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

University of Peradeniya68 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Oral Lichen Planus

Interventions

Tacrolimus 0.1%DRUG

This group was randomly allocated to receive topical Tacrolimus 0.1% for 3 consecutive weeks

Clobetasol 0.05%DRUG

This group was randomly allocated to receive topical Clobetasol 0.05% for 3 consecutive weeks

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Three weeks after the application of drugs

Data from ClinicalTrials.gov

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