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This study aimed to explore safety and effectiveness of two crisaborole (a non-steroidal anti-inflammatory phosphodiesterase 4 inhibitor) therapeutic regimens for managing pediatric and adult patients with atopic dermatitis.
In patients aged ≥2 years with
mild-to-moderate atopic dermatitis, both once daily and twice daily crisaborole
regimens (particularly crisaborole twice daily) displayed efficacy and good
tolerability.
This study aimed to explore safety
and effectiveness of two crisaborole (a non-steroidal anti-inflammatory
phosphodiesterase 4 inhibitor) therapeutic regimens for managing pediatric and
adult patients with atopic dermatitis.
In this randomized, phase 2b, double-blind study, each participant was allocated to one of the two age cohorts (≥12 years or 2-11 years) and randomized to 2% crisaborole ointment once daily or twice daily. Overall, there were 81 participants (Cohort 1: 41 participants; Cohort 2: 40 participants). All the participants had two target lesions that were each randomized to either vehicle or crisaborole at the baseline and managed for two weeks.
Occurrence of treatment-emergent
noxious events and an alteration from the baseline in Investigator's Static
Global Assessment (ISGA) and pruritic evaluations (Cohort 2: Caregiver-Reported
Itch Severity numeric rating scale [NRS] and Itch Severity Scale Self-Report;
Cohort 1: Peak Pruritus NRS) were the secondary outcomes ascertained. An
alteration from the baseline in total sign score (TSS) in the vehicle or
crisaborole-treated target lesions on the 15th day was the major
outcome ascertained.
Compared to vehicle-treated lesions, crisaborole-treated lesions demonstrated a substantial decline in TSS at day 15. In both cohorts 1 and 2, a numerically greater decline in TSS was witnessed with crisaborole twice daily when compared to crisaborole once daily, as shown in Figures 1a and b.
Regardless of the regimen or cohort, crisaborole-treated lesions illustrated more reductions in the secondary endpoints (ISGA, pruritic assessments) when compared to the vehicle-treated lesions. Mild treatment-emergent adverse events were noted with application site irritation being the most frequently reported adverse event.
A 2% crisaborole appears to be a
viable management option for pediatric and adult patients suffering from atopic
dermatitis.
The Journal of Dermatology
A phase 2b, randomized, double-blind, multicenter, vehicle-controlled study to assess the efficacy and safety of two crisaborole regimens in Japanese patients aged 2 years and older with mild-to-moderate atopic dermatitis
Kayo Fujita et al.
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