A randomised, double-blind comparison of 20 units of onabotulinumtoxinA with 30 units of incobotulinumtoxinA for glabellar lines.

BACKGROUND: Biological activity data indicate that the units of incobotulinumtoxinA are not equivalent to those of onabotulinumtoxinA. OBJECTIVE: This study compared 20 units of onabotulinumtoxinA with 30 units of incobotulinumtoxinA in the treatment of glabellar lines. METHODS AND MATERIALS: In this multicenter, randomised, double-blind study, subjects with moderate or severe glabellar lines received a single treatment with 20 units of onabotulinumtoxinA (n = 112), or 30 units of incobotulinumtoxinA (n = 112). The primary endpoint was the percentage of subjects with a reduction of ≥ 1 point on the Facial Wrinkle Scale at maximum contraction as rated by injectors on day 28 post injection. The same variable was evaluated on days 84, 98, and 112. RESULTS: At the primary endpoint, 20 units of onabotulinumtoxinA was as effective as 30 units of incobotulinumtoxinA (96% vs. 95% responders, respectively; difference in proportion of responders = 0.02, 95% confidence interval [CI] - 0.04, 0.07). At subsequent time points, a trend towards a higher percentage of responders was observed in the group treated with 20 units of onabotulinumtoxinA. Given that the 95% CI surpassed the upper equivalence margin at these time points, equivalence was not established. CONCLUSION: These data support the non-interchangeability of units of onabotulinumtoxinA and incobotulinumtoxinA, and the absence of a fixed dose ratio in clinical practice.

Intravenous immunoglobulin: an emerging treatment for immune-mediated skin diseases.

Intravenous immunoglobulins (IVIgs) exert a variety of immunomodulating activities and are therefore increasingly being used for the treatment of immune-mediated as well as autoimmune diseases. Although the exact mode of action is still poorly understood, the efficacy of IVIg in several diseases, such as thrombocytopenic pupura and Kawasaki disease, has been proven in clinical trials. According to some uncontrolled clinical studies and many case reports there is evidence for a high efficacy of IVIg in the treatment of skin diseases such as autoimmune blistering diseases, lupus erythematosus, dermatomyositis, scleroderma, toxic epidermal necrolysis, atopic dermatitis, chronic autoimmune urticaria and others. In contrast to other commonly used immunomodulating therapeutic strategies, the safety profile of IVIg treatment is significantly better. This update aims to give a current view on the efficacy and safety of IVIg treatment for dermatological diseases.

Allergenicity of natural rubber latex gloves.

The concentrations of proteins, allergens and rubber chemicals are essential parameters of the allergenicity of NRL gloves. To date, a standardized method has been given only for analysis of the protein concentration (DIN EN 455-3), and not for the concentrations of allergens and rubber chemicals. In the present study, we investigated 11 brands of surgical gloves currently available on the German market. Additionally 1 glove, not subjected to final leaching procedures, was added for comparison purposes. Protein concentrations were analysed by different methods in different laboratories. Allergen concentrations were assayed by prick tests in NRL-allergic volunteers and by RAST inhibition methods. Rubber chemicals were analysed by HPTLC and GC. The protein concentrations analysed by the Lowry method in the 2 laboratories gave concordant results, but the correlations between protein and allergen concentrations were low. The protein concentration analysed by HPLC correlated with the allergen concentration, and gave better information on the allergenicity of the gloves. The development of standardized methods for allergen analysis in the assessment routine is necessary, due to significant discrepancy between protein and allergen levels of some gloves. Thiurams were not found in any of the gloves, though carbamates were present in all gloves tested. Our data indicate that washing procedures have little or no effect on the concentration of rubber chemicals.