Multicenter prospective cohort study of the incidence of adverse events associated with cosmetic dermatologic procedures: lasers, energy devices, and injectable neurotoxins and fillers.

IMPORTANCE: Common noninvasive to minimally invasive cosmetic dermatologic procedures are widely believed to be safe given the low incidence of reported adverse events, but reliable incidence data regarding adverse event rates are unavailable to date. OBJECTIVE: To assess the incidence of adverse events associated with noninvasive to minimally invasive cosmetic dermatologic procedures, including those involving laser and energy devices, as well as injectable neurotoxins and fillers. DESIGN, SETTING, AND PARTICIPANTS: A multicenter prospective cohort study (March 28, 2011, to December 30, 2011) of procedures performed using laser and energy devices, as well as injectable neurotoxins and soft-tissue augmentation materials, among 8 geographically dispersed US private and institutional dermatology outpatient clinical practices focused on cosmetic dermatology, with a total of 23 dermatologists. Participants represented a consecutive sample of 20 399 cosmetic procedures. Data acquisition was for 3 months (13 weeks) per center, with staggered start dates to account for seasonal variation. EXPOSURES: Web-based data collection daily at each center to record relevant procedures, by category type and subtype. Adverse events were detected by (1) initial observation by participating physicians or staff; (2) active ascertainment from patients, who were encouraged to self-report after their procedure; and (3) follow-up postprocedural phone calls to patients by staff, if appropriate. When adverse events were not observed by physicians but were suspected, follow-up visits were scheduled within 24 hours to characterize these events. Detailed information regarding each adverse event was entered into an online form. MAIN OUTCOMES AND MEASURES: The main outcome was the total incidence of procedure-related adverse events (total adverse events divided by total procedures performed), as verified by clinical examination. RESULTS: Forty-eight adverse events were reported, for a rate of 0.24% (95% CI, 0.18%-0.31%). Overall, 36 procedures resulted in at least 1 adverse event, for a rate of 0.18% (95% CI, 0.13%-0.25%). No serious adverse events were reported. Adverse events were infrequently associated with known risk factors. CONCLUSIONS AND RELEVANCE: Noninvasive to minimally invasive cosmetic dermatologic procedures, including energy, neurotoxin, and filler procedures, are safe when performed by experienced board-certified dermatologists. Adverse events occur in less than 1% of patients, and most of these are minor and transient.

A short educational intervention measurably benefits keloid-prone individuals' knowledge of prevention and treatment.

BACKGROUND: The Internet is a commonly utilized health information resource that provides access to information of varying quality. OBJECTIVE: We sought to evaluate the use of the Internet as a health information resource within a keloid patient population and the effects of an educational intervention on patient knowledge about keloids.
METHODS: A consecutive convenience sample of subjects completed a questionnaire on keloid-related Internet use and on personal and family history of keloids. Participants listened to a short educational intervention on keloid-related topics followed by assessment of relevant knowledge at baseline, immediately postintervention, and 3 months after the intervention. RESULTS: Among 40 participants, 55% reported having used the Internet to obtain keloid-related information. Subjects who had used the Internet to obtain keloid-related information had baseline knowledge similar to those who had not. When subjects were assessed immediately and 3 months postintervention, the intervention improved knowledge that not all raised scars are keloids, that keloids are not cancerous, and that certain areas of the body are more prone to keloid formation. The proportion of subjects who reported being less likely to obtain piercings or tattoos because of the intervention was 80% and 75%, respectively. LIMITATIONS: This study was performed at a single academic center. CONCLUSION: The Internet is a commonly used information resource for keloid-prone individuals, but keloid-related knowledge was not greater among Internet keloid-related information seekers. A very short educational intervention benefits keloid-prone individuals by improving knowledge about keloid prevention and treatment and by discouraging them from obtaining piercings and tattoos.

Development and validation of a vitiligo-specific quality-of-life instrument (VitiQoL).

BACKGROUND: Vitiligo significantly affects a person's health-related quality of life (HRQL). Although a small number of generic, and disease-specific, dermatologic HRQL measures exist, currently no vitiligo-specific instrument is available to capture disease-targeted concerns and issues. OBJECTIVE: We sought to develop and validate a vitiligo-specific self-report instrument for HRQL. METHODS: A pool of vitiligo-specific items was created based on in-depth interviews with patients with vitiligo (n = 16) and their responses to items in several previously validated HRQL measures. These items comprising our new instrument, VitiQoL, along with Skindex-16 and Dermatology Life Quality Index were administered to patients with vitiligo (n = 90) at two academic centers. This new instrument was validated using psychometric analysis. RESULTS: The VitiQoL items showed high internal consistency (Cronbach alpha = 0.935). Exploratory factor analysis demonstrated 3 factors: participation limitation, stigma, and behavior. Concurrent validity was evidenced by large correlations between self-reported severity and VitiQoL scores (r = 0.51). Known groups validity was demonstrated for the VitiQoL behavior subscale between individuals with exposed and unexposed patches (P = .01). Convergent validity was shown by strong correlations between VitiQoL and outside dermatology scales measuring similar constructs (Skindex-16, r = 0.82; Dermatology Life Quality Index, r = 0.83). LIMITATIONS: Potential selection bias was a limitation as most patients were recruited from academic centers. Reliability of the instrument was tested only with internal consistency and not reproducibility. Responsiveness of the instrument was not tested because of the prolonged time course necessary to observe clinically significant change in vitiligo. CONCLUSION: VitiQoL is a reliable and valid HRQL instrument.

Safety of a novel microneedle device applied to facial skin: a subject- and rater-blinded, sham-controlled, randomized trial.

OBJECTIVE: To assess the safety of a novel microneedle device on facial skin of healthy individuals of all Fitzpatrick skin types. DESIGN: Subject- and live rater­blinded, sham-controlled, randomized trial. SETTING: University-based ambulatory dermatology service providing both primary and referral care. PARTICIPANTS: Healthy adults recruited from postings. INTERVENTION: Device or sham applied with finger pressure to the right or left sides, respectively, of the participants' lateral forehead, temple, and nasolabial fold. At the 24-hour visit, a larger area (3 × 3 matrix) at the central forehead was treated with the device, and the participants applied the device to their chins. MAIN OUTCOME MEASURE: Live blinded rater determination of local skin reaction scores (SRSs). RESULTS: At the 5-minute skin assessment, the median SRS was 1 for all skin type and age groups. There was no median pain score higher than 1 for any age or skin type group. For the sham device, median SRSs were 0 at all time points for all age and skin type groups. Mean SRSs for the device and sham were significantly different only for the lateral forehead at 5 and 30 minutes (P = .04). CONCLUSIONS: The microneedle device appears to be safe and well tolerated in both sexes and various skin types and ages. Facial skin application of the device elicits mild, self-limited, and rapidly resolving erythema marginally greater than that associated with the sham control.

Clinical severity does not reliably predict quality of life in women with alopecia areata, telogen effluvium, or androgenic alopecia.

BACKGROUND: Hair loss may significantly impact an individual's self-image, and studies indicate that patients with both clinically apparent and clinically imperceptible hair loss may have significantly decreased quality of life (QoL). Moreover, clinical severity of hair loss does not necessarily predict impact on QoL. OBJECTIVE: The aim of this study was to assess QoL in patients (n = 104) with alopecia areata, telogen effluvium, and androgenic alopecia, and to compare QoL with hair loss severity (HLS) as independently rated by both patient and dermatologist. METHODS: Questionnaires and clinical assessment tools were used to assess HLS, and QoL was measured by completion of Skindex-16. RESULTS: Overall, patients rated their hair loss as more severe than the dermatologist, and the patient's HLS rating more strongly correlated with QoL than the dermatologist's rating. Clinical assessment of HLS did not reliably predict the patient's QoL, nor did it predict the patient's perception of HLS. LIMITATIONS: A convenience sample was recruited from a referral clinic and Skindex-16 has not been validated for use in women's alopecia disorders. CONCLUSION: These findings indicate dermatologists should address these psychosocial and QoL issues when treating patients with alopecia.

Economic burden of dermatologic adverse events induced by molecularly targeted cancer agents.

OBJECTIVE: To report the financial impact of diagnosing and treating the dermatologic toxicities (dTs) that develop in patients receiving targeted anticancer therapies. DESIGN: Single-center retrospective and prospective medical record data extraction. SETTING: Department of Dermatology, Northwestern University, Chicago, Illinois. PATIENTS: One hundred thirty-two adults who presented between November 1, 2005, and June 30, 2008, and who were diagnosed as having 1 primary cancer type and were treated with 1 molecularly targeted agent. MAIN OUTCOME MEASURE: Standard billable costs to the patient for dT-related medications, clinic visits, laboratory and diagnostic testing, and therapeutic procedures. RESULTS: The 132 patients had a median of 3 clinic visits for dT management with a median cost of $1920 per patient. Sorafenib was associated with the most costly overall median cost per patient ($2509 per patient), and imatinib was associated with the least costly overall median cost per patient ($1263 per patient). Among the 7 targeted drugs and all 10 dTs, the most costly dT (measured by cost of treatment with medications) was hand/foot skin reaction, associated with sorafenib therapy (median cost, $968 per patient) (P < .001). The second most costly dT was panitumumab-associated acneiform eruption (median cost, $933 per patient) (P < .001). CONCLUSION: The cost of diagnosis and treatment of dTs associated with targeted agents contributes to the overall economic burden of cancer care. Efforts toward the prevention of dTs may be important for decreasing the financial burden in oncology.

Diffuse large B-cell lymphoma associated with the use of biologic and other investigational agents: the importance of long-term post-marketing safety surveillance.

This case report describes a patient who developed diffuse large B-cell lymphoma (DLBCL) after receiving courses of two investigational biologic agents and cyclosporine followed by more than four years of subcutaneous efalizumab for the treatment of extensive chronic plaque psoriasis. Three years later, the patient remains free of lymphoma and his psoriasis is well controlled with thrice-weekly narrow-band ultraviolet phototherapy. This case emphasizes the importance of continued long-term post-marketing safety surveillance and the early reporting of all possible serious side effects, including cancers, related to the use of any newly available product. In particular, surveillance should focus on the immunomodulating biologic agents in order to identify possible dangerous sequelae.

Scarring alopecia: clinical and pathologic study of 54 African-American women.

BACKGROUND: Cicatricial or scarring alopecia results in the destruction of hair follicles and is a significant cosmetic concern in African-American women. OBJECTIVE: To correlate the clinical examination and histologic findings in African-American women with scarring alopecia with a history of hairstyling practices. METHODS: We reviewed retrospectively the medical records and scalp biopsy specimens of 54 women with scarring alopecia. Patients were selected from two dermatologic practices in the Detroit Metropolitan area. RESULTS: Alopecia commonly presents in patients who use a variety of traumatic haircare techniques, including chemical and physical straighteners, traction, braiding, hair extensions, hair gluing, and chemical curls. Histologic findings are centered around the follicular infundibulum with a lymphocytic infiltrate and perifollicular fibrosis. CONCLUSION: Traumatic hairstyling techniques are common in African-American women, and all result in a similar picture of a peri-infundibular lymphocytic infiltrate and fibrosis, leading to alopecia.