Children as young as 2 years of age may benefit from the investigative agent crisaborole topical ointment 2% if they have been diagnosed with mild-to-moderate atopic dermatitis, according to pooled results from 2 identically designed clinical trials presented at the 74th Annual Meeting of the American Academy of Dermatology (AAD).
"If approved, crisaborole topical ointment 2% represents a new, promising, safe and effective treatment for reducing the severity of signs and symptoms of mild-to-moderate atopic dermatitis in patients 2 years age and older," said Adelaide Hebert, MD, University of Texas Medical School at Houston, Houston, Texas, speaking at a late-breaker oral presentation here on March 5.
Dr. Hebert and colleagues found that treatment with crisaborole ointment was superior to a placebo ointment in reducing atopic dermatitis assessed by the Investigator's Static Global Assessment (ISGA).
In study 301, by day 29 of the study, 32.8% of 503 patients treated with crisaborole had achieved at least a 2-grade improvement in their skin condition on the 5-point ISGA scale compared with 25.4% of 256 patients who were assigned the placebo vehicle (P = .038).
In study 302, 31.4% of 513 patients treated with crisaborole ointment had achieved the primary objective of at least a 2-grade improvement in ISGA assessment compared with 18% of 250 patients who were assigned the placebo ointment (P < .001).
Dr. Hebert said that crisaborole is a small molecule with unique benzoxaborole chemistry, incorporating boron to inhibit phosphodiesterase4 activity. Boron also exhibits anti-inflammatory properties. The ointment is a nonsteroidal agent.
Between the 2 trials, about 30% of the patients were aged 2 to 6 years; another 30% were aged 7 to 11 years; about 25% were aged 12 to 17 years; and about 15% were aged 18 years of age or older.
"We observed no treatment-related serious adverse events among patients treated with crisaborole," she said, adding "the majority of adverse events in crisaborole-treated patients were mild in severity." She noted that discontinuations due to adverse events was about 1.2% in patients treated with crisaborole and about 1.2% in the patients who were given the vehicle ointment.
"No clinically meaningful differences were observed between crisaborole-treated and vehicle-treated patients in their vital signs, electrocardiograms and clinical laboratory parameters," Dr. Hebert said.
Funding for both studies was provided by Anacor Pharmaceuticals, Inc., Palo Alto, California.
La rassegna stampa contiene articoli di interesse dermatologico tratti da testate nazionali e non intende fornire una revisione critica né essere una fonte di notizie scientificamente validate. Si accettano (e sono bene graditi) commenti da parte dei soci esperti nel settore.