Comparison the efficacy of Triamcinolone Acetonide 0.1 % in Orabase with it's nanoliposomal carriers formulation on oral Lichen Planus patients

Not Applicable

• Conditions: ichen Planus.; Papulosquamous disorders

• Registration Number: IRCT2014080416090N5
• Lead Sponsor: Dental Branch Islamic Azad University of Tehran

Brief Summary

Abstract:<br /> Background and Aim: Lichen planus (LP) is a chronic mucocutaneous disease, with different clinical subtypes. The erythematous-ulcerative type is accompanied by pain and burning sensation. Topical or systemic corticosteroid therapy is among the common treatments. No evidence is available supporting the superiority of any specific type or dose of treatment. Nano-drugs are recently used for the management of oral lesions. This study sought to compare the anti-inflammatory effects of 0.1% triamcinolone acetonide in Orabase® with and without nanoliposomal carriers on oral lichen planus (OLP).<br /> Materials and Methods: This randomized clinical trial was performed on 40 patients with erythematous-ulcerative OLP. Formulations of 0.1% Triamcinolone acetonide with and without nanoliposomal carriers in Orabase were used 3 times a day for a month in case and control groups, respectively. Pain intensity by linear Visual Analog Scale (0-10) and cross sectional area of the lesions by a grid paper (mm2) were measured before and one, two and four weeks after treatment. Data were analyzed using t-test, chi-square, Fisher’s Exact, Mann-Whitney and Wilcoxon Singed-Rank tests.<br /> Results: Although the pain intensity and size of oral lesions decreased statistically by each drug formulation (P=0.001), there were no significant differences between the two formulations after one, two and four weeks of treatment (P >0.05).<br /> Conclusion: Based on the results, the efficacy of the two formulations is similar for OLP. More investigations are required on topical drugs to obtain more efficient formulations.<br /> Keywords: Oral lichen planus, Triamcinolone acetonide, Nanoliposomal carriers, Orabase, Pain, area of lesion, Formulation<br />

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Inclusion Criteria: All referral patients to Oral Medicine Department of Dental Branch, Islamic Azad University of Tehran with symptomatic oral lesions suspected of Lichen Planus; with confirmed diagnosis clinically and histologically of atrophic or erosive oral Lichen Planus.

Exclusion Criteria

presence of dysplasia on histological examination; pregnancy; nursing; dysfunction of immune system(organ transplantation, lupus erythematous, ulcerative colitis); hematologic diseases; systemic diseases; history of systemic or topical corticosteroid therapy for Lichen Planus in the past month; Lichenoid reactions due to drug use or restorative materials.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain intensity. Timepoint: before treatment, 1, 2 and 4 weeks after treatment. Method of measurement: Visual Analogue Scale.;Area of the erythematous-erosive lesion. Timepoint: before treatment, 1, 2 and 4 weeks after treatment. Method of measurement: mm2.