Setting appropriate pain expectations: Lessons learned from a clinical trial.

OBJECTIVE: This retrospective study compares subject-reported pain levels and expectations set forth by industry and treating physicians during a clinical trial of an energy based device. The physiologic and emotional aspects of pain expectations are discussed and recommendations are made for strategic patient counseling. MATERIALS AND METHODS: Average and mode pain scores were collected from the records of a previously conducted clinical trial investigating a radiofrequency microneedling device at three different settings. The trial protocol and device manual were reviewed to ascertain language regarding procedural pain. Treating physicians were asked how they learned about procedural pain and how they described it to subjects. Subject-reported pain scores and verbal pain descriptors from the device manual and trial protocol were translated onto validated pain scales, the Numerical Rating Scale (NRS), and the Verbal Rating Scale (VRS), for comparison. RESULTS: A total of 90 procedural pain scores were collected from 30 subject charts. The average procedural pain scores for three different device settings were 5.3, 6.7, and 4.6 out of 10 and the mode pain score was 6 out of 10. This translated to a 5-6 and 7-8 on the NRS, respectively and classification as "painful but bearable" and "considerable pain" on the VRS. Industry sourced pain levels translated to a 2-4 on the NRS and classification as "little pain" on the VRS. CONCLUSION: Subject-reported pain scores were higher than those set forth by industry materials and personnel. Physicians should be wary of manufacturer materials or anecdotal evidence that might mislead patients and cause undue physiological or emotional stress. Lasers Surg. Med. 9999:XX-XX, 2018. © 2018 Wiley Periodicals, Inc.

Delayed-Onset Nodules to Differentially Crosslinked Hyaluronic Acids: Comparative Incidence and Risk Assessment.

BACKGROUND: Robust and long-term data on true incidence of delayed-onset nodules and immune tolerance of hyaluronic acid (HA) fillers are lacking. OBJECTIVE: To characterize the incidence of delayed nodules in Vycross (VYC) HA fillers compared with previously reported FDA and non-FDA data of all HA fillers. METHODS AND MATERIALS: The incidence of delayed nodules in all patients who had received VYC fillers in a 12-month period was assessed through a retrospective chart review. Nodule incidence for currently approved nonanimal-stabilized hyaluronic acid (NASHA) fillers was assessed using the FDA Summary of Safety and Effectiveness Data. RESULTS: Overall, 1,029 patients received 1,250 VYC filler treatments. Five patients developed delayed nodules to VOB, with an incidence of 1.0% per patient and 0.8% per syringe. No nodules were observed in patients who received VLR or VOL. All nodules were treated successfully using a combination of intralesional triamcinolone and hyaluronidase. Compared with other currently approved NASHA fillers, VOB is associated with a higher incidence of nodule formation. CONCLUSION: The introduction of VYC HAs has introduced a new variable that may be changing the immune tolerance of these substances, resulting in a higher incidence of delayed nodules than previously expected.

Evaluation of MITF, SOX10, MART-1, and R21 Immunostaining for the Diagnosis of Residual Melanoma In Situ on Chronically Sun-Damaged Skin.

BACKGROUND: Melanocytic immunostains can assist in margin evaluation of melanoma in situ (MIS) excisions; however, their accuracy and reliability relative to hematoxylin & eosin (H&E) is yet to be determined. OBJECTIVE: The objective of this study was to evaluate the sensitivity, specificity, and concordance of 4 melanocyte-specific immunostains for diagnosing MIS occurring on chronically sun-damaged skin. MATERIALS AND METHODS: Serial permanent sections from representative areas of negative margin and residual tumor were stained using H&E, MITF, MART-1, SOX10, and R21 and examined in a blinded fashion. The study set included 100 digital microscopy images from 10 cases of MIS excisions from the face. Two board-certified dermatopathologists, 4 fellowship-trained Mohs surgeons, 2 Mohs fellows, and 2 dermatology residents independently reviewed the 100 images. RESULTS: The average melanocyte density was 11 versus 28 melanocytes per 0.5 mm for chronically sun-damaged skin versus residual MIS on H&E, respectively. Statistically significantly higher melanocyte densities were observed using MITF, MART-1, and SOX10 on negative margins. The sensitivity and interobserver concordance was highest using MITF and SOX10. The intraobserver agreement on 4 duplicate images was 85%. CONCLUSION: In conclusion, the nuclear immunostains (MITF and SOX10) show the most promise for improving the diagnosis of MIS in chronically sun-damaged skin.

Demographic and Tumor Characteristics of Patients Younger Than 50 Years With Nonmelanoma Skin Cancer Referred for Mohs Micrographic Surgery.

BACKGROUND: An increase in nonmelanoma skin cancer (NMSC) in younger patients has been reported. Many are treated with Mohs micrographic surgery (MMS). OBJECTIVE: Investigate patient and tumor characteristics in patients less than 50 years undergoing MMS for NMSC at a large, referral-based practice. METHODS & MATERIALS: Retrospective chart review of 1,332 tumors occurring in 1,018 consecutive patients over a five-year period. RESULTS: 81.7% of tumors were BCC and 55.3% occurred in women. Patients less than 30 years were more likely to be female (P equals 0.016) and women were more likely to have BCC (P equals 0.010). SCCs were more likely with increasing age (P less than 0.001). Of all tumors, 3.6% were recurrent, 2.7% had diameters ≥ 2 centimeters, and 5.5% of all BCCs had a high-risk histologic subtype. Women were more than twice as likely as men to be referred to plastic surgery for repair (P equals 0.020). CONCLUSION: Patients < 50 years with NMSC may represent a growing population referred for MMS, especially young women with BCC. High-risk tumor features were rare among young patients, and female gender was associated with an increased rate of referral for repair by a plastics subspecialty. Study was performed at the Laser & Skin Surgery Center of New York. IRB STATUS: Approved by Essex Institutional Review Board, Protocol #MOHS40-65

J Drugs Dermatol. 2018;17(5):499-505.

A Clinical Review of Laser and Light Therapy for Nail Psoriasis and Onychomycosis.

BACKGROUND: There are considerable emerging data in the use of lasers and lights to treat onychomycosis and psoriasis of the nail subunit. OBJECTIVE: We aimed to review all of the medical literature on laser therapy of nail psoriasis and onychomycosis published since 1992. METHODS AND MATERIALS: We performed a PubMed literature search using the search terms "nail," "laser therapy," "laser surgery," "light," with search terms "psoriasis" and "onychomycosis." In addition, we performed extensive MeSH and bibliographic searches as delineated in the manuscript. Because of the poor quality of evidence, we were not able to complete a quantitative review and thus present our findings qualitatively. RESULTS: Although the trials are small, PDL (595 nm) and IPL with a 550-nm filter demonstrate compelling data in treating nail psoriasis. Laser studies of onychomycosis fall short on many levels. Q-switched Nd:YAG lasers with very short pulse durations and fractionated CO2 demonstrate the most promise for the treatment of onychomycosis. CONCLUSION: The data for treating nail psoriasis and onychomycosis with laser and light therapy are rapidly emerging. With increased subject data, improved study methodology, and more precise output parameters, lasers may become an important modality in the treatment of nail psoriasis and onychomycosis.

Simplifying Forehead Reconstruction: A Review of More Than 200 Cases.

The forehead is a unique facial region with distinct boundaries and variability in shape from patient to patient. When reconstructing the forehead, it is critical to take into account the regional boundaries as their distortion may result in noticeable facial asymmetry. We propose subdividing the forehead into newly defined zones and put forth a rational algorithm for forehead repair based on these divisions. We retrospectively reviewed a single surgeon's (F. H. S.) experience with Mohs excision and immediate reconstruction of the forehead over a 3-year period. A total of 227 consecutive post-Mohs forehead reconstructions were identified, and the reconstructive technique for a given defect size and location and postoperative complications were recorded. The average patient age was 69 years and 114 (50%) patients were female. Reconstructive techniques varied based on defect size and location within the five distinct forehead zones. Primary closure was the favored technique when appropriate, with variation in orientation based on forehead zone. Modified Burow's advancement flap was the most commonly utilized reconstruction for defects of midlateral forehead and suprabrow area, accounting for 51.7 and 62.5% of repairs, respectively. Other techniques included A-to-T flaps, rotation flaps, and full-thickness skin grafting. Using our defined zones, most common repair techniques, and final outcomes, a reconstructive algorithm for post-Mohs excisions on the forehead was derived. Consideration of the five distinct forehead zones and application of an algorithm to guide technique selection for post-Mohs forehead defect repair can lead to consistent results.

Extragenital bullous lichen sclerosus.

Lichen sclerosus (LS) is a chronic, inflammatory dermatosis that is characterized by pruritic, white, atrophic plaques that classically affect the anogenital region of postmenopausal women. Extragenital involvement also may occur with several reported morphologic variants. Extragenital bullous LS is a rare variant, which presents as flaccid bullae that favor the trunk and proximal aspects of the extremities. The treatment of extragenital bullous LS is similar to that of genital LS. However, extragenital LS is often less responsive and may present a therapeutic challenge. We describe a 65-year-old woman with a two-year history of vulvar and extragenital LS, who developed a bullous eruption within a pre-existing patch of lichen sclerosis on the breast. We review the clinical and histopathologic features of extragenital bullous LS and discuss current treatment options, which include those for recalcitrant cases.

Chronic actinic dermatitis occurring in an adult with atopic dermatitis.

Chronic actinic dermatitis (CAD) is a photosensitivity disorder that is characterized by a persistent eczematous eruption in sun-exposed sites. The hallmark of CAD is a reduced minimal erythema dose (MED) to ultraviolet B (UVB), ultraviolet A (UVA), and/or to visible light, which makes phototesting the essential diagnostic investigation. The uncommon subgroup of patients with atopic dermatitis (AD) that are affected by CAD has primarily been described in young patients in the United Kingdom. We present an atopic adult women with CAD who was diagnosed years after symptoms began. We believe it is important that dermatologists perform phototests on AD patients with features of a photoaggravated dermatitis in order to avoid delay in diagnosis of a true photosensitivity condition and provide appropriate management.

Current principles of sunscreen use in children.

PURPOSE OF REVIEW: Physicians need to be prepared to counsel patients on why and how to protect themselves from damaging ultraviolet (UV) radiation, including the proper use of sunscreens. In this article, we review the interplay between UV radiation, sunscreens and the skin, highlighting current controversies and recommendations surrounding sunscreen use. RECENT FINDINGS: An important concept is that excessive UV exposure has long-term damaging effects on the skin beyond the immediate sunburn. Recent discoveries of the role of UVA radiation in skin cancer development have set high standards for broad-spectrum coverage to be met by sunscreens. Current evidence does not support an association between sunscreen use and melanoma, systemic toxicity or vitamin D deficiency. Although sunscreen application is the most common modality for sun protection, many people do not use it correctly. Regular sunscreen use during childhood and adolescence can significantly reduce lifetime incidence of skin cancer; therefore, targeting children in pediatric offices regarding unprotected UV exposure may be a practical approach. SUMMARY: Sunscreens continue to be a major method of photoprotection among the public, offering numerous benefits that clearly outweigh potential risks; however, optimizing the use of sunscreens, especially among children and adolescents, remains a major challenge.

Dermatologic manifestations of endocrine disorders.

PURPOSE OF REVIEW: The diagnosis of many childhood endocrine disorders can be facilitated by an awareness of the associated dermatologic findings. In this review, we will survey examples of endocrine disorders in children that include a prominent or diagnostic dermatologic sign/symptom. RECENT FINDINGS: A key concept is that skin findings often accompany hormonal conditions, both those of hormone excess and hormone deficiency/resistance. Some dermatologic signs may also represent the hallmark lesion, or provide the first clinical sign in childhood, for both familial tumoral and nontumoral syndromes. Moreover, skin as an endocrine organ itself may provide new avenues both to understand disease mechanisms as well as to provide targeted therapy. SUMMARY: Early diagnosis, often aided by recognition of a keynote dermatologic lesion, may permit prompt, timely treatment that, in some cases, may even prove life saving. Conversely, when these associated signs go undetected or misdiagnosed, therapeutic intervention may be delayed unnecessarily.

Lymphatic malformation: risk of progression during childhood and adolescence.

Lymphatic malformations (LMs) in soft tissues tend to enlarge over time, causing distortion, obstruction, and functional problems. The purpose of this study was to determine the natural progression of LMs to facilitate patient counseling, gain insight into pathophysiology, and guide therapy. Our Vascular Anomalies Center database was reviewed for patients with cutaneous and soft tissue LMs; combined or visceral lesions were excluded. Predictive variables were age, channel type (macrocystic, microcystic, combined), sex, lesion size (localized, diffuse), and location (head/neck, extremities, trunk). The outcome variable was natural progression of the malformation defined by expansion or the onset/worsening of signs and symptoms. The study included 441 patients: 234 females (53.1%) and 207 males (46.9%). Lymphatic malformations were located in the head/neck (61.2%), extremities (17.5%), trunk (16.1%), or multiple sites (5.2%). Children had a 42.2% risk of progression before adolescence, 84.7% before adulthood, and 95.3% during their lifetime. Progression was more likely in adolescence (63.8%) than in childhood (40.8%); the odds ratio was 2.6 (P=0.003). Diffuse LMs worsened more often than localized lesions (P=0.001), whereas channel type (P=0.63), sex (P=0.42), and location (P=0.28) did not influence progression.Lymphatic malformations have a greater risk of progression in adolescence than in childhood; pubertal hormones may contribute to expansion. Because of this high rate of progression, early treatment of asymptomatic LMs should be considered.

Frequency of squamous cell carcinoma (SCC) invasion in transected SCC in situ referred for Mohs surgery: the Dartmouth-Hitchcock experience.

BACKGROUND: Squamous cell carcinoma (SCC) in situ may be transected in a superficial biopsy, which makes it difficult to distinguish between in situ and invasive carcinoma. This study investigated the frequency of invasive SCC in transected SCC in situ referred for Mohs surgery. METHODS: A retrospective chart review was performed to identify subjects with biopsy-proven, transected SCC in situ referred for Mohs surgery. The incidence of invasion, histologic variables, preoperative and intraoperative correlations, and clinical factors were determined and recorded. RESULTS: Of 51 cases identified, five (9.8%) were found to harbor invasive SCC, 15 (29.4%) showed SCC in situ, and 28 (54.9%) showed evidence of scarring, inflammation, or actinic keratosis at the prior biopsy site. Invasive lesions required significantly more stages of Mohs surgery to obtain tumor clearance but were similar with regard to patient age, symptoms, and family and personal histories of skin cancer. Preoperative lesion size and duration were greater in invasive cases, but these differences did not reach statistical significance. CONCLUSIONS: A small number of transected SCCs in situ, to which the caveat "invasion cannot be ruled out" can be applied, have an invasive component that is identified during Mohs surgery. Definitive treatment choices should depend on the physician's impression, the clinical characteristics of the lesion, tumor location, patient comorbidities, and patient desires.

Modification of Burow's advancement flap: avoiding the secondary triangle.

IMPORTANCE: Burow's advancement flap is a frequently used and versatile flap in cutaneous surgery because it provides an excellent method for repair of large defects in proximity to free margins. Its execution typically requires excision of 2 standing cones, which increases scarring and flap size. We describe a modification of this flap achieved with a simple, reproducible suturing technique that eliminates one of the standing cones and both minimizes suture lines and optimizes cosmesis at a variety of surgical sites. OBSERVATIONS: We describe 5 cases in which we successfully used our modified Burow's advancement flap to repair Mohs surgical defects in various cosmetic subunits of the face. CONCLUSIONS AND RELEVANCE: A simple suturing technique is proposed that can eliminate the need for a secondary triangle in Burow's advancement flaps. By implementing the "rule of halves" in suturing wound edges of unequal length, one can evenly distribute redundant tissue along the length of the flap, which avoids additional incisions, minimizes scarring, and allows for repair within a single cosmetic subunit. LEVEL OF EVIDENCE: NA.