Clinical evaluation of the safety and efficacy of a 1064 nm diode laser, and vacuum assisted pulsed electromagnetic fields and multipolar radio frequency for noninvasive fat reduction of the abdomen and flanks.

BACKGROUND: Noninvasive cosmetic body contouring techniques are growing rapidly, and noninvasive lipolysis has been shown to have low pain, little downtime and produce consistent long-term results. The objective of this study was to evaluate the safety and efficacy of a 1064 nm diode laser combined with vacuum assisted PEMF and RF energies for noninvasive fat reduction of the abdomen and flanks. METHODS: Subjects received a series of three treatments 8 weeks apart, each consisting of a diode laser session, followed by vacuum assisted PEMF and RF. Before and after photographs were graded for overall fat reduction by three blinded evaluators. Ultrasound was used to measure changes in the thickness of adipose tissue. Subject satisfaction was assessed using the 5-Point Likert Subject Satisfaction Scale and a subject questionnaire at 16 and 24-week follow-up visits. Throughout each treatment, the subjects were given the Wong-Baker Faces Pain Rating Scale (WBFS) to assess discomfort and pain of the treatment. RESULTS: Thirty-nine subjects (average age 48.6 years) from four clinical sites were enrolled. Evaluators identified the correct before and after images 73.1% of the time and images were graded an average score of 1.12 (SE 0.1) correlating to more than a "slight change." Adipose tissue was reduced by 31.9% based on ultrasound measurements (p < 0.001). Subject satisfaction was high with an average satisfaction score of 7.8 ("satisfied") out of 10. The overall pain over time on average was rated "hurts little bit." Ninety percent of subjects reported either a mild, moderate, or significant improvement in their fat reduction and skin surface appearance. Almost 77% (76.7%) of subjects reported that they would recommend the treatment to a friend. There were six reports of adverse events related to the device during the study that were all transient and resolved rapidly. CONCLUSION: A significant reduction of subcutaneous adipose tissue was measured after treatment with a combination of diode laser and vacuum assisted PEMF and RF. Treatment pain was low and tolerable, and subjects had high levels of satisfaction with the results.

Adverse event reporting for botulinum toxin type A.

A recent article published in the Journal of the American Academy of Dermatology reviewed adverse events regarding botulinum toxin type A (BTX-A) reported to the Food and Drug Administration between 1989 and 2003. Although postmarketing surveillance is a vital mechanism to ensure drug safety, the events reported in this paper must be considered in context to be appropriately interpreted. The majority of data was related to therapeutic rather than cosmetic use. The proportion of serious adverse events was 33-fold higher for therapeutic use and no deaths were reported after cosmetic use. The data were derived from a spontaneous reporting system and do not include assessments of causality between the BTX-A and purported adverse events. The report notes that over a third of these events were related to off-label use of BTX-A, a common practice in dermatology, yet no significant differences were reported in rates of adverse events between on-label and off-label use. The report reflects a favorable safety profile for cosmetic use of BTX-A, and if misinterpreted, could lead to unreasonable conclusions regarding a product considered to be highly safe and effective.

Predictors of extensive subclinical spread in nonmelanoma skin cancer treated with Mohs micrographic surgery.

BACKGROUND: In nonmelanoma skin cancer, the clinically visible portion may represent a small fraction of microscopic tumor spread. Previous studies have examined individual risk factors for subclinical spread based on patient and tumor characteristics. However, these risk factors have not been prioritized or studied in combination. OBJECTIVE: To identify the most predictive risk factors for extensive subclinical tumor spread. DESIGN: Retrospective analysis of 1131 Mohs micrographic surgical cases. Variables analyzed included patient age, sex, and immune status and lesion size, location, histologic subtype, and recurrence. Logistic regression was applied to identify important combinations of tumor characteristics and to quantify relative odds of spread. SETTING: Academic referral center. PATIENTS: Consecutive sample of all referred patients treated by a single Mohs micrographic surgeon in a 3-year period. MAIN OUTCOME MEASURE: Number of Mohs micrographic surgical layers required to clear a tumor, with 3 or more layers defined as extensive subclinical spread. RESULTS: The highest-risk tumors, with odds ratios greater than 6.0, were basosquamous and morpheaform basal cell carcinoma (BCC) on the nose, morpheaform BCC on the cheek, and those with a preoperative size greater than 25 mm. Other important risk factors were recurrent and nodular BCC on the nose; location on the eyelid, temple, or ear helix; neck tumors and recurrent BCC in men; and tumor size greater than 10 mm. Patients younger than 35 years were at lower risk. Increasing age and immunocompromise were not significant predictors. CONCLUSION: Identification of lesions likely to exhibit extensive subclinical spread can help guide management to ensure complete tumor eradication and thereby reduce the risk of recurrence and its associated morbidity and cost.

A prospective survey of patient experiences after laser skin resurfacing: results from 2 1/2 years of follow-up.

BACKGROUND: Laser skin resurfacing (LSR) is a common cosmetic surgical procedure, yet there are no prospective long-term studies on patients' perceptions of their procedure. OBJECTIVE: To prospectively document patients' subjective experiences after LSR. DESIGN: Twenty-seven consecutive patients who underwent combination carbon dioxide/erbium:YAG full-face laser resurfacing for acne scarring or photodamage were surveyed at postoperative days 1 and 3, within 1 week, at 3 weeks, 6 weeks, 3 months, and 30 months and asked standardized questions. SETTING: Referral-based academic practice. RESULTS: One day after LSR, 10 patients (37%) were concerned about the outcome, and 3 (11%) considered it a "terrible" experience. At 2.7 days after the procedure, 23 patients (85%) would recommend LSR, and after 3.7 days, 24 (89%) would have the procedure again. At 3 months, the patients' mean rating of appearance was 2.3 (0-3 scale), and all 27 (100%) felt that their appearance had been improved by LSR. After 30 months, 18 patients (75%) would recommend the procedure, 17 (71%) would have LSR again, 21 (88%) felt that their appearance was improved, and final appearance was rated 1.8 (0-3 scale). Patients undergoing LSR to treat acne scarring were as satisfied as patients treated for photodamage. CONCLUSIONS: Data on the evolution of patient perspective after LSR can improve patient preparation. This may help the surgeon and patient achieve shared, realistic expectations for the postoperative period and for long-term results.

A risk scale for predicting extensive subclinical spread of nonmelanoma skin cancer.

BACKGROUND: The clinical appearance of nonmelanoma skin cancer may represent only a portion of microscopic tumor invasion. OBJECTIVE: To develop a scale based on high-risk characteristics for predicting the probability of extensive subclinical spread of nonmelanoma skin cancer. METHODS: Retrospective analysis of 1095 Mohs micrographic surgical cases (MMS) yielded high-risk factors for extensive tumor spread, defined as requirement of greater-than-or-equal3 MMS layers. Predictive characteristics included: any BCC on the nose, morpheaform BCC on the cheek, neck tumors and recurrent BCC in men, location on the eyelid, temple, or ear helix, and size>10 mm. Multivariate logistic regression was applied to develop a risk index. RESULTS: Tumor characteristics were assigned point values calculated from the respective odds of extension and categorized into six risk classes with probabilities of extensive subclinical spread ranging from 10% to 56%. CONCLUSION: A risk scale simplifies and enhances prediction of extensive tumors. The associated probabilities can help to guide patient preparation and appropriate therapy.

Mohs micrographic surgery as an alternative treatment method for cutaneous mucormycosis.

BACKGROUND: Mucormycosis is an invasive fungal disease that most commonly occurs in immunocompromised patients. Early angioinvasion and dissemination can lead to the rapid demise of the patient. The growing number of organ transplant patients on pharmacologic immunosuppression has increased the risk for this opportunistic mycosis. Traditional therapy has included aggressive debridement and resection as well as antifungal medications. OBJECTIVE: To demonstrate that the margin control and tissue-sparing technique of Mohs micrographic surgery can effectively eradicate mucormycosis infection and decrease morbidity. METHODS: Case presentation of a 64-year-old transplant patient presenting with biopsy-proven cutaneous mucormycosis treated with Mohs micrographic surgery. Margin control was confirmed by a rapid Gomori methenamine silver stain. RESULTS: There has been no recurrence at 1-year follow-up with full preservation of extremity function. CONCLUSION: The use of the Mohs technique combined with rapid Gomori methenamine silver staining for mucormycosis can be an effective tissue-sparing method for local control of this fungal infection. Mohs micrographic surgery should be considered for the cutaneous manifestations of mucormycosis.

Evaluation of the role of exogenous estrogen in postoperative progress after laser skin resurfacing.

BACKGROUND: Recent studies indicate that exogenous estrogens may promote wound healing. Many laser skin resurfacing (LSR) patients use hormone replacement therapy (HRT) or oral contraceptive pills (OCPs). OBJECTIVE: To evaluate the effect of exogenous estrogen on LSR postoperative healing. METHODS: This is a retrospective case control study of 44 female patients who underwent combination CO2/Er:YAG full-face LSR. Sixteen postmenopausal patients using oral HRT during procedure and follow-up were compared with 16 controls. Six premenopausal patients on estrogen-containing OCPs during the procedure and follow-up were compared with six controls. Case and control groups were matched by age, skin type, and treatment technique. Premenopausal and postmenopausal groups were compared. The variables evaluated included erythema, swelling, crusting, purpura, pain, pruritus, reepithelialization, complications, and patient assessment of outcome. RESULTS: For premenopausal and postmenopausal women, there were no significant differences in outcome measures of postoperative morbidity between groups receiving and not receiving estrogen. The incidence of complications, time until re-epithelialization, and patient assessment of outcome were similar between groups. CONCLUSION: Our findings suggest that exogenous estrogen in the form of HRT or OCPs does not clinically alter postoperative progress in combination CO2/Er:YAG LSR patients. Premenopausal women heal comparably to postmenopausal women after LSR.