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

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

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

Study Overview

• Status: Completed
• Conditions: Oral Lichen Planus
• Intervention / Treatment: Drug: Clobetasol 0.05%; Drug: Tacrolimus 0.1%

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Peradeniya

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: April 6, 2016
• First Submitted That Met QC Criteria: April 19, 2016
• First Posted (Estimate): April 20, 2016

Study Record Updates

• Last Update Posted (Estimate): April 20, 2016
• Last Update Submitted That Met QC Criteria: April 19, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Stomatognathic Diseases; Mouth Diseases; Skin Diseases, Papulosquamous; Lichenoid Eruptions; Lichen Planus, Oral; Lichen Planus; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Calcineurin Inhibitors; Tacrolimus; Clobetasol
• Other Study ID Numbers: RG/2013/08/D