J Clin Aesthet Dermatol. 2023;16(2):24–28.
by Anwar Elawar, MD; Audrey Livache, MTA; Stéphanie Patault, LPN; and Damien Vila, PHYS
Dr. Elawar, Ms. Livache, and Ms. Patault are with the Aesthetic Dermatological Laser Center in Marseille, France. Mr. Vila is with the Faculty of Medicine of Montpellier-Nîmes at the University of Montpellier in Montpellier, France.
ABSTRACT: Background. Photobiomodulation therapy (PBMT) can significantly reduce inflammation and relieve pain, including postoperative pain and edema. The study aimed to evaluate the performance of a photobiomodulation-based device that includes a static magnetic field (SMF) to treat laser- or intensive and fractional radiofrequency-related side effects, such as pain, redness, and edema in patients treated for different dermatological conditions.
Methods. The study had a prospective, non-randomized, single-center design. Male and female patients aged 18 years or older underwent one or two PBMT-SMF (anti-inflammatory or anti-edematous) sessions on the same day, once or twice a week, after laser or radiofrequency facial treatments due to various dermatological disorders. Variables and efficacy assessments were pain, redness, edema, and their reduction from baseline to the last visit.
Results. Twenty-seven patients were included, seven (25.9%) men and 20 (74.1%) women, with a mean (SD) age of 43.7 (14.1) years. Seven (25.9%) patients were treated with radiofrequency, and 20 (74.1%) patients with a vascular laser (three [15%] for angioma, two [10%] for scars, three [15%] for erythrosis, and 12 [60%] for rosacea). After the PBMT-SMF protocol, overall mean pain reduction was 40 percent, and redness and edema reduction were shown by the pictures taken before and after the PBMT-SMF procedure.
Limitations. The primary limitations were the small number of patients and no quantitative variables for redness and edema.
Conclusion. PBMT-SMF reduced edema and inflammation after treatment with lasers or intensive or fractional radiofrequency for facial conditions, and probably, analgesic and anti-inflammatory drugs.
Keywords: Photobiomodulation; edema; erythema; low-power light therapy; light-emitting diode phototherapy; side effects; static magnetic fields; low-level laser therapy.
Lasers like pulsed dye laser (PDL) and energy-based devices like intense pulsed light (IPL) or intensive and fractional radiofrequency (RFI and RFF) are feasible to treat facial dermal conditions, such as acne or folliculitis, among others. Some benefits observed after their application are an improvement in unwanted facial appearance, facial redness, telangiectasias, and a reduction of superficial veins.1 These technologies activate growth factors, increasing vascularity, collagen, extracellular matrix production, and epithelium thickness.2 However, they are associated with mild postoperative side effects. After laser procedures, discomfort, erythema, and edema can occur, leading to a temporary increase in tissue thickness, vascularization, and redness.3
Although RFI and RFF are safe and effective in treating dermatological conditions, there is little literature on adverse reactions or side effects after the treatment session.4–6 Nevertheless, in a small number of cases, edema, burning, crusting, or long-lasting erythema may occur after treatment.7,8
Photobiomodulation therapy (PBMT), also known as low-level laser (light) therapy (LLLT), is a non-invasive therapy based on lasers or light-emitting diodes (LEDs) light that produces low-intensity light and cellular photoactivation. With this technology, valuable bioreactions can be achieved without heat or damage to promote tissue healing and regeneration.9–11 PBMT can significantly decrease inflammation and relieve pain, including postoperative pain and edema.11,12 Static magnetic fields (SMFs) can interact with several biological processes modulating cellular metabolism.13 Regarding the effect of SMFs on ROS levels, we have found that, although most studies showed that SMFs increased ROS levels,14 others have found opposite effects, observing a decrease in ROS production.15 In addition, some evidence also indicates that SMFs did not affect ROS levels.16 The combination of PBMT with SMF (PBMT-SMF) could offer a complementary therapy by attenuating oxidative stress.17
This study aimed to evaluate the performance of a PBMT-SMF device on pain, redness, and edema in patients treated with lasers, RFI, or RFF for different dermatological conditions.
Study design and participants. A prospective, non-randomized, single-center study was conducted at the Aesthetic Dermatological Laser Center (Marseille, France). Patients underwent PBMT-SMF (anti-inflammatory or anti-edematous) sessions to reduce the side effects of facial laser, RFI, or RFF treatments for various dermatological pathologies.
Eligible patients were adults aged 18 years or older who had previously received facial treatment with laser, RFI, or RFF for various dermatological conditions and reported pain after treatments through the visual analog scale (VAS) for pain. Patients were excluded if they had no pain, epilepsy, photosensitivity, or implantable devices sensitive to magnetic fields.
The study was conducted following the principles outlined in the current revised version of the Declaration of Helsinki, Good Clinical Practices (GCPs), and in compliance with all applicable laws and regulatory requirements relevant to the use of devices in France. After meeting the inclusion criteria and agreeing to participate, patients received the appropriate PBMT-SMF treatment according to medical criteria.
Study visits and procedures. PBMT-SMF procedures were carried out using the Milta Derm device (Milta-Physioquanta, Mudaison, France). Milta Derm technology is based on PBM and combines a Nano-Pulsed Cold Laser (NPCL), infrared, and LED lighting that stimulates fibroblasts’ activity18 and an SMF that increases collagen and elastin synthesis. Some studies have shown that combining SMF and PBMT improves the results for several conditions.19–21 This technology is suitable for all skin phototypes, and it is indicated to treat many conditions such as pain, dermatosis, acne, burns, or edema, and for rejuvenation or hair treatments. The technical characteristics of the device are shown in Table 1.
Two types of treatments were carried out: 1) a 10-minute anti-inflammatory treatment with red and infrared (IR) pulsed light at 1000 Hz; and 2) a 10-minute anti-edema treatment (3.33 min. with violet and IR pulsed light at 1000 Hz; 3.33 min. with yellow and IR pulsed light at 15 Hz; 3.33 min. with yellow and IR light at 24.3 Hz). The type of PBMT-SMF treatment applied to each patient was determined through medical criteria.
Patients underwent one or two 10-minute PBMT-SMF sessions, on the same day, immediately after laser, RFI, or RFF treatment. A complete treatment comprised eight sessions: once a week for anti-edema treatment or twice weekly for anti-inflammatory treatment if inflammation was high.
Before the first treatment, the target area was shaved, and a baseline assessment was performed, including the pain score and several face photographs. After the PBMT-SMF treatment, patients used the VAS pain scale to reassess perceived pain, and an anti-redness soothing intensive moisturizer was applied. After RFI and RFF, other anti-redness creams were also applied.
Variables assessed. Variables analyzed were redness, edema—characteristic signs of inflammation—and pain. The tools used to measure these variables were the VAS pain scale and the FotoFinder® device for assessing redness and edema decrease from baseline to the last visit through facial photographs. Adverse events were assessed and collected at all visits.
Efficacy assessments. Efficacy outcomes were VAS pain scores reduction, redness, and edema measured immediately after PBMT-SMF. The erythema redness was assessed through the Clinical Erythema Assessment (CEA) using a five-point scale: 0=clear skin with no signs of erythema; 1=almost clear, slight redness; 2=definite redness, very light pink, faintly detectable erythema; 3=marked redness, dull red, clearly distinguishable erythema; 4=severe erythema, fiery redness, deep, and dark red.22 There is no scale for the edema assessment, which unfortunately, remains qualitative and subjective. The level of edema was assessed directly on the patient’s face at the consultation.
Data management. Individual subject records were maintained in the investigator’s source documents. Case Report Forms (CRFs) did not include any personal data.
Statistical analysis. The statistical analysis was limited to describing study variables, and no hypothesis tests were performed. Quantitative variables were described as the mean and standard deviation (SD), categorical variables as percentages, and noncontinuous variables were the median and range. Efficacy outcomes were assessed as the corresponding variable changed from baseline to the final procedure. Analyses were performed using a regular spreadsheet program (Excel, Microsoft).
Patient characteristics. The study included 27 patients, seven men (25.9%) and 20 women (74.1%), with a mean (SD) age of 43.5 (13.9) years. (Table 2)
Initial facial treatments. All patients had previously undergone facial treatment with laser, RFI, or RFF for different skin conditions. Seven patients (25.9%) were treated with RFI or RFF for acne scars. (Table 2) Twenty patients (74.1%) were treated with vascular laser: Three for angioma (n=3/20, 15%), two for scars (n=2/20, 10%), three due to erythrosis (n=3/20, 15%), and 12 for rosacea (n=12/20, 60%). (Table 3)
Efficacy Outcomes. Post-initial treatment assessment and one-month post-PBMT-SMF treatment: After the laser, RFI, or RFF treatment, patients indicated their pain levels through the VAS pain (VAS-1). The median VAS-1 pain score was 5 (range 2-10). After the PBMT-SMF protocol (with one or two consecutive sessions for most patients), patients reassessed their pain level (VAS-2). The median VAS-2 pain score was 3 (range 0-7) Mean pain reduction was 40 percent (0%-100%). VAS-1 and VAS-2 pain scores, facial conditions, the PBMT-SMF protocol type, and percentages of pain reduction in each patient are shown in Table 2 and Table 3. Figures 1 to 4 show the improvement of some patients’ facial conditions (acne, angioma, erythrosis, and rosacea) and the reduction of redness and edema after the PBMT-SMF sessions.
The sensations of redness and edema or inflammation decreased instantly in the patients after applying the PBM, simultaneously with the pain. Instead of the usual 4-5 days, redness lasted an average of one day. The edema was reduced to two days with a maximum of 5 to 6 days. On the CEA scale, the erythema levels decreased by one degree after the PBMT. For example, patients with Grade 4 erythema progressed to Grade 3, and Grade 3 to Grade 2. In patients with rosacea, the reduction of episodes of persistent erythema changed to flushing or transient erythema. Despite the absence of a score, the improvement in edema was very significant.
Safety findings. Treatments did not require analgesia/anesthesia. There were no treatment complications or adverse effects associated with PBMT-SMF treatment.
Our results showed that patients had less pain, edema, and redness after treatment with PBMT-SMF. Generally, after a laser session treating erythrosis and rosacea, redness increases, the edema is pronounced, and these symptoms can last a week. When using PBMT immediately post laser, these sensations decreased instantly in patients, simultaneously with pain and edema. Despite the absence of a score, the improvement in edema was very significant. The redness lasted for a day instead of 4 to 5 days, and edema was reduced to two days or, at most, 5 to 6 days.
Overall mean VAS pain score reduction after PBMT-SMF was 40 percent (range 0%-100%): 34.7 percent (range 14%-100%) after RFI or RFF treatments and 46.9 percent (range 0%-100%) after laser treatments. The most relevant mean decrease of the VAS pain score was after PBMT-SMF in patients treated with a vascular laser for rosacea (61.5%, range 0%-100%). Redness and edema also decreased after the PBMT-SMF sessions, as shown in Figures 1 to 4, most remarkably in patients with rosacea. (Figure 4)
Laser therapy has long been considered a precise and predictable dermatologic treatment modality due to its properties for tissue regeneration and collagen remodeling through heat-induced collagen contraction. However, there are side effects associated with laser after the procedure, such as erythema and edema.8,23,24 Before PBMT was available, it was necessary to reduce redness from 7 to 10 days and one week for edema. The option proposed in this study to favor redness reduction was the addition of PBMT-SMF to minimize laser and RFI or RFF side effects and promote regeneration. With PBMT-SMF, time can be reduced to one week by applying two sessions on the same day in two days; with only four sessions, redness reduction is visible in most cases of acne, erythrosis, or rosacea (Figures 1, 3, and 4). Patients with other conditions, such as angioma, need more sessions (Figure 2).
PBMT rationale is based on its reported efficacy at a cellular and subcellular level, particularly for the 660nm, 850nm, and 600−1000nm wavelengths.25 PBMT may improve blood flow, and neovascularization,26 induces many cytokines, chemokines, and macromolecules; promotes collagen synthesis, reduces pain, including postoperative pain;27 and helps to reduce the use of analgesics.28 PBMT significantly reduces postoperative edema and inflammation,29 even after orthopedic or endodontic surgical procedures.30,31 The SMF rationale is based on its significant biological effects on some cells32 and the ability to increase total antioxidant capacity or decrease allergic inflammation.33 It has been observed that SMFs can also modulate DNA damage and damage repair.34,35 SMF exposure influences arteriolar diameters, primarily in resistance arterioles, and therefore microvascular tone, in a restorative fashion, normalizing the tone. Thus, SMF application could be helpful for the treatment of both ischemic and edematous tissue disorders involving compromised microvascular function.
Miltaderm is an innovative technology that combines a Nano-Pulsed Cold laser, infrared lighting diodes, colored LEDs, and an SMF to enhance better results, such as stimulating fibroblasts’ activity and increasing the synthesis of collagen and elastin to restructure the existing ones or restoring microvascular tone. The radiation emitted by this device penetrates the heart of the cell at the level of the mitochondria, the energy centers responsible for the production of adenosine triphosphate (ATP), which produces an anti-inflammatory, healing, and analgesic effect.19–21,36
Limitations. This study was not a multicenter, randomized case-control, or randomized trial. The number of patients included could have been higher; thus, it was impossible to obtain robust results with statistical significance; however, there were improvements for all variables. The reduction in redness and edema was not quantitatively measured, but satisfactory results were observed after the procedure.
PBMT-SMF reduced expected transitory side effects, like pain, edema, and inflammation, after treatment with lasers or RFF or RFI for facial conditions. This procedure could also help to reduce pharmacological treatments, such as non-opioid or non-steroidal anti-inflammatory drugs.
The authors would like to thank all their collaborators, especially the i2e3 Biomedical Research Institute medical writing team.
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