Correction of horizontal forehead wrinkles

Authors:

Vincent Wong, MD, consultant and trainer in aesthetic medicine, La Maison de l'Esthetique clinic (London, UK)

Fabien Giosserand, MD, specialist in aesthetic and anti-aging medicine, Center Laser Liberte (Lille, France)

Source: " Prime. Europe", march 2014, vol. 4, is. 2. Translation published in KOSMETIK international journal, No. 4 (58) / 2014, pp. 34-39 with the permission of the authors

* This study is independent and the authors did not receive funding from the developer. Dr. Vincent Wong is an authority on the use of the Iovera device, but is not employed by Myoscience, Inc. Dr. Fabien Giosserand is also not associated with this corporation

Reference Information:

It is traditionally believed that cryoneuromodulation can only be achieved through cryosurgery. However, the use of extremely low temperatures (approximately -180 °C) may pose a risk of damage to nervous system functions.

Focused cold therapy (FCT) is a platform technique from Silicon Valley-based medical technology company Myoscience, Inc. (Redwood City, California), and uses a more moderate but effective therapeutic temperature range to achieve cryoneuromodulation. SCT provided by the Iovera® device for the reduction of dynamic facial wrinkles has been used in Europe since April 2013 (in the US it is currently used only for pain relief).

Purpose of the study: to study the effectiveness of SCT on horizontal dynamic forehead wrinkles.

Methods: SCT treatment using the Iovera® device was performed on men and women aged 20–65 years with flat or concave temples and the presence of dynamic wrinkles in the forehead in varying degrees of severity - from moderate to severe (with maximum eyebrow elevation). The severity of wrinkles was assessed using the facial wrinkle scale (FMS) before and after SCT. The results were compared and analyzed using the Wilcoxon test. In addition, patients also rated the change in the severity of dynamic wrinkles on a 9-point scale and their degree of satisfaction on a 7-point scale.

Results: The study involved 25 patients aged 23–52 years. The average score of wrinkle severity at maximum eyebrow elevation was reduced by 2.24 times after SCT (0.44 ± 0.6) compared to before treatment (2.68 ± 0.5) (p < 0. 0001). 24 patients (96%) reported improvement in horizontal dynamic forehead wrinkles immediately after the procedure, and all study participants were generally satisfied with the treatment.

Conclusions: SCT is an effective method for reducing horizontal dynamic forehead wrinkles. This new non-toxic approach produces immediate results without leaving any marks on the patient's face. The treatment itself is well tolerated and has a high rate of patient satisfaction.

The ideal aesthetic treatment, according to demanding patients, is one that not only improves appearance, but is also “natural.”

Cold exposure was used for therapeutic purposes for centuries before being adapted by modern medicine [1]. Local application of cold in a small temperature range (from +10 to –5 °C) provides a block of nerve conduction, which can last from several hours to several days [2–3]. Traditionally, cryoneuromodulation was thought to be achieved solely through cryosurgery; however, despite its proven safety over decades of clinical use, cryosurgery involves the use of extremely low temperatures (around -180°C), which can lead to dysfunction of the nervous system [4]. ]. However, today, thanks to technological developments, cryoneuromodulation results can be achieved at more moderate but effective therapeutic temperature ranges using focused cold therapy (FCT).

SXT was developed by specialists from Myoscience, Inc. (California), specializing in the production of medical equipment, and is carried out using Iovera portable devices. Regarding its use in aesthetic medicine, now with this technology we can achieve temporary muscle relaxation and therefore a reduction in dynamic wrinkles, while the impulse conduction of the motor nerves is blocked without the use of neurotoxins. That is, this is an alternative method for correcting wrinkles for those patients who are opposed to the use of neurotoxins or are resistant to them.

During SCT, low temperatures block signal transmission by the temporal (motor) branches of the facial nerve. The target branches for the SCT are those that innervate the frontalis and corrugator muscles. When the target nerve is exposed to low temperatures (-20 to -88.5 °C), axonal and myelin degeneration occurs, causing secondary or Wallerian degeneration [5]. Because degeneration occurs instantly, cosmetic results can be seen immediately after the procedure is completed. In contrast to more traumatic nerve injuries resulting from the application of lower temperatures to the target nerve, SCT does not affect the acellular components of the nerve (i.e., endoneurium, perineurium, and epineurium), allowing normal axonal regeneration and remyelination within 16 weeks [6]. Animal studies by Hsu et al. [4], showed that SCT does not cause any permanent or long-term changes in the function or structure of motor nerves.

SXT has been commercialized and used in cosmetology in the UK since April 2013. Although SCT can help reduce both horizontal forehead lines and vertical glabellar lines, this article will focus on the effectiveness of this technique on horizontal frontal lines. The material presents clinical data and reviews of 25 patients who underwent treatment.

Patients and methods

We conducted a prospective, sequential study of the effectiveness of focused cold therapy on horizontal dynamic forehead wrinkles performed by a single physician. Consent was obtained from each patient prior to procedures.

Patients

Eligible patients were men and women aged 20–65 years with flat or concave temples and dynamic forehead wrinkles (moderate to severe at maximum brow elevation). The results were assessed using the facial wrinkle scale (FMS) (Table 1).

Table 1. Clinical evaluation criteria

Exclusion criteria were any medical conditions for which cold exposure is not recommended (eg, cryoglobulinemia, paroxysmal, cold hemoglobinuria, cold urticaria, and Raynaud's disease). Patients with open or infected wounds and existing neuromuscular diseases were also ineligible for participation in the study.

Treatment

During SCT, the temporal branches of the facial nerve were treated using an Iovera mobile device, which delivers compressive liquid nitrous oxide into a closed 27-gauge probe with three 6.9-mm-long needles.

After marking and numbing the area with subcutaneous injections of 2% lidocaine (without epinephrine), patients lay supine. The above probe, connected to the Iovera device, was inserted into the temporal region, filled with a cold agent, resulting in the formation of a cold zone around the temporal branches of the facial nerve. Each procedure consisted of 4–6 cycles of SCT on each temple (one cycle per probe insertion).

Performance criteria

The severity of dynamic wrinkles was assessed by a doctor using a SLM before and after treatment. Patients assessed changes in the severity of dynamic wrinkles on a 9-point scale and determined their satisfaction with treatment on a 7-point scale. Results of more than 2 points were considered improvement, and results of 6 points and above were considered complete satisfaction.

Security measures

Adverse events were noted based on patient reports and physical examination performed by the investigator.

Statistical analysis

The results of the severity of wrinkles before and after the procedure were analyzed for statistical significance using the Wilcoxon test.

results

The study involved 25 patients (22 women, 3 men) aged 23–52 years (mean age 35.6 ± 7.7 years).

All patients before the procedure had moderate to severe dynamic forehead wrinkles with maximum eyebrow elevation.

Table 2. Distribution of patients based on the assessment of SLM before and immediately after SCT ( * assessment was carried out at maximum eyebrow elevation)

As can be seen from the table, the assessment of wrinkles with maximum eyebrow elevation decreases immediately after SCT. An improvement in the severity of horizontal dynamic wrinkles on the forehead was observed in each patient.
After SCT, the average score of wrinkle severity at maximum eyebrow elevation decreased by 2.24 times (0.44 ± 0.6) compared to what it was before treatment (2.68 ± 0.5) (p <0.0001) .

24 patients (96%) reported a significant reduction in the severity of wrinkles immediately after the procedure, 1 patient (4%) reported a slight improvement.

Rice. 1. Reduction in the severity of dynamic forehead wrinkles (with maximum eyebrow elevation), according to study participants: 24 patients (96%) noted a significant improvement (1 patient (4%) noted a moderate improvement, 7 patients (28%) noted a noticeable improvement, 16 patients (64%) noted complete improvement); one patient (4%) noticed a slight improvement (considered minor)

6 patients (24%) were satisfied with the treatment, 19 patients (76%) were very satisfied.

Rice. 2. Patient satisfaction with treatment using SCT: 6 patients (24%) were satisfied and 19 patients (76%) were very satisfied with the results

conclusions

This study shows that SCT is an effective method for reducing the severity of horizontal dynamic forehead wrinkles. A new, non-toxin approach produces immediate results: no wrinkles on the forehead. The treatment itself is well tolerated and provides high levels of patient satisfaction.

Discussion

The temporal branch of the facial nerve is divided into three branches, namely anterior, middle and posterior [7]. The anterior branch innervates the orbicularis oculi muscle and the corrugator muscle, the middle branch innervates the frontalis muscle, and the posterior branch innervates the anterior and superior auricular muscles and the tragus muscle.

The course of treatment for the temporal branch of the facial nerve in the temporal region varies considerably between individuals, so the number of SCT cycles required for each temple cannot be accurately predicted [7–9]. In addition, SCT requires more time than when correcting facial wrinkles with neurotoxin-based drugs, especially during the patient’s first visit.
It is during the first visit that the doctor “maps” the unique branching of the nerves, assessing each SCT cycle and recording the cycles that gave a positive result. When the patient comes for the next treatment procedure, only positive cycles are repeated. Consequently, on the patient’s second visit, the duration of the procedure is significantly reduced. Typically, the first procedure takes approximately 1 hour, and subsequent procedures take less than 30 minutes.

Apart from the differential course, the depth of the branches in the temporal region may also be influenced by the thickness of the subcutaneous fat and temporal parietal fascia [8–9]. Since the thickness of the subcutaneous fat layer is usually directly related to the temporal contour, treatment with SCT is only suitable for patients with a flat or concave temple [9].

CHT is not a new concept. Myoscience, Inc. improved the method of influencing specific peripheral nerves and adapted it to influence the facial nerve for aesthetic purposes.

As with all treatments, safety is key. The mechanisms of axonal degeneration and regeneration are well understood, and unless SCT causes grade 3–4 degeneration, permanent effects on the nerve cannot be achieved [10]. At the boiling point of nitrous oxide (–88.5 °C), it is impossible to injure the target nerve beyond secondary (Wallerian) degeneration when using SCT [4, 10]. Adverse effects of SCT in the study were minimal and comparable to the side effects that may occur after injection procedures. Observed side effects included bruising, swelling, redness of the treated area, and short-lived pain associated with the swelling.

As shown in the study, direct application of SCT to the temporal branches of the facial nerve leads to a temporary decrease in the severity of dynamic wrinkles. Current treatments for dynamic wrinkles involve the use of neurotoxins that inhibit nerve signaling, sometimes with unwanted side effects [11]. The need for periodic neurotoxin injections has also led to immunoresistance in some aesthetic areas [11]. SCT offers an alternative to toxin to relax specific muscle groups with reproducible results and without the risk of long-term side effects.

Flexible alternative

An additional advantage of treatment with SCT is flexibility: doctors can tailor treatment according to the patient's wishes. Some patients want to maintain natural facial expressions, and professionals can help ensure this desire by involving the patient in midterm treatment evaluations. For example, one of the participants in this study wanted only minor improvements in horizontal dynamic forehead wrinkles and was satisfied with the results with an improvement score of 1 point (which was not considered a significant improvement). Since axonal regeneration occurs at a rate of 1-2 mm per day, muscle contractility and associated dynamic wrinkles will return gradually over 16 weeks after treatment with SCT.
Thanks to the SCT platform technology, doctors now have a gentle, safe and elegant device for temporarily inhibiting the motor nerves whose activity is associated with the formation of dynamic wrinkles on the forehead and glabella. Injections of neurotoxins often cause side effects; SCT, in turn, offers an effective alternative to meet the aesthetic demand for the treatment of dynamic wrinkles.

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