Safety and Efficacy of Nanosecond Pulsed Electric Field Treatment of Seborrheic Keratoses.

BACKGROUND: Nanosecond pulsed electric field technology (also known as Nano-Pulse Stimulation or NPS) is a nonthermal, drug-free, energy-based technology that has demonstrated effects on cellular structures of the dermis and epidermis in previous clinical studies. OBJECTIVE: To evaluate the safety and efficacy of a single NPS treatment for clearing seborrheic keratoses (SKs). MATERIALS AND METHODS: This study was a prospective, randomized, open-label, multisite, nonsignificant risk trial in which each subject served as their own control. Fifty-eight subjects had 3 of 4 confirmed SK lesions treated, resulting in 174 total treated lesions. Subjects returned for 5 to 6 follow-up evaluations and photographs. RESULTS: At 106 days after NPS treatment, 82% of treated seborrheic keratoses were rated clear or mostly clear by the assessing physician. Seventy-one percent of lesions were rated clear or mostly clear by the 3 independent reviewers based on the 106-day photographs. All treated subjects returned for all study visits, and 78% of the subjects were satisfied or mostly satisfied with the outcome of the treatment. No adverse events were reported. CONCLUSION: The NPS procedure was well tolerated and effective in the removal of SKs.

Safety and Efficacy of Nanosecond Pulsed Electric Field Treatment of Sebaceous Gland Hyperplasia.

BACKGROUND: Nanosecond pulsed electric field (nsPEF) technology involves delivery of ultrashort pulses of electrical energy and is a nonthermal, drug-free technology that has demonstrated favorable effects on cellular structures of the dermis and epidermis. OBJECTIVE: Determine the tolerability and effectiveness of nsPEF treatment of sebaceous gland hyperplasia (SGH). METHODS: This study was a prospective, randomized, open-label, multisite, nonsignificant risk trial in which each subject served as their own control. After injection of local anesthetic, high-intensity, ultrashort pulses of electrical energy were used to treat 72 subjects resulting in a total of 222 treated lesions. Subjects returned for 3 to 4 follow-up evaluations with photographs. RESULTS: At the final study visit, 99.6% of treated SGH lesions were rated clear or mostly clear and 79.3% of the subjects were satisfied or mostly satisfied with the outcome. At 60 days after nsPEF treatment, 55% of the lesions were judged to have no hyperpigmentation and 31% exhibited mild post-treatment hyperpigmentation. At the last observation for all lesions, 32% of the 222 lesions were noted as having slight volume loss. CONCLUSION: Nanosecond pulsed electric field procedure is well tolerated and is very effective in the removal of SGHs. TRIAL REGISTRATION: ClinicalTrials.gov NCT03612570.

Expertise in Head and Neck Cutaneous Reconstructive Surgery.

BACKGROUND: The management of skin cancers has evolved with the development of Mohs micrographic surgery and a greater emphasis on surgical training within dermatology. It is unclear whether these changes have translated into innovations and contributions to the reconstructive literature. OBJECTIVE: To assess contributions from each medical specialty to the cutaneous head and neck oncologic reconstructive literature. METHODS: The authors conducted a systematic review of the head and neck reconstructive literature from 2000 through 2015 based on a priori search terms relating to suture technique, linear closure, advancement, rotation, transposition and interpolation flaps, and identified the specialty of the senior authors. RESULTS: The authors identified 74,871 articles, of which 1,319 were relevant. Under suture technique articles, the senior authors were primarily dermatologists (58.2%) and plastic surgeons (20.3%). Under linear closure, the authors were dermatologists (48.1%), plastic surgeons (22.2%), and otolaryngologists (20.4%). Under advancement and rotation flaps, the senior authors were plastic surgeons (40.5%, 38.9%), dermatologists (38.1%, 34.2%), and otolaryngologists (14.4%, 21.6%). Under transposition and interpolation flaps, the senior authors were plastic surgeons (47.3%, 39.4%), dermatologists (32.3%, 27.0%), and otolaryngologists (15.3%, 23.4%). CONCLUSION: The primary specialties contributing to the cutaneous head and neck reconstructive literature are plastic surgery, dermatology, and otolaryngology.

ASDS Guidelines Task Force: Consensus Recommendations Regarding the Safety of Lasers, Dermabrasion, Chemical Peels, Energy Devices, and Skin Surgery During and After Isotretinoin Use.

BACKGROUND: Currently, the isotretinoin (13-cis-retinoic acid) package insert contains language advising the discontinuation of isotretinoin for 6 months before performing cosmetic procedures, including waxing, dermabrasion, chemical peels, laser procedures, or incisional and excisional cold-steel surgery. It is common practice to follow this standard because of concerns regarding reports of sporadic adverse events and increased risk of scarring. OBJECTIVE: To develop expert consensus regarding the safety of skin procedures, including resurfacing, energy device treatments, and incisional and excisional procedures, in the setting of concurrent or recent isotretinoin use. MATERIALS AND METHODS: The American Society for Dermatologic Surgery authorized a task force of content experts to review the evidence and provide guidance. First, data were extracted from the literature. This was followed by a clinical question review, a consensus Delphi process, and validation of the results by peer review. RESULTS: The task force concluded that there is insufficient evidence to justify delaying treatment with superficial chemical peels and nonablative lasers, including hair removal lasers and lights, vascular lasers, and nonablative fractional devices for patients currently or recently exposed to isotretinoin. Superficial and focal dermabrasion may also be safe when performed by a well-trained clinician.

ASDS Cosmetic Dermatologic Surgery Fellowship Milestones.

BACKGROUND: The American Council of Graduate Medical Education, which oversees much of postgraduate medical education in the United States, has championed the concept of "milestones," standard levels of achievement keyed to particular time points, to assess trainee performance during residency. OBJECTIVE: To develop a milestones document for the American Society for Dermatologic Surgery (ASDS) Cosmetic Dermatologic Surgery (CDS) fellowship program. METHODS: An ad hoc milestone drafting committee was convened that included members of the ASDS Accreditation Work Group and program directors of ASDS-approved Cosmetic Dermatologic Surgery (CDC) fellowship training programs. Draft milestones were circulated through email in multiple rounds until consensus was achieved. RESULTS: Thirteen milestones were developed in the 6 Accreditation Council for Graduate Medical Education (ACGME) competency areas, with 8 of these being patient-care milestones. Additional instructions for milestone administration more specific to the CDS fellowship than general ACGME instructions were also approved. Implementation of semiannual milestones was scheduled for the fellowship class entering in July 2018. CONCLUSION: Milestones are now available for CDS fellowship directors to implement in combination with other tools for fellow evaluation.

Current status of surgery in dermatology.

An article titled "Current issues in dermatologic office-based surgery" was published in the JAAD in October 1999 (volume 41, issue 4, pp. 624-634). The article was developed by the Joint American Academy of Dermatology/American Society for Dermatologic Surgery Liaison Committee. A number of subjects were addressed in the article including surgical training program requirements for dermatology residents and selected advances in dermatologic surgery that had been pioneered by dermatologists. The article concluded with sections on credentialing, privileging, and accreditation of office-based surgical facilities. Much has changed since 1999, including more stringent requirements for surgical training during dermatology residency, and the establishment of 57 accredited Procedural Dermatology Fellowship Training Programs. All of these changes have been overseen and approved by the Residency Review Committee for Dermatology and the Accreditation Committee for Graduate Medical Education. The fertile academic environment of academic training programs with interaction between established dermatologic surgeons and fellows, as well as the inquisitive nature of many of our colleagues, has led to the numerous major advances in dermatologic surgery, which are described herein.

A randomized, controlled trial of four ablative fractionated lasers for photoaging: a quadrant study.

BACKGROUND: Fractionated technology has revolutionized laser therapy. With the success of initial devices, several fractionated lasers have appeared on the market. Claims of superiority have made device choice difficult for physicians and patients. MATERIALS AND METHODS: Twelve subjects were treated with fractionated ablative lasers (10,600-nm carbon dioxide and 2790-nm yttrium scandium gallium garnet) in this institutional review board-approved trial. Each face was divided into four quadrants, and each quadrant was randomly treated using one of four lasers. Clinical experience was used to optimize settings. Two patients submitted biopsies from each quadrant immediately after treatment. Patients and blinded investigators assessed pain during treatment and post-treatment improvement in photoaging (measured by rhytides, lentigines, texture, and pore size) using a five-point scale. RESULTS: All devices resulted in statistical improvement in photoaging in all patients, but no device was statistically significantly superior. No statistically significant difference was found in pain scores. All patients reported satisfaction 1 month after treatment. Three patients experienced adverse reactions. Histologically, there were no statistically significant differences between devices. CONCLUSIONS: Fractionated ablative lasers reliably result in improvement in photoaging. Despite marketing claims, no statistically significant differences were found in outcomes, pain during treatment, or histologic findings. Even with experienced users, significant adverse reactions are possible.

Multicenter, prospective feasibility study of Nano-Pulse Stimulation™ technology for the treatment of both nodular and superficial low-risk basal cell carcinoma.

Background: Nano-Pulse Stimulation™ (NPS™) therapy is a new, non-thermal bioelectric modality that applies ultrashort pulses of electric energy to trigger regulated cell death (RCD) in treated tissues. Instead of initiating necrosis by heating or freezing, NPS therapy permeabilizes intracellular organelles to activate the cell's own self-destruct pathway of programmed or regulated cell death. Unlike cryotherapeutic procedures that can both damage structural tissues and diffuse into the periphery beyond the margins of the lesion, NPS therapy only affects cells within the treated zone leaving surrounding tissue and acellular components unaffected. Methods: In this study we treated 37 basal cell carcinoma lesions on 30 subjects (NCT04918381). The treated lesions were photographed on 3-, 7-, 14-, 30- and 60-days after treatment. All subjects then underwent surgical excision for histological examination of the treated tissue. Results: 92% of the BCC lesions (34 of 37) showed complete histological clearance of BCC. Histologic analysis of the 3 cases where residual BCC was noted indicated that full energy coverage was not achieved, which could be remedied with an improved treatment guide to standardize and optimize the CellFX® procedure based on NPS technology. Conclusion: The CellFX procedure was shown to be safe and effective for the treatment of low-risk nodular and superficial BCC lesions.

Striae and pelvic relaxation: two disorders of connective tissue with a strong association.

Pelvic relaxation, a weakening of pelvic support structures, is an under-reported condition that affects a multitude of women. In the United States alone, more than 338,000 procedures for prolapse are performed annually. Decreased collagen content has been noted in the tissues of women affected by this condition. Interestingly, biopsy specimens of women with striae also show a diminution of collagen. Using self-reported anonymous data, we compared the prevalence of striae in women with and without pelvic relaxation to see if an association between these two disorders of connective tissue existed. More than half the women with prolapse (54.7%) (n = 41) reported striae, whereas only 25.0% of women in the non-prolapse group (n = 8) reported striae (P < 0.01). Multivariate logistic regression analysis confirmed striae as a significant risk factor for the development of clinical prolapse (odds ratio 3.12, P < 0.05). There appears to be a strong association between the presence of striae and the development of pelvic relaxation, which is unrelated to conventionally cited risk factors, such as age, weight, number of pregnancies, or postmenopausal status.

Laser treatment of vascular lesions.

Laser treatment of vascular lesions remains one of the more common applications of lasers in dermatology. In fact, lasers have largely become the treatment of choice for vascular birthmarks such as hemangiomas and port-wine stains and the definitive treatment of the telangiectatic form of rosacea. The range of congenital and acquired vascular lesions effectively treated with lasers continues to expand.

Lasers and light therapy for acne vulgaris.

Acne vulgaris remains an emotionally and debilitating dermatologic disease, and is conventionally treated with a variety of oral and topical therapies with a number of significant side effects. An evolving understanding of laser-tissue interactions involving Propionibacterium acnes-produced porphyrins, and the development of infrared nonablative lasers to target sebaceous glands, has lead to the development of an escalating number of laser, light and radiofrequency devices for acne. Used as monotherapy or in combination, these devices are showing promise as a method to clear acne in a convenient, non-invasive manner, though there remains a clear need for long-term data and randomized, blinded studies.