Clinical Trial
Journal Article
Randomized Controlled Trial
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The effectiveness of 1% pimecrolimus cream in the treatment of oral erosive lichen planus.

BACKGROUND: The purpose of this study was to evaluate the efficacy, relative safety, and tolerability of 1% pimecrolimus cream in the treatment of oral erosive lichen planus (OELP).

METHODS: Twenty patients with OELP were randomized into equal groups; group 1 applied 1% pimecrolimus cream twice daily to their oral lesions for 4 weeks, whereas group 2 applied a placebo cream. Photographs of the lesions were taken and analyzed for areas of ulceration, erythema, and reticulation. Discomfort scores were also assessed with a visual analogue scale (VAS). Blood samples were taken at baseline and at study completion; a complete blood count with differential and comprehensive metabolic panel was ordered. The Wilcoxon signed rank test was used.

RESULTS: The experimental group showed a decrease in ulceration (alpha = 0.068) and erythema (alpha = 0.005) at the mid-point with continued reduction of erythema at the final (alpha = 0.075) time measurement. The control group demonstrated an increase in reticulation at the mid-point (alpha = 0.017) and final (alpha = 0.007) time measurement. The VAS scores for the experimental group decreased during the study (alpha = 0.022). Blood levels were within the normal range.

CONCLUSIONS: The OELP lesion size in the 1% pimecrolimus group decreased and the pimecrolimus cream was found to significantly reduce the patient's pain scores. Further study of 1% pimecrolimus as therapy for OELP is warranted since it was shown to be effective, relatively safe, and well tolerated by patients within the limits of this short-term study.

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