Therapeutic Effect of Quercetin and the Current Treatment of Erosive and Atrophic Oral Lichen Planus

NCT01375101 | Unknown Phase 1

• 1 other identifier: 88705
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Lichen planus (LP) is a common chronic inflammatory mucocutaneous disease with an immunologic etiology ,which has number of different clinical forms. Alternative natural or herbal origine drugs with antioxidant and anti-inflammatory properties have been used individually or in combination with systemic corticosteroids in order to decrease adverse drug reactions. This study was conducted to evaluate the effect of quercetin on treatment of erosive -atrophic lesions of oral lichen planus (OLP).

Conditions

Atrophic Oral Lichen Planus; Erosive Oral Lichen Planus

Keywords

lichen planus; quercetin

Outcome Measures

Primary Outcomes (1)

• the effects of this Drug on OLP measured with VAS scale for pain and evaluation of intensity of lesions.

  In the present work the Analogical Visual Scale is used TO evaluate pain,and we also record the intensity of lesions weekly and any side effect of this Drug

  2 months

Study Arms (2)

quercetin

ACTIVE COMPARATOR

quercetin is one of flavonoids , and having therapeutical anti-inflammatory and antioxidant action

Drug: Quercetin

placebo

PLACEBO COMPARATOR

placebo capsul is produced with lactose for using in placebo/ control group.

Drug: placebo

Interventions

placebo DRUG

The patient is directed to use placebo capsule two times a day, ,until the one mouth

placebo

Quercetin DRUG

The patient is directed to digest quercetin hydrate capsule two times a day,until one mouth

quercetin

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• confirmation of clinical diagnosis of Atrophic and erosive lichen planus by histological examination
• two weeks wash out periods after the last treatment
• having the experience of atrophic and erosive lesion greater than 1 cm having the experience of pain and burning greater than 3.5 in VAS Score

You may not qualify if:

• confirmation of dysplasia and malignancy in histologic examination
• confirmation of lichenoid reaction in histologic examination
• pregnancy and breast feeding
• using fluorokinolon and cyclosporin which interact with quercetin

Sponsors & Collaborators

• Mashhad University of Medical Sciences: lead

Study Sites (1)

Mashhad university of Medical science, Research Center of oral and maxillofacial medicine

Mashhad, Khorasan Razavi, 91735, Iran

RECRUITING

MeSH Terms

Conditions

Lichen Planus

Interventions

Quercetin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

maryam amirchaghmaghi, assistant professor

CONTACT

0098-0511889201; amirchakhmaghim@mums.ac.ir

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 14, 2011
• First Posted: June 17, 2011
• Study Start: April 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: July 26, 2011

Record last verified: 2011-07

Locations

IR (1)