A temperature-controlled radio frequency combined with ultrasounds and laser for skin laxity and cellulitis

Abstract

Skin laxity and Oedematous Fibrosclerotic Panniculopathy are common issues affecting the women population. Finding and developing treatments to counteract ageing indications and conform to social norms of beauty has been increasingly important in aesthetic medicine in recent times. Many non-invasive techniques, including radiofrequency, lasers, and ultrasounds, have been created. This study used a multi-handpiece device with laser (808 nm) and ultrasound (37 kHz) handpieces, as well as radiofrequency and various temperature-controlling applicators depending on the body site (3 or 6 tips). Based on their clinical features, 12 women with skin laxity on their arms, face/neck area, or lower limbs at phases I–III were divided evenly into two study groups. The majority of patients reported ‘Excellent-3’ treatment outcomes after it was over, and their impression of the course of treatment was generally better than the investigators. An objective analysis of the anthropometric measurement data shows a progressive decrease in circumferences, tight plicometry and body weight. In summary, the specific use of an radiofrequency handpiece with a temperature sensor decreased the likelihood of side effects, even with a small study population group. This increased patient compliance with treatment and overall satisfaction with the outcomes.

Introduction

Skin laxity and Oedematous Fibrosclerotic Panniculopathy (OFP) are very common problems affecting especially women population. In recent years, it has been crucial specifically for aesthetic medicine to find and improve technologies to contrast the signs of ageing and adjust to aesthetic social standards. Indeed, various non-invasive solutions have been developed such as ultrasounds (US), lasers and radiofrequency (RF). ¹ Specifically, RF can be used for many different applications such as the lifting of the brachial region with RF-assisted liposuction. ² More often, a combination of the aforementioned medical techniques is recommended, especially when OFP needs to be treated. As a matter of fact, it can be considered a chronic degenerative process of the hypodermal layer structures. It identifies changes in the subcutaneous adipose panniculum, and it is clear evidence of the suffering condition of the fat cells. This is due to haematic stasis followed by oedema, degeneration of the fundamental interstitial substances and collagen fibres, fragmentation of the elastic fibres and increase in the number (hyperplasia) and thickness (hypertrophy) of the reticular fibres, finally resulting in sclerosis. ³

When skin laxity is considered, targeting fibroblasts’ metabolism and local blood circulation with heat may be a solution because of the stimulation of elastin fibres and collagen self-regeneration processes. Indeed, fibroblasts produce collagen molecules organized in a triple helix structure that is the first one involved in the denaturation phenomenon of thermal shrinkage. Heat can transform these molecules from a highly ordered crystalline form to a randomly distributed and gel-like shape. ⁴ When heated, fibroblasts are also implicated in neocollagenesis and subsequent tissue remodelling, contributing to better skin tone and tightening. For this reason, regardless of the handpiece used during the treatment, it is crucial to maintain the correct temperature to avoid side effects. In detail, the US upon crossing through the skin induces vibrations in the adipocytes, thus exerting a mechanical massage. ⁵ This consequently produces ruptures of the fibres surrounding the adipocytes, thereby reducing fibrosis and stimulating vascular circulation, whereas the infrared deep laser stimulation reactivates the arterial, venous and lymphatic micro-circulations and also has beneficial effects on fibroblast activity. Finally, the RF stimulates the contraction of the collagen fibres and activates the microcirculation. ⁶ Depending on the handpiece used during treatment and the specific movements exerted by the operator, RF can be used not only for cellulitis and skin flabbiness but also to support the improvement of skin tone and induce drainage of excess fluids. ⁷

Case series: Cases 1–12

In this study, a multi-handpiece device (Triactive+, Deka M.E.L.A., Calenzano, Italy) was used. It is equipped with RF with different temperature-controlling applicators depending on the body site (3 tips: Very Small, Small, Medium, Large; 6 tips: Hexapolar), laser (808 nm) and US (37 kHz) handpieces. The patients were asked not to change their habits and daily lifestyle, neither on a nutritional level nor a physical activity level to prevent confounding factors. Written informed consent was obtained from the whole study population. They were 12 women with a mean age of 45 years. They were equally split into two study groups based on their clinical characteristics. Group I was characterised by important skin laxity on the face and neck area (67%, 4 patients) and arms (33%, 2 patients). The patients underwent six treatment sessions (2/week) with laser and RF (3-tip applicator). Specifically, the laser treatment was performed on the area with linear movements directed toward the closest lymph node station (supraclavicular and lateral-cervical for the face/neck area; axillary for the arms) for 3 min. The face area was further divided into subareas (cheeks; right and left neck) and treated with a power of 6–10 W depending on the handpiece tip used, for 20–25 min with circular movements. On the arms, the session lasted 10 min at a power up to 50 W.

Differently, Group II showed OFP of lower limbs at stages I-II-III. They underwent 10 sessions of sequential US, laser and RF (1/week). The US was always performed in the first place, and the sessions were gradually reduced during the whole cycle of treatment in favour of the RF treatments. In detail, US parameters were set based on the patient tolerability. No pain should be perceived but a vibrating sensation. Then, the laser session was performed for 5 min with linear movements towards the nearest lymph node station. Lastly, for the RF, the power was set up to 50 W, and the handpiece used was tripolar with a sensor controlling and maintaining constant the correct temperature on the skin (41°C). Apparently, 40–48°C is the ideal epidermal surface temperature since this correlates with a dermal temperature of 70°C required for the denaturation of collagen. ⁸ The parameters set reduced the side effects and made the treatment easier to tolerate and complete. Indeed, treatment side effects, such as localized purpura, mild ecchymosis, erythema, heat sensation and pain in the treatment area, were monitored. None was observed during or at the end of the treatment course. For Group I, a 4-point Global Aesthetic Improvement Scale (GAIS) (None-0, Slight-1, Mild-2, Excellent-3) ⁹ was used by the investigator to evaluate the wrinkle level and assess the improvement patient’s skin tone after the last treatment (T₁) compared to baseline (T₀). On the other hand, for Group II, clinical measurements concerning body weight, waist–hips–tight–calf circumferences and tight plicometry were taken at T₀ and after 5 and 10 treatments. Eventually, for the whole study population, a Self-Assessment Form (SAF; None-0, Slight-1, Mild-2, Excellent-3) ¹⁰ was administered to evaluate the subjects’ satisfaction at T₁ (see Table 1) and standardized clinical photos of the body areas treated at T₀ and at T₁ were taken (Figure 1).

Table 1.

Results’ detail for each study group. Group I showed important skin laxity on the face and neck area or arms. Group II showed OFP of lower limbs at stages I-II-III. For Group I, a 4-point Global Aesthetic Improvement Scale (GAIS) (None-0, Slight-1, Mild-2, Excellent-3) was used by the investigator to assess the improvement patient’s skin tone before vs after the treatment. However, a Self-Assessment Form (SAF) was used to evaluate the subjects’ satisfaction at the end of the course of treatment. For Group II, anthropometric measurements concerning body weight, circumferences and tight plicometry were taken at baseline and after 5 (T × 5) and 10 (T × 10, T1) treatments.

Group I
	GAIS (Investigator) %
None-0
Slight-1	10
Mild-2	30
Excellent-3	20
Group II
Body weight (kg)	T0	T × 5	T × 10 (T1)
	66.4	66.25	66.05
Body circumferences (cm)
Waist	79.45	79.1	78.6
Tight	54.83	53.8	53.15
Hips	96.85	96.3	96.3
Calf	37.15	37.1	36.95
Tight plicometry (cm)	3.71	3.46	3.36
Groups I and II
SAF (patient) %
None-0
Slight-1	10
Mild-2	20
Excellent-3	30

Figure 1.

Three different patient area treatments are shown as examples. For every subject, pre- and post-treatment evaluations were made. Patients were equally split into two study groups based on their clinical characteristics. Group I showed important skin laxity on the face and neck area or arms. This group underwent six treatment sessions (2/week) with laser and RF. Differently, Group II showed OFP of lower limbs at stages I-II-III. (a) Group I patient, face treatment. (b) Group I patient, arm treatment. (c) Group II patient OFP treatment.

Discussion

Skin laxity and cellulitis are very common aesthetic problems that affect the women population especially. For this reason, it is very important to always find new and effective strategies to try to improve the patient’s condition. As Mulholland et al. ¹ already described the treatment of OFP is not standard and often not fully resolutive. For this reason, the best approach is a combination of strategies such as the one described in this study with US, laser and RF. Indeed, our results showed general improvement in all body areas after the combined treatment. For example, a sensible reduction in lower-limb body circumferences was noted. These achievements were also confirmed by the patient’s perception. This was better than the investigators’ since most of them reported ‘Excellent-3’ results after the treatment. Objectively, when the anthropometric evaluation data are analyzed, a progressive reduction in body weight, circumferences and tight plicometry are registered. Moreover, it is relevant to acknowledge the limitations of the study. Indeed, there was no parameter of objective laxity/tightening such as US or cutometer device to assess the patients’ condition after the treatment.

Conclusions

In conclusion, our study confirmed the existing data in the literature about the combination of US, laser and RF as a highly effective solution for treating skin laxity and OFP. Moreover, thanks to the quick warming-up step, it has been possible to maintain a constant and homogeneous temperature over the whole treated body area. Indeed, even if the study population group was small, the specific use of an RF handpiece with a temperature sensor reduced the possibility of side effects raising patient compliance with treatment and general satisfaction with the results achieved.