Efficacy and safety of crisaborole ointment in pediatric atopic dermatitis: A 4-week open-label study

Abstract

Objectives: Managing mild-to-moderate atopic dermatitis (AD) often necessitates topical therapies, and one such recently introduced option is crisaborole ointment. This study sets out to assess the efficacy and safety of crisaborole ointment in pediatric cases of AD over four weeks. Material and Methods: Nineteen children between 2 and 16 years old with mild-to-moderate AD were enrolled and treated with crisaborole ointment twice daily in affected areas for 30 days. The primary objective was to appraise the shift in the investigator’s static global assessment (ISGA) scores (0–4) every week for the four-week follow-up. The severity of pruritus score (SPS) was another secondary objective. Furthermore, individual indicators of clinical signs that included erythema, exudation, excoriation, induration/papulation, and lichenification, were examined with subjective scores (0–3). Children’s dermatology quality of life index (CDLQI) was employed to study the quality of life. Results: Following four weeks of crisaborole ointment treatment, the average ISGA score declined from 2.58 ± 0.61 to 0.95 ± 0.78, signifying a substantial reduction in AD severity (P < 0.001). The SPS score also decreased from a mean of 2.32 ± 0.478 to 0.84 ± 0.60 (P < 0.001), underscoring a significant reduction in itching. Moreover, individual markers for clinical signs of AD, including erythema, exudation, excoriation, induration/papulation, and lichenification, all exhibited statistically significant improvement. Crisaborole ointment was well tolerated. Only 6 of the 19 patients reported a localized burning sensation, which was manageable. No patient needed to be withdrawn during the study period. The CDLQI showed a substantial drop in scores, decreasing from an average of 13.79 ± 3.57 at the commencement to 6.74 ± 1.97 (P < 0.001). Furthermore, 14 out of 19 patients met the study’s primary goal, achieving at least a 2-point reduction in ISGA along with the attainment of clear or nearly clear skin (ISGA 0–1). Conclusion: Our study found crisaborole ointment significantly improved pediatric AD symptoms and was well-tolerated. The only adverse event was localized burning in a few patients. Further, research is needed for validation.