Efficacy and Safety of Crisaborole 2% Ointment in the Treatment of Mild-to-moderate Atopic Dermatitis – A Prospective, Open-label Study at a Tertiary Care Centre in Eastern India

Objectives: Atopic dermatitis (AD) is a common occurrence worldwide, where topical corticosteroids and calcineurin inhibitors, along with antihistamines, are being used for the treatment of mild-to-moderate AD. Crisaborole 2% ointment, a phosphodiesterase-4 inhibitor, has been recently approved for AD treatment by the Food and Drug Administration. Crisaborole is proposed to have lesser side effects in comparison to its counterparts. However, the impact of crisaborole on the Indian population has only been studied in the paediatric population and has not been widely explored. We conducted this study to find the safety and efficacy of crisaborole 2% ointment in mild-to-moderate AD in the Indian population. Materials and Methods: Thirty consecutive mild-to-moderate AD patients were included in the study. The patients were advised to apply crisaborole 2% ointment at the site of involvement twice daily for 28 days. The evaluation was done at baseline and day 28 using the SCORing AD (SCORAD), investigator static global assessment (ISGA) and eczema-associated severity index (EASI) scores. The patients were followed up to report any side effects. Results: There was a statistically significant decrease in the mean SCORAD, ISGA and EASI scores after the end of treatment. According to SCORAD, there were 58.3% of patients with moderate AD which reduced to 41.6% at the end of treatment. ISGA defined treatment success as only being achieved by 36.6% of patients, out of which complete resolution was achieved only by 20% of patients at the end of treatment. The mean EASI scores showed a considerable decreasing trend from 8.47 at baseline to 4.73 at the end of the study. Six patients withdrew from the study due to exacerbation of symptoms, possibly burning at the site of application. Conclusion: Although crisaborole reduced symptoms, it did not provide any instant relief to symptoms of AD, leading to discontinuation in a few patients, making it a viable drug for maintenance rather than a first-line therapy.