Treatment of Wrinkles and Acne Scars Using the TriFractional, a Novel Fractional Radiofrequency
Technology—Clinical and Histological Results
One treatment of the TriFractional applicator with a
high power pulse (150 msec) was performed.
Subjects were provided with a “patient-controlled manual
switch” which enabled them to stop the treatment should
they experience significant discomfort. The TriFractional
treatment parameters for each subject were defined ac-
cording to the area being treated and the severity of the
condition. During the first visit, the first few pulses were
of low power level, in order to assess the immediate re-
sults. Once the initial skin response was assessed the
physician decided on the power level according to sub-
ject’s skin condition.
Subjects were asked to provide feedback regarding the
pain level during treatment and were also questioned
about the recovery process following each TriFractional
treatment. Typically erythema and edema appeared and
lasted for 1 - 3 days. A fractional eschar (matrix) pattern
typically appeared 1 to 2 days post treatment and lasted 3
days to one week, depending on the skin characteristics
and treatment strength. Subjects were instructed to use
sun screen continuously to avoid risk of pigmentary
To demonstrate the TriFractional effect on epidermal and
dermal skin layers, preliminary tests were performed on
porcine skin followed by comprehensive in-vivo and ex-
vivo histological examinations.
2.3.1. Porcine Skin
Fresh porcine abdomen and ear skin samples were ex-
posed to different TriFractional energy levels.
2.3.2. In-Vivo Human Abdominal Skin
One abdominal patient consented to a series of TriFrac-
tional pulses prior to her scheduled mini abdominoplasty.
Pulses of the High power default settings (160 msec)
were performed at one week and one day before the sur-
gery. Skin samples of treated and untreated control area
were taken from this patient during her abdominoplasty
procedure for histological analysis. Formalin fixed, par-
affin embedded sections were prepared and stained with
H&E for pathological examination by Patho-Lab Diag-
nostics Ltd., Nes Ziona, Israel. Pathological examination
was performed by Andrea Gat, M.D., Head of Dermato-
pathology Unit, Sourasky Medical Center, Tel Aviv, Is-
2.3.3. Ex-Vivo Human Skin Study
The Gredeco ex vivo skin model for maintaining skin frag-
ments (harvested from donors undergoing plastic surgery)
in survival condition and artificially aging by Ultraviolet
(UV) irradiation, was used as previously described by
Boisnic and Branchet .
• Histological modifications of the skin were analyzed
at different intervals between Day 0 (D0) and Day 10
(D10), using H&E staining.
• Immunohistochemical analysis of mitotic index of the
epidermis was done on D2. An antibody Ki67 (Dako,
clone MIB-1, marker cells in the M, S, G1, G2 phases
of the cell cycle) was used. The immunodetection was
made with an indirect technique of immunoperoxy-
dase in 4 levels, amplified (kit DAKO) and stained in
red by AEC (3-amino-9-ethylcarbazole).
The results were expressed in % of positive epithelial
• Morphometrical analysis of collagen fibers was done
Serial sections of 4 µm thickness were obtained and
specifically stained with a picric acid solution containing
0.1% Sirius red. Collagen was analyzed by computerized
morphometrical analysis. For a quantitative analysis of
these macromolecules, a computerized image analysis of
each section was made. The stained slides were exam-
ined using a microscope (Leitz) (magnification ×160)
connected with a camera unit (XC-75 CE type) and a
The surface of collagen bundles were measured in µm2
and the relative collagen content of the dermis was then
expressed as a percentage.
For both the analyses of epidermal mitotic index and
quantitative collagen content, samples with more than
one pulse on the same area were included to amplify the
reaction comparing to control samples.
2.3.4. Statistical Analysis
The statistical significance of changes recorded was de-
termined using the Student’s t-test when p < 0.05 was
considered as statistically significant.
3.1. TriFractional Facial Treatments Results
The results of the TriFractional treatments included re-
duction of fine wrinkles, improved appearance of acne
scars, a general improvement of skin texture and scar tis-
sue, skin brightening, skin tightening, improvement of
skin irregularities and reduction in pore size. The sub-
jects treated with the TriLipo Med procedure displayed
an additional facial contouring effect especially visible
on the jaw-line area.
No significant undesired effects were experienced by
the subjects and they reported a tolerable pain level. All
subjects expressed satisfaction with the clinical results.
Figures 1 - 3 demonstrate results of TriFractional treat-
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