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Comparison of Triamcinolone Acetonide Mucoadhesive Film and Licorice Mucoadhesive Film Effect on Lichen Planus

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ClinicalTrials.gov Identifier: NCT02453503
Recruitment Status : Completed
First Posted : May 25, 2015
Last Update Posted : May 25, 2015
Information provided by (Responsible Party):
Mehdi Nasr Isfahani, Isfahan University of Medical Sciences

Brief Summary:

Introduction :Oral lichen planus (OLP) is one of the most common disorders of the oral cavity which is basically a chronic and inflammated mucocutaneous .There is no cure for OLP currently. The main focus of treatment is to reduce the duration and severity of the symptoms. This study was designed to determine and compare the parameters of improvement in patient symptoms and lesions caused by oral lichen planus by using triamcinolone acetonide mucoadhesive film and licorice mucoadhesive film.

Methods and materials :The study was randomized by double-blind clinical trial . Patients with symptomatic OLP who referred to the Oral Medicine School of Dentistryin Medical Sciences in Isfahan University participated voluntarily. The patients were divided into two groups that were including 30 samples in each group. The first group was treated with triamcinolone mucoadhesive film and the second group were treated with licorice mucoadhesive film. Data were analyzed by using the Mann-Whitney test and t-test in SPSS software.

Condition or disease Intervention/treatment Phase
Oral Lichen Planus Drug: Licorice Drug: Triamcinolone Acetonide Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Triamcinolone Acetonide Mucoadhesive Film and Licorice Mucoadhesive Film Effect on the Duration and Symptoms of Lesions That Caused by Symptomatic Oral Lichen Planus
Study Start Date : January 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : April 2015

Arm Intervention/treatment
Active Comparator: Triamcinolone acetonide
Triamcinolone acetonide mucoadhesive films 1 mg every 6 hours for two weeks.
Drug: Triamcinolone Acetonide
Triamcinolone acetonide mucoadhesive films 1 mg every 6 hours for two weeks.
Other Name: Triamcinolone

Experimental: Licorice
Licorice mucoadhesive films 1 mg every 6 hours for two weeks.
Drug: Licorice
licorice mucoadhesive films evey 6 hours for two weeks
Other Name: Aftogel

Primary Outcome Measures :
  1. VAS [ Time Frame: 12 months ]
    Pain severity was measured by visual analogue scale : 0 for no pain and 10 for most painful experience

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • All patients over 18 years old
  • All non pregnant women

Exclusion Criteria:


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Responsible Party: Mehdi Nasr Isfahani, Director, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02453503    
Other Study ID Numbers: 394115
First Posted: May 25, 2015    Key Record Dates
Last Update Posted: May 25, 2015
Last Verified: May 2015
Keywords provided by Mehdi Nasr Isfahani, Isfahan University of Medical Sciences:
Lichen planus
Mucoadhesive film
Additional relevant MeSH terms:
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Lichen Planus, Oral
Lichen Planus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Mouth Diseases
Stomatognathic Diseases
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action