Clinical Trial Details
— Status: Suspended
Administrative data
| NCT number |
NCT03931525 |
| Other study ID # |
8042019 |
| Secondary ID |
|
| Status |
Suspended |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2019 |
| Est. completion date |
May 1, 2025 |
Study information
| Verified date |
June 2024 |
| Source |
Quiropraxia y Equilibrio |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study aims to explore the effects of fractional Radiofrecuency (RF), as well as
demonstrate the performance of the new semi-ablative radiofrequency model in the treatment of
stretch marks. This research is a randomized, controlled clinical trial where 32 female
patients complaining of glutes and / or abdomen striations. The participants were divided
into two equal groups, G1 and G2. G1 will be treated at 30-day intervals, and subdivided into
2 subgroups: G1A, 8 patients with striations in the abdomen; and G1B, 8 patients with gluteal
striations. The G1A and G1B groups will be divided into 2 subgroups of 4 people each, where
one group will be treated with Fractional RF associated to drug delivery, and the other
group, with only Fractional RF, without the application of drug delivery. The same rule of
subdivisions will occur in G2, G2A and G2B, however, the interval between applications will
be every 15 days. The treatment area will be divided into a rectangle 10cm high by 10cm wide.
For evaluation, the contralateral side will be used as a control, using Photogrammetry and
histological analysis as a resource, which will be collected through the punch skin fragment
of the infraumbilical and gluteal region, performed by a specialized physician.
Description:
1. INTRODUCTION
Stretch marks are characterized by common dermatological conditions, being aesthetically
unpleasant, disturbing especially women of different age groups. Analyzing the
histological aspect, they present as atrophic lesions that disperse collagen and elastic
tissue, in addition to reducing the presence of skin cells such as keratinocytes,
melanocytes and fibroblasts.
It is noted that the striations may be distributed locally or numerously, disposed
parallel to one another and perpendicular to the skin cleavage lines. At the beginning,
the striae appear erythematous-violet, thin and may generate pruritus, characterizing
its inflammatory phase.
When the inflammatory phase passes, the striations develop into an atrophic condition,
they acquire a whitish appearance, almost pearly, becoming wider, due to the rupture of
elastic and collagen fibers.
Dermatofunctional physiotherapy already has several resources to treat these effects,
such as therapeutic ultrasound, cryolipolysis, radiofrequency, low intensity laser and
high intensity focused ultrasound. RF heating is commonly used to cause shrinkage of
dermal collagen and induce stimulation of fibroblast cells that produce a new collagen.
Radiofrequency is a non-invasive treatment, which leads to better circulatory and
nutrient supply, tissue hydration, increased oxygenation, acceleration of elimination of
catabolites, lipolysis, contraction of the connective tissue promoting reorientation of
collagen fibers and increase in as well as soft tissue regeneration, and is indicated
for patients with mild to moderate skin flaccidity, to improve the facial and body
contour, to attenuate furrows and ridges, to moderate retraction of the fibers, and to
increase the thickness and density of the epithelial tissue. sub-mental area and neck
and treatment of gynoid lipodystrophy, like all equipment of deep thermo therapy, causes
a great cellular excitation, leading to an accentuated caloric expenditure, while we
will be promoting an expressive improvement of localized fat or cellulite in the
circulatory part promoting a important vasodilatation, but when there is fibrosis very
early, rapid preheating with radiofrequency is recommended initially.
Fractional RF is another possibility for the treatment of cutaneous aging. It is a
procedure that emits waves that reach the deeper layers of the skin, generating energy
and strong heat, but keeping the surface cooled and protected. the procedure reaches the
depth of 100 microns, that is, it reaches the papillary dermis, where it causes ablation
and coagulation of surrounding proteins by residual thermal damage. This both leads to
contraction of existing collagen fibers and stimulates the formation of new fibers,
making them more efficient in supporting the skin.
After discovering the advantages of fractionation applied to some forms of light for
skin rejuvenation, several other researches have been done, and today we have different
types of laser, radiofrequency and infrared devices that use this property as a way to
keep treatments safer and effective. The development of RF fractionation was then
initiated. In the fractured form this feature can be used ablatively and sub ablatively,
where tissues suffer less trauma.
There is still a lot to be studied about this new therapeutic resource, and the
literature on the subject is very scarce. For this reason, this research aims to
elucidate and increase the knowledge about Fractional RF. Through histological analysis
and other data, we seek to ensure and clarify the effects of Fractional Radiofrequency
at the dermal and epidermal level.
2. GENERAL OBJECTIVE:
-Investigate the effects of Fractional Radiofrequency in the treatment of striae of the
abdominal and gluteal regions associated or not with the active permeation (Drug
Delivery).
3. SPECIFIC OBJECTIVES:
- Compare the effects of Fractional Radiofrequency on the dermal tissue in the
abdominal and gluteal regions of women, associated or not with the drug permeation
(Drug Delivery), through the histological analysis.
- Demonstrate the performance of Fractional Radiofrequency equipment in the treatment
of stretch marks in the abdominal and gluteal regions of women in different
treatment periods (15 and 30 days), when or not associated with drug delivery.
- Identify the performance of Fractional RF equipment in the treatment of stretch
marks in abdominal and gluteal regions in different treatment periods (every 15 and
30 days).
4. HYPOTHESES:
- The application of Fractional Radiofrequency does not interfere in the treatment of
stretch marks.
- The application of Fractional Radiofrequency interferes in the treatment of stretch
marks.
- The permeation of assets associated with fractional RF interferes with the
treatment of stretch marks.
- Asset permeation associated with Fractional RF does not interfere with the
treatment of stretch marks.
5. METHODOLOGY
5.1 CHARACTERIZATION OF STUDY AND SAMPLE:
The research is characterized as a randomized clinical trial in which 32 female
volunteers will be selected, whose main complaint is the appearance of stretch marks in
the abdominal area and gluteal areas.
5.2 LOCATION OF THE RESEARCH:
The participats will be assisted in an outpatient dermatological and physiotherapy
treatment appropriately structured for the proposed study, containing electrical network
compatible with the fractional RF equipment used, an appropriate environmental cooling
system for the proper functioning of the machine, and good hygiene and lighting
conditions, according to the provisions of the local Sanitary Surveillance, will be in
the clinic of physiotherapy, located at Av. Antônio Basílio - Lagoa Seca / Natal-RN
owned by Dr. Eneida Carreiro.
MATERIALS:
Fractional RF Equipment, Artis model, manufactured by Tone Derm will be used. A tape
measure of the brand Fiber, a scale of the mark Glicomed, a device of Plicometria and a
device of ultrasonografia of high frequency (12MHz), a punch of procedure, camera of the
mark Canon. For the application of the assets will be used the Concept TI Strill
Monodose Fluid manufactured by Mezzo Dermocosmetics, registered in Anvisa nº
25351.379480 / 2018-17, composed by water, Edta, Hydroxyacetophenone, 1,2 - Hexanediol,
Caprylyl Glycol, Disodium Edta, Glycine Soy Glycerin, Hydrogenated Lecithin, Citric
Acid, Sh-Polypeptide-5, Butylene Glycol, Cetyl Hydroxyethylcellulose, Rutin, Palmitoyl
Tripeptide-1, Palmitoyl Tetrapeptide-7, Phaseolus Lunatus Seed Extract, Bulbine
Frutescens Leaf Juice, Bht.
5.3 PROCEDURE METHOD:
During treatment the participants will be treated with fractional radiofrequency, G1
will be applied at 30-day intervals and subdivided into 2 GA groups. Abdomen with 8
patients and GB gluteal with 8 patients, the GA and GB groups were divided into 2
subgroups of 4 people each, 1 group with application of drugdelivery and 1 group without
the application of drugdelivery. G2 will be applied at 15-day intervals and subdivided
into 2 GC groups. Abdomen with 8 patients and gluteal GD with 8 patients, the GC and GD
groups were divided into 2 subgroups of 4 people each, 1 drug application group and 1
group without the application of drug delivery. The drug consists of a solution rich in
cell growth factors and the investigators will be applied after the intervention with
Fractal Radiofrequency.
The following modulation parameters will be used in the Fractional Radiofrequency
equipment: Deep application mode, amplitude: 100% - ON time: 50 mseg - OFF time: 5 mseg
- Pulsed mode - Pulse: 1mseg. In the gluteus and abdomen will be treated using -
specific radiofrequency tips fractioned with the "fork" electrode (A distance between
perforations of about 1 to 2 mm must be observed). The areas where the needle will
penetrate will be cleaned with 70% alcohol before the procedure, the applications in the
abdomen and gluteus will occur on the right side, the left side will not receive any
radiofrequency treatment, being therefore used as a control, where later participants
will be invited to treat the contralateral side.
For the histological analysis, two patients from group G1 (abdomen and gluteus) and two
patients from group G2 (abdomen and gluteus), a sample of the superficial tissue through
a punch 3 mm in diameter, will be removed. The procedure will be under local anesthesia
and performed by a medical plastic surgeon in order to minimize the risks.
6. RISKS AND BENEFITS OF RESEARCH:
The Radiofrequency apparatus is registered with ANVISA, the treatment is considered safe
by the FDA and duly legalized its use in Brazil. Even if it is a new technique, the
researchers will be assisted by a technician responsible for the machine during the
entire treatment period to avoid any technical problem.
The risks include the use of anticoagulants and liver problems (previously questioned in
the initial interview with the patient during the first evaluation). If so, the
participant will be excluded from the survey. Other risks are hyperemia of the skin due
to the mechanism of application of the equipment that will be smoothed by the control
and questioning at the beginning of the application and the patients must be with
preserved sensitivity, by having the metal applicators, it can scratch, but this will be
avoided with the inspection of the device before the application and with the speed of
the moderate application, if it occurs the patient would receive all the necessary care
and assistance to heal. The risk of burns will be reduced by controlling the
temperature.
For the patient submitted to punch the risk is scar formation and fibrosis in the area
where the skin fragment will be collected, but in order to avoid these complications the
removed fragment will have the smallest possible size so that it is minimally
perceptible and the procedure will be performed by physician.
In the event of any complications, we will provide the necessary assistance, including
coverage of expenses, compensation for any damages resulting from research procedures,
duly substantiated by specific consultations and examinations.
The benefits of this research are related to the improvement of the striae in the
treated region. As the literature cites, as well as increasing self-esteem of it.
7. DATA ANALYSIS:
After histological study, a statistical analysis will be performed to compare the degree
of organization of the collagen and elastic fibers between the different treatment
groups. A descriptive and inferential statistical analysis of the data will be performed
through SPSS 19.0 (StatisticalPackage for the Social Science - Version 19.0). The
normality of the date will be observed by the Kolmogorov - Smirnov (KS) test. For the
comparison between groups whose parametric form data will be applied the one-way anova
test for intergroup comparison. The significance level of 5% (p <0.05) will be adopted.
8. EXPECTED RESULTS:
It is expected at the end of the study that the differentiated effects for conventional and
Radiofrequency equipment in the dermal tissue will be demonstrated.
This study intends to evaluate the Fractional Radiofrequency effects as well as the
parameters to be used, seeking to confirm what the literature cites in relation to its
physiological effects. A more detailed analysis of the whole process after the application is
sought, not yet clearly described by scientific studies.
Fractional Radiofrequency is expected to increase the increase of collagen fibers, preventing
the process of natural skin aging and improving the appearance of stretch marks.
