Comparison of the Therapeutic Effects of Oral Fluoxetine and Topical Clobetasol with Topical Clobetasol and Placebo in Vitiligo Patients: A Triple Blinded Placebo Control Clinical Trial

Abstract

Background: Assess whether adding fluoxetine (20 mg daily) to topical clobetasol 0.05% is more effective than clobetasol with placebo for vitiligo. Methods: Triple-blind randomized clinical trial (CRT) in Isfahan, Iran between 2022 and 2023. Forty-one patients were randomized to: Fluoxetine+clobetasol and Placebo+clobetasol. Lesions were photographed at baseline and after 3 months. Two blinded dermatologists categorized improvement (mild, moderate, good, excellent) based on lesion size and perifollicular pigmentation. Patient satisfaction (VAS) and side effects were recorded. Results: Forty-one patients, 91 lesions (19 in the fluoxetine group, 22 in the control). Significant baseline differences: More males and older age in the fluoxetine group. No difference in lesion improvement between groups (P = 0.879). More adverse effects with fluoxetine (P = 0.006); satisfaction was similar (P = 0.310). After adjusting for age/gender, no significant differences were found. Conclusions: Adding fluoxetine to topical clobetasol did not improve vitiligo outcomes compared with clobetasol alone.