Buttocks' Skin Laxity Severity Scale.

BACKGROUND: Clinical scales are useful to assess skin laxity in different areas of the body. OBJECTIVE: To elaborate and validate a photonumeric scale to assess buttocks skin laxity. MATERIALS AND METHODS: The Buttocks' Skin Laxity Severity Scale (SLSS) was developed based on a sample of 120 patients. The SLSS validity and reliability were assessed in 2 validation cycles, performed by 8 dermatologists assessing 50 clinical cases. Both criteria and construct validity were tested. RESULTS: The Buttocks' SLSS is composed by 5 clinical aspects of skin laxity graded from absent (0) to severe (3): buttocks ptosis, skin scalloped appearance, infragluteal fold, localized fat on the lower third of the buttocks, and linear depressed lesions. Final skin laxity classification results from the sum of each item grade multiplied by its weight and varies from 0 to 24. Overall, Kendall, weighted kappa, and intraclass correlation coefficients indicated very good reliability and consistent interrater and intrarater agreement (p < .001). Cronbach alpha of 0.82 indicates high scale reliability. The scale validity was confirmed by criteria validity tests (rs: 0.72, p < .05). CONCLUSION: Buttocks' SLSS is a reliable and valid scale to identify skin laxity severity and its different features, and it is an accurate tool for clinical research.

L-Lift Technique Using Poly-l-Lactic Acid: A Pilot Study.

BACKGROUND: Minimally invasive procedures that prevent and delay the aging process can be an alternative to more invasive surgical procedures. OBJECTIVE: To assess the efficacy and safety of L-Lift technique to improve skin firmness, facial global aesthetics, and the patient and investigator satisfaction. METHODS: Prospective, open, single-center study. Thirty participants underwent 3 treatment sessions 1 month apart and were assessed 8, 16, and 24 weeks after first injections. Assessments included the Facial Laxity Rating Scale (FLRS), Global Aesthetic Improvement Scale (GAIS), objective measurement of skin elasticity, and the Skin Distension Test. RESULTS: At Week 24, 60% of the patients had at least 1-class improvement in the FLRS for the middle face and 33% for the lower face. At Week 24, investigators considered that 90.0% of the patients improved according to the GAIS and 90.0% of the subjects considered they have improved. Skin elasticity (at Week 8 and at Week 16) and Skin Distension Test (at Week 24) assessments indicated improvement in skin firmness. Both patients and investigators were satisfied with the treatment at the study end. CONCLUSION: The technique is safe and efficacious. It may be particularly suitable for patients presenting initial signs of facial skin laxity.

Effective and Safe Repeated Full-Face Treatments With AbobotulinumtoxinA, Hyaluronic Acid Filler, and Skin Boosting Hyaluronic Acid

Background: It is important to study full-face aesthetic combination treatments to establish well-founded individual treatment plans. Objective: To evaluate clinical outcome and perception of treatment with either abobotulinumtoxinA (ABO) or hyaluronic acid (HA) filler followed by repeated combined treatment with ABO, HA filler, and Restylane® Skinboosters (RSB). Methods & Materials: This study was conducted at four sites in Sweden, France, and Brazil and included subjects aged 35-50 years with mild/moderate nasolabial folds and moderate/severe upper facial lines. Monotherapy was ≤125 s.U ABO in at least two upper facial indications with optional touch-up or ≤1 mL HA filler in nasolabial folds/cheeks. At months 6 and 12, both cohorts received ≤125 s.U. ABO in upper facial lines with optional touch-up, ≤2 mL HA filler in nasolabial folds/cheeks (and other facial areas as applicable), and ≤1 mL RSB. Assessments included global facial aesthetic appearance and improvement, first impression, perceived age, wrinkle severity, satisfaction questionnaires, and adverse events. Results: Repeated full-face treatment with ABO, HA filler, and RSB was associated with better aesthetic outcome and higher levels of satisfaction than treatment with ABO or HA filler alone. However, even modest volumes of HA filler achieved good aesthetic outcomes and high satisfaction. Treatment of several indications was well tolerated. Conclusion: Aesthetic improvement and subject satisfaction was high and increased with each treatment. All treatments were well tolerated. These data may be used as support when establishing individual treatment plans. J Drugs Dermatol. 2019;18(7):682-689.

Efficacy, Safety, and Subject Satisfaction After AbobotulinumtoxinA Treatment of Upper Facial Lines.

BACKGROUND: Botulinum toxins are the treatment of choice for wrinkles in the upper third of the face. OBJECTIVE: The purpose of this study was to evaluate the efficacy, safety, and subject satisfaction of abobotulinumtoxinA (ABO) for treatment of upper facial lines. MATERIALS AND METHODS: Subjects aged 35 to 50 years with moderate-to-severe upper facial lines were included in this study. Subjects received a maximum of 125 s.U. ABO in at least 2 indications with optional touch-up after 2 weeks. Assessments included wrinkle severity, global aesthetic improvement, subject satisfaction, and adverse events (AEs) 1, 3, and 6 months after treatment. RESULTS: At Month 1, 100, 94, and 93% of subjects were responders in dynamic glabellar, lateral canthal, and forehead lines, respectively. All subjects were improved 1 month after treatment, and the majority of the subjects were still improved after 6 months. After treatment, most subjects were satisfied with the appearance of their face, felt better about themselves, and agreed that the treatment made them look the way they feel. Seven subjects (22%) had 8 ABO-related AEs (mild-moderate); headache was most commonly reported (9%). CONCLUSION: AbobotulinumtoxinA effectively treated upper facial lines, with high patient satisfaction. Treatment was generally well-tolerated.

Acoustic wave therapy for cellulite, body shaping and fat reduction.

BACKGROUND: Cellulite is a common aesthetic condition that affects almost every woman. OBJECTIVE: To evaluate the efficacy of acoustic wave therapy (AWT) for cellulite and body shaping. METHODS: In this open-label, single-centre trial, 30 women presenting moderate or severe cellulite underwent 12 sessions of AWT on the gluteus and back of the thighs, over six weeks. The following assessments were performed at baseline, and up to 12 weeks after treatment: Cellulite Severity Scale (CSS), body circumference measurements, subcutaneous fat thickness by magnetic resonance imaging (MRI), quality of life related by Celluqol® and a satisfaction questionnaire. RESULTS: The treatment reduced cellulite severity from baseline up to 12 weeks after the last treatment session (subjects presenting severe cellulite: 60% to 38%). The mean CSS shifted from 11.1 to 9.5 (p < 0.001). Hips circumferences reduced from 99.7 and 103.2 cm to 96.2 and 100.3 cm (respectively, p < 0.001). The average thickness of the subcutaneous fat tissue also decreased (28.3 ± 6.5 mm to 26.7 ± 6.1mm; p < 0.001). The treatment also improved quality of life. More than 90% of the subjects would undergo the treatment again and 89% were satisfied with the results. No serious adverse events were reported. CONCLUSIONS: AWT is a safe treatment to improve cellulite appearance and reduce body circumferences.

Fields of anhidrotic effects of abobotulinumtoxinA in patients with compensatory hyperhidrosis.

BACKGROUND: Botulinum toxin type A can be used to treat compensatory hyperhidrosis (CHH), which presents areas of different intensity of sweating. More information about the anhidrotic effects is needed. OBJECTIVE: To evaluate the fields of anhidrotic effects (FAEs) resulting from different doses (5 and 10 U), dilution, and depths of injection of abobotulinumtoxinA in patients with CHH. METHODS: This was a prospective, single-center, pilot study. Ten patients suffering from CHH received 20 different injections of abobotulinumtoxinA on their backs. Midline received higher doses because of more intense sweating. The diameters of the FAEs were measured at 7, 30, and 180 days after the procedure. RESULTS: Diameters of the FAEs were significantly larger at Day 30 (p < .0001) and did not significantly differ when compared with different injection depths and volumes. Points injected with 10 U exhibited significantly larger vertical diameters at 7, 30, and 180 days (p values .05, <.0001, and .043, respectively) than those injected with 5 U, but no statistical significance was observed for the horizontal diameters. CONCLUSION: Areas of more intense sweating need higher doses to present similar diameters of the FAEs. Depth and volume of injections do not play a remarkable role on the FAEs diameters in patients suffering from CHH.

Fields of muscular and anhidrotic effects of 2 botulinum toxin-A commercial preparations: a prospective, double-blind, randomized, multicenter study.

BACKGROUND: Longevity of effects and dose equivalence of different botulinum toxin type A (BoNT-A) preparations need to be better clarified because BoNT-A units are manufacturer-specific. These points are of particular importance for new brands emerging in the market. OBJECTIVE: To assess the field of muscular and anhidrotic effects of 2 commercial preparations of BoNT-A (incobotulinumtoxinA: Xeomin [XEO]; abobotulinumtoxinA: Dysport [DYS]) administered to the upper third of the face. METHODS: Patients were randomized for the side of the forehead (left or right) in which the products were administered. All were treated receiving BoNT-A injections in 10 points (5 on each side) at a dose equivalence of 1.0:2.5 U (XEO:DYS). Clinical assessments and Minor test were performed at baseline and Days 28, 84, 112, and 140. Electromyography was performed at baseline and Days 28 and 140, and ultrasound was performed only at baseline. RESULTS: Eighty patients were enrolled in 2 research centers. Xeomin and DYS presented similar results regarding fields of muscular effects. However, a larger field of anhidrotic effects was found for DYS. There was a positive correlation between the muscle thickness and electromyography results. CONCLUSION: The results of this study suggest that a lower dose equivalence between DYS and XEO could be established.

Superficial dermabrasion versus topical tretinoin on early striae distensae: a randomized, pilot study.

BACKGROUND: Striae distensae (SD) is a common skin condition, with a prevalence ranging from 40% to 90%, depending on the population studied. OBJECTIVES: To evaluate the efficacy of superficial dermabrasion and compare it with that of topical tretinoin cream in the treatment of narrow and early SD. MATERIALS AND METHODS: Prospective, single-center, randomized, open-label study. Thirty-two women presenting with early, untreated SD (striae rubra) were included in this study. One group received 16 weekly sessions of superficial and localized dermabrasion, and the other used 0.05% tretinoin cream daily. Striae width and length were measured and compared between groups and over time. Global Aesthetic Improvement Scale scores and subject satisfaction were also assessed. Biopsies were performed for subjects who agreed to undergo this procedure, followed by histologic analyses of the skin samples. RESULTS: Both treatments were efficacious, with significant improvement in early SD from baseline, but there was no significant difference between the two treatments. Histologic assessment showed improvement in epidermal and dermal layers for the dermabrasion treatment group. CONCLUSION: Both treatments had similar efficacy, but superficial dermabrasion had a lower frequency of side effects and better adherence of the patients.

Objective assessment of erythema and pigmentation of melasma lesions and surrounding areas in long-term management regimens with triple combination.

BACKGROUND: Melasma has a negative impact on quality of life since it typically occurs on the face. OBJECTIVES: To evaluate the erythema and pigmentation of melasma lesions and the surrounding areas in patients receiving triple combination (TC: hydroquinone, tretinoin, and fluocinolone acetonide) regimens. METHODS: Patients first received an 8-week daily TC treatment and were then randomized to twice weekly or tapering regimen with TC. Melanin and erythema levels of lesions and surrounding areas were objectively measured using a narrowband reflectance spectrophotometer. RESULTS: Progressive reduction in the mean melanin levels was observed in the treatment phase. Following both maintenance regimens, there was no difference between melanin levels in the melasma lesions. Adverse effects were rare in both phases of the study and there was borderline reduction in erythema with regimen II. CONCLUSION: Both maintenance regimens were effective in maintaining results obtained during the initial treatment phase, and were safe and well-tolerated. Erythema was less intense with the tapering regimen.

A comparative study of the anatomy of adipose tissue in areas with and without raised lesions of cellulite using magnetic resonance imaging.

BACKGROUND: Cellulite is considered a noninflammatory phenomenon characterized by alterations to the skin surface, with depressed and raised lesions. Few studies have evaluated subcutaneous fat in patients with cellulite, and there is no information about the anatomy of raised lesions. METHODS: Sixty women with raised cellulite lesions were evaluated using magnetic resonance imaging (MRI). Cellulite grade was evaluated using the Cellulite Severity Scale (CSS). Raised cellulite lesions were marked and compared with control areas on the opposite side of the body (buttocks, abdomen, and upper thighs). RESULTS: Mean age was 39.3 ± 11.0 years and average body mass index (BMI) was 25.4 ± 4.1 kg/m(2) . There were no differences between the raised lesions and the control areas in the anatomy of the fat lobes and their size. CSS scores were higher in older patients and in those with higher BMI. Patients with higher BMI had more fat lobes. CONCLUSIONS: The anatomy of subcutaneous fat was similar in raised and control areas for shape, size, and thickness. Higher CSS scores were found in older patients and those with higher BMI.

Evaluation of self-esteem and depression symptoms in depressed and nondepressed subjects treated with onabotulinumtoxinA for glabellar lines.

BACKGROUND: Botulinum toxin type A (BoNT-A) injection has become the most popular cosmetic nonsurgical procedure, and it has been suggested that BoNT-A injections may improve emotional states when frown lines are treated. OBJECTIVES: To evaluate symptoms of depression and self-esteem before and after onabotulinumtoxinA (ONA) injections in the glabella in subjects with and without depression. METHODS: Twenty-five subjects with depression were allocated into one group and 25 subjects without depression were matched to those according to demographic characteristics. The Beck Depression Inventory (BDI) and Rosenberg Self-Esteem Scale (RSES) were used to assess depression symptoms and self-esteem, respectively. Patients were assessed up to 12 weeks after the intervention. RESULTS: Patients with depression had significant improvement in depression symptoms after ONA injections. The maximum effect occurred within the first 8 weeks after treatment. A significant reduction from baseline in BDI score and significant improvement in self-esteem were also observed in patients with depression. CONCLUSION: This research presents new data regarding BoNT-A as a potential treatment to improve depression symptoms in patients with Major Depressive Disorder. Self-esteem scores alone cannot explain the improvement in depression symptoms.

Noninvasive treatment of cellulite utilizing an expedited treatment protocol with a dual wavelength laser-suction and massage device.

BACKGROUND: Over the past few years, noninvasive devices based on radiofrequency and/or lasers and light sources technologies are being used for the treatment of cellulite. OBJECTIVES: To evaluate the effects of an expedited treatment for cellulite and body measures. METHODS: Fifteen female subjects aged from 20 to 42 years were enrolled. All the subjects underwent three treatment sessions of 30 minutes for each area in three consecutive days. Subjects were evaluated at 7, 30, and 60 post treatment. Outcome measurements included Cellulite Severity Scale (CSS) grading, body mass index (BMI), and thigh circumferences were recorded. Celluqol(®) and a satisfaction questionnaire were also applied. RESULTS: At 2 months, improvements in at least one of the four CSS categories were found in 14 of the 15 subjects (93%) while 60% of patients showed improvement in both the number and depth of depressions at follow-up visits. Most of patients (93%) reported that they would get the treatment again. DISCUSSION: This was the first study to examine the effects of this device on cellulite performed over a shortened treatment period. The treatment proved to be safe and effective, representing a new treatment modality that is also time and cost-effective for physicians and patients.

Full-face injections of variable total doses of abobotulinum toxin type A: A randomized, phase IV clinical trial of safety and efficacy.

BACKGROUND: Botulinum toxin type A (BoNT-A) has been used for almost 20 years in cosmetic dermatology to reduce dynamic wrinkles on single or multiple facial areas. OBJECTIVE: To evaluate the safety and efficacy of full-face treatments with various total doses of abobotulinum toxin A (ABO). METHODS: A total of 90 participants were enrolled. Subjects had at least two indications for BoNT-A treatments on each third of the face (upper, middle and lower). They were randomized into 3 groups, with pre-defined total dose range of ABO, varying from 120 to 250 U. RESULTS: Most of the subjects were women (96.5%). The statistically significant improvement from baseline lasted for more than 24 weeks for glabellar lines, and more than 16 weeks for forehead wrinkles and crow's feet, all P<0.001, with no differences between groups. The most frequent adverse event (excessive perioral weakness) was related to high dose in the perioral area. CONCLUSIONS: This is the first study to compare safety and efficacy of different doses of ABO administered to the entire face simultaneously. As long as the recommended doses are used, concomitant injections of ABO are safe and efficient, with no increase in adverse events.

Quality of life and satisfaction of patients after full-face injections of abobotulinum toxin type A: A randomized, phase IV clinical trial.

BACKGROUND: Although botulinum toxin type A (BoNT-A) has been used effectively and safely to reduce facial dynamic wrinkles, few studies assessed patients' quality of life and satisfaction after treatment. OBJECTIVE: To assess the quality of life and satisfaction of patients treated with full-face injections of variable doses of abobotulinum toxin A (ABO). METHODS: Ninety subjects were randomized into 3 different groups, receiving 120-165 U, 166-205 U and 206-250 U, respectively. WHOQOL- BREF and Satisfaction and Self-assessment Questionnaire (SSQ) were completed by subjects up to 6 months after treatment. RESULTS: Most of the subjects were women (96.5%). For the physical domain in WHOQOL, a difference was observed between baseline and visit 2 (p = 0.036). There was no difference between groups for mean grades regarding amount of wrinkles, beauty, harmony and symmetry. However, there was a significant difference in the mean grades between visits. Patients' opinions also showed an improvement in their self-image up to four months after treatment, according to the self-grading. CONCLUSION: The results presented in this study show improvements in patients' quality of life during the peak of action of BoNT-A treatment, regarding the physical aspect. In addition, patients reported good satisfaction after a full-face approach.

A new skin laxity scale for the buttocks: the Skin Laxity Visual Scale (SLVS).

BACKGROUND: The Skin Laxity Severity Scale for the buttocks was previously developed to separately assess buttock ptosis, a scalloped appearance of the skin, infragluteal fold, localized fat on the lower third of the buttocks, and linear depressed lesions. A more objective, faster and shorter version of this scale, to be evaluated visually, would be more feasible to apply in daily practice. OBJECTIVES: To present a new skin laxity scale for the buttocks: the Skin Laxity Visual Scale (SLVS). MATERIALS & METHODS: To establish the scale, investigators chose, by consensus, the most representative cases of each skin laxity grade. The images were graphically edited to better represent the degree of skin laxity identified in a previous study. Scale validity and reliability were assessed in two validation cycles, performed by eight dermatologists assessing 50 clinical cases. RESULTS: Overall, Kendall's, weighted-kappa, and intraclass correlation coefficients indicated very good reliability and consistent inter- and intra-rater agreement (p<0.001). The scale validity was confirmed by criteria validity tests (rs: 0.76, p<0.05). CONCLUSION: The SLVS for the buttocks is a reliable, reproducible, accurate and valid scale to identify skin laxity severity and its different features. It will very likely be an easy-to-use and convenient tool to appropriately assess improvement obtained with treatment and follow patients.

Double-blind, randomized, controlled clinical trial to compare safety and efficacy of a metallic cannula with that of a standard needle for soft tissue augmentation of the nasolabial folds.

BACKGROUND: Injection-related side effects and complications are likely to occur during or after filler injections; they are mainly caused by the injection technique. OBJECTIVE: To assess safety and efficacy of a metallic cannula to inject hyaluronic acid (HA) filler in the nasolabial folds and to compare the safety of this cannula with that of a standard needle. METHODS: This was a prospective, randomized, phase II, double-blinded study that included 25 participants with Grade 2 to 3 for bilateral nasolabial folds according to the Modified Fitzpatrick Wrinkle Scale (MFWS). The side of the injection was randomized (cannula or needle), and 0.5 mL of HA was injected into each nasolabial fold. RESULTS: At day 3, mean MFWS score fell from 2.40 ± 0.40 to 1.46 ± 0.52 (p < .001) on the cannula-injected side and from 2.40 ± 0.40 to 1.48 ± 0.60 (p < .001) on the regular needle-injected side. Participants reported fewer side effects on the side injected with the new tool on the day of the injections: pain (p = .03), edema (p < .001), redness (p = .01) and hematoma (p < .001) than on the needle side. CONCLUSION: The new cannula is a safe and useful tool to inject HA fillers in the nasolabial folds, producing less pain, edema, hematoma, and redness than regular needles.

Botulinum toxin type A for aging face and aesthetic uses.

Botulinum neurotoxin type A injection to correct and/or reverse the physical effects of aging process has become one of the most frequently requested cosmetic procedures at an outpatient setting. Careful clinical evaluation together with proper use of the techniques, including pre- and post-procedures recommendations, reconstitution of the products, techniques, and doses, are described in this article. This article also covers the main indications of botulinum neurotoxin type A for aging face and other aesthetic uses, as well as some possible adverse reactions and their management.

A bipolar radiofrequency, infrared, vacuum and mechanical massage device for treatment of cellulite: a pilot study.

Cellulite has a complex and multifactorial etiology. Synergistic action on treating cellulite has gained support in the treatment of cellulite. This study evaluated safety and efficacy of a bipolar radiofrequency, infrared, vacuum and mechanical massage device for cellulite treatment and reduction of body measures. This was a pilot study, which assessed 9 subjects who presented body mass index from 18 to 25 Kg/Kg and at least grade 6 in the Cellulite Severity Scale (CSS). All subjects underwent a 12-session treatment of posterior thighs and buttocks. There was a significant reduction of the hip circumference (p = 0.001), however, no changes in thigh circumferences were observed (p = 0.4). CSS has improved specifically on both buttocks [p = 0.002 (left side) and p = 0.038 (right side)], and no changes were observed on thighs. The studied device demonstrated efficacy in the reduction of cellulite severity and body circumference measures in the buttocks.

Effects of different doses of abobotulinumtoxinA for the treatment of anterior gingival smile.

Botulinum toxin type A (BoNT-A) is an easy and fast treatment for gingival smile (GS). The objective of the study was to compare the reduction of gingival exposure using three different doses of abobotulinumtoxinA (ABO) in patients with different severities of anterior GS, and to assess treatment safety and patients' satisfaction. A prospective, single-center, randomized, double-blind study was conducted. Mild GS (2 to < 3 mm) was treated with 2.5 U of abobotulinumtoxinA (ABO) per side, moderate GS (3 to < 4 mm) with 5 U of ABO per side, and severe GS (4 mm or more) with either 2.5 U, or 5 U or 7.5 U of ABO per side. All the 41 enrolled patients completed the study. The mean gingival exposure reduced significantly 4 and 12 weeks after treatment. The average reduction of gingival exposure with 5 U was significantly larger than that obtained with 2.5 U, (3.46 ± 1.39 vs. 2.05 ± 1.29 mm; p = 0.004). All groups of GS severity presented statistically significant reduction in the gingival exposure 4 and 12 weeks after ABO injections. Twelve weeks after treatment, more than 80% of the patients were satisfied or very satisfied. There were no treatment-related adverse events reported by the patients or noticed by the investigators. Gingival smile can be safely and effectively managed with BoNT-A injections and specifically with ABO injections to target the LLSAN muscle. Further and larger studies may determine the exact influence of each factor on BoNT-A treatments of GS.