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

Phase 2

Completed

• Conditions: Oral Lichen Planus
• Interventions: Drug: Tacrolimus 0.1%; Drug: Clobetasol 0.05%

• Registration Number: NCT02744378
• Lead Sponsor: University of Peradeniya

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2015-07
• Study Completion: 2015-12
• Status Verified: 2016-04
• Study First Submitted: 2016-04-06
• Study First Submitted QC: 2016-04-19
• Last Update Submitted: 2016-04-19
• Study First Posted: 2016-04-20
• Last Update Posted: 2016-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tacrolimus Group	Tacrolimus 0.1%	tacrolimus (0.1%) cream
Clobetasol Group	Clobetasol 0.05%	clobetasol propionate (0.05%) cream

Primary Outcome Measures

Name	Time	Method
The intensity of Pain	Three weeks after the application of drugs	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.
The clinical response	Three weeks after the application of drugs	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.