Tecar CRV 200

Scientific Literature

What is the Tecar methodIt is the application of a radio-frequency energy emission system, applied to the human body as a curative method, which controls and quantifies the quality and quantity of energy accumulated by the organism.Therefore, Tecar is also a medical device that uses the energy applied to registered therapeutic processes.

How Tecar worksIt is a generator that uses the physical principle of the high frequency condenser, it creates an electromagnetic field between the active and negative electrodes, involving the human body in a hyperactivity of movement through the shifting of electrolytic charges found in the organism. All these elements work when the circuits close, creating an electric differential that generates the energy and creates a shifting of charges equal to the number of pulses that the generator emits.The electric differential is measured like a voltage source. The human body is a second class armature and has the function of a conductor with resistances that can be superficial and deep.All this explains why all those tissues between the active electrode and the counter electrode are affected, in fact forcing us to take into account not only the cutaneous impedance but also the impedances that develop inside the organism in the various tissues crossed by the energy. Therefore the unit of measurement cannot be limited to voltage alone, but necessarily the electrical conductivity with all surface and deep resistance parameters.All this allows:

• Greater efficacy, provided by the optimal energy dose• Lesser contraindications and certainties of the result, eliminating energy overdose.This technology creates an epochal change by placing different parameters on the use and application of the physical principles of radiofrequency applied to the organism for a therapeutic process.

What is the Transdermal Vehiculation methodIt is a painless method with no side effects. This makes it possible to transdermally vehiculate active ingredients with high molecular weight to cell interstitial spaces without the intermediation of blood circulation in the first phase (ex. pharmaceutical drugs, homeopathic products, phyto-pharmaceutical products).

The system uses low frequency electrical pulses as a carrier (electroporation). The stimulation electric wave is produced by a direct current generator, that is able to assess variations in skin resistance in stable and reproducible conditions.

With an appropriate variation of the electrical parameters, this method makes it possible the transcutaneous vehiculation of substances without altering the tissues and reaching optimal depth.

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Tecar and interactions with biological tissuesTecartherapy has its roots in the eminent discoveries of Nikola Tesla, carried out in the last twenty years of the nineteenth century: in 1891 and 1889 the scientist brought to the attention of the academic (medical and scientific) world the biological consequences observed in the application of high frequencies and high voltages to the human body. In his conferences, he claimed that a man could completely get out of the expanses of the Arctic simply by covering himself with a high frequency current, which would guarantee him not only protection but also a sanitary benefit, "revitalised organs and cleaned up mind". Initially he called diathermy the appearance of this technique concerning heat.

At the beginning of the twentieth century a French physician and physicist, Jacques Arsene d'Arsonval, acquired the fundamental intuitions of Tesla and began to experience the beneficial potentials of high frequencies applied to biological tissues: the researcher noticed that applying frequencies higher than 100KHz, determined changes in plasma membrane permeability. This gave rise to further experimentations and to the creation, by the same Arsonval, together with other doctors and researchers, of the first energy application system through two different electrodes: a capacitive and a resistive one.

The rationale of this discovery led the English doctor William Beaumont to realize the first electromedical diathermy instrument in 1939.

But it is starting from 1995, by a team of Italian researchers, that the application field of this method was extended to the field of sports medicine (it spread throughout physical medicine and rehabilitation only later) and that the diathermic system began to be named according to the acronym TECaR (Capacitive and Resistive Energy Transfer).

Tecartherapy stimulates the production of endogenous energy at the level of biological tissues, activating and accelerating the natural reparative and anti-inflammatory processes. The rationale for this therapy lies in the observation that every trauma or osteoarticular (and soft tissue) pathology slows down and modifies the natural reparative processes due to the damage suffered.

The therapeutic process is triggered by the recall of electrical charges, already found in the tissues in the form of ions (displacement charges), in the treatment area. The movement of these charges and the micro-friction between them determines cause an increase in intratissutal temperature, converting the kinetic energy into thermal energy (diathermic effect). The whole phenomenon is possible by affixing an electric circuit to the human body, composed by a capacitive or resistive electrode and a fixed counter electrode (return plate). At present there is the possibility to convey the circuit in a single handpiece with double polarity (double electrode), eliminating the need to use the fixed counter electrode.

The capacitive mode allows a concentration of the charges exclusively in the proximity of the electrode: therefore it allows to develop energy only in the biological layers closest to the handpiece such as integument, connective fascia, superficial musculature. It has a greater specificity of action and ease of management of the treatment area.

The resistive mode operates in depth (deep musculature, joints, bone tissue) and manages to act on biological damage and in all forms of chronic degenerative disease and/or in the presence of fibrosis. It permits a wide and deep revascularization of these areas and a quick restoration of tissue metabolism.

The biological effects of Tecartherapy can be recognised not only with respect to the

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depth of action, but also on the basis of the energy intensity applicable in: low, medium and high energy intensity effects.

- low energy intensity effects determine an increase in metabolic activity with an increase in ATP production (biostimulation and tissue reparation);

- medium energy intensity effects allow an increase in lymphatic and blood circulation, greater tissue oxygenation and a better reabsorption of interstitial catabolites;

- high energy intensity effects, for diathermy - thermal effect.

In the same therapeutic path, it should be possible to include different energy levels in order to care for the patient: in a phase of pain and inflammatory state control, in the regeneration of the injured tissue and in the recovery of the function affected by the damage, with a global improvement of the quality of life for the patient.

General biological effects of TecartherapyThe effects of Tecartherapy can be summarized as follows:

• acceleration of the natural systemic reparative reaction;

• reactivation of the superficial lymphatic and blood microcirculation by the

capillary vasodilation;

• facilitates the reabsorption of oedemas;

• increase in internal temperature;

• reduction of contractures and muscle spasms;

• increase in nerve conduction;

• increase in the extensibility of collagen due to viscosity reduction;

• acceleration of enzymatic activity;

• increase in the nociceptive threshold;

A global combination of thermal and non-thermal effects allows faster healing of tissues after a trauma or degenerative diseases (where it also indirectly plays a protective role), allows a rapid reabsorption of oedemas, reduces joint stiffness and allows an increase in joint ROM if the treatment occurs in combination with specific stretching sessions.

The presence of a duty cycle (pulsed mode) to regulate the supply of the electric circuit applied to the human body also allows Tecar to determine:

• an increase in the cellular function of protein synthesis by creation of molecular

bonds between tissue ions;

• increased production of ATP;

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• a cascade of physiological reactions that includes the activation of growth factors

for fibroblasts and neurons;

• an increase in macrophage activity;

• an alteration of myosin phosphorylation;

It is proven that an improved local perfusion increases tissue oxygenation at the deep level, thus reducing anaerobic metabolism, increasing the phagocytic activity of catabolites and increasing nutrient availability.

Tecar of WinformWith the Tecar devices of Winform it is possible to obtain all the listed biological effects, customizing the therapy on the basis of the specific needs of each pathology and each treated patient.

Moreover, thanks to the presence of SCE and SIVSEA control systems, the highest degree of safety and respect for biological tissues is guaranteed, optimizing the effectiveness of the treatment and avoiding incurring secondary effects (due to a return of energy to the handpiece or an energetic overdose in the treated tissues): this is possible thanks to a constant control of the impedance of the substrates and an automatic regulation of the emission intensity.

In addition, specific biological effects can be obtained in the course of treatment and the efficacy of the treatment can be assessed on the basis of the modification of the tissue density obtained, depending on the set SIVSEA and its variation.

Transdermal vehiculation and its biological effectsTransdermal vehiculation is a system of pharmacological administration, used in clinical environment since 1981 (Davidson et al), through which it is possible to input specific molecules (drugs, hormones, phytocompounds, PRP) at the dermal and transdermal levels.One of the main benefits of this method is that the release of the drug can be protracted for a long time, from a few hours up to several days, exploiting the reserve role played by the tegument. In addition, it minimises any incompatibilities with the active ingredients of the drug and the potential toxicological risks associated with the use of the most traditional administration routes (such as gastro-intestinal or intravenous ones for instance).

The stratum corneum is the most superficial one of the skin barriers against the intake

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of external material and constitutes a real obstacle to the transdermal diffusion of active pharmacological and cosmetic principles.Physiologically, only a small number of molecules with low molecular weight and high lipophilicity is suitable to pass through the stratum corneum (highly hydrophobic), to reach the treatment target and thus perform the relevant therapeutic action, while the majority of hydrophilic molecules cannot “passively” cross the barrier of the integument and they remain thus superficial. Furthermore, if some of these molecules were able to penetrate at the epidermal level, they would risk to be prematurely degraded by the epidermal enzymes, thus further reducing their bioavailability.

At the base of these considerations and of the remark that the cutaneous route was an innovative means of pharmacological administration (with great benefits), over the years several methods of transdermal vehiculation of molecules have been developed.The research on the first generation of vehiculation systems focused primarily on adapting the physicochemical properties of drugs to allow their transcutaneous intake.

The molecules for transdermal vehiculation were specifically selected or modified so that they presented a specific partition coefficient and a low molecular weight, to facilitate their diffusion through the skin barrier.Regarding the second generation of vehiculation systems, they focused on increasing skin's permeability to the drug through the use of chemical "facilitators" and specific stimulation means (external conductive forces): chemical facilitators and emulsions with nano-carriers allowed the solubilization of drugs and simplified the permeability of the drug, while the intervention of external forces (which used heat, electricity and non-cavitation ultrasounds) provided the final propulsive pulse for the entrance of macromolecules through the skin.

Third generation research and developments have adopted slightly invasive methods in which a microscopic destruction of the epidermis (radiofrequency and ablative lasers, microneedles) was foreseen, temporarily interrupting the stratum corneum in some of its portions to allow penetration of the drug.

The latest generation has focused on the development of devices for transdermal assisted vehiculation, using machines specifically designed to allow the maximum adaptation to the tissues of the patients and personalizing the therapy on the base of the needs / necessities / pathology found in the subject (the devices for vehiculation of Winform fully fall into this category).

Among the different transdermal vehiculation systems still available on the market and used in the clinical environment (iontophoresis, sonophoresis, microneedling, ablative lasers and radiofrequencies) the latest generation devices optimize the benefits provided by this method which are countless:

• allows a controlled and biosustainable (for the organism) release of the drug;

• promotes patient compliance due to its non-invasiveness and being a painless method;

• it is a good alternative to the administration of oral or injective drugs (transmuscular, intravenous, etc.);

• requires lower drug dosages compared to oral administration;

• non-invasiveness allows repeated administration of the drug on the same body are in a forecast of medium and long term treatments;

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• thanks to a shorter diffusion pathway to vascular networks, it is possible to avoid secondary effects due to digestion and metabolism of the drug (first pass hepatic metabolism).

Transdermal vehiculation of WinformWinform transdermal vehiculation devices exploit a patented and unique method to allow active ingredient molecules to cross the epidermal layer: after properly cleansing the skin with a specific product (editor's note SAN C which allows the removal of the hydrolipidic film overlying the stratum corneum and its reduction), through a specific pulse train associated with the capacitive diathermy, transient pores on the epidermis are obtained. [as is the case for sonophoresis, however, this method is not without risks and if not carefully administered it risks damaging the tissues in depth due to hyperthermia with sudden resorption of the drug by the blood channel].

The macromolecules of active principles are then pushed inside the dermis and from there they move to the intracellular level for a concomitant and transient opening of the transmembrane channels.

This occurs when the induced membrane potential reaches a critical threshold which increases plasma permeability of the hydrophobic molecules (Hibino et al), due to the formation of the so-called electropores.

The transfer efficiency of the molecules of active principle depends on the characteristics of the molecule (weight, size and charge), the characteristics of the electrical pulse (amplitude, duration, n° of pulses, frequency) and the combination with the diathermic physical principle and its intrinsic physical characteristics.

The molecules of active principle that do not pass the cell membrane remain available at the tissue level in the dermis (the reserve capacity of the tegument is exploited) and enter at the cellular level when the cellular metabolism requires it, through an increase in the Na+/K+ pump activity and relevant opening of specific channels.

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General biological effects oftransdermal vehiculationThe therapeutic indications vary based on the active principle chosen to convey and on the specific technology of the vehiculating device. The general actions of transdermal vehiculation optimize treatment performance in terms of healing and functional recovery times and are described as follows:

• anti-inflammatory action;

• analgesic action;

• anti-oedema action;

• biostimulant action;

• decontracting action;

• anti-fatigue, draining and decongestant (venous) action;

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Therapeutic applications in physiotherapyTecartherapy is applied in the following physiotherapeutic areas:

• Treatment of acute inflammatory pain;

• Treatment of post-traumatic or post-surgical oedema;

• Therapeutic massage;

• Preparatorymassage in athletes (with respect to sports performance or training);

• Decontracting massage;

• Myofascial treatment;

• Osteoarthritis treatment;

• Treatment of arthrosis (hip joint, gonarthrosis and intervertebral);

• Treatment of tendinopathies in the acute or degenerative phase;

• Treatment of post-operative pain;

• Treatment of pain and/or the inflammatory state in the case of a prosthetic

patient or with metallic type of implants;

• Treatment of low back pain of myofascial origin;

• Treatment of lumbosciatica;

• Treatment of plantar fasciitis and retraction of the tricipital fascia;

• Treatment of myofascial and irradiative neck pain;

• Treatment of the fibromyalgia patient (pain and muscular relaxation);

• Reactivation of the hemolymphatic system in case of stasis;

• Treatment of lymphoedema;

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Therapeutic applications in medicine and aestheticsTecartherapy is applied in the following medical and aesthetic areas:

• Treatment of wrinkles and unstructured skin;

• Treatment of acne vulgaris;

• Treatment of melasma;

• Treatment of cutaneous dyschromia;

• Treatment of tissue re-oxygenation (tropism);

• Treatment of skin firming of the face, neck and décolleté;

• Treatment of lifting of the face;

• Treatment of lip refill;

• Treatment of miniaturisation of the pores of the nose;

• Treatment of tissue rejuvenation;

• Treatment of lymphatic drainage;

• Treatment of androgenetic alopecia;

• Treatment of scalp imperfections (oily or dry dandruff, seborrhoea);

• Deep hair restructuring treatment;

• Treatment of striae rubrae;

• Treatment of oedematous cellulite;

• Treatment of fibrotic cellulite;

• Treatment of localised adiposity;

• Treatment of cutaneous ptosis (sagging);

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Before the treatment with CRV

After the treatment with CRV

Internal Gastrocnemius lesion

Female soccer player, 16 years old. Medial gastrocnemius strain of the right leg.

Excellent 2nd - 3rd degree cicatritial resolution of distal myotendinous junction of medial head gastrocnemius with slight detachment of the muscular fascia.

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Before the treatment with CRV

After the treatment with CRV

1st - 2nd sprain degree

Excellent strain cicatrization.

Before the treatment with CRV

After the treatment with CRV

Good cicatrization

Enthesitis

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Introduction Melasma is acquired hypermelanosis with multifactorial etiology characterised by grey-brown patches that affects sun-exposed areas and which mainly occurs on the face, with an alteration of pigmentation characterised by a localised or widespread increase in melanin at epidermal and dermal level (1). Currently available conventional therapies, including laser-therapy (2-6) and chemical peeling (7-11), are ineffective in the medium- and long-term most of the times due to the occurrence of relapses. Grekin and colleagues (12) did not observe any improvement in patients suffering from melasma and treated with dye laser. Fitzpatrick and colleagues (13) successfully used a dye laser in the treatment of post inflammatory hyperpigmentation, but observed no results in melasma cases. Goldberg (14) and McBurney (15) observed improvements after treatment of hyperpigmentation, using respectively a Q-switched ruby laser and an argon laser, followed by the appearance of relapses after a short time. Wanitphakdeedecha and colleagues (16) observed the onset of recurrences after treatment of epidermal melasma with Er: Yag laser. Wattanakrai and colleagues (17) report recurrence in patients with dermatological or mixed melasma and treated with Q-switched Nd: Yag laser.The best strategy is based on simultaneous use, promoting the removal of that already deposited in the stratum corneum. Guevara and Pandya (20) have demonstrated the safety and effectiveness of a 4% hydroquinone cream, buffered with glycolic acid 10%, vitamin C, vitamin E. Espinal Perez and colleagues (24) compared the results of melasma treatment using about a 5% ascorbic acid based cream on half face and a 4% hydroquinone cream on the other half. Lim (26) observed an improvement using a gel made with 2% kojic acid, 10% glycolic acid and 2% hydroquinone. Azzam and colleagues (27) appraised the effectiveness of trichloroacetic acid 20% compared to Jessner’s solution (resorcinol, salicylic acid, lactic acid) and a 2% hydroquinone and kojic acid based cream. Based on these considerations, a study was conducted on a group of 25 female patients suffering from melasma to assess the effectiveness and safety of using a transdermal vehiculation system. The system is equipped with a radio-frequency pulse energy generator in association with a 1% kojic acid-based phytocomplex capable of reducing the melanin biosynthesis by inhibiting the tyrosinase enzyme at different levels and with different mechanisms of action: reduction in new melanin biosynthesis through inhibition of the tyrosinase enzyme activity with a chelation mechanism of copper ions and competition with DOPA for binding with the tyrosinase receptors; blocking intermediate oxidation reactions of the non-enzymatic phase; inhibiting the transfer of newly formed melanin from melanocytes to keratinocytes.

MethodsFrom January 2008 to December 2009, 25 female patients underwent treatment, aged between 24 and 63 (average age 49.6) suffering from face melasma. All patients signed the informed consent form prior to being recruited for the study. The phytocomplex was tested for contact allergies with a patch test, read at 48 and 72 hours. For melasma classification, a Wood lamp was used (28), which highlighted in 10 patients (40%, average age 55.2 years) superficial melasma and in 15 patients (60%, average age 38.5 years) deep melasma. All lesions were documented photographically. The 1% kojic acid based phytocomplex was delivered with a quick-release transdermal vehiculation system (Endosit [now called TecarCRV], Winform, Italy) fitted with a generator able to emit radio-frequency pulsed energy at 480 KHz and a low-frequency modular current at 10 Hz, connected to a handpiece with steel electrode (diameter 25 mm, thickness 3 mm) and a neutral return plate. Throughout the duration of the treatment, the low energy transfer “vehiculation” operative mode was set (generator power: 25%). Before each treatment session the affected area was thoroughly cleansed to fluidise and remove the hydrolipidic film, promoting subsequent vehiculation of the phytocomplex. At the end of each session, the treated area was buffered with 10% sodium bicarbonate solution and a preparation containing collagenase plus chloramphenicol was applied, 3 times a day for the following 5 days. For the entire duration of the study the patients applied daily a high protection solar filter SPF 50+. The individual session lasted 3 minutes per lesion, during which approximately 2 ml of product were delivered. Sessions were weekly. At the end of the treatment the check was carried out by photographic comparison. The effectiveness of the treatment was assessed comparing the MASI score (Melasma Area and Severity Index) assigned to the lesions at the start of the study (T0), at the end of the sessions (T1) and at the check after 1 month (T2), 6 months (T3) and 12 months (T4).

ResultsAll patients tolerated the treatment well and there were no side effects. Between 4 and 6 sessions were required for treatment of superficial melasma in 8 patients. 2 patients suffering from superficial melasma required 6 and 8 sessions, respectively. In the 15 cases of deep melasma, between 8 and 10 sessions were carried out. One was able to observe progressive and constant improvement of the lesions with conspicuous decrease in the pigmented component starting from the second session in all patients. In the superficial melasma cases (tab. 1) total disappearance of lesions was observed in 5 patients after 4 sessions and in 3 patients after 6 sessions. One patient (figures 1 and 2) reported attenuation of the pigmented area compared to the initial lesion after 6 sessions (MASI score from 6.3 to 1.8); one patient showed attenuation of the pigmented area compared to the initial lesion after 8 sessions (MASI score from 9.6 to 3.6). In patients suffering from deep melasma (tab. 2) total disappearance of the hyperchromic lesion was observed after 8 sessions in 1 case, and after 1 session in 2 cases. An improvement was observed with respect to the initial lesion in 3 cases (MASI score from 4.5 to 0.6; from 6

NON-INVASIVE TREATMENT OF MELASMAUse of a quick release transdermal vehiculation system

University of Studies of Rome "La Sapienza" Department of Skin and Venereal Diseases and Plastic-Reconstructive Surgery[1]Director Prof. S. Calvieri

Alfredo Rossi, Maria Caterina Fortuna, Fabio Colaiuda, Elisabetta Scali, Paolo Greco, Alessandro Iorio, Victor Desmond Mandel, Valentina Garelli

to 0.9; from 7.2 to 1.2). The subsequent follow up was conducted at 1, 6 and 12 months on 11 patients; at 1 and 6 months on 9 patients; at 1 month on 5 patients. In all cases, it was observed that the results achieved were preserved, with no recurrences. In cases of partial resolution, no worsening of the pathology was observed.

Tab. 1: results in patients suffering from superficial melasma

Tab. 2: results in patients suffering from deep melasma

Discussion Transdermal vehiculation is increasingly emerging as a safe and effective method in the field of bone and joint inflammatory diseases, as well as in dermatology, and especially in the treatment of skin blemishes. A number of studies (29-34) have shown how this method allows the epidermal anatomical structures to be crossed, taking advantage of the interaction mechanisms of an electromagnetic field with biological tissues. The electrically charged ionic and molecular aggregates interact with the electromagnetic field through conduction mechanisms, which induce electrical currents in the tissue determined by the movement of the electrons and ions it contains, as well as through polarisation mechanisms. In relation to the frequency bands, the interaction mechanisms are divided into low-frequency interaction mechanisms, in which interaction is brought about by the variable electric and magnetic fields that generate currents in the tissues, and high frequency interaction mechanisms, in which interaction is caused by the activation of states of rotation, vibration, and alignment of the electric charges. The system used by us is able to control independently and simultaneously the high and low frequency pulses with a dual effect that results in both tissue stimulation with localized heating and polarity alignment, and delivery of active ingredients through the epidermis, with increased absorption capacity. Through the safety system built into the device, this is also able to constantly assess the change in impedance of the tissues concerned and to correct in real time the energy emission, thereby allowing bio-stimulation to be optimised in an automatic manner and assure the utmost clinical effectiveness. The synergistic action of the phytocomplex and transdermal vehiculation method has its scientific rationale in the dual tissue bio-stimulation effect with increased ability to penetrate through the epidermis up to the intracellular level, and interaction of the phytocomplex at various levels of the cutaneous melanogenesis metabolic pathway:• decrease in new melanin biosynthesis through inhibition of the tyrosinase enzyme’s activity with a chelation mechanism of copper ions;• decrease in new melanin biosynthesis through competition with DOPA for binding with the tyrosinase receptors;• blockage of intermediate oxidation reactions of the non-enzymatic phase;• inhibition of newly formed melanin transfer from melanocytes to keratinocytes;

• de-pigmenting action of existing lesions, induced by transformation of the melanin deposited in the keratinocytes into colourless pigments.

Fig. 1: patient with superficial forehead melasma.MASI TO score: 6.3

Fig. 2: patient with superficial forehead melasma after 6 treatment sessions.MASI T1 score: 1.8

Conclusions Conventional therapies for melasma treatment are long, costly and often burdened by relapses (16, 17, 35, 36). That is why, in order to achieve good aesthetic results, new methods are being put forth characterised by the absence of invasiveness, low costs and good effectiveness. Among these, a significant role is played by transdermal vehiculation associated to radio-frequency, which as is known, is able to interact with tissues, delivering substances through the epidermis at intracellular level. This method is wholly non-invasive, painless and free of side effects, it does not require anaesthesia and may be performed routinely at an outpatient facility. The results observed in our study show good attenuation of the hyperpigmentation lesions compared to the initial lesions. The follow-up conducted at 1, 6 and 12 months showed persistence of the results obtained. The novelty of this method consists in the ability to deliver the phytocomplex at intra and extra-cellular level, thus being able to interact with the metabolism of skin melanogenesis. In our opinion we may conclude that said method stands as a new and valid alternative in melasma treatment, having shown good efficacy, speed of execution, safety and low costs, in total absence of invasiveness. It should be duly underlined that execution of said technique requires personnel to be instructed on the protocols to be used in the various aesthetic treatments. Furthermore, we wish to highlight that said method has been recently introduced, and therefore requires the results obtained by us to be confirmed by further studies.

Declared conflicts of interest: none

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[1]Study published on: Hi Tech Dermo n. 6/20101. Nicolaidou E, Antoniou C, Katsambas AD. Origin, clinical presen tation, and diagnosis of facial hyper melanosis. Dermatol Clin. 2007;25:321-6.2. Chan HH, Kono T. The use of lasers and intense pulsed light sources fur the treatment of pigmentary lesions. Skin Therapy Lett 2004 Oct;9(8):5-7.3. Yamashita T, Negishi K, Hariya T, Kunizawa N, Ikuta K, Yanai M, Wakamatsu S. Intense pulsed light therapy for superficial pigmented lesions evaluated by reflectance-mode confocal microscopy and optical coherence tomography. J. lnvest Dermatol 2006 Oct;l 26(10).-2281-6.4. Rahman Z, Alam M, Dover JS. Fractional Laser treatment for pigmentation and texture improvement. Skin Therapy Lett 2006 Nov; 11(9):7-11.5. Sadighha A, Saatee S, Muhaghegh Zahed G. Efficacy and adverse effects of Q-switched ruby laser on solar lentigines: a prospective study of 91 patients with Fitzpatrick skin type II, III, and IV Dennatol Surg. 2008 Nov;34(11):1465-8.6. Trafeli JP, Kwan JM, Meehan KJ, Domankevitz Y, Gilbert S, Malomo K, Ross EV Use of a long-pulse alexandrite laser in the treatment of superficial pigmented lesions. Dennatol Surg 2007 Dec;33(12): 1477-827. Picardo M, Carrera M. New and experimental treatments of cloasma and other hypennelanoses. Dermatol Clin 2007;25:353-62.8. Plensdorf S, Martinez J. Common pigmentation disorders. Am Fam Physician 2009 Jan 15;79(2):109-16.9. Stulberg DL, Clark N, Tovey D. Common hyperpigmentation disorders in adults: Part li. Melanoma, seborrheic keratoses, acanthosis nigricans, melasma, diabetic dermopathy, tinea versicolor, and postinflammatory hyperpigmentation. Am Fam Physician 2003 Nov 15;68(10):1963.10. Grover C, Reddu BS. The therapeutic value of glycolic acid peels in dermatology. Indian J Dermatol Venereo/Leprol 2003;69: 148-50.11. Gupta AK, Cover MD, Nouri K, Taylor S. The treatment of melasma: a review of clinical trials. J Am Acad Dennatol 2006 Dec;55(6):1048-65.12. Crekin RC, Shelton RM, Ceisse JK, Frieden I. 510-nm pigmented lesion dye laser: its characteristics and clinical uses. J Dermatol Surg Oncol 1993; 19:380-387.13. Fitzpatrick RE, Goldman MP, Ruiz-Esparza J. Laser treatment of benign pigmented epidermal lesions using a 300-nsecond pulse and 510-nm wave-length. J Dermatol Surg Oncol 1993;18:341-347.14. Coldberg 01. Benign pigmented lesions of the skin: treatment with the Q-switched ruby laser. J Dennatol Surg Oncol 1993;18:376-379.15. McBurney El. Clinical usefulness of the argon laser for the 1990s. J Dennatol Surg Oncol 1993;19:358- 362.

16. Wanitphakdeedecha R, Manuskiatti W, Siriphukpong S, Chen TM. Treatment of melasma using variable square pulse Er:YAC laser resurfacing. Dermatol Surg 2009 Mar;35(3):475-81; discussion 481-2.17. Wattanakrai P, Momchan R, Eimpunth S. Low-Fluence Q-Switched Neodymium-Doped Yttrium Aluminium Garnet (1,064 mn) Laser for the Treatment of Facial Melasma in Asians. Dermatol Surg 2010; 36(1): 76-87. 18. Bandyopadhyay D. Topical treatment of Melasma. Indian J Dermatol 2009 Oct-Dec; 54(4): 303-309.19. Halder RM, Richards GM. Topical agents used in the management of hyperpigmentation. Skin Therapy Lett 2004;9:1-3.20. Guevara IL, Pandya AG. Safety and efficacy of 4% hydroquinone com bined with 10% glycolic acid, antioxidants, and sunscreen in the treatment of melasma. lnt J Dermatol 2003;42:966-72.21. Chawla S, deLong MA, Visscher MO, Wickett RR, Manga P Boissy RE. Mechanism of tyrosinase inhibition by deoxy Arbutin and its second-genera tion derivatives. Br J Dermatol 2008; 159.1267-7 4.22. Hamed SH, Sriwiriyanont P, deLong MA, Visscher MO, Wickett RR, Boissy RE. Comparative efficacy and safety of deoxyarbutin, a new tyrosinase-inhibiting agent. J Cosmet Sci 2006;57:291-308.23. Funasaka Y, Komoto M, Ichihash M. Depigmenting effect of alphatocopheryl ferulate on normal human melanocytes. Pigment Cell Res 2000;13:170-4.24. Espinal-Perez LE, Moncada B, Castanedo-Cazares JP A double-blind randomized trial of 5% ascorbic acid vs. 4% hydroquinone in melasma. lnt J Dermatol 2004; 43:604-7.25. Greatens A, Hakozaki T, Koshoffer A, Epstein H, Schwemberger S, Babcock G, et al. Effective inhibition of melanosome transfer to keratinocytes by lectins and niacinamide is reversible. Exp Dermatol 2005; 14:498-508.26. Lim 1T. Treatment of melasma using kojic acid in a gel containing hydroquinone and glycolic acid. Dermatol Surg 1999 Apr;25(4):282-4.27. Azzam OA, Leheta TM, Nagui NA, Shaarawy E, Hay RM, Hilal RF. Different therapeutic modalities for treatment of melasma. J Cosmet Dermatol 2009 Dec;8(4):275-81.28. Prignano F, Ortonne JP, Buggiani G, Lotti T Therapeutic approaches to melasma. Dermatol Clin 2007; 25:337-42.29. Banga AK. Microporation applications for enhancing drug delivery. Expert Opin Drug Deliv 2009 Apr,-6(4)-343-54.30. Marra F, Levy JL, Santi P, Kalia YN. In vitro evaluation of the effect of electrotreatment on skin permeability. J Cosmet Dermatol 2008 ]un;7(2):105-11.31. OMS, Electromagnetic fields and public health. Physical properties and effects on the biological systems. Memorandum no. 182, 1998.32. Sammeta SM, Vaka SR, Murthy SN. Transdermal drug delivery enhan ced by low voltage electropulsation (LVE). Pharm Dev Technol 2009; 14(2): 159-64.33. Xu Q, Kochambilli RP, Song Y, Hao J, Higuchi WI, Li SK. Effects of alternating current frequency and per meation enhancers upon human epi dermal membrane. lnt J Pharm 2009 May 8;372(1-2).24-32.34. Grégoire S, Ribaud C, Benech F, Meunier JR, Garrigues-Mazert A, Guy RH. Prediction of chemical absorption into and through the skin from cosmetic and dermatological formulations. Br J Dermatol 2009 Jan; 160(1).80-91.35. Lee HS, Won CH, Lee DH, An JS, Chang Hw, Lee JH, Kim KH, Cho S, Chung JH. Treatment of melasma in Asian skin using a fractional 1,550-nm laser: an open clinical study. Dermatol Surg 2009 Oct;35(10): 1499-504.36. Cestari T, Arellano I, Hexsel D, Ortonne JP; Latin American Pigmentary Disorders Academy. Melasma in Latin America: options for therapy and treatment algorithm. J Eur Acad Dermatol Venereo/ 2009 ]ul;23(7):760-72.

Introduction Patients: 50 women between 30 and 60 years old with melasma, voluntarily offered to participate in this study between October and November 2012.Patients presented phototype 2 to 4. The inclusion criteria were the following: idiopathic melasma, voluntary participation, previous resistance to common therapies, termination of previous therapies at least 12 months before starting the study, consent not to use other therapies during the study and consent to use a daily solar filter.

ResultsAll the patients completed the study. A 12 month period of suspension of any depigmenting treatment before enrolment of the study.After each application, the area of treated skin appeared normal in colour, texture and swelling.There were no side effects, such as erythema, scars and post-inflammatory hyperpigmentation at the one month and six month follow-ups. (Fig.6)All patients returned to their daily activities immediately.The reappearance of melasma was 0% at T1 and 4% at T2.The analysis showed that the hyperpigmentation was significantly reduced one month after the last treatment session (T1) and at the 6 month follow-up (T2) it was T0.The MASI degree reference equal to 21.3 decreased to 15.7 (p<0.001) one month after the end of treatment and had a value of 16.9 at the 6 month follow-up. These results were also confirmed by the Mexameter. (Fig. 7-8) (Table 2)The degree of erythema also showed a significant reduction. (Table 3)

TABLE 3. Erythema Scores Recorded by Mexameter at the Baseline (T0), 1 Month After Treatment (T1) and 6 Months After Treatment (T2)

TABLE 2. Melanin Scores Recorded by Mexameter at the Baseline (T0), 1 Month After Treatment (T1) and 6 Months After Treatment (T2)

Combined Use of Monopolar Radiofrequency and Transdermal Drug Delivery in the Treatment of Melasma

Summary of a clinical study carried out by the Department of Dermatology of the San Gallicano IRCCS Institute in Rome [2]

Norma Cameli, MD, PhD, Elva Abril, MD, Maria Mariano, MD, and Enzo Berardesca, MD, PhD

treated area

treated area

Figure 2b. Visioface digital (A) and ultraviolet (B) photograph of a 47-year-old patient affected by melasma 6 months after the treatment (T2).

Figure 2. Visioface digital (A) and ultraviolet (B) photograph of a 47-year-old patient affected by melasma at the baseline (T0).

Figure 1b. Visioface digital photograph of a 39-year-old patient affected by

melasma 6 months after treatment (T2).

Figure 1a. Visioface digital photograph of a 39-year-old patient affected by

melasma 1 month after treatment (T1).

Figure 1. Visioface digital photograph of a 39 year-old patient affected with

melasma at the baseline (T0).

ConclusionsThese results suggest that the combined use of monopolar RF with a transdermal delivery system of depigmenting agents is a valid non-invasive and safe method for treating melasma.

[2] Full article published in: American Society for Dermatologic Surgery

Introduction Wrinkles are the most obvious sign of time-induced cutaneous atrophy, characterised by progressive damage to the collagen and elastic fibres; their aetiology is varied and complex, under the combined action of endogenous and exogenous factors. Facial wrinkles are the most noticeable ones, mainly due to gravity and the loss of support by the elastic tissue. Their development is accelerated by ultraviolet light, by lack of skin hydration, and by tobacco smoke. With ageing, hyper-dynamic lines also develop on the face, i.e. furrows caused by repeated stretching of the underlying mimic muscles. Intrinsic and extrinsic factors are involved in inducing skin ageing, as well as a stochastic process that involves random cell damage caused by mutations during metabolic processes due to the production of free radicals. Extrinsic ageing is caused by environmental factors such as exposure to sunlight, atmospheric pollution, cigarette smoke, alcohol abuse and poor diet. On the other hand, intrinsic ageing reflects the genetic background and is time-dependent. There are a number of intrinsic ageing expressions that include smooth and thinned skin with prominent expression wrinkles, while ageing caused by extrinsic factors is characterised by wrinkles, hypo/hyper-pigmented macules and actinic keratoses. Prevention is important, by using chemical and physical sun filters. A network of antioxidants such as vitamins E and C, coenzyme Q10, alpha-lipoic acid, glutathione, may reduce the signs of ageing. Other anti-ageing products are three generations of retinoids, the first generation of which is the most commonly used one. A diet rich in anti-oxidant substances contained in fruit and vegetables may be useful in preventing and delaying the onset of wrinkles. A number of treatments are currently available and commonly used for facial wrinkles, based on the use of laser, Botox, chemical peeling and fillers. The growing demand for effective, non-expensive and non-invasive approaches has resulted in the development of new methods for treating wrinkles.

Methods20 female patients were enrolled, aged between 30 and 63 (average age 46.4) who had I, II, III and IV degree facial wrinkles according to the Glogau scale. Due to the heterogeneous age of the patients, the pathogenetic mechanisms underlying the onset of wrinkles were variously represented. In addition, 10 case-control patients with similar features were recruited. A device was used (Endosit®, Winform) equipped with a generator able to emit 480 KHz modulated radiofrequency pulsed energy and a low frequency,10 Hz modular current, connected to a handpiece, to which an active steel electrode was applied (diameter 35 mm, thickness 3 mm) and a neutral return plate. Throughout the duration of the treatment, the low energy transfer VEHICULATION operative mode was set (generator power: 25%), using a phytocomplex made with substances able to moisturise the stratum corneum, increase collagen biosynthesis and stimulate the metabolic activity of fibroblasts to enhance skin firming, reduce Trans Epidermal Water Loss (TEWL) and finally, induce an antioxidant and elasticising action. In the case-controls, the turned off machine and a base cream were used. The phytocomplex was tested through a patch by patch to assess its tolerance and ability to cause contact dermatitis with reading at 48 and 72 hours. Before each treatment session the affected area was adequately cleansed to remove the hydrolipidic film, thus promoting subsequent vehiculation of the substances. 10 sessions were carried out, lasting 4 minutes per area, during which approximately 5 ml of product were delivered. The frequency of sessions was twice-weekly. A check was carried out at the end of the treatment by photographic comparison.

ResultsTreatment was well tolerated by all patients, no side effects occurred and, starting from the 10th session, a progressive and constant improvement of the lesions was observed, with decreases in the width and depth of individual wrinkles. The results were assessed by photographic score: assessment of linear wrinkles via an 8-level scale (Tab. 1) and with the Glogau scale (Tab. 2). The results assessed by using these scores showed a positive effect in all patient. Specifically, a 3 points improvement of the photographic score was observed in 0.5% of the patients, 2 points in 50% and 1 point in 49.5%. Periocular wrinkles were the most responsive, followed by nasolabial and forehead wrinkles. No correlation was found between patients’ age and the extent of the clinical improvement of the blemish, whereas enhanced responsiveness was found in all patients starting from a higher score (Tab. 3). At the end of treatment the improvement was clearly visible (photo 1b, 2b). The follow up at the 5th month showed the results achieved were retained in 100% of patients (photo 1c, 2c). No improvement was found in control-case patients (photo 3a, 3b).

Discussion Transdermal vehiculation by means of radio-frequency has turned out to be an extremely interesting therapy method in view of the encouraging results, especially as they concern treatment of a condition for which conventional therapies are either too invasive and costly, or not satisfying nor long-lasting. Contrary to our expectations, the study has shown that response to therapy was affected to a greater extent by the position and severity of the wrinkles than by patients’ age. As a matter of fact, the best results were obtained where wrinkles were deeper and wider, and where the skin was thinner. This observation leads us to hypothesise that the synergistic action of radio-frequency and vehiculation is better suited to areas with thinner skin. Therefore, the preferential therapeutic target for this method is the face. The system used is able to control independently and simultaneously the high and low frequency pulses with a dual effect that results in both tissue stimulation with localised heating and polarity alignment, and vehiculation of active ingredients through the epidermis, with increased absorption capacity. Through the built-in safety system, the device is also able to constantly assess the change in impedance of the tissues concerned and to correct in real time the energy emission, thereby allowing bio-stimulation to be optimised in an automatic manner and assure the utmost clinical effectiveness.

NON-INVASIVE TREATMENT OF WRINKLES OF THE FACEQuick release transdermal vehiculation system

University of Studies of Rome "La Sapienza" Department of Skin and Venereal Diseases and Plastic-Reconstructive Surgery [3]Director Prof. S. Calvieri

Alfredo Rossi, Maria Caterina Fortuna, Fabio Colaiuda, Elisabetta Scali, Paolo Greco, Alessandro Iorio, Victor Desmond Mandel, Valentina Garelli

Fig. 1c : T2 (follow up after 5 months) Fig. 1b : T1 (after 10 sessions)Fig. 1a : T0 (pre-treatment)

Fig. 3b: T1 (after 10 sessions) Fig. 3a: T0 (pre-treatment)

Fig. 2c: T2 (follow up after 5 months) Fig. 2b: T1 (after 10 sessions)Fig. 2a: T0 (pre-treatment)

ConclusionsTherefore, one may conclude that this technique may be a new and valid method for the treatment of wrinkles, showing to be effective, non-invasive, rapid, easy to perform and totally safe. However, one should underline the need to confirm the results achieved with more studies. Declared conflicts of interest: none

Bibliography [3] Study published on: Hi Tech Dermo n. 6/20101. Banga AK. Microporation applications for enhancing drug delivery. Expert Opin Drug Deliv. 2009 Apr;6(4):343-54.2. Marra F, Levy JL, Santi P, Kalia YN. In vitro evaluation of the effect of electrotreatment on skin permeability. J Cosmet Dermatol. 2008 Jun;7(2):105-11.3. OMS, Electromagnetic fields and public health. Physical properties and effects on the biological systems. Memorandum no. 182, 1998.4. Sammeta SM, Vaka SR, Murthy SN. Transdermal drug delivery enhanced by low voltage electro-pulsation (LVE). Pharm Dev Tech-nol. 2009;14(2):159-64.5. Xu Q, Kochambilli RP, Song Y, Hao J, Higuchi WI, Li SK. Effects of alternating current frequency and permeation enhancers upon human epidermal membrane. Int J Pharm. 2009 May 8;372(1-2):24-32.6. Grégoire S, Ribaud C, Benech F, Meunier JR, Garrigues-Mazert A, Guy RH. Prediction of chemical absorption into and through the skin from cosmetic and dermatological formulations. Br J Der-matol. 2009 Jan;160(1):80-91.7. R. James Koch, MD An Over- view of Facial Wrinkles. Epitomes- Otolaryngology 428 WJM, December 1997-Vol 167, No. 6.8. N. Puizina-Ivic Skin Aging. Acta Dermatoven APA Vol 17, 2008, No 2.9. Hun Lee, MD, Jin Sook Yoon, MD, Sang Yeul Lee, MD Fractional Laser Photothermolysis for Treatment of Facial Wrinkles in Asians Korean Journal of Ophthalmology 2009;23:235-23910. P. Daniel Ward, MD, MS; Shan

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• “Dermal and Transdermal delivery of pharmaceutically relevant macromolecules” Munch S, Wohlrab J, Neubert RHH European Journal of Pharmaceutics and Biopharmaceutics (2017) DOI: 10.1016/j.ejpb.2017.06.019

• “Radiofrequency-microchannels for transdermal delivery: characterization of skin recovery and delivery window” Kdun Y, Sacks H, Kaplan KM, Stern M, Levin G PP (2012);03; 20-28

• “Electroporation as an efficient physical enhancer for skin drug delivery” Escobar-Chavez JJ, Bonilla-Martinez D, Villegas-Gonzales MA, Revilla-Vazquez AL J Clin Pharmacol (2009); 49; 1262-1283

• “Transdermal sonophoresis technique – an approach for controlled drug delivery” Kumar SK, Bhowmik D, Komala M Indian Journal of Research in Pharmacy and Biotechnology (2013); 379-381

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HandpiecesThe device is equipped with bipolar and monopolar handpieces (using a neutral plate) of different sizes, to allow different areas of the body to be treated.

SIVSEA and SCETecarCRV has the revolutionary SIVSEA/SCE system that allows you to view and control the energy transferred to the tissue in real time and to immediately calibrate the correct energy dose to be administered, thereby avoiding unnecessary overdoses.

Photographic and thermal scanningTecarCRV can be used together with the W200 handpiece, a digital system for photographic scans with 200X magnification to accurately display the condition of the skin. W200 is also equipped with a thermal and humidity sensor to complete the analysis of the skin on the area to be treated.

Guaranteed safetyTecarCRV has safety systems that actively intervene if excess energy is given to the patient, thereby eliminating any errors.Safety is guaranteed by a “watch dog” system that constantly checks that the software is working correctly.

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Software

Example of acquisition of an enlarged image of the client's epidermis with Handpiece W200.The software allows the before and after treatment photographs of the skin to be shot and compared.The data detected with the W200 handpiece can be saved on a USB stick and transferred to its own computer file

Monitoring of feedback data, (SIVSEA/SCE levels) coming from the tissue change detection system, present on the handpiece.Control of the energy absorbed by the patient, to prevent an energetic overdose.

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P1 - 4.5 W 28 Agosto 2017 15:34

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With the W200 handpiece to document the progressof the treatmentsThe W200 handpiece allows an analysis to be carried out with a magnification of up to 200X and an immediate reading of the temperature and humidity of the skin. This allows the evolution of the treatment to be controlled, thereby allowing the operator to take “before and after” photos and save them directly to a USB for them to be easily catalogued in each client folder.

Ergonomic handle and soft touch surfaces.

Temperaturesensor

Optical zoomup to 200X

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Potenza 200 Watt assorbiti

RESISTIVO e VEICOLAZIONE Frequenza 480 kHz - continuoFrequenza CAPACITIVO e VEICOLAZIONE Frequenza 480 kHz - Modulata 10 Hz - Dudty Cycle 90%

Tipo di emissione 1/2

Display TFT 10,2 “

Dimensioni cm 35x25x28 H

Peso 10 Kg

Classif. secondo 92/42/CE Classe IIb

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25 m

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MANDM2PLIGHTBipolar handpiece with AISI 316 stainless steel electrodes for Tecar treatments, 50mm in diameter.

MANDBBipolar face handpiece with AISI 316 stainless steel electrodes for Tecar treatments, 35mm in diameter.

Bipolar kit MANKITSINB

MANHANDBipolar handpieces with AISI 316 stainless steel electrodes for Tecar massage treatments, 50mm in diameter.

Two-pole Handpiece MANDM2LIGHT

Massage handpieces MANHAND

MANDM2LIGHTBipolar handpiece with AISI 316 stainless steel electrodes for Tecar treatments, 50mm in diameter.

75 m

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PG345/35Electrode in AISI 316 stainless steel with a diameter of 35mm.35

mm

MANDMDISKElectrode cover for disc with a diameter of 55mm.55

mm

PG345/55Electrode in AISI 316 stainless steel with a diameter of 55mm.55

mm

MANDMSingle-pole handpiece for Tecar treatments with interchangeable electrodes.

55 m

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CABWF022Stainless steel neutral plate cable.

WF022Neutral plate in AISI 316 stainless steel for treatments with a single-pole handpiece.

Mono-polar kit MANKITSINM

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TERCAMDigital thermal camera for thermographic detection of the tissues.

W200Skin analysis handpiece with optical zoom up to 200X with an image storage system directly on USB.

Assessment kit KITVAL01

Optional accessories

CASEWFENDO3Trolley to transport the device.

STAWF01Stand with wheels that makes it easier to move the device inside the centre.

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YOUR VALUE

OUR PASSION

YOUR SUCCESS

University La Sapienza of Rome,IFO Hospitaller Physiotherapeutic Institutes-Rome,

Local Health Care Unit of:Milan, Venice, Palermo, Florence,

Padua, Udine, Treviso

WINFORM Medical Engineering srl

T. +39 0421 222026

info@winformweb.it

www.winformweb.it

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