Topical application of RTA 408 lotion activates Nrf2 in human skin and is well-tolerated by healthy human volunteers

Table 2 Overview of adverse events

Category	Part A	Part B	Part C	Total
Preferred Term	(N = 12)	(N = 10)	(N = 10)	(N = 32)
Preferred Term	N (%)	N (%)	N (%)	N (%)
Subjects with Any Adverse Event	1 (8.3)	3 (30.0)	7 (70.0)	11 (34.4)
Subjects with Any Study Drug Related Adverse Event	0 (0.0)	0 (0.0)	1 (10.0)	1 (3.1)^a
Subjects with Any Serious Adverse Event	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Subjects with Any Study Drug Related Serious Adverse Event	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Subjects with Any Adverse Event Leading to Discontinuation	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)

^aIn total, 1 (3.1 %) subject, in Part C, had an RTA 408 Lotion-related adverse event, described as mild application site erythema and pruritus (Table 2). This subject had a modified Draize Score of 1 (barely perceptible, faint to pink) on Days 5–9, which subsided on Day 10, and was not observed during the remainder of the study. Scores for all other subjects on all other days were 0 (no erythema)

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