A randomized, prospective, comparative study of topical clobetasol propionate 0.05% versus topical tacrolimus 0.1% in localized cutaneous lichen planus
Ummul Khair, Fatima Razvi, Nayeem Sadath HaneefObjectives:
To compare the efficacy and safety of topical clobetasol propionate 0.05% (w/w) versus topical tacrolimus 0.1% (w/w) ointment in the treatment of localized cutaneous lichen planus (CLP).
Materials and Methods:
This was a randomized, prospective, open-label study conducted in a tertiary-level hospital over 18 months, with each patient receiving 6 weeks of treatment. A total of 106 patients with localized cutaneous lichen planus meeting the selection criteria were enrolled and assigned to apply either clobetasol propionate 0.05% (Group A, n =53) or tacrolimus 0.1% (Group B, n =53) ointment twice daily for 6 weeks. Efficacy was measured using visual analog scale (VAS) scores for pruritus and lesion thickness every 2 weeks for 6 weeks, and improvement percentages were calculated. Adverse effects were also recorded.
Results:
At 6 weeks, Group A exhibited an 88% mean improvement compared to 53% in Group B ( p <0.01). Complete clearance was achieved in 58.49% of Group A patients versus only 9.43% in Group B. However, in Group B, despite a complete clearance rate of only 9.43%, moderate to marked improvement was seen in nearly 40% (30.19% moderate and 9.43% marked improvement). Adverse effects were more common in Group A (66%) than in Group B (17%).
Conclusion:
In our study, both groups showed improvement; however, clobetasol propionate 0.05% demonstrated superior efficacy compared to tacrolimus 0.1% for localized cutaneous lichen planus, though it was associated with more frequent side effects. Tacrolimus may serve as a safer alternative or adjunct, particularly for atrophy-prone areas such as the face and intertriginous regions. To the best of our knowledge, this is one of the first prospective studies comparing topical clobetasol propionate 0.05% and topical tacrolimus 0.1% ointment in patients with cutaneous lichen planus.