Treatment with synchronized radiofrequency and facial muscle stimulation: Histologic analysis of human skin for changes in collagen and elastin fibers.

BACKGROUND: Skin's exposure to intrinsic and extrinsic factors causes age-related changes, leading to a lower amount of dermal collagen and elastin. AIM: This study investigated the effects of a novel facial muscle stimulation technology combined with radiofrequency (RF) heating on dermal collagen and elastin content for the treatment of facial wrinkles and skin laxity. METHODS: The active group subjects (N = 6) received four 20-min facial treatments with simultaneous RF and facial muscle stimulation, once weekly. The control subject (N = 1) was untreated. Skin biopsies obtained at baseline, 1-month and 3-month follow-up were evaluated histologically to determine collagen and elastin fibers content. A group of independent aestheticians evaluated facial skin appearance and wrinkle severity. Patient safety was followed. RESULTS: In the active group, collagen-occupied area reached 11.91 ± 1.80 × 106 µm2 (+25.32%, p < 0.05) and 12.35 ± 1.44 × 105 µm2 (+30.00%, p < 0.05) at 1-month and 3-month follow-up visits. Elastin-occupied area at 1-month and 3-month follow-up was 1.64 ± 0.14 × 105 µm2 (+67.23%, p < 0.05), and 1.99 ± 0.21 × 105 µm2 (+102.80%, p < 0.05). In the control group, there was no significant difference (p > 0.05) in collagen and elastin fibers. Active group wrinkle scores decreased from 5 (moderate, class II) to 3 (mild, class I). All subjects, except the control, improved in appearance posttreatment. No adverse events or side effects occurred. CONCLUSION: Decreased dermal collagen and elastin levels contributes to a gradual decline in skin elasticity, leading to facial wrinkles and unfirm skin. Study results showed noticeable improvement in facial appearance and increased dermal collagen and elastin content subsequent to simultaneous, noninvasive RF, and facial muscle stimulation treatments.

The role, safety, and efficacy of hyperbaric oxygen therapy in aesthetic practice-An evidence-based review.

BACKGROUND: Hyperbaric oxygen therapy (HBOT) involves patients breathing 100% oxygen in a pressurized chamber, above 1 atmosphere. Many centers are now promoting the use of HBOT for skin rejuvenation. However, the current indications for HBOT do not encompass aesthetic applications. AIM: The aim of this evidence-based review was to assess the existing literature regarding the utilization of HBOT in medical aesthetics and rejuvenation, evaluate its effectiveness and safety, and conduct a cost analysis. MATERIALS AND METHODS: PubMed Interface, Cochrane Library, Google Scholar, and Embase searches were carried out. The Best Bets methodology was used, and the risk of bias was appraised using the Quality Assessment Tool for Quantitative Studies. RESULTS AND MAIN FINDINGS: This review included a total of 17 human studies with a total of 766 participants. Three studies were classified as level II evidence, three studies were of level III evidence, and 11 were of level IV evidence. All the included studies were judged at high risk of bias. The most relevant findings supported by level II evidence were that HBOT decreased the shedding rate post-FUE hair transplant (27.6 ± 2.6% vs. 69.1 ± 2.4%) but this did not affect the final outcome between HBOT (96.9 ± 0.5%) and the control (93.8 ± 0.6%). Moreover, level III evidence demonstrated that following HBOT, there was a significant increase in elastic fiber length (p ≤ 0.0001, effect size = 2.71) and a significant decrease in fiber fragmentation (p = 0.012). There was also a significant increase in collagen fiber density following HBOT (p = 0.0001, effect size = 1.10). However, there was no significant effect of antioxidant vitamins A, C, and E with HBOT. The inflammatory response significantly decreased after 7 days of HBOT with a decreased expression of IL-12p40, MIP-1ß, and PDGF-BB and a higher expression of IL-1Ra. Moreover, HBOT was used prophylactically prior to abdominoplasty to decrease the risk of complications. In this study, complications were decreased from 32.6% (89 patients) to 8.4% (7 patients) with a p < 0.001, and in a multivariate analysis, preoperative HBOT was an independent protective factor against postoperative complications (p < 0.001). CONCLUSION AND RECOMMENDATIONS: There is conflicting evidence on how the method of action of HBOT can have a beneficiary effect in aesthetic and whether the treatment is justifiable. To our knowledge, this is the first comprehensive review discussing the available evidence regarding the use of HBOT in many aesthetic clinical scenarios, including preventive, medical, and surgical settings. However, randomized clinical trials with longer follow-up and better patient selection are needed to be able to generate a reliable conclusion.

Efficacy and safety of combined microneedling therapy for androgenic alopecia: A systematic review and meta-analysis of randomized clinical trials.

OBJECTIVE: To provide dermatologists with more clinical experience in treating androgenetic alopecia, we evaluated the effect and safety of combined microneedling therapy for androgenetic alopecia. METHODS: Studies on combined microneedling for hair loss were comprehensively searched by us in PubMed, Excerpta Medica Database, and the Cochrane Library Database. The literature search spanned the period from 2012 to 2022. Inclusion and exclusion criteria were developed, and the literature was screened according to this criteria. The Cochrane Risk of Bias Tool was used to assess the quality of the studies. The researcher applied Revman 5.3 and Stata 15.1 software to analyze the data after extracting information from the data. RESULTS: Finally, 13 RCTs involving 696 AGA patients were included to compare the clinical effectiveness and adverse events of combined MN therapy with single MN therapy or single drug therapy for AGA. The results of meta-analysis showed as follows: (1) Hair density and diameter changes: The combined MN group was significantly better than any single treatment group, and the differences were statistically significant (MD = 13.36, 95% CI = [8.55, 18.16], Z = 5.45, p < 0.00001; MD = 18.11, 95% CI = [13.70, 22.52], Z = 8.04, p < 0.00001; MD = 13.36, 95% CI = [8.55, 18.16], Z = 5.45, p < 0.00001; MD = 2.50, 95% CI = [0.99, 4.02], Z = 3.23, p = 0.001); (2) the evaluation of satisfaction for efficacy: The doctor satisfaction rating of the combined MN group was significantly higher than that of any single treatment group, with statistical difference (RR = 2.03, 95% CI = [1.62, 2.53], Z = 6.24, p < 0.00001). The difference between the two groups regarding patients satisfaction was not significant (RR = 3.44, 95% CI = [0.67, 17.59], Z = 1.49, p = 0.14). (3) Safety: There was no statistical difference in the incidence of adverse reactions between combination therapy and monotherapy (RR = 0.83, 95% CI = [0.62, 1.12], Z = 1.22, p = 0.22). CONCLUSION: The combined MN group showed statistically significant improvement in hair density and diameter, and good safety compared with monotherapy.

Efficacy and Safety of Tapencarium (RZL-012) in Submental Fat Reduction.

BACKGROUND: Tapencarium (RZL-012) (5-(3.6-dibromo-9H-carbazol-9-yl)-N, N, N-trimethylpentan-1-aminium chloride) is a novel injectable synthetic molecule with cytolytic properties, capable of reducing subcutaneous fat volume. OBJECTIVES: The goal of this 3-armed, randomized, double-blind, placebo-controlled phase 2b study was to determine the safety and efficacy of low- and high-dose RZL-012 vs placebo on submental fat (SMF) reduction. METHODS: Patients (n = 151, age 18-65 years) with excess SMF received a single treatment session of RZL-012 or placebo in the submental area, after which they were monitored for 84 days. SMF was assessed at baseline and after dosing with newly developed scales, namely the Clinician Chin Assessment Tool (C-CAT) and Subject Chin Assessment Tool (S-CAT). SMF was also assessed by magnetic resonance imaging (MRI) at screening and on Day 84 after treatment. RESULTS: The proportion of patients who had a 1-grade or 2-grade improvement in C-CAT and/or S-CAT on Day 84 vs baseline was significantly higher in the high-dose RZL-012 group vs the placebo group (P < .002). The relative percentage reduction in MRI-measured SMF volume (Day 84 vs screening) was significantly greater in the high-dose RZL-012 group vs the low-dose RZL-012 or the placebo group (P < .0001). Local injection site reactions were the most common adverse events (AEs). CONCLUSIONS: A single administration of RZL-012 into SMF resulted in significant improvement in submental appearance as assessed by clinicians, patients, and MRI. From a safety perspective, there were no serious AEs and no clinically significant changes in vital signs or laboratory tests over the course of the study.

Evaluation of the efficacy and safety of hyaluronic acid and supplemented with amino acids, and glutathione or colin, for the prevention and treatment of wrinkles on the face, neck, décolleté and hands.

OBJECTIVE: Hyaluronic acid has been used for a long time as a biorevitalizer to treat skin aging both in single formulation and in association with other compounds such as amino acids or vitamins. The purpose of this study was to evaluate the efficacy and safety of class III medical devices SKIN B, SKIN R, SKIN OX, SKIN COLIN, for the treatment of wrinkles on the face, neck, décolleté and hands. These medical devices are all based on hyaluronic acid and supplemented with amino acids (SKIN B and SKIN R) and glutathione (SKIN OX) or colin (SKIN COLIN). This gives broader possibilities to the aesthetic surgeon for personalization and pharmacological diversification based on the patient's deficits to treat. PATIENTS AND METHODS: A total of 60 subjects affected by skin damage such as rhytidids, dehydration, reduced sebum production and skin hypoxia were enrolled. The patients were treated with a session of mesotherapy every 7 days for 30 days, followed by other 2 sessions every 15 days for 30 days and the follow-up on day 90. The primary efficacy endpoint was evaluated by means of a 0-10 visual analog scale at day 60; the secondary efficacy endpoint was evaluated by means of a 0-10 visual analog scale at day 90. RESULTS: All patients completed the 3-month follow-up. Treatment with SKIN B, SKIN OX, SKIN COLIN and SKIN R medical devices for the prevention and treatment of wrinkles on the face, neck, décolleté and hands were associated with favorable and positive results. A clear reduction of wrinkles has been clinically observed with improvement in the texture, brightness, and turgor of the skin. No adverse events were reported. CONCLUSIONS: The medical devices SKIN B, SKIN SKIN OX, SKIN COLIN produce an aesthetic improvement in patients affected by skin defects, when administered by mesotherapy technique. This study confirms the safety and efficacy of the medical devices based on hyaluronic acid supplemented with amino acids and glutathione or colin.

[Consideration of Supervision of Mesotherapy Needles for Cosmetic Injection].

With the development of medical aesthetics industry in China, sodium hyaluronic is injected into the facial dermis with multi needles to relieve wrinkles, thick pores, skin relaxation and other aging problems, is more and more popular nowadays. The wide application of mesotherapy for cosmetic injection and the subsequent adverse events are widely reported. This study attempts to explore the adverse events and countermeasures for the application of mesotherapy from the perspective of medical device supervision.

Clinical and histological evaluation of microneedle fractional radiofrequency treatment on facial fine lines and skin laxity in Koreans.

BACKGROUND: Facial wrinkles and sagging are the most visible signs of aging and can cause profound distress. Microneedle fractional radiofrequency (MFR) is a minimally invasive procedure, which utilizes both microneedling and radiofrequency energy to rejuvenate the skin. OBJECTIVE: To describe the safety and efficacy of a temperature-controlled MFR device on facial fine lines and laxity. PATIENTS AND METHODS: A retrospective chart & histology review was performed on individuals who received bipolar MFR for facial rejuvenation. A total of 15 Koreans with a median age of 46 years were included. All participants underwent a single treatment session. The results were assessed objectively using serial photography and subjectively based on the participants' satisfaction scores. Histologic changes before, immediately after MFR and at 4 months follow-up was examined. Complications were also recorded. RESULTS: Partially denatured collagen fibers and dermal shrinkage was observed immediately after MFR whereas an increase in elastin and collagen was noted at 4 months follow-up. 86.7% of recipients considered the results satisfactory. Consensus ratings by two independent dermatologists on the objective outcomes at 4-month follow-up were very much improved (53.3%), much improved (26.7%) and improved (20%). Treatment was well tolerated and did not cause any significant long-lasting discomfort. CONCLUSION: Temperature-controlled bipolar MFR is a minimally invasive treatment option to consider for facial fine lines and laxity via neo-collagenesis and neo-elastogenesis. The procedure was safe and clinically effective.

Hyperbaric oxygen therapy for treatment of a late presenting ischaemic complication from hyaluronic acid cosmetic filler injection.

Vascular compromise and resulting ischaemic injury are known rare complications of cosmetic filler injections. Most hyaluronic acid vascular compromises present early and can be treated effectively by hyaluronidase. Here we present a case of ischaemic wound and mucosal necrosis after cosmetic facial hyaluronic acid injection that appeared within hours of injection but was not diagnosed and treated for 5 days. At day 5, the patient was treated with hyaluronidase injection immediately followed by 14 sessions of daily hyperbaric oxygen therapy (HBOT). Despite the delayed treatment, the patient had essentially complete recovery and the hyperbaric therapy was overall well-tolerated. Our case report suggests that hyaluronidase injection with concurrent daily HBOT sessions may be effective to allow recovery from late-presenting filler ischaemic complication. Furthermore, given the safety profile of HBOT, we suggest a more deliberate approach to this modality as a therapeutic adjunct by cosmetic practitioners when similar complications arise.

Alopecia After Cosmetic Injection Procedures: A Review.

BACKGROUND: Cosmetic procedures for antiaging carry inherent risks of adverse events. One that has not yet been well characterized is transitory or permanent alopecia. This is attributable to numerous mechanisms including pressure, ischemia, inflammation, and necrosis. Cases of postcosmetic procedure alopecia have been reported after mesotherapy as well as hyaluronic acid filler, deoxycholic acid, and botulinum toxin injections. OBJECTIVE: This review serves to describe the currently known causes of postcosmetic procedure alopecia and the mechanisms by which alopecia is attained. Furthermore, this review highlights the risk of unregulated mesotherapy injections for cosmetic enhancement and to bring attention to the increasing number reports of alopecia after these procedures. METHODS: A systematic review of the literature from 2000 to 2022 was conducted looking for keywords such as "alopecia," "cosmetic procedures," "mesotherapy," and "hyaluronic acid" in Google Scholar and PubMed. RESULTS: Ten articles met the criteria set forth in the authors' literature review. Many of the procedures resulted in partial or complete resolution of alopecia. CONCLUSION: Alopecia after cosmetic injection procedures is an underreported adverse effect. More research is needed to further characterize the risk of alopecia after mesotherapy and other injection procedures.

Calcium Hydroxyapatite Filler With Integral Lidocaine CaHA (+) for Soft Tissue Augmentation: Results from an Open-Label Multicenter Clinical Study.

BACKGROUND: Soft tissue augmentation with calcium hydroxylapatite (CaHA) is a versatile technique for line filling, skin tightening, lifting, contouring, and volumizing. The present study was designed to confirm safety and effectiveness of the product with lidocaine (CaHA (+)) in a holistic treatment of nasolabial folds (NLFs), marionette lines, and/or cheeks. METHODS: A total of 207 subjects with moderate to severe facial volume deficit were treated with CaHA(+) in this open-label study. Effectiveness assessments included Merz Aesthetics Scales® (MAS), investigator- and subject-assessed Global Aesthetic Improvement Scales (iGAIS/sGAIS), and FACE-QTM questionnaires. Responder rates were defined as at least one-point improvement on MAS according to blinded rating. Safety was assessed through adverse event reporting. RESULTS: Primary endpoint was evaluated 12 weeks after last injection. Responder rates were 93.6%, 88.7%, and 81.9% in the NLFs, marionette lines, and cheeks, respectively, and were statistically significant above the pre-defined 60% threshold (P< 0.0001). Investigator- and subject-assessed GAIS were consistent and showed high rates of improvement throughout the study, with peak values of 98.0% at week 4 on iGAIS and 93.5% at 12 weeks after last injection on sGAIS. After 18 months, the majority of subjects (52.5%) still perceived improvement via sGAIS. Moreover, total FACE-Q scores demonstrated high subject satisfaction with treatment. All related treatment emergent adverse events were transient and expected injection-site reactions mostly of mild to moderate intensity. CONCLUSION: CaHA (+) has demonstrated safety and effectiveness in the treatment of NLFs, marionette lines, and cheek volume loss in real-life conditions up to 18 months. J Drugs Dermatol. 2022;21(5):481-487. doi:10.36849/JDD.6737.

Hyaluronic Acid Compound Filling Plus Mesotherapy vs Botulinum Toxin A for the Treatment of Horizontal Neck Lines: A Multicenter, Randomized, Evaluator-Blinded, Prospective Study in Chinese Subjects.

BACKGROUND: Although energy devices and botulinum toxin A (BTX-A) can alleviate age-related laxity, ptosis, and platysmal bands, they have limited efficacy on horizontal neck lines. OBJECTIVES: The purpose of this study was to investigate the efficacy, safety, and subject satisfaction of a combined treatment of non-cross-linked hyaluronic acid (HA) compound filling plus mesotherapy for the correction of horizontal neck lines, in comparison with BTX-A. METHODS: This multicenter, randomized, evaluator-blinded, prospective study enrolled female patients with moderate-to-severe horizontal neck lines corrected with either 2 or 3 sessions of of non-cross-linked HA compound filling plus mesotherapy or 1 session of BTX-A injection. Improvement of the neck lines grades, Global Aesthetic Improvement Scale (GAIS), patient satisfaction, and adverse events (AEs) were evaluated and compared at 1, 3, 6, and 10 months after the final treatment. RESULTS: Twenty-five patients received HA filling plus mesotherapy and 23 received BTX-A injection. Compared with BTX-A, the HA compound filling plus mesotherapy significantly improved the horizontal neck lines grades on all follow-up visits (P = 0.000). Cases of different baseline grades (2, 2.5, and 3) demonstrated similar outcomes. The GAIS and patients' satisfaction ratings were significantly higher for the HA filling plus mesotherapy treatment group (P = 0.000). Significantly higher pain ratings, higher incidence, and longer recovery of AEs (erythema, edema, and ecchymosis) were noticed in the combined treatment group (P < 0.001). No serious AEs occurred. CONCLUSIONS: Compared with BTX-A, combined treatment with HA compound filling plus mesotherapy significantly improved moderate-to-severe horizontal neck lines and achieved a high level of patient satisfaction.

Common Dermatologic Procedures and the Associated Complications Unique to Skin of Color.

BACKGROUND: The skin of color (SOC) population in the United States continues to grow, and these patients are undergoing various cosmetic and surgical procedures at increasing rates. There is a paucity of data on the potential complications associated with surgical and cosmetic procedures in this patient population. OBJECTIVE: We aim to educate dermatologic surgeons and clinicians on surgical and cosmetic procedures in patients of color and increase awareness of the potential complications unique to this patient population. MATERIALS AND METHODS: A thorough PubMed literature search was performed to conduct this review. RESULTS: There are a number of complications in SOC that require special attention, including keloids, postoperative infections, postinflammatory hyperpigmentation, and hypopigmentation. There are also various precautions to consider when performing cosmetic procedures, such as neurotoxin and filler injections, laser therapy, microneedling, and chemical peels. CONCLUSION: Dermatologists should be aware of the potential cosmetic and surgical complications of this growing patient population to provide optimal evidence-based medical care.

Carboxytherapy Mask as Post Nanofractional Radiofrequency Treatment for Improvement of Facial Skin Quality and Photoaging.

BACKGROUND: Skin rejuvenation can be achieved with minimally invasive treatments using energy-based devices that feature reduced side effects and downtime. Post-treatment care is key to minimize any potential side effects and skin reactions such as erythema, dryness, or dyschromia. OBJECTIVE: The objective of this study was to evaluate the efficacy and patient satisfaction of a novel carboxytherapy gel mask compared with petroleum-based lanolin-containing ointment to accelerate wound healing facial post-nanofractional radiofrequency treatment. METHODS AND MATERIALS: Ten subjects were enrolled in this pilot, prospective, randomized, single-blind study and randomized into two arms. One arm received one nanofractional radiofrequency treatment with ointment right after and four consecutive days of ointment applications twice a day, while the second arm followed this regimen with a carboxytherapy gel mask application right after and four consecutive days after treatment. Investigator, safety, and patient assessments were conducted at 24 hours and one-week post treatment. Safety was monitored throughout. The primary endpoint was defined as the degree of investigator global assessment (IGA) in photodamage, pigmentation, and wrinkles using standardized photographs. Secondary endpoints included investigator-rated degree of erythema, edema, crusting, exudation, percentage healing, improvement of skin quality, and patient satisfaction. RESULTS: Nine patients completed the study. There was improvement of one degree in IGA for photodamage, pigmentation and wrinkles in all patients using the carboxytherapy gel mask at the one-week follow up. Blinded investigator ratings showed significant improvement of dryness, erythema, edema, crusting, and percentage healing at the 24-hour follow up, with all patients remaining the same a week post treatment. All patients in the carboxytherapy group were satisfied with the treatment and had no adverse effects. Three patients in the petroleum-based lanolin-containing group experienced mild edema and acne breakout that resolved two weeks after treatment. CONCLUSION: Carboxytherapy delivered via a gel mask after skin rejuvenation procedures is a safe and effective strategy to improve clinical outcomes and reduce post-treatment side effects. J Drugs Dermatol. 20(4):461-465. doi:10.36849/JDD.5856.

Intense Pulsed Light: A Methodical Approach to Understanding Clinical Endpoints.

BACKGROUND: Intense Pulsed Light (IPL) is a non-coherent polychromatic broadband filtered flashlamp that emits light in the spectrum of approximately 400–1200 nm. Its effects on photorejuvenation are well documented. The goal of this study is to help practitioners better conceptualize and fine tune IPL device settings in order to produce the most effective and safest clinical outcome. MATERIALS/METHODS: This was a prospective study testing several filters (515 nm; 560 nm; 590 nm and 530–650; 900–1200 nm vascular filter), fluences, pulse durations, and pulse numbers (ie, multiple sequence pulsing or MSP) with a new IPL system. RESULTS: Post-procedure erythema response was more pronounced with increasing fluence, decreasing wavelength, fewer pulses and shorter pulse duration. The exception was the 515 nm filter with regard to pulse duration, which was observed to have a more pronounced response with longer pulse durations. The overall clinical outcome at the 4-week follow-up visit demonstrated greatest improvement in erythema and pigmentation using the 515 nm filter on a Fitzpatrick Skin Type III individual. CONCLUSION: Greatest clinical endpoint response at 4-week follow-up was observed with more robust initial responses. This was most apparent at higher fluence levels and fewer pulse counts. However, when the IPL is pushed to aggressive parameters, there is risk of hypopigmentation and hair loss as seen in this case study. Skin type is an important consideration when using IPL and MSP adds to its safety profile. J Drugs Dermatol. 2021;20(2):203-207. doi:10.36849/JDD.5638.

A Prospective, Split-Face, Comparative Study of Combined Treatment With Fractional Microneedle Radiofrequency and Nonablative 1927-nm Fractional Thulium Fiber Laser for Wrinkle Treatment.

BACKGROUND: Fractional microneedle radiofrequency (FMR) and nonablative 1927-nm fractional thulium fiber laser (TFL) are widely used for skin rejuvenation treatment. OBJECTIVES: To investigate the efficacy and safety of combined treatment with both devices for wrinkles. PATIENTS AND METHODS: Twenty-five patients with wrinkles were enrolled. One side of the face was treated with FMR alone, while the other side was treated with a combination of FMR and TFL. Each treatment consisted of 3 sessions at four-week intervals and patients were followed up 12 weeks after the last treatment. Overall improvement was assessed by patient global assessment (PGA) and investigator global assessment (IGA). Depression scores for the evaluation of wrinkles were objectively assessed by Antera 3D system. RESULTS: Both sides of the face led to clinical improvement in both mean PGA and IGA. Combination treatment demonstrated a greater improvement in both mean PGA and IGA compared with FMR alone. In addition, wrinkle grading scales and depression scores showed greater improvement in the combination group than in FMR alone. CONCLUSION: This study demonstrated that FMR and TFL comprise a good combination treatment for the treatment of wrinkles because both treatments have a synergistic effect on wrinkle improvement.