Comparison of Tacrolimus 0.1% and Clobetasol 0.05% in the Management of Symptomatic Oral Lichen Planus

Study Overview
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Brief Summary
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This clinical study is carried out to assess the efficacy of Tacrolimus and Clobetasol in symptomatic Oral Lichen Planus.

Official Title
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Comparison of Tacrolimus 0.1% and Clobetasol 0.05% in the Management of Symptomatic Oral Lichen Planus- A Double-blinded Randomized Clinical Trial in Sri Lanka

Conditions
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Oral Lichen Planus

Intervention / Treatment
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* Drug: Tacrolimus 0.1%
* Drug: Clobetasol 0.05%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinically and Histologically proven Oral Lichen Planus Symptomatic Exclusion Criteria: topical/ systemic medication for OLP in the previous three months contraindication for medications use such as a history of allergy to either corticosteroids/ tacrolimus immunosuppression, or pregnant / lactating females lichenoid reactions either drug induced or due to dental amalgam diabetes mellitus and on oral hypoglycemic drugs systemic involvement such as concurrent skin/genital lesions

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clobetasol Group<br>clobetasol propionate (0.05%) cream | Drug: Clobetasol 0.05%<br>* This group was randomly allocated to receive topical Clobetasol 0.05% for 3 consecutive weeks<br>|
| Active Comparator: Tacrolimus Group<br>tacrolimus (0.1%) cream | Drug: Tacrolimus 0.1%<br>* This group was randomly allocated to receive topical Tacrolimus 0.1% for 3 consecutive weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The intensity of Pain | The intensity of pain was assessed using visual analog scale (VAS) - The patients were asked to score their intensity of pain using a VAS where the pain scores ranged from 0 (no pain) to 10 (extreme pain) Four VAS was recorded one for spicy food and the other one for without spicy food for right side and left sides separately. The mean VAS was calculated for each side and the severity of pain was evaluated according to the following scales: Scale 0: no pain: VAS=0, Scale 1: mild pain: 0< VAS≤3.5, Scale 2: moderate pain: 3.5 <VAS≤7, Scale 3: severe pain: 7< VAS≤10. | Three weeks after the application of drugs | 
| The clinical response | The clinical response of the lesion was scored according to the grading system formulated by Thongprasom et al.,in 1992 for the mucosal lesions: Score 5 = white striae with erosive area more than 1 cm, Score 4 = white striae with erosive area less than 1 cm, Score 3 = white striae with atrophic area more than 1 cm, Score 2 = white striae with atrophic area less than 1 cm, Score 1 =mild white striae, no erythematous area Score 0 = no lesion, normal mucosa. This scorings were performed for both right and left sides separately. | Three weeks after the application of drugs |