A comparative study in efficacy and safety of 0.1% tacrolimus and 0.05% clobetasol propionate ointment in discoid lupus erythematosus by modified cutaneous lupus erythematosus disease area and severity index.

Objective: To compare the efficacy and safety between 0.1% Tacrolimus ointment twice a day and 0.05% clobetasol propionate.

Material And Method: Twenty-one Thai patients 18 to 60 years old with DLE lesions on both right and left sides of the body, without SLE, were included in the present study. Each patient was randomly allocated to determine the use of one side for twice-daily 0.1% topical tacrolimus ointment and the other side for once-daily 0.05% clobetasol propionate ointment for six weeks. Clinical outcomes were evaluated by modified cutaneous lupus erythematosus disease area and severity index (CLASI) and global assessment score for patient efficacy evaluation.

Results: Disease activity score were significantly decreased from baseline in both groups but clobetasol had better efficacy (p < 0.05). No significant change in disease damage score between the two groups. Both drugs were well tolerated. Transient pruritus and burning sensation were found in the tacrolimus group. Telangiectasia and acneiform eruption were found in the clobetasol group.

Conclusion: The present study proved the efficacy of twice-daily tacrolimus and once-daily clobetasol treatment for DLE lesion. Clobetasol has significantly higher efficacy and tacrolimus may be an alternative treatment.