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Development of a Core Outcome Set for Basal Cell Carcinoma (BCC), Including Low-Risk and Advanced Tumors

Schlessinger, Daniel I; Reynolds, Kelly A; Dirr, McKenzie A; Ibrahim, Sarah A; Yanes, Arianna F; Lazaroff, Jake M; Godinez-Puig, Victoria; Chen, Brian R; Kurta, Anastasia O; Cotseones, Jill K; Chiren, Sarah G; Furlan, Karina C; Iyengar, Sanjana; Behshad, Ramona; DeHoratius, Danielle M; Denes, Pablo; Drucker, Aaron M; Dzubow, Leonard M; Etzkorn, Jeremy R; Harwood, Catherine A; Kim, John Y S; Lawrence, Naomi; Lee, Erica H; Lissner, Gary S; Marghoob, Ashfaq A; Matin, Rubeta N; Mattox, Adam R; Mittal, Bharat B; Thomas, J Regan; Zhou, Xiaolong Alan; Zloty, David; Schmitt, Jochen; Kirkham, Jamie J; Armstrong, April W; Basset-Seguin, Nicole; Billingsley, Elizabeth M; Bordeaux, Jeremy S; Brewer, Jerry; Brown, Marc; Brown, Mariah; Collins, Scott A B; Fargnoli, Maria Concetta; De Azevedo, Sergio Jobim; Dummer, Reinhard; Eggermont, Alexander; Goldman, Glenn D; Haedersdal, Merete; Hale, Elizabeth; Hanlon, Allison; Harms, Kelly L; Huang, Conway C; Hurst, Eva A; In, Gino K; Kelleners-Smeets, Nicole; Kheterpal, Meenal; Leshin, Barry; Mcdonald, Michel; Miller, Stanley J; Miller, Alexander; Mostow, Eliot N; Trakatelli, Myrto; Nehal, Kishwer S; Ratner, Desiree; Rogers, Howard; Sarin, Kavita Y; Soon, Seaver L; Stasko, Thomas; Storrs, Paul A; Tagliaferri, Luca; Vidimos, Allison T; Wong, Sandra L; Yu, Siegrid S; Zalaudek, Iris; Zeitouni, Nathalie C; Zitelli, John A; Poon, Emily; Sobanko, Joseph F; Cartee, Todd V; Maher, Ian A; Alam, Murad
BACKGROUND:There is variation in the outcomes reported in clinical studies of basal cell carcinoma (BCC). This can prevent effective meta-analyses to answer important clinical questions. OBJECTIVE:To identify a recommended minimum set of core outcomes for BCC clinical trials. METHODS:Patient and professional Delphi process to cull a long-list, culminating in a consensus meeting. To be provisionally accepted, outcomes needed to be deemed 'important' (score: 7-9, of maximum of 9) by 70% of each stakeholder group. RESULTS:235 candidate outcomes identified via a systematic literature review and survey of key stakeholders were reduced to 74 that were rated by 100 health care professionals and patients in two Delphi rounds. 27 outcomes were provisionally accepted. The final core set of 5 agreed-upon outcomes after the consensus meeting was: complete response; persistent or serious adverse events; recurrence-free survival; quality of life; and patient satisfaction, including with cosmetic outcome. LIMITATIONS/CONCLUSIONS:English-speaking patients and professionals rated outcomes extracted from English-language studies. CONCLUSIONS:A core outcome set (COS) for basal cell carcinoma has been developed. Use of relevant measures may improve the utility of clinical research and the quality of therapeutic guidance available to clinicians.
PMID: 35551965
ISSN: 1097-6787
CID: 5214802

Laser-Assisted Photodynamic Therapy: Two Novel Protocols for Enhanced Treatment Results

Stevenson, Mary L; Karen, Julie K; Hale, Elizabeth K

Photodynamic therapy (PDT) uses a topical photosensitizing agent which is activated by a light source to cause destruction of specific cells. Commonly used for the treatment of actinic keratoses and photodamage, PDT can also be used for other conditions including acne and sebaceous hyperplasia. Here we report our experience with two treatment protocols. The first protocol utilizes laser assisted delivery of topical 5-aminolevulinic acid for enhanced efficacy of blue light photodynamic therapy in the treatment of actinic keratoses and photodamage. The second protocol utilizes red light photodynamic therapy followed by pulsed dye laser to effectively target sebaceous glands in patients with extensive sebaceous hyperplasia

J Drugs Dermatol. 2017;16(4):329-331

PMID: 28403266
ISSN: 1545-9616
CID: 2541192

Melanoma diagnosed following excision of "dysplastic nevi" [Letter]

Lewin, Jesse M; Hale, Elizabeth K
PMID: 25485801
ISSN: 1076-0512
CID: 1474422


Bloom, Bradley; Orbuch, David; Greenbaum, Joshua; Brauer, Jeremy; Bernstein, Leonard; Hale, Elizabeth; Karen, Julie; Brightman, Lori; Weiss, Elliot; Anolik, Robert; Geronemus, Roy
ISSN: 0196-8092
CID: 953252

Adverse events associated with mohs micrographic surgery: multicenter prospective cohort study of 20 821 cases at 23 centers

Alam, Murad; Ibrahim, Omer; Nodzenski, Michael; Strasswimmer, John M; Jiang, Shang I Brian; Cohen, Joel L; Albano, Brian J; Batra, Priya; Behshad, Ramona; Benedetto, Anthony V; Chan, C Stanley; Chilukuri, Suneel; Crocker, Courtney; Crystal, Hillary W; Dhir, Anir; Faulconer, Victoria A; Goldberg, Leonard H; Goodman, Chandra; Greenbaum, Steven S; Hale, Elizabeth K; Hanke, C William; Hruza, George J; Jacobson, Laurie; Jones, Jason; Kimyai-Asadi, Arash; Kouba, David; Lahti, James; Macias, Kristi; Miller, Stanley J; Monk, Edward; Nguyen, Tri H; Oganesyan, Gagik; Pennie, Michelle; Pontius, Katherine; Posten, William; Reichel, Jennifer L; Rohrer, Thomas E; Rooney, James A; Tran, Hien T; Poon, Emily; Bolotin, Diana; Dubina, Meghan; Pace, Natalie; Kim, Natalie; Disphanurat, Wareeporn; Kathawalla, Ummul; Kakar, Rohit; West, Dennis P; Veledar, Emir; Yoo, Simon
IMPORTANCE Detailed information regarding perioperative risk and adverse events associated with Mohs micrographic surgery (MMS) can guide clinical management. Much of the data regarding complications of MMS are anecdotal or report findings from single centers or single events. OBJECTIVES To quantify adverse events associated with MMS and detect differences relevant to safety. DESIGN, SETTING, AND PARTICIPANTS Multicenter prospective inception cohort study of 21 private and 2 institutional US ambulatory referral centers for MMS. Participants were a consecutive sample of patients presenting with MMS for 35 weeks at each center, with staggered start times. EXPOSURE Mohs micrographic surgery. MAIN OUTCOMES AND MEASURES Intraoperative and postoperative minor and serious adverse events. RESULTS Among 20 821 MMS procedures, 149 adverse events (0.72%), including 4 serious events (0.02%), and no deaths were reported. Common adverse events reported were infections (61.1%), dehiscence and partial or full necrosis (20.1%), and bleeding and hematoma (15.4%). Most bleeding and wound-healing complications occurred in patients receiving anticoagulation therapy. Use of some antiseptics and antibiotics and sterile gloves during MMS were associated with modest reduction of risk for adverse events. CONCLUSIONS AND RELEVANCE Mohs micrographic surgery is safe, with a very low rate of adverse events, an exceedingly low rate of serious adverse events, and an undetectable mortality rate. Common complications include infections, followed by impaired wound healing and bleeding. Bleeding and wound-healing issues are often associated with preexisting anticoagulation therapy, which is nonetheless managed safely during MMS. We are not certain whether the small effects seen with the use of sterile gloves and antiseptics and antibiotics are clinically significant and whether wide-scale practice changes would be cost-effective given the small risk reductions.
PMID: 24080866
ISSN: 2168-6084
CID: 782592

Post-filler vascular occlusion: a cautionary tale and emphasis for early intervention

McGuire, Lindsay K; Hale, Elizabeth K; Godwin, Loyd S
We report a case of a 36-year-old female who experienced significant vascular occlusion after injection with hyaluronic acid into the nasolabial folds. The patient experienced immediate pain after the injection, however, the vascular compromise was not diagnosed and treated until 48 hours later. The patient suffered tissue damage despite treatment with hyaluronidase, hyperbaric oxygen, nitropaste, and aspirin. The case highlights the importance of proper injection technique by a qualified physician, as well as the need for immediate recognition and treatment of vascular occlusion should it occur.
PMID: 24085057
ISSN: 1545-9616
CID: 952442

Retrospective study of the treatment of infantile hemangiomas using a combination of propranolol and pulsed dye laser

Reddy, Kavitha K; Blei, Francine; Brauer, Jeremy A; Waner, Milton; Anolik, Robert; Bernstein, Leonard; Brightman, Lori; Hale, Elizabeth; Karen, Julie; Weiss, Elliot; Geronemus, Roy G
BACKGROUND: Infantile hemangioma (IH) clearance may be slow or incomplete in response to pulsed dye laser (PDL) or propranolol alone. OBJECTIVES: To evaluate whether IH treated with PDL and propranolol displayed more rapid and complete clearance than IH treated with propranolol alone. MATERIALS AND METHODS: Retrospective review of facial-segmental IH treated with propranolol and PDL and controls treated with propranolol was conducted. Blinded physicians used patient photographs to select clearance level and the earliest date of near-complete clearance. Days of propranolol, PDL sessions, and propranolol dose, each until date of near-complete clearance; total days of propranolol; and total propranolol dose were recorded. RESULTS: Infantile hemangiomas treated concurrently with propranolol and PDL achieved complete clearance (6/12) more often than IH treated with propranolol followed by PDL (2/5) or IH treated with propranolol alone (1/8; difference in clearance scores p = .01) and achieved near-complete clearance after fewer days of propranolol (mean 92 days for concurrent propranolol and PDL vs 288 days for propranolol; p < .001). Cumulative propranolol dose until near-complete clearance was lowest in the concurrent propranolol and PDL group (149.16 vs 401.25 mg/kg for propranolol; p < .001). CONCLUSION: Facial-segmental IH treated with propranolol and PDL displayed morerapid and complete clearance and required a lower cumulative propranolol dose to achieve near-complete clearance.
PMID: 23458381
ISSN: 1076-0512
CID: 409902

Topical perfluorodecalin resolves immediate whitening reactions and allows rapid effective multiple pass treatment of tattoos

Reddy, Kavitha K; Brauer, Jeremy A; Anolik, Robert; Bernstein, Leonard; Brightman, Lori; Hale, Elizabeth; Karen, Julie; Weiss, Elliot; Geronemus, Roy G
BACKGROUND AND OBJECTIVE: Laser tattoo removal using multiple passes per session, with each pass delivered after spontaneous resolution of whitening, improves tattoo fading in a 60-minute treatment time. Our objective was to evaluate the safety and efficacy of topical perfluorodecalin (PFD) in facilitating rapid effective multiple-pass tattoo removal. STUDY DESIGN: In a randomized, controlled study using Q-switched ruby or Nd:YAG laser, 22 previously treated tattoos were treated with 3 passes using PFD to resolve whitening after each pass ("R0 method"). In previously untreated symmetric tattoos, seven were treated over half of the tattoo with the R20 method, and the opposite half with 4 passes using PFD (R0 method); two were treated over half with a single pass and the opposite half with 4 passes using PFD (R0 method); and six treated over half with a single pass followed by PFD and the opposite half with a single pass alone. Blinded dermatologists rated tattoo fading at 1-3 months. Optical coherence tomography (OCT) imaging of whitening was performed in two tattoos. RESULTS: Topical PFD clinically resolved immediate whitening reactions within a mean 5 seconds (range 3-10 seconds). Tattoos treated with the R0 method demonstrated excellent fading in an average total treatment time of 5 minutes. Tattoo areas treated with the R0 method demonstrated equal fading compared to the R20 method, and improved fading compared to a single pass method. OCT imaging of whitening demonstrated epidermal and dermal hyper-reflective "bubbles" that dissipated until absent at 9-10 minutes after PFD application, and at 20 minutes without intervention. CONCLUSIONS: Multiple-pass tattoo removal using PFD to deliver rapid sequential passes (R0 method) appears equally effective as the R20 method, in a total treatment time averaging 5 minutes, and more effective than single pass treatment. OCT-visualized whitening-associated "bubbles," upon treatment with PFD, resolve twice as rapidly as spontaneous resolution.
PMID: 23255145
ISSN: 0196-8092
CID: 409932

1927-nm Fractional resurfacing of facial actinic keratoses: A promising new therapeutic option

Weiss, Elliot T; Brauer, Jeremy A; Anolik, Robert; Reddy, Kavitha K; Karen, Julie K; Hale, Elizabeth K; Brightman, Lori A; Bernstein, Leonard; Geronemus, Roy G
BACKGROUND: Actinic keratoses (AK) are precancerous epidermal proliferations commonly present on chronically sun-damaged skin. These lesions are among the most often treated dermatologic conditions. OBJECTIVE: We sought to investigate the 6-month safety, tolerance, and efficacy of nonablative 1927-nm fractional resurfacing of facial AK. METHODS: This was a prospective clinical trial of 24 individuals with facial photodamage and AK receiving up to 4 treatments with the fractionated 1927-nm nonablative thulium laser. RESULTS: At 6 months, an 86.6% reduction in absolute number of lesions was noted by independent physician assessment. In addition, at this same time point, patients reported marked or noticeable improvement in overall photodamage. LIMITATIONS: This prospective study does not provide safety, tolerance, and efficacy data beyond 6 months of follow-up, nor does it identify the precise mechanism of action involved in AK clearance after 1927-nm resurfacing. CONCLUSION: The clinical and histologic findings, as well as the reported patient satisfaction and safety, suggest that the treatment of AK and photodamage with a fractionated 1927-nm nonablative thulium laser is a promising new therapeutic option.
PMID: 23041112
ISSN: 0190-9622
CID: 179395

Treatment of port-wine stains with a short pulse width 532-nm Nd:YAG laser

Reddy, Kavitha K; Brauer, Jeremy A; Idriss, Munir H; Anolik, Robert; Bernstein, Leonard; Brightman, Lori; Hale, Elizabeth; Karen, Julie; Weiss, Elliot; Elston, Dirk; Geronemus, Roy G
BACKGROUND AND OBJECTIVE: Pulsed dye laser treatment often results in port-wine stain (PWS) improvement; however, results vary. A frequency-doubled neodymium-doped yttrium aluminum garnet (Nd:YAG) laser that allows for shorter pulse widths along with large spot sizes and high fluences has been developed for the treatment of cutaneous vascular lesions. STUDY DESIGN: A prospective, controlled study was performed in 5 adults with PWS using a frequency-doubled Nd:YAG laser (Excel V; Cutera Inc, Brisbane, CA) in 4 quadrants, using spot sizes of 6 to 10 mm, fluences of 4.8 to 9 J/cm2, and pulse durations of 3 to 6 ms. An adjacent control area was not treated. Each was assessed immediately posttreatment for purpura and edema and at 1 month for PWS color, size, texture, and thickness. Skin biopsies obtained immediately after and at 1 month posttreatment were evaluated. RESULTS: All treatment quadrants displayed purpura. At 1-month follow-up, all treatment quadrants showed at least 1 grade of color improvement, from a minimum of 1% to 25% to a maximum of 51% to 75% improvement (12/20 quadrants with 1%-25% improvement, 3/20 with 26%-50%, 5/20 with 51%-75%, and 0/20 with 76%-100%). Histologic evaluation of treatment quadrants revealed vascular changes ranging 0.35 to 4 mm in depth. Immediately posttreatment, thrombi and extravasated red blood cells were observed in treatment quadrants. Histology at 1 month revealed decreased number and diameter of vessels in treatment quadrants (superficial vessels decreased by mean 1.1 vessels per section [13%], and diameter by 3.0 mum [47%], midlevel vessels decreased in number by 2.3 [20%], diameter by 2.42 mum [25%], and deep vessels decreased in number by 1.5 [83%], and diameter by 7.44 mum [88%]). CONCLUSIONS: A single treatment with a short pulse width, frequency-doubled Nd:YAG laser resulted in safe and effective improvement of PWS, with up to 75% improvement in color observed at 1 month. Histologic evaluation demonstrated vascular injury at depths of 0.35 to 4 mm with a reduction in vessel number and size at multiple dermal levels.
PMID: 23377330
ISSN: 1545-9616
CID: 409912