The incidence of application site reactions compares favorably with that of other studies of TD delivery systems.
However, despite this higher incidence of application-site pain, the pain increase and the use of medication for treatment-related discomfort was comparable, as described above.
Published short-term trials of TDiclo in the adult population report that the incidence of application site related skin dryness ranges from 18.2% to 39.3%.
Long-term studies suggest that prolonged exposure to TD systems does not increase the incidence of application site reactions (Dmochowski et al 2003).
The incidence of application-site erythema in this study (100%) was similar to an incidence of 94% and 92% reported in previous studies of NGX-4010 in patients with PHN [ 14, 17].
The three treatment groups differed in overall incidence of application site related adverse events, with a higher incidence in the TDiclo (39.1%; P < 0.0001) and control (23.3%; P = 0.014) groups than in the placebo group (5.1%).
For instance, injectable esters were associated with peaks and troughs of serum testosterone outside the physiological range, patches were associated with a high incidence of application site reactions, and pellets were associated with the risk of extrusion and infection.
Finally, the adverse effect profile of the contraceptive patch is similar to that of oral contraceptives (most frequent adverse events: headache and nausea), with the exception of a higher incidence of application site reactions, breast discomfort and dysmenorrhoea in the patch group, most of them mild or moderate in severity [ 24].
Where companies used to have a testing stage and they're adding 300 new changes and they are all live at the same time in the same application, you now have a separate incidence of your application for each of your small changes.
The overall incidence of severe application site related adverse events in the TDiclo (1.4%) and control (0.0%) groups was similar to that in the placebo group (0.0%).
It meets the stringent sensitivity, ease of use, and short assay time requirements for point-of-care and point-of-incidence applications.
