Comparing the efficacy of oral apremilast, intralesional corticosteroids, and their combination in patients with patchy alopecia areata: a randomized clinical controlled trial.

Introduction: Alopecia areata (AA) is a chronic, immune-mediated inflammatory disorder characterized by nonscarring hair loss. The management of AA poses challenges due to its unpredictable course and variable response to treatment. In this comparative study, we evaluated the efficacy and safety of oral apremilast, intralesional corticosteroids (ILC) and a combination of both in patients with patchy AA.

Methods: Sixty patients with patchy AA were randomly assigned to three treatment groups: oral apremilast (Group A), ILC (Group B), and a combination of both (Group C). The Severity of Alopecia Tool (SALT) score was used to assess the extent of hair loss before treatment, after 3 months, and at 6 months of follow-up. Adverse events and complications were also monitored. The changes in SALT score from baseline between the three groups were assessed by using non-parametric statistical tests. The statistical significance was judged at 5% level of significance.

Results: Findings demonstrated significant higher reduction in median SALT scores after treatment i.e., 2.47 (1.76, 5.07), p < 0.001 as well as after six months follow up 5.08 (3.80, 7.53), p < 0.001 in patients treated with ILC compared to other two groups. Neither apremilast monotherapy nor its combination with ILC demonstrated statistically significant improvement, although individual responses were observed. Complications were minimal, with transient pain and burning sensation reported during ILC injections and a few cases of gastritis and relapse in the oral apremilast group.

Conclusion: These findings suggest that ILC remains an effective treatment option for patchy AA. This study did not demonstrate statistically significant efficacy of oral apremilast, either as monotherapy or in combination with ILC, though larger studies may be needed to evaluate potential benefits in specific patient subgroups. Further research with larger sample sizes and longer-term follow-up is needed to validate these findings and optimize treatment approaches for AA.