Efficacy and Safety of PrabotulinumtoxinA in Subjects With Benign Masseteric Hypertrophy: A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Phase 3 Trial and Open-Label Extension Study.

BACKGROUND: Despite the widespread use of botulinum toxin (BTX) injection for the treatment of masseter muscle hypertrophy (MMH), there is no standard treatment option. OBJECTIVE: We report the efficacy and safety for BTX in MMH over a period of 48 weeks. METHODS: In double-blinded, placebo-controlled phase 3 trials, 180 patients (randomized 1:1) received treatment with placebo (normal saline) or prabotulinumtoxinA (48 units). Masseter muscle thickness (at maximal clenching and resting positions), 3D imaging analysis, and masseter muscle hypertrophy scale grades were analyzed at each time point. After the 24-week CORE study, all patients who met the same criteria of the CORE study at week 24 ( n = 114) received only prabotulinumtoxinA, regardless of previous treatment, for an additional 24 weeks (48 weeks in total) for the open-label extension study. RESULTS: The largest differences in mean and percent changes from baseline in masseter muscle thickness were observed at 12 weeks, and there were significant differences between the 2 groups at all time points (all p < .001). The effect was independent of the number of injections. No serious adverse event was observed. CONCLUSION: PrabotulinumtoxinA could effectively ameliorate MMH without major complications.

The use of epidermal growth factor in dermatological practice.

Epidermal growth factor (EGF) is a growth factor that plays a pivotal role in wound healing and maintaining tissue homeostasis by regulating cell survival, proliferation, migration, and differentiation. Exogenous administration of bioidentical human recombinant epidermal growth factor (rhEGF) has been known to promote skin wound healing, although rhEGF is increasingly being used in drug delivery systems and nanotechnology. However, despite considerable attention being focused on the potential clinical applications of rhEGF in several dermatological conditions beyond wound healing, the number of studies still remains relatively low. Herein, we conducted a literature search of PubMed/Medline and Google Scholar databases to retrieve published literature related to rhEGF and summarised the effects of rhEGF in the treatment of various wound types, radiotherapy or chemotherapy-related skin reactions, atopic dermatitis, skin aging, and post-inflammatory hyperpigmentation.

Treatment of facial pigmented disorders with a 785-nm picosecond Ti:sapphire laser in Asians: A report of three cases.

Since the advent of the theory of selective photothermolysis, the importance of targeting the chromophore and minimizing the surrounding damage has been extensively discussed. Picosecond-domain laser (ps-laser) treatment with a wide range of wavelengths is an emerging option for various pigmented lesions; however, no definitive treatment choice has been confirmed. The authors aimed to investigate the efficacy and safety of a ps-laser with a 785-nm wavelength for the treatment of facial pigmented lesions in Asians. Three Korean patients with facial pigmented lesions were recruited for the study. A 785-nm ps-laser with a fractionated and an unfractionated handpiece was utilized to administer the treatment. The clinical outcome was evaluated by a clinician by comparing pre- and post-treatment photographs. All patients exhibited a significant improvement in pigmented lesions including freckles, lentigines, and melasma, after three to four sessions of treatment. No adverse events, including post-inflammatory hyperpigmentation or hypopigmentation were observed. In conclusion, this novel 785-nm Ti:sapphire ps-laser may be an effective and safe modality for treating pigmented lesions in skin of color.

Split-face comparative trial of 785-nm picosecond neodymium:yttrium-aluminum-garnet laser and precision cryotherapy combination treatment for facial benign pigmented lesions.

Cryotherapy (or cryosurgery) has been performed to treat various skin lesions in the field of dermatology; however, to the best of our knowledge, no study has investigated its efficacy and safety for benign pigmented lesions. Therefore, we conducted a split-face study to evaluate the efficacy and safety of cryotherapy in the treatment of benign pigmented lesions. A total of five subjects were included. Picosecond laser therapy was performed to treat the whole face and cryotherapy for half the face. Four weeks after completing the treatment sessions, patients showed more clinical improvement on the laser and cryotherapy combination treatment side than on the laser-only side, with no adverse events. Our study demonstrated that cryotherapy is a potential adjuvant therapeutic modality for benign pigmented lesions.

Cryolipolysis for abdominal subcutaneous fat reduction: A prospective, multicenter, single arm, clinical study.

Various treatment methods are used for noninvasive body contouring. To evaluate the efficacy and safety of a newly designed cryolipolysis device using a three-dimensional cooling method for abdominal fat reduction. Twenty-five participants with clinically apparent abdominal fat tissue participated in the study. The thickness of fat tissue below the umbilicus level was measured using a caliper at baseline and 12 weeks after the first treatment. The height of abdominal subcutaneous fat tissue on ultrasonography and participant satisfaction were assessed at every visit for 16 weeks. All adverse events (AEs) during the study period were recorded. p values <0.05 were considered statistically significant. Twenty-four participants completed this study; the mean BMI of participants was 29.34 ± 2.36 kg/m2 . The mean thickness of abdominal subcutaneous fat was significantly lower at 12 weeks (40.4 ± 6.8 mm, p < 0.001) than at baseline (49.3 ± 8.5 mm). Differences in the height of abdominal subcutaneous fat compared to that at baseline were 1.02 ± 0.41 cm (12 weeks, p < 0.001) and 1.13 ± 0.44 cm (16 weeks, p < 0.001). Rates of abdominal subcutaneous fat reduction at 12 and 16 weeks compared to that at baseline were 28.45% and 31.13%, respectively. The ratio of abdominal circumference to hip circumference at 12 and 16 weeks was significantly decreased compared to that at baseline. Most participants (95.8%) reported improvement in satisfaction scores at 16 weeks. There were no serious AEs during the entire study period. The study demonstrated the efficacy of a noninvasive cryolipolysis device using a three-dimensional cooling method for reducing abdominal subcutaneous fat.

Low-intensity cold atmospheric plasma reduces wrinkles on photoaged skin through hormetic induction of extracellular matrix protein expression in dermal fibroblasts.

BACKGROUND: Recent evidence indicates that cold atmospheric plasma (CAP) can upregulate the production of extracellular matrix (ECM) proteins in dermal fibroblasts and enhance transdermal drug delivery when applied at a low intensity. OBJECTIVES: The aim of this study was to evaluate the effect of low-intensity CAP (LICAP) on photoaging-induced wrinkles in an animal model and the expression profiles of ECM proteins in human dermal fibroblasts. METHODS: Each group was subjected to photoaging induction and allocated to therapy (LICAP, topical polylactic acid (PLA), or both). The wrinkles were evaluated via visual inspection, quantitative analysis, and histology. The expression of collagen I/III and fibronectin was assessed using reverse transcription-quantitative polymerase chain reaction, western blot analysis, and immunofluorescence. The amount of aqueous reactive species produced by LICAP using helium and argon gas was also measured. RESULTS: Wrinkles significantly decreased in all treatment groups compared to those in the untreated control. The differences remained significant for at least 4 weeks. Dermal collagen density increased following LICAP and PLA application. LICAP demonstrated a hormetic effect on ECM protein expression in human dermal fibroblasts. The production of reactive species increased, showing a biphasic pattern, with an initial linear phase and a slow saturation phase. The initial linearity was sustained for a longer time in the helium plasma (~60 s) than in the argon plasma (~15 s). CONCLUSION: LICAP appears to be a novel treatment option for wrinkles on the photodamaged skin. This treatment effect seems to be related to its hormetic effect on dermal ECM production.

The efficacy of enoxolone in reducing erythema and pain after laser treatment: A randomized split-face pilot study.

BACKGROUND: Enoxolone, derived from licorice, possesses potent anti-inflammatory, and antioxidant properties. However, its effectiveness in alleviating post-laser reactions has not been extensively studied. AIMS: This randomized split-face pilot study aimed to evaluate the effects of enoxolone on skin following laser treatment. PATIENTS/METHODS: Ten healthy subjects underwent non-ablative 1550 nm Er:Glass fractional laser treatment and then randomly applied a moisturizer without enoxolone on one side of the face and a dermo-cosmetic formular containing 2% enoxolone mixed with the same moisturizer on the other side. The erythema index (EI), clinician's erythema assessment (CEA), and pain scores were recorded at 30 min, 60 min, and 24 h posttreatment. RESULTS: The group treated with enoxolone showed significantly lower EI and CEA compared to the control group at 24 h posttreatment. Additionally, pain scores were notably reduced in the enoxolone-treated group 30 min after treatment. CONCLUSIONS: This study suggests that dermo-cosmetic formular containing 2% enoxolone is effective in reducing erythema and pain following laser treatment.

Efficacy and safety of a novel 785 nm picosecond neodymium-doped yttrium aluminum garnet laser for the treatment of facial benign pigmented lesions in Asian skin: a pilot study.

BACKGROUND AND OBJECTIVES: Benign pigmented lesions and a general uneven tone in people with skin of color are growing issues that have been presented to dermatologists. To the best of our knowledge, this is the first controlled study to examine the efficacy and safety of using the newly introduced 785 nm neodymium-doped yttrium aluminum garnet (Nd:YAG) picosecond laser to treat facial benign pigmented lesions in Asian patients with diffractive lens array. MATERIALS AND METHODS: A 785 nm Nd:YAG picosecond laser was used to treat 15 healthy female volunteers older than 18 years who had Fitzpatrick skin types II-IV and facial benign pigmented lesions. Each volunteer received five weekly treatments in dual modes. The clinical improvement was assessed by independent investigators and by objectively measuring the melanin index. RESULTS: After the treatment, the melanin and erythema indices decreased, and the pigmented lesions showed clinical improvements. No serious adverse effects were observed during the study period. CONCLUSIONS: A 785 nm Nd:YAG picosecond laser may be safe and effective in treating facial benign pigmented lesions in Asian skin.

A multicenter, double-blind, randomized, parallel-group, active-controlled, phase 3 clinical trial to compare the effectiveness and safety of two botulinum toxin type A formulations for improving moderate to severe glabellar wrinkles in Asians.

Botulinum toxin type A (BoNT-A) was first isolated in 1946, and since then, several formulations have been developed and widely used to treat wrinkles by inducing muscle paralysis. This multicenter, double-blind, randomized, parallel-group, active-controlled phase 3 clinical trial was designed to evaluate the efficacy and safety of a newly developed BoNT-A formulation, BMI2006, in improving moderate to severe glabellar wrinkles and to compare with existing onabotulinumtoxin A (OBoNT) injections. A total of 276 subjects were enrolled and received 20 units of the randomized material, which was intramuscularly injected into five different locations on the forehead. The primary endpoint, assessed at 4 weeks, showed no statistically significant difference in the improvement rate of glabellar wrinkles between the two groups, with BMI2006 demonstrating non-inferiority to comparator BoNT-A. Secondary endpoints, evaluated by both treating investigators and independent investigators, also exhibited similar improvement rates throughout the study period. Both groups reported high levels of satisfaction with no statistical difference between the two groups. Safety evaluations indicated mild and transient adverse events, with no serious reactions observed. In conclusion, BMI2006 is an effective and safe BoNT-A for treating glabellar wrinkles with an expected duration of action between 8 and 12 weeks.

Cold anesthesia for pain reduction during intralesional steroid injection for nodulocystic acne.

BACKGROUND: In any dermatologic procedure, patient acceptance of treatment is heavily influenced by intraprocedural pain. Intralesional triamcinolone injections are very important in keloid scar and nodulocystic acne treatment. However, the main problem of needle-stick procedures is pain. Cryoanesthesia is ideally intended to cool only the epidermis during treatment and has advantage which did not require application time. AIMS: The aim of this study was to investigate the pain-reducing effect and safety of CryoVIVE® (newly introduced cryoanesthesia device) during triamcinolone injections for nodulocystic acne in actual clinical settings. PATIENTS/METHODS: In this two-staged, non-randomized clinical trial, a total of 64 subjects underwent intralesional triamcinolone injections for their acne lesions with cold anesthesia using CryoVIVE®. The pain intensity was assessed with Visual Analogue Scale (VAS) scores. Safety profile was also evaluated. RESULTS: The mean pain VAS scores on the lesion with and without cold anesthesia were 3.667 and 5.933, respectively (p = 0.0001). No side effects, discoloration, and scarring were observed. CONCLUSION: In conclusion, the anesthetic use of CryoVIVE® with intralesional corticosteroid injections is a practical and well-tolerated modality.

Adipose-derived stem cell exosomes for treatment of dupilumab-related facial redness in patients with atopic dermatitis.

BACKGROUND: Dupilumab facial redness (DFR) is a side effect of dupilumab treatment that has only been recently reported. We previously reported on two patients with DFR who were successfully treated with a topical formulation containing human adipose tissue-derived mesenchymal stem cell-derived exosomes (ASCEs). OBJECTIVES: The study aimed to evaluate the efficacy and safety of ASCEs in DFR. PARTICIPANTS AND METHODS: We performed 12-week prospective study at single center. Twenty adult atopic dermatitis patients diagnosed with DFR were enrolled. They were treated with a topical application of the exosome formulation every week for five consecutive weeks. RESULTS: After exosome treatment, both the average investigator global assessment score and clinical erythema assessment scale scores decreased. 19 patients (95%) were satisfied with the treatment. Compared to baseline, erythema index at week 4 were decreased by 31, 27, 13, and 25 units on the forehead, chin, right and left cheek respectively. The analysis of stratum corneum samples revealed the expression of IL-1α and human thymic stromal lymphopoietin was suppressed after exosome treatment, whereas filaggrin and vascular endothelial growth factor expression increased. CONCLUSIONS: This study suggests topical formulation containing ASCEs can alleviate DFR by downregulating local inflammation and restoring skin barrier function.

A Double-Blinded, Randomized, Dose-Comparison Pilot Study to Comparatively Evaluate Efficacy and Safety of Two Doses of Botulinum Toxin Type A Injection for Deltoid Muscle Hypertrophy.

BACKGROUND: Botulinum toxin type A (BTX-A) injection is being widely used off-label for muscular hypertrophy, including deltoid muscle hypertrophy. However, very few studies have evaluated the optimal dosage and its clinical response. OBJECTIVE: This study aimed to assess the efficacy and safety of different doses of Prabotulinum toxin A (PBoNT) for treating deltoid muscle hypertrophy. METHODS: Twelve particiapants with bilateral deltoid muscle hypertrophy were enrolled and randomly received either 16 U or 32 U of PBoNT. In each participant, the same dose was administered to both deltoid muscles. Both participants and evaluators were blinded. Deltoid muscle thickness and upper arm circumference were measured on day 0, and weeks 2, 4, and 12 after the PBoNT injection. RESULTS: Upper arm circumference significantly decreased in both groups; however, deltoid muscle thickness was reduced in the 16 U group only. No major complications were reported in both groups. However, a few minor complications were reported in the 16 U injection group. CONCLUSION: Both 16 U and 32 U of PBoNT intramuscular injections are safe and effective in treating deltoid hypertrophy.

Efficacy and safety of oral palmitoleic acid supplementation for skin barrier improvement: A 12-week, randomized, double-blinded, placebo-controlled study.

Background: Palmitoleic acid (omega-7) has been reported to be effective primarily for metabolic disorders. Recently, it has been reported to help improve quality of life (QoL) by improving skin symptoms. Objective: The aim of this randomized, double-blinded, placebo-controlled clinical study is to evaluate the efficacy and safety of oral palmitoleic acid in improving skin barrier, elasticity, and wrinkle formation in adult women. Methods: In this randomized, double-blind, placebo-controlled clinical study, 90 healthy participants were enrolled and received 500 mg/day palmitoleic acid (intervention) or corn oil without palmitoleic acid (control) for 12 weeks. Skin hydration and transepidermal water loss and skin elasticity, surface roughness, eye wrinkle volume, and wrinkle severity were measured at 6-week intervals to assess the skin barrier function and efficacy in wrinkle improvement, respectively. Results: After 12 weeks, skin hydration and transepidermal water loss significantly improved in the intervention group compared to the control group. Skin elasticity, surface roughness, eye wrinkle volume, wrinkle severity, and participant-assessed clinical improvement score did not significantly improve compared with the control group. Conclusion: Oral palmitoleic acid effectively improves the skin barrier function improvement, which may enhance QoL in aging adults.

The effect of low-intensity cold atmospheric plasma jet on photoaging-induced hyperpigmentation in mouse model.

BACKGROUND: Cold atmospheric plasma (CAP) produces reactive oxygen/nitrogen species (RONS) in the target and can induce cytoprotective effects by activating hormesis-related pathways when its intensity is in the low range. OBJECTIVES: The aim of this study is to evaluate the effect of low-intensified CAP (LICAP) on skin with photoaging-induced hyperpigmentation in an animal model. METHODS: Changes in cell viability and RONS production following LICAP treatment were measured. For the in vivo study, 30 hairless mice underwent antecedent photoaging induction followed by the allocated therapy (i.e., LICAP, topical ascorbic acid (AA), or both). During the first 4 weeks of the treatment period (8 weeks), ultraviolet (UV)-B irradiation was concurrently administered. Visual inspection and measurement of the melanin index (MI) were performed to assess the change in skin pigmentation at Weeks 0, 2, 4, 6, and 8. RESULTS: RONS production increased linearly until the saturation point. Cell viability was not significantly affected by LICAP treatment. At Week 8, MI was significantly decreased in every treatment group compared with the values at Week 0 and Week 4. The treatment effect of the concurrent therapy group was superior to that of the LICAP and AA groups. CONCLUSION: LICAP appears to be a novel modality for photoprotection and pigment reduction in photodamaged skin. LICAP treatment and topical AA application seem to exert a synergistic effect.