Clinical evaluation of the efficacy and safety of combined bipolar radiofrequency and optical energies vs. optical energy alone for the treatment of pigmented lesions and photo-damage in aging hands

Abstract

Noninvasive skin rejuvenation therapy is becoming increasingly popular in aesthetic medicine, with innovative treatment modalities now also targeting the aging hands, a cosmetic indication that reaches beyond the more traditional aging face and décolletage indications. With noninvasive facial rejuvenation becoming very efficacious in recent years, a patient’s true age is becoming apparent on the hands leading to the demand and need for efficacious treatment modalities for this area. Continued research has led to the steady development of ablative and nonablative energy-based devices that are being increasingly used for the cosmetic improvement of aging hands, which can be typically characterized by the development of dyschromias, solar lentigines, solar keratoses, fine telangiectasias, as well as a progressive loss of skin texture and skin atrophy resulting in varying degrees of wrinkling, fine lines and skin laxity that occur as a result of both intrinsic and extrinsic aging processes [1,2]. Topical agents, such as hydroquinone-based preparations and others, have long been employed to lighten and improve the cosmesis of pigmented lesions seen in aging skin; however, these topically applied preparations are not sufficiently effective in the treatment of solar lentigines (a very common complaint) and, moreover, they do not address other aspects photoaging, such as wrinkles, fine lines and skin laxity.

Full text

Global Dermatology
Research Article ISSN: 2056-7863
Glob Dermatol, 2016 doi: 10.15761/GOD.1000180 Volume 3(3): 307-310
photo-aged skin ranging from the injection of neurotoxins and a
multitude of ller products of varying compositions, chemical peels,
to the use of energy-based modalities, such as focused ultrasound, RF,
laser and light-based technologies. However, many of the modalities,
particularly peels or ablative devices that are currently used to improve
the typical signs of photoaging are limited by unwanted side eects
that include post-inammatory hyperpigmentation (PIH), prolonged
downtime, low treatment tolerability and a risk for scarring [1-4].
Moreover rejuvenation of the hands has been associated with a higher
risk for side eects than facial rejuvenation. Hand skin is thin and has
few pilosebaceous units leading to a slow wound healing process and a
higher risk for scarring. us, only low peel agent concentrations and
low energies of energy-based devices can be used in this area.
Ever since their inception, RF-based devices have become very
popular in skin rejuvenation therapy due to the excellent treatment
outcomes achievable coupled with minimal downtime, a favorable
Introduction
Noninvasive skin rejuvenation therapy is becoming increasingly
popular in aesthetic medicine, with innovative treatment modalities
now also targeting the aging hands, a cosmetic indication that reaches
beyond the more traditional aging face and décolletage indications.
With noninvasive facial rejuvenation becoming very ecacious in
recent years, a patient’s true age is becoming apparent on the hands
leading to the demand and need for ecacious treatment modalities
for this area. Continued research has led to the steady development
of ablative and nonablative energy-based devices that are being
increasingly used for the cosmetic improvement of aging hands, which
can be typically characterized by the development of dyschromias, solar
lentigines, solar keratoses, ne telangiectasias, as well as a progressive
loss of skin texture and skin atrophy resulting in varying degrees
of wrinkling, ne lines and skin laxity that occur as a result of both
intrinsic and extrinsic aging processes [1,2]. Topical agents, such as
hydroquinone-based preparations and others, have long been employed
to lighten and improve the cosmesis of pigmented lesions seen in aging
skin; however, these topically applied preparations are not suciently
eective in the treatment of solar lentigines (a very common complaint)
and, moreover, they do not address other aspects photoaging, such as
wrinkles, ne lines and skin laxity.
A number of minimally invasive and noninvasive techniques are
currently available for the treatment and cosmetic improvement of
Clinical evaluation of the ecacy and safety of combined
bipolar radiofrequency and optical energies vs. optical
energy alone for the treatment of pigmented lesions and
photo-damage in aging hands
Ines Verner*
Dermatologist, Verner Clinic, Tel Aviv, Israel
Abstract
Background: Dierent treatment modalities are used for the treatment and aesthetic improvement of aging hands. is study evaluated the ecacy and safety of a
novel technology, which combines bipolar radiofrequency (RF) and optical energies for the cosmetic treatment of aging hands.
Objective: To assess the ecacy, safety, tolerability and patient satisfaction of combined bipolar radiofrequency and optical energies versus optical energy alone for
the treatment of aging hands.
Methods: irteen female patients with solar lentigines on the back of the hands were enrolled. Participants received 3 treatments: Combined RF and Intense Pulsed
Light (IPL) on one hand and IPL treatment alone on the other. Standardized clinical photographs were taken and patient and investigator improvement assessment
(Global Aesthetic Improvement (GAI) scale), patient satisfaction and tolerability were evaluated.
Results: At the 1 and 3 months follow-up skin laxity and pigmentation, investigator and patient improvement assessments and satisfaction, were signicantly better
in the hand treated with combined bipolar RF and IPL.
Conclusion: is study demonstrates the safety and ecacy of combining RF and optical energies for the aesthetic improvement of aging hands. Combined RF and
IPL treatment was more ecient than IPL alone in improving skin pigmentation, skin laxity and texture.
Correspondence to: Ines Verner, Dr. Verner Clinic Tel Aviv, 39 Jerusalem St.,
POB 39, Kiriat Ono 55423, Israel, Tel: 972-3-6353183; Fax: 972-3-5341381;
E-mail: ines.verner@gmail.com
Key words: bipolar radiofrequency, intense pulsed light, laser, photodamage,
pigmentary disorders, noninvasive skin rejuvenation
Received: May 05, 2016; Accepted: May 30, 2016; Published: June 01, 2016

Verner I (2016) Clinical evaluation of the ecacy and safety of combined bipolar radiofrequency and optical energies vs. optical energy alone for the treatment of
pigmented lesions and photo-damage in aging hands
Glob Dermatol, 2016 doi: 10.15761/GOD.1000180 Volume 3(3): 307-310
aging. e applicator delivers pulsed light optical energy at 470-980 nm
wavelengths, and bipolar RF energy, which has been found in previous
clinical trials to be ideal for photorejuvenation treatments. e hand
piece delivers light uence of up to 45 J/cm2 and RF energy up to 25 J/
cm2, and covers a treatment area of 25 × 12 mm.
Study design
is was a prospective, open label, single center clinical trial that
included 13 healthy Caucasian female patients, ranging in age from 47
to 75 years (mean age 64 years) with Fitzpatrick Skin Type III, who
presented with pigmented lesions and other hallmark signs of skin
aging on the backs of the hands. Using the SRA Plus applicator, all
study participants received a total of three treatment sessions spaced
3 to 4 weeks apart. Randomly one hand received IPL and RF energy
and the other hand received IPL alone. Treatment parameters increased
slightly on average from the 1st to the 2nd treatment with 14.2 J/cm3 of
RF increasing to 17 J/cm3 on the hand treated with combined energies
and 9.7 J/cm2 of IPL energy increasing to 10.2 J/cm2 for the 2nd and 3rd
treatments. e optical energy used was identical in both study arms.
Patients were followed-up at baseline and at 1 and 3 months aer
the nal treatment session. Clinical photographs were taken in a
standardized manner using the Profect® Photography System (Profect™
Medical Technologies, Vancouver, BC, Canada) and the Antera 3D®
(Miravex Ltd., Dublin, Ireland) for 3D photography at baseline and at
each follow-up visit, and comparisons were made at the end of the clinical
trial. A number of study evaluations were performed and recorded,
including patient and investigator improvement assessments made at
each follow-up time point using the Global Aesthetic Improvement
(GAI) scale (0-4) with ‘0’=worsened and ‘4’=marked improvement.
Other evaluations included patient satisfaction using a 0-4 point scale
(0=unsatised; 4=signicantly satised), and tolerability of treatment
using a 0-10 point scale (0=no discomfort at all; 10=intolerable pain).
e safety of treatments was assessed by the frequency and severity
of the adverse events reported throughout the clinical trial. All study
participants met the inclusion/exclusion criteria, and written informed
consent was obtained from all patients prior to the initiation of the
clinical trial.
Results
All patients tolerated the treatments without the need for any
topical anaesthesia and completed successfully the clinical trial. None
had experienced any adverse events. e average physician assessment
values at 1-month and 3-month post-treatment in the combined RF and
IPL treated hands were 3.7 and 3.8, respectively, compared to 2.1 and
2.5 for the IPL-energy treated hands (Figure 1). Subject assessments
were very similar to the physician assessments and also showed
increased improvement in the combined treated hands at both follow-
ups. All patients had a faster and more pronounced improvement in
solar lentigines on the IPL and RF-treated side with remarkable results
already aer the 2nd treatment. A typical example is shown in Figure
2. Textural improvement was also much more remarkable on the IPL
and RF-treated hand.
Patient satisfaction from treatment and clinical outcomes were also
reported to be improved in the RF and IPL treated hands compared to
the IPL-energy treated hands with 71% of subjects reporting that they
were signicantly satised with outcome on the combined treated hand
(Figure 3).
As expected, the study participants associated the combined RF
safety prole and a high tolerability associated with the noninvasive
treatment approach [2,5]. Moreover, the use of RF in skin rejuvenation
procedures is proven to be safe and eective in those individuals of
darker phototypes due to the nature of the delivery of heat energy to
the skin [5]. e use of optical energy in the form of IPL, a broadband
light source, has long been viewed as an eective and safe modality for
the treatment of solar lentigines, skin rejuvenation and the treatment of
photo-damaged skin [6,8]; however, the treatment modality has been
shown to be only marginally eective for wrinkles and lines. Moreover,
frequently the light (IPL) energy needed to achieve clinical results in
skin laxity or textural improvement is higher than the skin can tolerate,
leading to the risk of side eects such as a prolonged and severe wound
healing process, postinammatory hyper and hypopigmentation and
even scarring.
Elōs technology, which combines optical energies (laser or light)
with bipolar RF energy, has been proven in previous clinical studies to
be a safe and eective treatment modality for the cosmetic improvement
of aging and photo-aged skin, while keeping unwanted side eects and
downtime to a minimum [9,10]. By adding RF energy to light (IPL)
energy, the light energy level can be lowered while compensating for this
lower light energy by RF energy. In this way there is sucient energy
for the treatment to be eective, while the risk for side eects is kept
to a minimum. is compensation for the lowering of light energy by
RF energy not only lowers the risk for side eects, but also allows us to
treat darker skin types due to the fact that there is no preference of the
RF energy for absorption in melanin as opposed to light energy (IPL).
Moreover, it has been shown in recent years that RF energy is capable
of inducing volumetric heating in the dermis leading to new collagen
formation, tissue tightening and textural improvement of wrinkles and
lines. We assumed that combining these two energies together for
skin rejuvenation will not only lead to a better clinical improvement of
solar lentigines with a very low risk for side eects, but will also allow
for remarkable tissue tightening and textural improvement of the skin
surface and of wrinkles. We chose a high risk area such as the hands for
this study to be able to eectively demonstrate the ecacy and safety of
combining IPL and RF energy.
e purpose of this clinical study was to evaluate and compare
the ecacy and safety of a combined RF and IPL energy treatment to
IPL energy only treatment for the improvement of aging and photo-
damaged skin on the back of the hands.
Device description
All subjects were treated with the elōs Plus system (Syneron
Medical, Yokneam, Israel). Optical energy (either laser or light)
is emitted and preheats dermal structures, which then creates a
temperature dierential between the targeted structures and the
surrounding tissues. Movement of charged particles between the
RF electrodes, through preheated dermal structures where there is
lower impedance, generates further heating of the target structures.
Addition of RF energy allows for lower optical energy to be used than
in traditional light-based systems. e utilization of lower energy levels
potentially allows for much safer treatments, even in darker Fitzpatrick
Skin Types, resulting in minimal downtime and an excellent safety
prole. e system incorporates an active dermal monitoring feature
to monitor changes in skin impedance during pulse delivery, so that
optimal energy is delivered to target structures, while protecting the
surrounding tissues.
In this study, we utilized the SRA Plus (Skin Rejuvenation
Advanced) applicator for the treatment of the typical signs of skin

Verner I (2016) Clinical evaluation of the ecacy and safety of combined bipolar radiofrequency and optical energies vs. optical energy alone for the treatment of
pigmented lesions and photo-damage in aging hands
Glob Dermatol, 2016 doi: 10.15761/GOD.1000180 Volume 3(3): 307-310
and IPL treatment with more pain (moderate on average) compared
to the IPL-only treated hand (mild on average). A mild, but transient,
erythema was seen in both treated hands with a higher incidence
observed in the hands treated with the combined energies (92% vs.
38%). In all of the physician and patient assessments, data showed
that improved results were achieved with the combined RF and IPL
treatment when compared to the IPL energy only treatment.
Discussion
e processes of both intrinsic and extrinsic aging contribute
to a number of aesthetic changes seen in aging skin including
the development of dyschromias, keratoses, solar lentigines, ne
telangiectasias, a progressive loss of skin texture with, wrinkles, ne
lines and sagging skin. Several treatment modalities are currently being
used to address some of dierent aspects of the aging skin including
peels, ablative and non-ablative lasers, focused ultrasound, RF-based
devices as well as combined RF and optical energy modalities with
each modality demonstrating varying degrees of success, safety and
tolerability [1,3,11-17].
e use of these dierent modalities and approaches in limited by
patient tolerability, wound healing response and time and the risk for
side eects such as postinammatory hyper and hypopigmentation and
scarring. Moreover we see nowadays a higher demand for rejuvenation
of skin areas o the face, such as the neck, décolleté and the hands.
ese areas have fewer pilosebaceous units, a slower wound healing
process and a higher risk for complications.
IPL has been shown in previous studies to be useful in the treatment
of solar lentigines and general skin rejuvenation with improvement of
the cosmesis of the aging skin [6-8]; however, the broadband light source
works largely supercially and, therefore, is less eective for wrinkles,
lines and skin tightening. RF energy, on the other hand, has been
shown to be very eective in the treatment of wrinkles and lines and
other aspects of the aging skin [2,4,5,9,10,12,18-20]. In this study, we
compared the ecacy, safety and tolerability of a combined RF and IPL
treatment to IPL energy only treatment in the aging hands of 13 healthy
Caucasian female patients aged 47 to 75 years (mean age 64 years) with
Fitzpatrick Skin Type III. At each of the follow-up visits, results showed
that the combined RF and IPL energy treatment was superior to the
IPL energy only treatment for the improvement of aging and photo-
aged skin on the back of the hands, reected in the higher physician
and patient GAI scores. e RF and IPL-treated hands not only showed
improved lightening and clearing of pigmented lesions (mainly solar
lentigines), but also achieved a much smoother skin when compared to
the IPL energy only treated hands. e appreciable improvement in the
skin’s smoothness is more likely due to neocollagenesis and elastogenesis
processes that take place in the targeted skin following the application
of the RF energy, which targets the dermis volumetrically, and less likely
from the impact of the applied IPL energy, which is more supercial in
the skin. e synergistic eects of the RF and IPL energies lead to the
superior clinical outcomes seen with this treatment approach compared
to the IPL energy only treatment approach.
Patient satisfaction was also found to be signicantly higher for
the RF and IPL treated hands compared to the IPL energy only treated
hands, correlating with the clinically visible results. Interestingly,
all patients but one wanted the IPL-only side to be retreated by the
combined IPL and RF modality aer completing the study. Patients
did, however, associate the combined treatment with somewhat more
discomfort (moderate on average) compared to the IPL energy only
Figure 1. Physician assessment of improvement for both treatment modalities at the 1 and
3-month follow-up visits.
Figure3. Patient satisfaction of treatment for both treatment modalities at the 1 and 3 month
follow-up visits.
Figure 2a. 71-year-old female with pigmentation and photo-aged hands before treatment.
Figure 2b. Same patient’s hands after 3 combined RF and IPL treatments to the right hand
and 3 IPL-only treatments to the left hand.

Verner I (2016) Clinical evaluation of the ecacy and safety of combined bipolar radiofrequency and optical energies vs. optical energy alone for the treatment of
pigmented lesions and photo-damage in aging hands
Glob Dermatol, 2016 doi: 10.15761/GOD.1000180 Volume 3(3): 307-310
treatment (mild on average), which was expected due to the increased
heat energy generated by the applied RF energy in the targeted skin.
A mild but transient post treatment erythema was seen in both study
arms and as expected, a higher percentage of patients observed the
erythema following the combined treatment of the hands compared to
the IPL-only treated hands.
e combination of both the RF and IPL energies, as opposed to IPL
treatment alone, resulted in a synergistic eect of the applied energies
in the targeted dermis, stimulating most probably collagen remodeling,
neocollagenesis and elastogenesis. e combined treatment approach
not only led to lightening and clearance of pigmented lesions, but also
to a visually appreciable improvement in the smoothness and laxity
of the skin with minimal procedural downtime, resulting in a more
complete skin rejuvenation of the back of the hands.
Conclusion
e clinical trial data presented here robustly support the ecacy
and safety of a combined RF and IPL treatment approach compared
to IPL only when treating aging hand skin. e elōs Plus device using
the SRA Plus applicator appears to be an excellent treatment modality
for the aesthetic improvement of benign pigmented lesions, as well
as for overall skin rejuvenation of the aging hands, particularly when
RF and IPL energies are combined, due to the minimal downtime and
minimal risk coupled with the superior clinical outcomes associated
with treatment.
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