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

Erosive Oral Lichen Planus Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01375101
• Other study ID #: 88705
• Status: Recruiting
• Phase: Phase 1
• First received: June 14, 2011
• Last updated: July 25, 2011
• Start date: April 2010
• Est. completion date: September 2011

Study information

• Verified date: July 2011
• Source: Mashhad University of Medical Sciences
• Contact: maryam amirchaghmaghi, assistant professor
• Phone: 0098-0511889201
• Email: amirchakhmaghim[@]mums.ac.ir
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrophic Oral Lichen Planus
• Atrophy
• Erosive Oral Lichen Planus
• Lichen Planus
• Lichen Planus, Oral

Intervention

Drug:
• placebo
The patient is directed to use placebo capsule two times a day, ,until the one mouth
• Quercetin
The patient is directed to digest quercetin hydrate capsule two times a day,until one mouth

Locations

Country	Name	City	State
Iran, Islamic Republic of	Mashhad university of Medical science, Research Center of oral and maxillofacial medicine	Mashhad	Khorasan Razavi

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes