Effect of Radiofrecuency on Stretch Marks
Condition: Stretch Marks
MeSH terms: Striae Distensae
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Fractitional Radiofrecuency with Drug Delivery; Fractitional Radiofrecuency
Intervention type(s): Device; Device
Intervention description(s): Electromagnetic energy within the spectrum of radio frequencies applied to the skin whose purpose is to generate thermal effects and which will be complemented with a skin drug; Electromagnetic energy within the spectrum of radio frequencies applied to the skin whose purpose is to generate thermal effects
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Stretch Marks; Skin Disease; Diathermy; Drug Delivery Systems