Table 2. Adverse Events.

Characteristic	Patients, No. (%)
	Roflumilast foam, 0.3% (n = 154)	Vehicle foam (n = 72)
Any TEAE	37 (24.0)	13 (18.1)
Any treatment-related TEAE	3 (1.9)	3 (4.2)
Any serious AE	0	0
Discontinued study due to AEa	2 (1.3)	1 (1.4)
Most common TEAEs (>1.5% in any group), preferred term
Contact dermatitisb	3 (1.9)	2 (2.8)
Insomnia	3 (1.9)	1 (1.4)
Nasopharyngitis	3 (1.9)	0

Abbreviations: AE, adverse event; TEAE, treatment-emergent adverse event.

^a Adverse events leading to discontinuation were application site pain, migraine, and dyspnea in the roflumilast-treated group and application site dysesthesia in the vehicle-treated group.

^b Contact dermatitis was reported to be unrelated to treatment in all cases, and no cases caused interruption of drug application; 2 cases were reported as “poison ivy rash” by investigators.