Crisaborole ointment reduces AD lesions
The non-steroidal phosphodiesterase-4 inhibitor crisaborole may reduce lesions in patients with mild-to-moderate atopic dermatitis (AD), according to an intrapatient randomized study presented at the Inflammatory Skin Disease Summit (ISDS) 2018.
This phase IIa, single-centre, placebo-controlled trial enrolled 40 patients (aged ≥18 years) with mild-to-moderate AD (two target lesions of ≥3 cm2). Target lesions of each patient were randomized in a 1:1 ratio to have either crisaborole ointment 2% or placebo applied twice daily for a 15-day double-blind period, followed by another application of crisaborole twice daily for an additional 28-day open-label period. The study’s primary endpoint was the change from baseline in target lesion total sign score (TSS) at 15 days of follow-up. Investigator’s Static Global Assessment (ISGA) and pruritus numeric rating scale (NRS) were also measured to assess lesion severity. [ISDS 2018, abstract 117]
At 15 days, lesions treated with crisaborole had a significantly greater reduction in TSS from baseline compared with those treated with placebo (change from baseline, -4.5 vs -2.1; p<0.0001).
More crisaborole-treated lesions also achieved a significantly greater reduction in ISGA from baseline than placebo-treated lesions (change from baseline, -1.9 vs -0.8; p<0.0001).
Of note, at 1 day after the first application of crisaborole ointment, researchers found that there was significant improvement in pruritus NRS for the lesions treated with crisaborole than those treated with placebo (-1.9 vs 1.0; p=0.0188), which “continued to improve or was maintained through day 15,” said lead author Dr Robert Bissonnette from Innovaderm Research Incorporated in Montreal, Quebec, Canada.
Application site pain/pruritus adverse event (AE) occurred more frequently for the placebo-treated lesions at 12.5 percent (n=5) compared with the crisaborole-treated ones at 7.5 percent (n=3). However, no patients discontinued treatment due to this AE.
“[The] crisaborole [treatment] was well tolerated, significantly reduced lesion AD signs, and improved lesion pruritus within 1 day after [the] initial application in adults with mild-to-moderate AD,” Bissonnette concluded.