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Clinical Papers

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ORIGINAL ARTICLE IN Journal of Dermatological Treatment

Clinical and Histopathological Study of the TriPollar Home-Use Device for Body Treatments

S.Boisnic1 ,   M.C. Branchet2,  O. Birnstiel3 , G. Beilin4 

ABSTRUCT

Background: Professional non invasive treatments for body contouring based on radiofrequency (RF) became popular in aesthetic clinics due to proven efficacy and safety. A new home-use RF device for body treatments has been developed based on TriPollar™ technology.

Objective: To evaluate the TriPollar home-use device for circumference reduction, cellulite improvement and skin tightening using objective and subjective methods.

Methods: An ex-vivo human skin model was used for histological and biochemical evaluations of the TriPollar clinical effect. Additionally, twenty four subjects used the new device at the abdomen and thighs areas and circumference reduction was measured.

Results: Ex-vivo model indicated a significant increase of 82% in hypodermal glycerol release. Histology revealed 34% alteration of adipocytes appearance. Collagen synthesis increased by 31% following TriPollar treatment.
A significant average reduction of 2.4 cm was measured on the treated thighs. On the control thighs a lesser, non significant reduction was found. Average abdominal laxity was reduced from 1.4 at baseline to 0.8 following treatments.  A certain reduction was measured in the abdomen circumferences although not significant. 

Conclusions: The reported results demonstrated safety and efficacy of the new TriPollar home-use device for body contouring and skin tightening. Treatments may yield to discrete circumference reduction and moderate laxity improvement.


 

 

ORIGINAL ARTICLE IN Journal of Dermatological Treatment

Ex vivo study of the home-use TriPollar RF device using an
experimental human skin model

SYLVIE BOISNIC1,2 & MARIE CHRISTINE BRANCHET2

ABSTRUCT

Background: A wide variety of professional radio frequency (RF) aesthetic treatments for anti-aging are available aiming at skin
tightening. A new home-use RF device for facial treatments has recently been developed based on TriPollar technology.

Objective: To evaluate the mechanism of the new home-use device, in the process of collagen remodeling, using an ex vivo skin
model. Methods: Human skin samples were collected in order to evaluate the anti-aging effect of a home-use device for facial
treatments on an ex vivo human skin model. Skin tightening was evaluated by dermal histology, quantitative analysis of
collagen fibers and dosage of collagen synthesis. Results: Significant collagen remodeling following RF treatment with the
device was found in the superficial and mid-deep dermis. Biochemical measurement of newly synthesized collagen showed an
increase of 41% in the treated samples as compared to UV-aged control samples.

Conclusions: The new home-use device has been demonstrated to affect significant collagen remodeling, in terms of the structural and biochemical improvement of dermal collagen on treated skin samples.
 

 

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ORIGINAL ARTICLE IN Medical Journal of Dermatological Treatment

Treatment of striae distensae with a TriPollar radiofrequency device: A pilot study
 

By: Woraphong Manuskiatti, Einapak Boonthaweyuwat, Supenya Varothai
Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand

ABSTRUCT

Background: Striae distensae are a frequent skin condition for which treatment remains a challenge. Objectives: To determine
the efficacy and safety of a TriPollar radiofrequency (RF) device for the treatment of striae in skin phototypes IV–V.
Methods: Seventeen females with striae received six weekly treatments with a TriPollar RF device. The participants were evaluated
using standardized photographs and a UVA-light video camera at baseline, and at 1 and 6 weeks after the final treatment.
Side effects of treatment were recorded at every session.
Results: At 1 week after the final treatment, 38.2% and 11.8% of the subjects were assessed to have 25–50% and 51–75% improvement of their striae, respectively. Compared with the 1-week follow-up, at the 6-week follow-up a higher percentage of the subjects were rated to have improvement of their striae. There were no significant differences in the striae surface smoothness at the 1- (p = 0.907) and 6-week (p = 0.057) follow-ups, compared with that of baseline. Twelve percent (2/17), 23% (4/17), and 65% (11/17) of the study subjects rated their satisfaction of the overall improvement as slightly satisfied, satisfied, and very satisfied, respectively. No adverse effect was reported.
Conclusion: TriPollar RF appears to be a promising alternative for the treatment of striae distensae.
 

 ORIGINAL ARTICLE Circumference reduction and cellulite treatment with a TriPollar radiofrequency device: a pilot study

W Manuskiatti, C Wachirakaphan, N Lektrakul and S Varothai

Department of Dermatology and Department of Radiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand

ABSTRUCT

Background
A wide variety of treatments for circumference reduction and cellulite are available, but most procedures offer suboptimal clinical effect and/or delayed therapeutic outcome.
Objective
To determine the safety and efficacy of the TriPollar radiofrequency device for cellulite treatment and circumference reduction.
Methods
Thirty-nine females with cellulite received eight weekly TriPollar treatments. Treatment areas included the abdomen, thighs, buttocks and arms. Subjects were evaluated using standardized photographs and measurements of body weight, circumference, subcutaneous thickness, and skin elasticity of the treatment sites at baseline, immediately after and 4 weeks after the final treatment. Physicians’ evaluation of clinical improvement scores using a quartile grading scale was recorded.
Results
Thirty-seven patients (95%) completed the treatment protocol. There was significant circumference reduction of 3.5 and 1.7 cm at the abdomen (P=0.002) and thigh (P=0.002) regions, respectively. At 4 weeks after the last treatment, the average circumferential reductions of the abdomen and thighs were sustained. No significant circumferential reductions of the buttocks and arms at the last treatment visit compared to baseline were demonstrated (P=0.138 and 0.152, respectively). Quartile grading scores correlating to approximately 50% improvement in cellulite appearance were noted.
Conclusions
Tripollar radiofrequency provided beneficial effects on the reduction of abdomen and thigh circumference and cellulite appearance.

ABSTRUCT

Background It has been well established that Asian skin types are more sensitive to laser or IPL treatments (light-based treatments) due to a larger concentration of melanin in the skin. A new non-ablative treatment modality based on selective electro-heating, TriPollar RF Technology, was recently introduced aimed at skin tightening for skin laxity and circumference reduction on facial, neck and arm skin. As this new treatment does not utilize any type of light it is not skin color dependent and is wholly suitable for Asian skin types.

 

Objective This study aims to determine the clinical efficacy and safety of the non-ablative regen™ system, employing TriPollar RF technology, in the treatment of skin tightening and circumference reduction of facial, neck and arm skin in Asian skin types.

Method 100 Asian adult patients with lax and excess fatty facial, neck and arm skin were recruited for the study. Using the regen™ system, the patients underwent a regimen of one TriPollar RF treatment at weekly intervals. Throughout the study, before and after each treatment, the patient’s progress was photographically documented. Treatment continued until expectations were met. These results were evaluated during a final clinical assessment, which included patient self assessment as well.

 Results Immediate visible results were noticed from the first treatment. As seen in the photographs below (fig. 7), the patient’s results, observed gradually over the full course of treatment, revealed a significant circumference reduction and observable lifting of sagging skin. The patient’s self assessment after the full course of the treatment was “excellent”. This patient experienced no adverse side effects during or after any of the treatments. Further, throughout the study none of the patients experienced any need for downtime following the treatments.

 Conclusions This clinical study concluded a very good overall improvement in skin laxity and circumference reduction with absolutely no downtime for any patients. The TriPollar RF treatments are safe and effective for skin tightening and circumference reduction on Asian skin types. Further studies are needed to optimize the number and frequency of treatments.

 

ABSTRACT:

Background It has been well established that TriPollar RF treatments depict immediate visible results. The question of long term collagen remodeling and maintaining the clinical results have been addressed in this study by way of thorough analysis.
 
Objective This study aims to determine the long term clinical efficacy and safety of the non-ablative regen™ system, employing TriPollar RF technology, in the treatment of skin tightening and circumference reduction of facial, neck and abdominal skin.
 
Method Subjects enrolled in the study were healthy female patients between the ages of 18-65 with lax and excess fatty facial, neck and abdominal skin were recruited for the study. Using the regen™ system,the subjects (patients) underwent a regimen of 8 TriPollar RF treatments at weekly intervals. Throughout the study, before and after each treatment, the patient’s progress was photographically documented. Treatments continued until expectations were met. These results were evaluated during a final clinical assessment 6 months after the last treatment, which included patient self-assessment as well.
 
Results Immediate visible results were noticed from the first treatment. The patient’s results, observed gradually over the full course of treatment, revealed a significant circumference reduction and observable lifting of sagging skin. Further, these clinical results improved 6 months after last treatment due to collagen remodeling. The patient’s self-assessment after the full course of the treatment was “excellent”. No adverse side effects during or after any of the treatments. Further, throughout the study none of the patients experienced any need for downtime following any of the treatments.
 
Conclusions This clinical study concluded a very good overall improvement in skin laxity and circumference reduction with absolutely no downtime for any patients.The TriPollar RF treatments are safe and effective for non-surgical face lifting, skin tightening and circumference reduction on all skin types. Long term results are excellent.

 

 ABSTRACT:

Background: It is well established that individuals are able to lose large amounts of weight by gradually reducing the volume of stored fat at the individual fat cell level by the process of lipolysis. The aesthetic problem for most individuals who achieve modest or even significant
degrees of weight loss, is that the adipose tissue volume reduction is often not lost from the specific anatomical sites they desire (e.g. tummy, buttock, thigh), but occurs rather unpredictably from all anatomical areas. Recently a new treatment modality based on selective electro-heating (TriPollar RF Technology) was introduced for inducing lipolysis and skin tightening in specific body sites.
 
Objective: To clinically test the safety and efficacy of the regen™ system using TriPollar RF technology for waist circumference reduction.
 
Method: A 31 year old woman having normal weight and waist size underwent 8 weekly TriPollar RF treatments using the regen™ system. Each treatment session lasted 45 minutes, initial skin temperature in the treatment area was 290C and at the end of each treatment session increased to 400C.
 
Results: A significant circumference reduction of 5cm was gradually observed during the treatment course. The patient’s self-assessment after the 8th treatment was “excellent”. There were no adverse side effects during or after the treatments.
 
Conclusions: The TriPollar RF treatments are safe and effective for circumference reduction. Further studies are needed to optimize the number and frequency of treatments.

 

ABSTRACT:
 
Cellulite is one of the most disturbing and challenging skin disorders affecting the lives of more than 80% of women worldwide. Current treatments consist of: Liposuction, deep mechanical massage, applying pharmacological agents, exercise and diet regimens. Any of these treatments can reduce the signs of cellulite and its symptoms to some extent and only temporarily. It is now evident that weakened connective tissue, enlarged fat cells, and diminished micro-circulation, play key roles in the patho-physiology of cellulite. Therefore, long term correction of cellulite is possible through the modification of weakened connective tissue, reducing fat cell size and improve the overall function of micro-circulation. Regen™, from Pollogen™ Ltd., is an innovative system for the treatment of cellulite and skin tightening using TriPolar™ RF technology. The combined effect of uni-polar RF and bi-polar RF is a unique feature of this technology and provides simultaneous deep and shallow dermal heating/tightening. Treatment results include: reduction in size of fat cell size, enhancement of micro-circulation, enhancement of lymphatic drainage and controlled inflammation. The cosmetic effect is an immediate visible reduction of cellulite and skin tightening.

 

 

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