The following is an excerpt from the original published work. The full article can be accessed on the PRIME Journal website.
BACKGROUND: Cellulite is a multifactorial condition characterized by a dimpled, ‘orange peel’ appearance of the skin and is associated with histologic changes in the dermis, adipose tissue and fibrous septae.1 The etiology of cellulite has not yet been fully elucidated; however, the efficacy of treatment strategies targeting fibrous septae suggests that these structures play a significant role in its development.1
Estimates suggest that cellulite affects approximately 80% to 90% of post-pubertal women of all races.2 No direct associations with morbidity or mortality have been identified, leading to the consideration of cellulite as a secondary gender-related characteristic of females rather than a disease process or pathological state. However, aesthetic concerns remain closely related to physical and psychological wellbeing.3 In regions of the world where there is more frequent body exposure, up to 80% of individuals have reported feeling pressure to seek cellulite treatment.4 These treatments have targeted some combination of adipose tissue, dermis, and fibrous septae, with varying degrees of success.1
OBJECTIVES: To evaluate the evidence for controlled focal subcision and acoustic subcision, and provide physicians and practitioners with an overview of studies examining these therapeutic options.
Note: The full review evaluated the evidence for three subcision treatments aimed at reducing the appearance of cellulite by targeting fibrous septae. This excerpt focuses on controlled focal subcision and acoustic subcision via a rapid acoustic pulse device.
METHODS: Clinical data on controlled focal subcision and acoustic subcision were obtained directly from the manufacturers.
Two published articles on the controlled focal subcision device, and one article on the rapid acoustic pulse device, were obtained from their respective manufacturers; however, no published randomized controlled clinical trials (RCTs) are yet available on these treatment modalities.
Treatment Modalities – A Summary:
Subcision-Based Treatments
Subcision is a surgical technique first described in 1995 in which subcutaneous fibrous septal bands tethered to the reticular dermis are divided.5 The resulting redistribution of mechanical tension and adipose tissue contributes to a smoother appearance of the skin. Subcision techniques include manual6, vacuum-assisted7 , and laser-assisted.8 However, these have been noted to have limitations, including operator dependence, bruising, hyperpigmentation and the persistence of post-procedural pain.9 The subsequent sections will address three novel approaches designed to minimize these adverse effects.
Controlled Focal Fibrous Septae Release Device Controlled focal fibrous septae release is a minimally invasive method designed for in-office use. This single-use instrument manually releases fibrous septae. Cellulite depressions are marked with the patient in a relaxed, standing position and local anesthesia is applied to these areas. The device is inserted into the subcutaneous adipose tissue and once at a marked area the operator reproduces the depression. Using the device’s sharpened link, the septae are then divided. This technique is designed to allow multiple depressions to be accurately and comprehensively treated through a small entry point, minimizing the risk of pain, scarring and adverse events.
An open-label, multi-center study evaluated female patients (n=20) aged 21- 55 with moderate-to-severe cellulite on the buttocks and thighs that underwent controlled focal fibrous septae release. Efficacy was measured by the primary endpoint of a ≥1 point reduction in Cellulite Severity Scale (CSS). 95% of patients achieved the primary endpoint at day 180 post-procedure, with a mean improvement of 2.6. In unblinded scoring of baseline and day 180 follow-up images, 100% of patients were rated as ‘much improved’ or ‘very much improved’ against the Global Aesthetic Improvement Scale (GAIS). Day seven post-procedure, 85% of patients reported satisfaction with the outcome, with low pain scores. No serious or unexpected adverse events were recorded.
In an earlier feasibility study, female patients (n=10) aged 21-55 with moderate-to-severe cellulite underwent the same procedure unilaterally on the buttocks and thighs.10 The primary feasibility endpoint was the number of subjects achieving a GAIS score improvement of ≥1 point 90 days post-procedure. The researchers reported that at day 90, most regional treatment areas (84.6%) demonstrated an improvement of ≥1 point in GAIS scores, while 90% of subjects achieved an improvement of ≥2 points.
These studies suggest that controlled focal septae release is safe, efficacious, and acceptable to patients. However, it is important to note that both studies have several design limitations and were not powered for assessment of statistical significance. Both studies were sponsored by the device manufacturer.
Acoustic Therapies for Cellulite
Acoustic wave therapy (AWT) has an established range of clinical applications and is widely utilized as a treatment for renal calculi and a range of musculoskeletal conditions.11 The use of AWT as a treatment approach for cellulite is also well-documented in the literature.
Generally, study results examining AWT as a treatment for cellulite have been inconsistent; however, three randomized control trials12,13,14 demonstrated a significant improvement in the appearance of cellulite. It is important to mention while these studies were designed to evaluate the effects of AWT on cellulite, none examined the effects on fibrous septae.
Rapid Acoustic Pulse Device Acoustic subcision is a non-invasive approach to cellulite treatment utilizing a rapid acoustic pulse device. The device is designed to use rapid acoustic pulses to non-invasively disrupt fibrous septae leading to tissue release, which results in the improvement of cellulite appearance. For treatment, target areas are identified on the buttocks or thighs and the patient is positioned on a bed in a prone or lateral decubitus position. An acoustic coupling hydrogel pad and hydrogel are applied to the marked treatment areas before one-minute doses of acoustic o local anesthesia is required for this procedure.
In an open-label, multi-center trial, female patients (n=56) aged 18-50 with moderate-to-severe cellulite on a six-point CSS, as determined by investigators, were enrolled to receive a single office-based treatment using the rapid acoustic pulse device.15 A total of 9-15 treatment areas were identified and one-to two minute-long doses of 50 Hz were administered to each area. Baseline and 12-week photographs were taken under standardized conditions and analyzed by three blinded, independent reviewers. The primary efficacy endpoint was a reduction of a simplified CSS score of ≥1. Secondary efficacy endpoints were the correct identification of >60% of post-treatment photographs by reviewers, an average improvement of cellulite appearance in GAIS scoring, and an average improvement of skin laxity in GAIS and skin Laxity Scale (LS).
The baseline CSS score was 3.41 (±0.89) and investigators reported that a statistically significant mean CSS reduction of 1.01 ±0.5 (p<0.0001) was noted by reviewers at 12 weeks compared to baseline images.
At 12 weeks, 90.9% of the treated cellulite sites were noted as appearing ‘improved’, ‘much improved’, or ‘very much improved’ using a GAIS score for cellulite appearance. A mean LS reduction of 0.57 from baseline was noted in treatment sites. The difference between the baseline and 12-week LS was statistically significant (p<0.0001). ><0.0001).
Patients largely found the procedure comfortable (76.8%) and felt their cellulite appearance had improved (92.9%). All adverse effects (AEs) were mild and self-resolving, and no serious or unexpected AEs were noted.
This study, sponsored by the device manufacturer, suggests that acoustic subcision is effective, tolerable and safe. It is worth noting that no data was provided on the percentage of patients that achieved the efficacy endpoints, only on individual treatment sites.
Furthermore, as previous studies of AWT modalities did not examine the effects on fibrous septae, focused analysis on their utility for acoustic subcision would enable more direct comparison with the other novel treatment modalities available for cellulite.
CONCLUSION: The advent of new subcision-based treatments is an exciting development for the treatment of cellulite. The studies reviewed suggest that these treatments are safe and efficacious; however, the clinical data for acoustic and controlled focal subcision modalities remains limited and warrants further investigation through future research.
References:
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13. Russe-Wilflingseder K, Russe E, Vester JC, Haller G, Novak P, Krotz A. Placebo controlled, prospectively randomized, double-blinded study for the investigation of the effectiveness and safety of the acoustic wave therapy (AWT®) for cellulite treatment. J Cosmet Laser Ther. 2013;15(3):155-62.
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15. Tanzi EL, Capelli CC, Robertson DW, LaTowsky B, Jacob C, Ibrahim O, et al. Improvement in the appearance of cellulite and skin laxity resulting from a single treatment with acoustic subcision: Findings from a multicenter pivotal clinical trial. Lasers Surg Med. 2022;54(1):121-8.
Editor’s Note: The original article State-of-the-art Treatment Modalities for Cellulite A Comprehensive Review is available and can be accessed online at: https://www.prime-journal.com/prime-journal-jan-feb-2023/ page 50
