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

NCT02453503 | Completed Phase 2 DMC

• 1 other identifier: 394115
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Oral Lichen Planus

Keywords

Lichen planus; Mucoadhesive film; licorice

Outcome Measures

Primary Outcomes (1)

• VAS

  Pain severity was measured by visual analogue scale : 0 for no pain and 10 for most painful experience

  12 months

Study Arms (2)

Triamcinolone acetonide

ACTIVE COMPARATOR

Triamcinolone acetonide mucoadhesive films 1 mg every 6 hours for two weeks.

Drug: Triamcinolone Acetonide

Licorice

EXPERIMENTAL

Licorice mucoadhesive films 1 mg every 6 hours for two weeks.

Drug: Licorice

Interventions

Licorice DRUG

licorice mucoadhesive films evey 6 hours for two weeks

Also known as: Aftogel

Licorice

Triamcinolone Acetonide DRUG

Triamcinolone acetonide mucoadhesive films 1 mg every 6 hours for two weeks.

Also known as: Triamcinolone

Triamcinolone acetonide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

MeSH Terms

Conditions

Lichen Planus, Oral; Lichen Planus

Interventions

Glycyrrhiza glabra extract; Triamcinolone Acetonide; Triamcinolone

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 15, 2015
• First Posted: May 25, 2015
• Study Start: January 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 25, 2015

Record last verified: 2015-05