vehicle; the majority (98.7%) were mild or moderate (Table 2). There were an equal number of SAEs with tazarotene 0.045% lotion and vehicle (N=4). Less than half of the tazarotene 0.045% lotion AEs were treatment-related AEs (88/209). Most common were application site pain (5.3%), dryness (3.6%), exfoliation (2.1%) and erythema (1.8%). Only four subjects reported serious AEs (SAEs) following tazarotene 0.045% lotion treatment; none were treatment-related (abortion induced [2], abortion spontaneous, suicidal ideation). There was no death reported in either study. Cutaneous Safety and Tolerability
At baseline, there were few reports of itching (N=75, 9.6%), burning (N=14, 1.8%), or stinging (N=13, 1.7%) in the tazarotene 0.045% lotion treatment groups. There were slight transient in-creases in these reports following treatment, peaking at week 2 (N=137, 18.1%; N=165, 21.7%; and N=114, 15.0%).
The severity of itching, burning and stinging was very low over the course of the studies (Figure 5). Mean scores for itching, burning and stinging at baseline (0.11, 0.02, and 0.02, respectively) increased slightly all peaking at week 2 (0.21, 0.29, and 0.20, respectively, where 1=mild) following tazarotene 0.045% lotion treatment, returning to below, or similar to baseline levels by week 12.
Reports of scaling (N=71, 9.1%) or erythema (N=207, 26.6%) were more common at baseline, although in most instances these were mild. Again, following treatment with tazarotene 0.045% lotion there were transient increases in mean scores,
