Ointment Shows Positive Results for Atopic Dermatitis

An investigational topical ointment demonstrated statistically significant improvements in atopic dermatitis (AD) compared with vehicle across all primary and secondary efficacy endpoints, according to results of 2 Phase 3, multicenter, double-blind, vehicle-controlled studies presented at the late-breaking research: clinical trials session at 2016 American Academy of Dermatology on March 5, 2016, in Washington, DC.

The studies evaluated the efficacy and safety of the investigational, nonsteroidal, anti-inflammatory, PDE4 inhibitor, crisaborole topical ointment, 2%, in patients ≥2 years of age with mild to moderate AD. The primary efficacy endpoint defined success using the Investigator’s Static Global Assessment (ISGA) (clear [0] or almost clear [1] with ≥2-grade improvement from baseline at day 29). Secondary efficacy endpoints included the proportion of patients achieving ISGA clear (0) or almost clear (1) at day 29 and time to success in ISGA. Safety measures included monitoring adverse events, vital signs, ECGs, and clinical laboratory parameters. Efficacy analyses were performed using the intent-to-treat population.

For the primary efficacy endpoint, significantly more patients achieved success in ISGA with crisaborole than with vehicle at day 29 (P=0.038 and P< 0.001 for 301 and 302, respectively.) In addition, more patients achieved success in ISGA with crisaborole versus vehicle across all study visits. For the secondary efficacy endpoint, significantly more patients treated with crisaborole achieved success in ISGA earlier than those treated with vehicle by Kaplan-Meier analysis (log-rank P < 0.001). Significantly more patients achieved clear (0) or almost clear (1) ISGA scores with crisaborole at day 29. The study found that crisaborole topical ointment, 2% demonstrated a favorable safety profile in patients as young as 2 years of age.

“Crisaborole Topical Ointment, 2%, may represent a new safe and efficacious treatment for patients 2 years of age and older with mild to moderate atopic dermatitis,” concluded the researchers.

—Lisa Samalonis

Reference:
Source Reference: Paller AS, et al "Analysis of efficacy and safety from two phase III studies of a novel, investigational, nonsteroidal, topical, anti-inflammatory,phosphodiesterase 4 inhibitor, crisaborole topical ointment, 2%, in children and adults with mild-to-moderate atopic dermatitis" AAD 2016; Late-breaking Research Session F053.