosis in subjects undergoing elective mini-facelift surgery. Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week post-surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks, followed by efficacy assessments at 30 days, 3 months, and 6 months. The primary endpoint is the difference in scar pliability between LED-RL-treated and control sites as determined by skin elasticity and induration measurements. Secondary outcomes include clinical and photographic evaluations of scars, 3D skin imaging analysis, histological and molecular analyses, and adverse events. Discussion: LED-RL is a therapeutic modality of increasing importance in dermatology, and has the potential to limit skin fibrosis clinically by decreasing dermal fibroblast activity and collagen production. The administration of LED-RL phototherapy in the early postoperative period may optimize wound healing and prevent excessive scarring. The results from this study may change the current treatment paradigm for fibrotic skin diseases and help to pioneer LED-RL as a safe, non-invasive, cost-effective, portable, at-home therapy for scars. Trial registration:, NCT03795116 . Registered on 20 December 2018.
Full-text available
Background Adequate bowel preparation is required for magnetic resonance enterography (MRE), which can be achieved by administering contrast solution after mid-gut tubing or taking contrast solution orally. We present the design of randomized controlled trial (RCT) to compare the efficacy and compliance of bowel preparation between mid-gut tubing and oral administering for MRE in patients with Crohn’s disease (CD). Methods/design This is an open-label, multicenter RCT. Ninety-six patients with CD in need of MRE examination and mid-gut tubing (prepared for fecal microbiota transplantation and/or enteral nutrition), aged ≥ 14 years, will be included. Patients will be randomized 1:1 into either bowel preparation by oral administering (oral group) or bowel preparation through mid-gut transendoscopic enteral tubing (TET) (tubing group). The primary outcome measures are: (1) degree of discomfort before/during/after bowel preparation for MRE using a visual 5-grade scale (1 = few, 5 = very severe); and (2) grade of bowel distention evaluated by a 5-grade scale (1 = 0–20% segmental distention, 2 = 20–40% distention, 3 = 40–60% distention, 4 = 60–80% distention, 5 = 80–100% distention). The secondary outcome measure is the accuracy of lesion detection through MRE confirmed by colonoscopy which is evaluated by a 5-point scale. Discussion The outcome of this study is expected to provide a novel effective clinical protocol of bowel preparation for MRE in patients with CD. We hope to highlight the concept of physician–patient satisfaction based on different methods of bowel preparation for MRE. Trial registration, NCT03541733. Registered on 30 May 2018. Electronic supplementary material The online version of this article (10.1186/s13063-018-3101-x) contains supplementary material, which is available to authorized users.
Full-text available
Hypertrophic scars and keloids are fibroproliferative disorders that may arise after any deep cutaneous injury caused by trauma, burns, surgery, etc. Hypertrophic scars and keloids are cosmetically problematic, and in combination with functional problems such as contractures and subjective symptoms including pruritus, these significantly affect patients’ quality of life. There have been many studies on hypertrophic scars and keloids; but the mechanisms underlying scar formation have not yet been well established, and prophylactic and treatment strategies remain unsatisfactory. In this review, the authors introduce and summarize classical concepts surrounding wound healing and review recent understandings of the biology, prevention and treatment strategies for hypertrophic scars and keloids.
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Within the field of dermatology, advances in the use of light emitting diodes (LEDs) have led to their clinical application for a variety of medical and cosmetic uses. Of note, one phototherapy device has demonstrated beneficial effects over a range of clinical applications (Omnilux™; GlobalMed Technologies, Glen Ellen, California). The study included a literature review of published studies. Using LEDs with frequencies of 415nm (blue), 633nm (red), and 830nm (infrared), this device has demonstrated significant results for the treatment of medical conditions, including mild-to-moderate acne vulgaris, wound healing, psoriasis, squamous cell carcinoma in situ (Bowen's disease), basal cell carcinoma, actinic keratosis, and cosmetic applications. Although photodynamic therapy with the photosensitizer 5-aminolevulinic acid might cause stinging and burning, phototherapy is free of adverse events. We determined that phototherapy using LEDs is beneficial for a range of medical and aesthetic conditions encountered in the dermatology practice. This treatment displays an excellent safety profile.
Background: Therapeutic applications of light emitting diode-red light (LED-RL) are expanding, yet data on its clinical effects are lacking. Objectives: To evaluate the safety of high fluence LED-RL (≥160 J/cm2 ). Methods: In two phase I, single-blind, dose escalation, randomized controlled trials, healthy subjects received LED-RL or mock irradiation to the forearm thrice weekly for three weeks at fluences of 160 to 640 J/cm2 for all skin types (STARS 1, n=60) and at 480 to 640 J/cm2 for non-Hispanic Caucasians (STARS 2, n=55). The primary outcome was the incidence of adverse events (AEs). The maximum tolerated dose was the highest fluence that did not elicit predefined AEs. Results: Dose-limiting AEs, including blistering and prolonged erythema, occurred at 480 J/cm2 in STARS 1 (n=1) and 640 J/cm2 in STARS 2 (n=2). AEs of transient erythema and hyperpigmentation were mild. No serious AEs occurred. Conclusions: LED-RL is safe up to 320 J/cm2 for skin of color and 480 J/cm2 for non-Hispanic Caucasian individuals. LED-RL may exert differential cutaneous effects depending on race and ethnicity, with darker skin being more photosensitive. These findings may guide future studies to evaluate the efficacy of LED-RL for the treatment of various diseases. This article is protected by copyright. All rights reserved.
Skin fibrosis is a chronic debilitating feature of several skin diseases that lead to characteristic increases in dermal fibroblast proliferation and collagen deposition through upregulation in components of the transforming growth factor beta (TGF‐B)/SMAD pathway. In contrast to ultraviolet phototherapy, high‐fluence light‐emitting diode‐generated red light (HF‐LED‐RL, 633 nm ± 15 nm) is a safe, economic, and non‐invasive therapy with in vitro evidence that supports modulation of the key cellular characteristics involved in the pathogenesis of skin fibrosis. Limited data exists pertaining to the effects of HF‐LED‐RL on human skin fibroblast microRNA (miRNA). Herein, we explored the effects of HF‐LED‐RL on fibroblast miRNA levels using RNA‐seq and miRNA expression analysis. Using RNA‐seq analysis we found that HF‐LED‐RL at 320 and 640 J/cm² increased transcription of key miRNA that are involved in skin fibrosis including miRNA‐29, miRNA‐196a, and Let‐7a, and decreased transcription of miRNA‐21, miRNA‐23b, miRNA‐31. These microRNA findings provide insight into the molecular underpinnings of HF‐LED‐RL and highlight potential therapeutic targets of interest for the treatment of skin fibrosis. Additional research on the specific molecular mechanisms underlying HF‐LED‐RL effects on fibroblasts may provide further mechanistic insight into this therapy and may reveal additional future therapeutic targets for skin fibrosis. This article is protected by copyright. All rights reserved.
Objective This study aims to clarify whether the effect of intralesional triamcinolone acetonide injection during the early stage of scarring differs from the static stage, which still remains unclear. Methods A total of 108 patients with pathological scars were enrolled in this study and were divided into 2 groups according to the time of first treatment after injury: the early stage group(≤6 months after injury) and the static stage group(>6 months after injury). Patients of both groups were then treated with intralesional triamcinolone acetonide injection. The Vancouver scar scale was adopted for the evaluation of scars, and a durometer was utilized for the measurement of the hardness of the scar. The visual analog scale was adopted for the assessment of patients’ subjective feelings (pruritus and pain). In the meantime, adverse drug reactions were also recorded. Results After intralesional injection of triamcinolone acetonide, most of the hypertrophic scars and keloids improved in color, thickness, softness, and vascular distribution. The hardness of scars improved significantly. The overall efficacy of the static stage group was superior to the early stage group. Most patients, after the injection of triamcinolone acetonide, had significant alleviation or even total loss of cicatricial pain and pruritus. Conclusions This study demonstrates that the treatment efficacy was better when applied during the static stage of pathological scarring rather than the early stage, which might be due to macrophages and their released cytokines. This study provides new clinical evidence for optimizing drug therapy of pathological scars.
Background: Skin fibrosis is a significant medical problem with limited available treatment modalities. The key cellular characteristics include increased fibroblast proliferation, collagen production, and transforming growth factor-beta (TGF-B)/SMAD pathway signaling. The authors have previously shown that high-fluence light-emitting diode red light (HF-LED-RL) decreases cellular proliferation and collagen production. Objective: Herein, the authors investigate the ability of HF-LED-RL to modulate the TGF-B/SMAD pathway. Materials and methods: Normal human dermal fibroblasts were cultured and irradiated with a commercially available hand-held LED array. After irradiation, cell lysates were collected and levels of pSMAD2, TGF-Beta 1, and TGF-Beta I receptor were measured using Western blot. Results: High-fluence light-emitting diode red light decreased TGF-Beta 1 ligand (TGF-B1) levels after irradiation. 320 J/cm HF-LED-RL resulted in 59% TGF-B1 and 640 J/cm HF-LED-RL resulted in 54% TGF-B1, relative to controls. 640 J/cm HF-LED-RL resulted in 62% pSMAD2 0 hours after irradiation, 65% pSMAD2 2 hours after irradiation, and 95% 4 hours after irradiation, compared with matched controls. High-fluence light-emitting diode red light resulted in no significant difference in transforming growth factor-beta receptor I levels compared with matched controls. Conclusion: Skin fibrosis is a significant medical problem with limited available treatment modalities. Light-emitting diode-generated red light is a safe, economic, and noninvasive modality that has a body of in vitro evidence supporting the reduction of key cellular characteristics associated with skin fibrosis.
The ability of laser treatment to affect wound healing and subsequently minimize scar formation has been investigated in recent years. However, no systematic review links these clinical trials. The aim of this study is to systematically review and evaluate clinical evidence for early laser intervention to reduce scar formation in studies where laser treatment were introduced less than 3 months after wounding. We searched PubMed using relevant key words in June 2017. Titles, abstracts and articles were sorted according to inclusion and exclusion criteria. Methodological quality was evaluated according to Cochrane Collaborations risk-of-bias assessment guideline by two independent authors. Twenty-five articles met the inclusion criteria. In total 22 of 25 studies were controlled studies and 17 of 25 studies compared laser treatment versus untreated control scars. The following laser devices have been investigated; pulsed-dye laser (PDL) laser, potassium-titanyl-phosphat (KTP) laser, fractional Erbium:Glass 1540 nm/1550 nm, fractional/full-ablation erbium-doped-yttrium-aluminium-garnet (Er:YAG) laser, or fractional CO2-laser. Eighteen studies applied laser treatments 2-4 times with 2-8 weeks intervals, while 7 studies applied only one laser treatment. Follow-up time ranged from 1-12 months with 18 studies using a follow-up time ≤3 months. In general, laser treated wounds and scars showed benefit from laser intervention, though not always reaching significance. Significant scar improvement were found in: 3 of 4 studies using laser treatment in inflammation phase, in 6 of 16 studies with laser initiated in the proliferation phase and in 2 of 5 studies in the remodeling phase. High risk-of- bias were found in randomization and allocation concealment, and low risk-of-bias with regard to blinding of outcome assessment and lost to follow-up. In conclusion, laser intervention when introduced in inflammation, proliferation or remodeling phase has the potential to reduce cutaneous scar formation. Further high quality studies are needed before standard protocols can be implemented in clinical practice.
Objective: To evaluate the effectiveness of a topical silicone gel on scars in patients who had undergone bilateral direct brow lift surgery. Design: A randomized double-blind clinical trial with a placebo applied to one scar and topical silicone gel (Dermatix Ultra; Valeant Pharmaceuticals, Laval, Que.) used on the other scar for 2 months. Participants: Twelve patients (for a total of 24 surgical scars evaluated) were included in the study. Methods: This study was performed in 2 academic hospitals of the University of Montreal in Montreal, Que. (Maisonneuve-Rosemont Hospital and Notre-Dame Hospital). Inclusion criteria were all bilateral direct brow lift surgeries performed in our hospitals. Exclusion criteria included revision surgery, silicone or latex allergy, and wound infection. Each patient received 2 tubes (1 with silicone gel and 1 with placebo) and applied 1 tube to their right brow scar and the other tube to their left brow scar, following the preassigned instructions. The patient and surgeon were blinded to the nature of the substance that was applied to each scar. At each visit, pictures of both scars were taken, and a questionnaire titled "The Patient and Observer Scar Assessment Scale" was filled out by the patient and the surgeon. A grade ranging from 0 to 10 was given on the multiple criteria in the questionnaire, and the sum of these grades was subsequently used for the data analysis. A lower sum was interpreted as improved scarring. At the end of the study, an independent evaluator graded both scars based on pictures. Follow-up visits were held on day 7, week 6, month 3, and month 6 after surgery. A comparison of the experimental and placebo group was performed with nonparametric tests of Wilcoxon signed rank. Results: A total of 24 scars of 12 patients were analyzed (based on 4 follow-up visits). General improvement of scars was reported by the patient, the surgeon, and based on pictures. No statistically significant difference was found between the group treated with silicone gel and the group treated with placebo. All tests had a p value ≥0.08. Conclusions: We did not find a statistically significant difference between scars treated with silicone gel and scars treated with the placebo after direct brow lift surgery.