NCT00484250

Brief Summary

Oral lichen planus (OLP) is a chronic inflammatory disorder which causes local irritation,discomfort and subsequent poor dentition and discomfort in eating . Various treatments have been suggested for OLP but their results are unsatisfactory .Despite the fact that steroids have been the main therapeutic choice for many years,some researches have been done regarding the efficacy of other medication such as metronidazole and doxycycline.The purpose of this study is to determine whether metronidazole and doxycycline are effective in the treatment of oral lichen planus and to compare their efficacy with each other.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2007

Completed
Last Updated

June 11, 2007

Status Verified

June 1, 2007

First QC Date

June 7, 2007

Last Update Submit

June 8, 2007

Conditions

Oral Lichen Planus

Keywords

Oral Lichen PlanusMetronidazoleDoxycycline

Interventions

metronidazole,doxycyclineDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • a biopsy-proven untreated OLP of every type with no symptom.

You may not qualify if:

  • pregnancy, presence of dysplasia in lesions,unilateral lesion suspected lichenoid reaction,history of drinking alcohol in at least 1 month prior to the study, smoking, systemic disease, use of systemic medications and hypersensitivity to the metronidazole and doxycycline.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mashhad University Of Medical Sciences(Dentistry School)

Mashhad, Khorasan, 91375345, Iran

Location

Related Links

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

MetronidazoleDoxycycline

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesLichen PlanusLichenoid EruptionsSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

NitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Arash Mansourian, DDS,MS

    Tehran University of Medical Sciences

    STUDY CHAIR

  • Majid Sanatkhani, DDS,MS

    Mashhad University of Medical Sciences

    STUDY DIRECTOR

  • Fatemeh Momen Heravi

    Tehran University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 7, 2007

First Posted

June 8, 2007

Study Start

September 1, 2005

Study Completion

May 1, 2006

Last Updated

June 11, 2007

Record last verified: 2007-06

Locations

IR(1)