Efficacy and Safety of Once-Daily Dapsone Gel, 7.5% for Treatment of Adolescents and Adults With Acne Vulgaris: First of Two Identically Designed, Large, Multicenter, Randomized, Vehicle-controlled Trials.

BACKGROUND: Treatment of acne vulgaris (acne) with dapsone gel, 5% requires twice-daily dosing, and some patients may not adhere to this regimen.
OBJECTIVE: The objective of this study was to assess the efficacy and safety of a new, once-daily formulation of dapsone gel, 7.5%, with a 50% higher dapsone concentration, versus vehicle over 12 weeks in patients with acne.
METHODS: This 12-week, randomized, double-blind, vehicle-controlled, multicenter clinical trial enrolled patients with moderate acne aged 12 years and older with 20 to 50 inflammatory lesions and 30 to 100 noninflammatory lesions on the face, and an acne grade of 3 (moderate) on the Global Acne Assessment Score (GAAS). Patients were randomized to receive topical dapsone gel, 7.5% or vehicle once daily for 12 weeks. Investigators assessed GAAS success rate (proportion of patients with GAAS of 0 or 1) and percent change from baseline in inflammatory, noninflammatory, and total lesions.
RESULTS: The intent-to-treat population comprised 2102 patients, 1044 in the dapsone gel, 7.5% group and 1058 in the vehicle group. At week 12, 29.9% of patients in the dapsone gel, 7.5% group and 21.2% in the vehicle group (P<.001) had GAAS success. Mean inflammatory lesions decreased by 55.5% and 49.0%, noninflammatory lesions decreased by 44.4% and 38.4%, and total lesions decreased by 48.7% and 42.4% in the dapsone gel, 7.5% and vehicle groups (all P<.001), respectively, at week 12. The incidence of adverse events was similar in the dapsone gel, 7.5% (19.1%) and vehicle (20.6%) groups. Most events in both groups were mild or moderate in severity. Most patients receiving dapsone gel, 7.5% and vehicle had a severity rating of "none" for stinging/burning, dryness, scaling, and erythema scales at all time points.
CONCLUSIONS: Dapsone gel, 7.5% applied topically once daily is an effective, safe, and well-tolerated treatment for acne.

J Drugs Dermatol. 2016;15(5):553-561.

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 randomized, placebo-controlled, double-blind study to evaluate the efficacy of a citrus bioflavanoid blend in the treatment of senile purpura.

BACKGROUND: Senile purpura is a common, chronic skin condition affecting more than 10 percent of individuals over the age of 50. Despite being a benign condition, the continual development of purpura lesions in afflicted patients is frequently a source of significant visual and social concern. To date, there are no known effective treatments for this condition. OBJECTIVES: To evaluate the efficacy of a novel nutraceutical citrus bioflavonoid blend in improving the skin's appearance in patients with senile purpura. METHODS: A six-week, randomized, multicenter, placebo-controlled, double-blind study was conducted to determine whether a uniquely formulated, oral citrus bioflavonoid supplement could treat active lesions of senile purpura while preventing new lesions from arising. Seventy patients with senile purpura were enrolled and 67 completed the study. Subjects were randomized into two groups receiving either a citrus bioflavonoid blend or placebo medication, which was taken orally twice daily for six weeks. Clinical evaluations were performed by blinded investigators at two locations. RESULTS: A statistically significant reduction in the number of new purpura lesions in the skin area undergoing clinical study was documented. At the end of six weeks, the citrus bioflavonoid blend treated group showed a 50 percent reduction in purpura lesions from baseline. Patient self-assessment of the effectiveness of the medication echoed the results of an investigator global assessment with a statistically significant improvement in the skin's appearance noted by the patients receiving the active medication. No adverse effects were noted by either the patients or investigators. CONCLUSION: This new treatment appears to both safely and effectively diminish skin bruising in patients with senile purpura.

Current and emerging treatment strategies for the treatment of actinic keratosis.

Actinic keratoses are encountered by physicians worldwide on a daily basis. As these precancerous lesions can transform to skin carcinomas, it is important to understand the many available options to use as treatment. In recent years, new therapeutic options have emerged to treat this common condition. These treatments as well as a review of the literature of conventional therapies will be discussed.

Diclofenac sodium 3% gel in the treatment of actinic keratoses postcryosurgery.

BACKGROUND: Actinic keratoses are increasingly common skin lesions that are evaluated and treated by dermatologists on a daily basis. It is estimated that more than 90% of actinic keratoses in the US are treated by destructive therapies, such as cryosurgery. The purpose of this study was to evaluate the efficacy of sequential therapy of cryosurgery followed by diclofenac sodium 3% gel. METHODS: This prospective, double-arm, multicenter, open-label, phase 4 study was performed at 82 community dermatology centers in the US. A total of 714 subjects who had a clinical diagnosis of actinic keratosis with between 5 and 15 lesions contained in a target area such as the forehead, scalp, and hands were enrolled in the study. These subjects were randomized into 2 arms of the study: cryosurgery alone and cryosurgery followed by diclofenac sodium 3% gel for a period of 90 days. Lesion counts were assessed at baseline, and 45, 75, 105, and 135 days after cryosurgery. RESULTS: Of the 521 patients enrolled in the study who successfully completed all of the visits concluding on day 135, 277 were in the cryosurgery alone arm and 244 were in the cryosurgery followed by diclofenac sodium 3% gel arm. At the conclusion of the study, 46% of the subjects in the cryosurgery followed by the use of diclofenac sodium 3% gel arm achieved 100% cumulative (target plus new lesions) lesion clearance compared to 21% in the cryosurgery alone arm (P < .0001). One hundred percent target lesion clearance was achieved in 64% of the subjects in the active arm compared to 32% in the cryosurgery alone arm (P < .0001). CONCLUSIONS: With the increased prevalence of actinic keratoses, it is important to consider and evaluate emerging therapeutic options. The sequential treatment with cryosurgery followed by diclofenac sodium 3% gel for 90 days is well tolerated and can provide a therapeutic modality that may provide patients with actinic keratoses a more successful outcome than monotherapy with cryosurgery by effectively treating clinical and subclinical lesions.

Metastatic gastric adenocarcinoma presenting as an enlarging plaque on the scalp.

We present a case report of metastatic gastric adenocarcinoma in which the cutaneous metastases were the first sign of disease recurrence. A 73-year-old man presented with painless red plaques on his scalp and forehead. He was diagnosed with gastric carcinoma with metastases to perigastric lymph nodes 3 1/2 years earlier. Histopathology results revealed signet-ring cells consistent with gastric adenocarcinoma. The patient failed to respond to treatment with intralesional interleukin 2, previously reported to be effective, and expired 7 months later.

Beryllium dermatitis.

Chronic beryllium disease is a granulomatous disorder characterized by a cell-mediated immune response to beryllium. Most reports of chronic beryllium disease discuss pulmonary and noncutaneous immunologic findings. This report of occupational chronic beryllium disease emphasizes cutaneous findings and discusses the potential role of skin exposure in the disease.

Metastatic basal cell carcinoma presenting as unilateral axillary lymphadenopathy: report of a case and review of the literature.

BACKGROUND: Although basal cell carcinoma (BCC) is one of the most common forms of cancer worldwide, the incidence of metastatic basal cell carcinoma (MBCC) is exceedingly low. Of reported cases, it is estimated that up to 85% arise in the head and neck region. OBJECTIVE: Case presentation of a BCC measuring 1.1 cm arising in a nonfacial site that presented with unilateral axillary lymphadenopathy. METHODS: Case presentation with literature review. RESULTS: Risk factors which should lead to a higher index of suspicion among clinicians for identifying these patients include large tumor size, previous irradiation, local invasion, and recurrence. The lymph nodes, lungs, bones, and skin are among the most common sites in which metastases arise. CONCLUSION: We report an unusual case of MBCC arising from a small, nonfacial primary BCC that presented with unilateral axillary lymphadenopathy.