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.

Energy-based devices for the treatment of Acne Scars: 2022 International consensus recommendations.

BACKGROUND AND OBJECTIVES: Acne scars are one of the most distressing and long-term consequences of acne vulgaris, with damaging effect on a person's physical, mental, and social well-being. Numerous treatment options are available including surgical and nonsurgical techniques, depending on the clinical presentation. Although considerable advances in the development of new treatment technologies and applications have been made in the last decade, international treatment guidelines and reimbursement schemes have not yet caught up with current knowledge and practice in many centers. The authors intend to highlight the potential utility of energy-based devices (EBDs) for acne scarring, offer recommendations for safe and efficacious treatment, and provide consensus-based EBD treatment options based on varying presentations demonstrated in a series of real-life clinical photographs. STUDY DESIGN/MATERIALS AND METHODS: An international panel of 24 dermatologists and plastic surgeons from 12 different countries and a variety of practice backgrounds was self-assembled to develop updated consensus recommendations for the treatment of acne scars. A two-step modified Delphi method took place between March 2020 and February 2021 consisting of two rounds of emailed questionnaires. The panel members approved the final manuscript via email correspondence. RESULTS: The manuscript includes a comprehensive discussion and panel recommendations regarding the following topics: 1. the role of EBD in mitigating and treating acne scars in a patient with active acne, 2. the use of various EBDs for the treatment of different acne scar types with special focus on commonly used laser platform such as vascular lasers, ablative fractional lasers (AFLs) and non-AFLs (NAFLs), 3. treatment combinations, and 4. acne scar treatments in skin of color. The last part comprised of 10 photos of real-life clinical cases with the panel recommendation treatment plan to achieve best aesthetic outcome. CONCLUSION: Panel members were unanimous in their view that EBDs have a role in the management of acne scars, with AFLs, NAFLs, vascular lasers, and RF devices preferentially selected by most of the panel experts. EBDs are considered a first-line treatment for a variety of acne scar types and patients without access to these treatments may not be receiving the best available care for optimal cosmetic results. Future high-quality research and updated international treatment guidelines and reimbursement schemes should reflect this status.

Objective evaluation of an occlusive overnight intensive patch containing onion extract and allantoin for hypertrophic scars.

BACKGROUND: Patients suffering from hypertrophic scars often describe esthetic, functional, and psychological impairments. While current guidelines for the treatment of pathologic scarring recommend the use of onion extract containing gels and sheets, hard evidence for its efficacy remains scarce due to inconsistent data. Onion extract and allantoin containing occlusive overnight intensive patches (OIP) were introduced as a recent option for noninvasive scar management. However, objective data demonstrating their efficacy are missing. AIMS: This study is the first to objectively evaluate the benefit and safety of an OIP for hypertrophic scars using a three-dimensional imaging device and a standardized scar scale. METHODS: Twelve patients with untreated, three to twelve months old hypertrophic scars received an OIP for 3 months. The assessment was performed using PRIMOS®pico , a three-dimensional imaging device and POSAS, a standardized scar questionnaire at baseline, one and 3 months after the last treatment. RESULTS: Objective evaluation at three months follow-up (FU) showed a significant decrease in scar height of 28.8% (baseline mean: 2.08 ± 0.68 mm, three months FU mean: 1.48 ± 0.52 mm) and a reduction in scar volume of 31.9% (baseline mean: 454.33 ± 265.53 mm3, 3 months FU mean: 309.58 ± 224.28 mm3). Pain and pruritus subsided under treatment. There were no negative side effects. CONCLUSION: Overnight intensive patches is a convenient, painless, safe, affordable and effective prevention and treatment option for hypertrophic scars. Treatment should be performed at least for 3 months for visible effects.

Effectiveness and Safety of an Overnight Patch Containing Allium cepa Extract and Allantoin for Post-Dermatologic Surgery Scars.

BACKGROUND: An occlusive overnight intensive patch medical device (OIP) containing onion extract and allantoin has been developed for preventing and treating dermatologic scars and keloids. Here, we examined the efficacy and safety of the OIP for post-dermatologic surgery scars. METHODS: This was an intra-individual randomized, observer-blind, controlled study in adults with post-dermatologic surgery scars. Two scars per subject were randomized to no treatment or overnight treatment with the OIP for 12-24 weeks. Scar quality was assessed using the Patient and Observer Scar Assessment Scale (POSAS) and a Global Aesthetic Improvement Scale. RESULTS: A total of 125 subjects were included. The decrease in observer-assessed POSAS from baseline was significantly greater for treated than untreated scars at week 6 (p < 0.001) and 24 (p = 0.001). The decrease in patient-assessed POSAS was significantly greater for the treated scar than the untreated scar at week 12 (p = 0.017) and 24 (p = 0.014). Subject- and investigator-evaluated Global Aesthetic Improvement Scale scores were higher for the treated than the untreated scar at all visits. All subjects considered the global comfort of the OIP to be good or very good, and no safety concerns were identified. CONCLUSIONS: This study confirmed that the OIP safely promotes scar healing after minor dermatologic surgery. LEVEL OF EVIDENCE II: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Current Strategies in the Treatment of Scars and Keloids.

Hypertrophic scars (HTSs) and keloids are a major health concern for aesthetic and functional reasons. Despite a plethora of rapidly evolving treatment options and technical advances, the management of pathologic scarring remains difficult. The development of standardized treatment algorithms has been problematic for years due to the lack of sound randomized controlled trials. Expert panels are more and more establishing guidelines to provide an evidence-based framework on a national and international level. This article aims to evaluate the current strategies and upcoming trends in the therapy and prevention of unpleasant scars and keloids from a clinical perspective. There is strong evidence to support a growing role of early combination treatments, particularly the application of 5-fluoruracil adjunct to intralesional steroid injections. Furthermore, the use of fractional ablative laser technologies such as the CO2 laser has recently yielded promising results with respect to aesthetic outcomes and patient satisfaction at tolerable side effects.

Up-to-date approach to manage keloids and hypertrophic scars: a useful guide.

Keloids and hypertrophic scars occur anywhere from 30 to 90% of patients, and are characterized by pathologically excessive dermal fibrosis and aberrant wound healing. Both entities have different clinical and histochemical characteristics, and unfortunately still represent a great challenge for clinicians due to lack of efficacious treatments. Current advances in molecular biology and genetics reveal new preventive and therapeutical options which represent a hope to manage this highly prevalent, chronic and disabling problem, with long-term beneficial outcomes and improvement of quality of life. While we wait for these translational clinical products to be marketed, however, it is imperative to know the basics of the currently existing wide array of strategies to deal with excessive scars: from the classical corticotherapy, to the most recent botulinum toxin and lasers. The main aim of this review paper is to offer a useful up-to-date guideline to prevent and treat keloids and hypertrophic scars.

Treatment of striae distensae using an ablative Erbium: YAG fractional laser versus a 585-nm pulsed-dye laser.

Abstract Striae distensae (SD) represent a common disfiguring cutaneous condition characterized by linear reddish smooth bands of atrophic-appearing skin. Most often SD develop in areas of dermal damage produced by stretching. Numerous treatment modalities have been applied with varying success. Novel approaches include treatments with various types of lasers with the flashlamp-pumped pulsed dye laser (PDL; 585 nm) being the most commonly reported. Very recently, fractional photothermolysis has been suggested as an effective method for the treatment of SD. Here, we report on the effect of an ablative Erbium:YAG fractional laser in two cases of axillary SD in comparison with a 585-nm PDL.