# Abstract

 

## Background and Objectives: Oral lichen planus (OLP) is a relatively common, chronic inflammatory condition that frequently presents with symptoms of pain and burning sensation. It is generally a very unrelenting disorder despite several kinds of treatment. Only symptomatic OLP requires treatment, and it remains a challenging predicament. Efforts are made in a sustained manner for searching for novel therapies for symptomatic OLP. Therefore, this study was aimed to compare the efficacy of treatment with topical pimecrolimus cream 1% with that of triamcinolone acetonide oral paste 0.1% in subjects with symptomatic OLP. 

## Materials and Methods: A prospective, parallel-group, randomized, active control clinical study was conducted among 30 symptomatic OLP subjects (20 females and 10 males, with 15 patients in each treatment group) treated with topical pimecrolimus 1% cream and triamcinolone acetonide 0.1% oral paste four times daily for two consecutive months and treatment-free follow-up was performed for 2 months. Pain or burning sensation, mean clinical score and presence of erythematous areas were assessed. The data obtained were statistically analyzed using Wilcoxon's Rank test and the Mann Whitney test. 

## Results: Subjects in both the groups showed significant improvement in symptom scores; however, the overall treatment response was higher in the pimecrolimus group compared with the triamcinolone acetonide group. On intergroup comparison, there was no statistically significant difference between the groups in the reduction in burning sensation ( *P* = 0.18) and erythematous area ( *P* = 0.07), but there was a statistically highly significant improvement in reduction of clinical scoring ( *P* < 0.01%). Following the termination of the treatment, sustained remission of symptoms and long-lasting therapeutic effects was detected in 93.3% of the patients treated with pimecrolimus. 

## Interpretation and Conclusion: Topical pimecrolimus 1% cream showed better therapeutic response compared with triamcinolone acetonide 0.1% oral paste in subjects with symptomatic OLP. # RESULTS A total of 30 adult subjects were enrolled in the study, 20 females and 10 males, suggesting female predilection with a male to female ratio of 2:1. The age of the patients ranged from 20 to 64 years, and the mean age of the subjects was 36.7 ± 13.4 years. All the patients were symptomatic with erosive, ulcerative lesions and with additional reticular lesions as well. In both Group A and Group B, reduction in mean scores of burning sensation was observed during the treatment period. However, this reduction was higher in the pimecrolimus group than that in the triamcinolone acetonide group at the end of the 1 ^st^ month, i.e. 57% and 49%, respectively, and at the end of the 2 ^nd^ month (93% and 92%, respectively) Reduction in burning sensation was higher in Group A than in Group B, and it was statistically highly significant ( *P* < 0.01). During the treatment-free follow-up period, at the end of the 4 ^th^ month, reduction of burning sensation was 98% and 89%, respectively, and it was statistically highly significant ( *P* < 0.01). But, on intergroup comparison, at the end of the 1 ^st^ , 2 ^nd^ and 4 ^th^ months, it was statistically nonsignificant \[ [Table 1](#) and [Figure 1](#) \]. ::::table-wrap

::: caption
Intra and inter group comparision of burning sensation (before and after
treatment)
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![](<>):::: <figure> <p><img src="" /></p> <figcaption>Intergroup comparison of burning sensation</figcaption> </figure> There was reduction in mean clinical scores in both the groups after the treatment. However, this reduction during the treatment was higher in the pimecrolimus group than in the triamcinolone acetonide group, i.e. 49% and 44%, respectively, at the end of the 1 ^st^ month (2 ^nd^ visit). Similar reductions were seen at the end of the 2 ^nd^ month, 80% and 85%, respectively, and this was statistically highly significant ( *P* < 0.01). During the posttreatment follow-up of 2 months, it was 95% and 80%, respectively, which was statistically highly significant ( *P* < 0.01). On intergroup comparison, at the end of the 1 ^st^ and 2 ^nd^ months, it was statistically nonsignificant, but at the 4 ^th^ month during treatment-free follow-up it was highly significant ( *P* < 0.01) \[ [Table 2](#) and [Figure 2](#) \]. ::::table-wrap
::: caption
Inter and intra group comparison of clinical scores (before and after
treatment)
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![](<>):::: <figure> <p><img src="" /></p> <figcaption>Intergroup comparison of clinical score</figcaption> </figure> Improvement in resolution of erythematous areas during the treatment at the end of the 1 ^st^ month was 80% and 20%, respectively in the pimecrolimus and triamcinolone acetate groups, which was statistically highly significant ( *P* < 0.01). At the end of the 2 ^nd^ month, none of the patients had existence of erythematous areas in both Group A and Group B and no statistical difference was found. After the posttreatment follow-up of 2 months, the erythematous areas reappeared in 6.7% and 33.3% subjects in the pimecrolimus and triamcinolone acetonide groups, respectively, but no statistical difference was found ( *P* = 0.07) \[ [Table 3](#) and [Figure 3](#) \]. ::::table-wrap
::: caption
Inter and intra group comparison of erythematous areas (before and after
treatment)
:::

![](<>):::: <figure> <p><img src="" /></p> <figcaption>Intergroup comparison of the erythematous area</figcaption> </figure>


Extracted trial result:
Outcome: reappearance of erythematous areas after 2 months posttreatment (binary)
Intervention: pimecrolimus
Comparator: triamcinolone acetate
Intervention events: 1
Intervention group size: 15
Comparator events: 5
Comparator group size: 15
Notes: significance found in abstract and numbers in results