Clinical and Optical Coherence Tomography Correlation of Vascular Conditions Treated With a Novel, Variable-Sequenced, Long-Pulsed, 532 and 1,064 nm Laser With Cryogen Spray Cooling.

BACKGROUND: Patients frequently seek laser treatment for vascular conditions. More recently, a novel 532 and 1,064 nm laser was developed to offer greater flexibility. OBJECTIVE: A prospective clinical trial evaluated the safety and efficacy of a novel, variable-sequenced, long-pulsed, 532 and 1,064 nm laser with cryogen spray cooling (DermaV, Lutronic, South Korea). MATERIALS AND METHODS: Subjects with vascular conditions were enrolled for laser treatments. Clinical evaluations and optical coherence tomography (OCT) imaging were performed. RESULTS: Thirteen subjects were enrolled. The mean age was 51.3 years, and 92.3% were women. Fitzpatrick skin types I-IV were included. Treatment indications included broken blood vessels, rosacea, port-wine birthmark, and spider angioma. For physician investigator grading, all subjects were graded as improved at both 30-day and 90-day follow-up. Blinded photographic review by 3 independent, blinded physicians had a mean of 89.7% of cases selected correctly with at least 2 of 3 in agreement for 100.0% of cases. Optical coherence tomography imaging showed significant reductions in vessel density ( p = .018) and diameter ( p = .003) of the superficial vascular plexus. No serious adverse events occurred. CONCLUSION: A novel, variable-sequenced, long-pulsed, 532 and 1,064 nm laser with cryogen spray cooling can safely and effectively improve vascular conditions and lesions as determined by both clinical and OCT evaluation.

Paired Treatment Using Radiofrequency Microneedling and 755-nm Picosecond Laser With Fractionated Lens Array for Facial Rejuvenation.

BACKGROUND: Patients frequently complain about fine lines, wrinkles, dyschromia, and photoaging, for which lasers and energy-based devices can treat each of these. Pairing various devices in a single treatment session can be safe and effective, but different technologies, mechanisms, histologies, parameters, and techniques must be considered. OBJECTIVE: To examine the utility of a paired treatment regimen using radiofrequency microneedling and 755-nm picosecond laser with fractionated lens array to improve the clinical appearance of facial wrinkles and photoaging. MATERIALS AND METHODS: A prospective clinical study investigated this paired treatment regimen using 4 monthly sessions. RESULTS: Twenty-five subjects were enrolled, while 18 subjects completed 3-month follow-up. The mean age was 54 years, and 92% were women. Fitzpatrick Skin Types I to IV were represented. Assessments compared baseline with the 3-month follow-up. Two of 3 blinded reviewers agreed in identifying pretreatment and post-treatment photographs for 94.4% of cases. For physician Global Aesthetic Improvement Scale, 100% of subjects had clinical improvement. Overall, 88.9% of subjects were considered to be satisfied with their treatment. No serious or unanticipated adverse events occurred. CONCLUSION: Paired treatment using radiofrequency microneedling and 755-nm picosecond laser with fractionated lens array can safely and effectively improve facial wrinkles and photoaging.

High-Intensity, High-Frequency, Parallel Ultrasound Beams for Cellulite of the Buttocks and Thighs.

BACKGROUND: Ultrasound energy can successfully treat fine lines and wrinkles, as well as lift the eyebrow and submentum. Ultrasound waves of high intensity induce thermal injury in the dermis with subsequent tissue remodeling. OBJECTIVE: To examine the utility of a novel ultrasound device that utilizes high-intensity, high-frequency, parallel ultrasound beams to improve the clinical appearance of cellulite on the thighs and buttocks. MATERIALS AND METHODS: A prospective, multicenter, clinical study investigated this novel ultrasound device using 2 treatments. RESULTS: Sixty-five subjects completed both treatments. The mean age was 46 years, and 100% were women. Fitzpatrick skin types I to VI were represented. Assessments compared 3-month follow-up with baseline. Two blinded reviewers agreed in identifying pretreatment and post-treatment photographs for 89.2%. For Cellulite Severity Scale rating, there was significant improvement of 1.61 units (p < .001). For cellulite Global Aesthetic Improvement Scale (GAIS), 89.2% had improvement, with a mean of 0.87 units (p < .001). For Laxity Scale rating, there was significant improvement of 0.70 units (p < .001). For skin laxity GAIS, 89.2% had improvement, with a mean of 0.76 units (p < .001). No device-related adverse events occurred. CONCLUSION: A novel ultrasound device that utilizes high-intensity, high-frequency, parallel ultrasound beams can safely and effectively improve the clinical appearance of cellulite on the thighs and buttocks.

Extension Phase of a Multi-Center, Randomized, Blinded Clinical Study Evaluating the Efficacy and Safety of a Novel Topical Product for Facial Dyschromia.

BACKGROUND: Dyschromia can be associated with increased production and/or reduced clearance of pigmentation in the skin. Multiple pathways are involved in causality. A novel topical product was recently developed, which contains actives that have been validated through in-vitro and clinical studies to counteract pigmentation related to photodamage, PIH, and melasma. This study further evaluates the safety and efficacy of this product for facial dyschromia during an additional 3-month extension period following the completion of the previous 12-week multi-center trial.  Study Design: Subjects from the previous multi-center trial with mild to severe facial dyschromia at baseline were eligible to participate in this 3-month extension study upon completion of that trial. This extension study evaluated the continued use of the novel topical product with PATH-3 Technology (Alastin Skincare, Carlsbad, CA) over a 3-month period. Subjects who were previously randomized to the novel topical product continued using it and for those previously randomized to hydroquinone 4% discontinued its use. Both cohorts continued daily sunscreen use. Blinded investigators assessed subjects at follow-up visits at 16, 20, and 24 weeks. RESULTS: Twenty-six (26) subjects completed the extension phase of the pivotal trial, with 13 subjects in each of the AL and HQ-BREAK cohorts. Significant improvements were seen within the AL cohort from weeks 12 to 24 for facial dyschromia (P=0.0158) and skin tone/clarity/evenness (P=0.0067), while there were no significant improvements seen in the HQ-BREAK cohort. The HQ-BREAK cohort had more subjects who worsened with facial dyschromia and skin tone/clarity/evenness. For the mMASI, the HQ-BREAK cohort demonstrated regression at week 24 compared to week 12, while the AL cohort instead experienced continued improvement. This difference was found to be significant (P=0.02). No study-related adverse events were reported for either cohort.  Conclusion: A novel topical product designed to counteract various steps in pigmentation pathways using PATH-3 Technology has been demonstrated to be safe and effective in treating facial dyschromia on a long-term basis. In contrast to the significant rebound experienced by subjects with HQ, the AL cohort continued to demonstrate ongoing improvement. J Drugs Dermatol. 2024;23(1):1266-1270.     doi:10.36849/JDD.7622.

Prospective Evaluation of the Safety and Efficacy of Thermomechanical Fractional Injury for Perioral Rhytides.

BACKGROUND: Perioral rhytides can be treated with laser and energy-based devices. More recently, a novel fractional thermomechanical skin rejuvenation system was developed to cause controlled thermal injury through direct heat transfer. OBJECTIVE: A prospective clinical trial evaluated the safety and efficacy of a thermomechanical fractional injury device (Tixel 2, Novoxel, Netanya, Israel) for perioral rhytides. MATERIALS AND METHODS: Subjects with moderate-to-severe perioral rhytides were enrolled and underwent 4 monthly treatments. RESULTS: Twenty-three subjects were enrolled and completed all study visits. Mean age was 62.5 years, and 100.0% were women. Fitzpatrick Skin Types I-IV were included. For Fitzpatrick Wrinkle Classification System (FWCS), mean baseline score was 6.9. Per investigator, there was a mean 1.9-grade improvement in FWCS at 3-month follow-up ( p < .0001). At 3-month follow-up, 8.7% (n = 2) of subjects had a 3-grade improvement, 69.6% (n = 16) had a 2-grade improvement, and 21.7% (n = 5) had a 1-grade improvement. For physician Global Aesthetics Improvement Scale at 3-month follow-up, 69.6% (n = 16) had 76% to 100% improvement, 13.0% (n = 3) had 51% to 75% improvement, and 17.4% (n = 4) had 26% to 50% improvement. There were no severe adverse events, and subjects experienced minimal pain. CONCLUSION: A novel device using thermomechanical fractional injury was demonstrated to be safe and effective in the treatment of perioral rhytides.

Safety and Efficacy of a Thermomechanical Fractional Injury Device for Periorbital Rhytides.

BACKGROUND: Periorbital rejuvenation is a common cosmetic concern. A fractional thermomechanical skin rejuvenation system was developed to offer clinical improvements from direct heat transfer. OBJECTIVE: A prospective study evaluated the efficacy and safety of the device for periorbital fine lines and wrinkles. MATERIALS AND METHODS: Subjects with moderate-to-severe periorbital rhytides were enrolled and underwent 4 monthly treatments with a novel device using thermomechanical fractional injury (Tixel 2; Novoxel, Netanya, Israel). RESULTS: Fifty-one subjects were enrolled. Mean age was 56.8 years, and 88.2% were women. Fitzpatrick skin Types I to IV were included. For Fitzpatrick Wrinkle Classification System (FWCS), mean baseline score was 5.7. Per investigator, there was a mean 2.0-grade improvement in FWCS at 3-month follow-up ( p < .0001). Per 3 blinded physician raters, there was a mean improvement of 2.2 ( p < .0001), 2.0 ( p < .0001), and 1.2 ( p < .0001) in FWCS at 3-month follow-up. Each of the raters correctly identified posttreatment images for 87.5%, 77.1%, and 75.0% of subjects. At least 2 raters agreed on grading 83.3% of subjects as responders. There were no severe adverse events. Subjects experienced minimal pain and downtime. CONCLUSION: A novel device using thermomechanical fractional injury was demonstrated to be safe and effective in the treatment of periorbital rhytides.

Safety and Efficacy of a Novel, Variable-Sequenced, Long-Pulsed, 532-nm and 1,064-nm Laser With Cryogen Spray Cooling for Pigmented and Vascular Lesions.

BACKGROUND: Patients frequently seek treatment for vascular and pigmented lesions. More recently, a novel, variable-sequenced, long-pulsed, 532-nm and 1,064-nm laser with cryogen spray cooling was developed to offer greater flexibility in treatments. OBJECTIVE: A prospective clinical trial evaluated the safety and efficacy of a novel, variable-sequenced, long-pulsed, 532-nm and 1,064-nm laser with cryogen spray cooling (DermaV, Lutronic, South Korea). MATERIALS AND METHODS: Subjects with vascular and/or pigmented lesions were enrolled and underwent laser treatments. RESULTS: Twenty-three subjects were enrolled with vascular lesions (39.1%), pigmented lesions (17.4%), and both (43.5%). Mean age was 53.1 years, and 91.3% were women. Fitzpatrick skin types II-IV were included. All subjects were treated with 532 nm, and 4 were also treated with 1,064 nm. According to 4 blinded physician reviewers, correct before and after photographs were selected in 94.7%, 92.1%, 84.2%, and 76.3% of cases. Overall, 86.8% were responders, meaning that at least 3 of 4 reviewers agreed. For Global Aesthetic Improvement Scale, improvement occurred in 81.6%, 81.6%, 81.6%, and 76.3% of cases. No serious adverse events occurred. Overall, 87.0% of subjects reported being very satisfied or satisfied. CONCLUSION: A novel, variable-sequenced, long-pulsed, 532-nm and 1,064-nm laser with cryogen spray cooling can safely and effectively improve vascular and pigmented lesions.

A Multi-Center, Randomized, Blinded Clinical Study Evaluating the Efficacy and Safety of a Novel Topical Product for Facial Dyschromia.

BACKGROUND: Dyschromia can be caused by abnormalities in the increased production and/or reduced clearance of pigmentation in the skin. Causes of hyperpigmentation include excessive sun exposure, medications, hormones, post-inflammatory hyperpigmentation (PIH), and medical disorders, such as melasma. A novel topical product was recently developed, which contains actives that have been validated through in vitro studies to counteract various steps in the pigmentation pathways, including photodamage, PIH, and melasma. This study evaluates the safety and efficacy of this product for facial dyschromia. STUDY DESIGN: Subjects with mild to severe facial dyschromia were enrolled to receive either the novel topical product with PATH-3 Technology (Alastin Skincare, Carlsbad, CA) or hydroquinone 4% topical to apply twice daily. Both cohorts received cleanser, sunscreen, and moisturizer. Follow-up occurred at weeks 4, 8, and 12. Blinded investigators used the modified Melasma Area Severity Index (mMASI) and modified Griffiths scales at baseline and final follow-up. Tolerability assessments and subject questionnaires were completed. RESULTS: Forty-three subjects were enrolled and randomized to either the novel topical product (n=22) or hydroquinone 4% (n=21) cohort. At week 12 follow-up, subjects using the novel topical product had significant improvements in mMASI scores for the right cheek (P=0.0097), left cheek (P=0.0123), combined cheeks (P=0.0019), and total facial area (P=0.0046). In contrast, subjects using hydroquinone 4% had no significant improvements in any of these areas. Although both cohorts demonstrated improvements in dyschromia and skin tone, the novel topical product also offered significant improvements in skin radiance (P=0.0015) and skin texture (P=0.0058), which the hydroquinone 4% cohort did not demonstrate. The hydroquinone 4% cohort experienced 5 adverse events, while there were no adverse events associated with the novel topical product. Subjects in the hydroquinone 4% cohort also more frequently experienced burning/stinging, tingling, itching, erythema, and dryness. CONCLUSION: A novel topical product with PATH-3 Technology, designed to counteract various steps in pigmentation pathways, has been demonstrated to be safe and effective in treating facial dyschromia. CITATION: Wang JV, Fabi SG, Mraz Robinson D, et al. A multi-center, randomized, blinded clinical study evaluating the efficacy and safety of a novel topical product for facial dyschromia. J Drugs Dermatol. 2023;22(4):333-338. doi:10.36849/JDD.7340.

Preventing complications in dermatologic surgery: Presurgical concerns.

Cutaneous surgery has become critical to comprehensive dermatologic care, and dermatologists must therefore be equipped to manage the risks associated with surgical procedures. Complications may occur at any point along the continuum of care, and therefore assessing, managing, and preventing risk from beginning to end becomes essential. This review focuses on preventing surgical complications pre- and postoperatively as well as during the surgical procedure.

Preventing and managing complications in dermatologic surgery: Procedural and postsurgical concerns.

The second article in this continuing medical education series reviews the evidence regarding the intraoperative and postoperative risks for patients and health care workers. We share the most up-to-date recommendations for risk management and postoperative complication management to ensure optimal surgical efficacy and patient safety.

Technological advances for the detection of melanoma: Advances in molecular techniques.

The growth of molecular technologies analyzing skin cells and inherited genetic variations has the potential to address current gaps in both diagnostic accuracy and prognostication in patients with melanoma or in individuals who are at risk for developing melanoma. In the second article in this continuing medical education series, novel molecular technologies are reviewed. These have been developed as adjunct tools for melanoma management and include the Pigmented Lesion Assay, myPath Melanoma, and DecisionDx-Melanoma tests, and genetic testing in patients with a strong familial melanoma history. These tests are commercially available and marketed as ancillary tools for clinical decision-making, diagnosis, and prognosis. We review fundamental principles behind each test, discuss peer-reviewed literature assessing their performance, and highlight the utility and limitations of each assay. The goal of this article is to provide a comprehensive, evidence-based foundation for clinicians regarding the management of patients with difficult pigmented lesions.

Technological advances for the detection of melanoma: Advances in diagnostic techniques.

Managing the balance between accurately identifying early stage melanomas while avoiding obtaining biopsy specimens of benign lesions (ie, overbiopsy) is the major challenge of melanoma detection. Decision making can be especially difficult in patients with extensive atypical nevi. Recognizing that the primary screening modality for melanoma is subjective examination, studies have shown a tendency toward overbiopsy. Even low-risk routine surgical procedures are associated with morbidity, mounting health care costs, and patient anxiety. Recent advancements in noninvasive diagnostic modalities have helped improve diagnostic accuracy, especially when managing melanocytic lesions of uncertain diagnosis. Breakthroughs in artificial intelligence have also shown exciting potential in changing the landscape of melanoma detection. In the first article in this continuing medical education series, we review novel diagnostic technologies, such as automated 2- and 3-dimensional total body imaging with sequential digital dermoscopic imaging, reflectance confocal microscopy, and electrical impedance spectroscopy, and we explore the logistics and implications of potentially integrating artificial intelligence into existing melanoma management paradigms.