The Use of a Self-Occluding Topical Anasthetic in Daily Practice: A Non-Interventional Study.

INTRODUCTION: A variety of topical anesthetic creams are available to reduce pain associated with dermatological procedures. Pliaglis is a self-occluding eutectic mixture of lidocaine and tetracaine. STUDY OBJECTIVES: To evaluate the post-marketing safety profile of Pliaglis and efficacy in terms of pain reduction, product satisfaction, and daily practice use prior to pre-defined dermatological procedures. METHODS: A prospective, non-interventional study conducted at 44 sites in four European countries; 581 patients were treated prior to dermatological procedures such as pulsed-dye laser therapy, laser-assisted hair removal, non-ablative laser resurfacing, dermal filler injections, and vascular access. Efficacy was assessed by patients and investigators and included pain intensity (visual analogue scale [VAS]), satisfaction, and adequacy of pain relief. Safety was evaluated by adverse event (AE) reporting. RESULTS: In 75% of the performed procedures, patients scored the pain experienced during the procedure as ≤30 mm on the VAS and most were very satisfied or satisfied with the pain reduction. The investigators assessed the product as providing adequate anesthesia in 97% of the performed procedures and were mostly very satisfied or satisfied with the convenience of use (79%) and tolerability (95%). Twenty-four AEs were reported in 18 (3%) patients. DISCUSSION: Most patients experienced mild pain only as evident by the ≤ 30 mm VAS scores. Patients and investigators were aligned with regards to both product satisfaction and their opinion on adequacy of pain reduction. The AE frequency was low compared to previous studies, possibly relating to different ways of collecting AEs. CONCLUSION: Pliaglis was well-tolerated and provided adequate pain reduction prior to dermatological procedures. www.clinicaltrials.gov (NCT01800474).

J Drugs Dermatol. 2018;17(4):413-418.

Partial study data have been presented at the Anti-Aging Medicine European Congress (AMEC), Paris; October, 24-25, 2014, and the European Academy of Dermatology and Venereology (EADV), Istanbul; October 2-6, 2013.

Mask-like metastasis: report of 2 cases of 4 eyelid metastases and review of the literature.

Bilateral periorbital edema and swelling are frequent in clinical practice and are commonly attributed to orbital contact dermatitis due to different drugs and cosmetic products. However, when there is a background of a solid cancer, the possibility of eyelid metastasis should be also considered. Metastases to the eyelids are rare, and in most cases, these lesions are unilateral. Because only a few cases of bilateral involvement have been reported in the literature, clinical and morphological data of this variant are under recognized. We report the clinical and histopathological characteristics of 2 patients with 4 eyelid metastasis and review the previous cases reported in the literature.

Recurrence rate of superficial basal cell carcinoma following treatment with imiquimod 5% cream: conclusion of a 5-year long-term follow-up study in Europe.

Imiquimod 5% cream is an immune response modifier approved for the treatment of superficial basal cell carcinoma (sBCC) once daily, 5 x per week for 6 weeks. This report reveals the final results of a 5-year follow-up study to evaluate the recurrence rate of sBCCs treated with imiquimod. As previously reported, 182 patients were enrolled in the study and 163 (89.6%) had no clinical evidence of their target sBCC at the 12-week post-treatment assessment; these 163 were followed for up to 5 years. During the follow-up period, 18 clinical recurrences occurred at the target tumour site, 8 and 10 of which occurred during the first 6 and 12 months of follow-up, respectively. The 5-year Kaplan-Meier and life-table estimates for sustained clinical clearance of those patients initially cleared were 84.5% and 86.9%, respectively, and 90.3% considering histology. The estimate of overall treatment success for all treated patients at the end of follow-up was 77.9% (80.9% considering histology). The data support clinical assessment of initial response as predictive of long-term outcome. Most of the recurrences occurred early, indicating that careful follow-up is important during the first year after treatment.

Recurrence rate of superficial basal cell carcinoma following successful treatment with imiquimod 5% cream: interim 2-year results from an ongoing 5-year follow-up study in Europe.

Imiquimod is an immune response modifier that acts through Toll-like receptor 7 to induce innate and cell-mediated immune responses. This ongoing phase III, open-label study conducted in Europe is evaluating the long-term (5 year) clinical efficacy and safety of imiquimod 5% cream applied once daily 5 times per week (5 x/week) for 6 weeks for the treatment of superficial basal cell carcinoma (sBCC). A total of 182 subjects were enrolled. The initial sBCC clearance rate was 90% (12-week post treatment), whereas the proportion of subjects who were clinically clear at 2 years (current time point) was estimated to be 79.4%. Local skin/application site reactions were the most frequently reported safety findings. Initial efficacy rates of imiquimod applied 5 x/week for 6 weeks demonstrate its clinical utility as an alternative approach to the treatment of sBCC. The recurrence rate seen to date supports ongoing follow up of subjects treated with imiquimod.