Back to resultsStudy of Metronidazole and Doxycycline to Treat Oral Lichen Planus and to Compare Their Efficacy With Each Other
Primary Purpose
Oral Lichen Planus
Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
metronidazole,doxycycline
Sponsored by
About this trial
This is an interventional treatment trial for Oral Lichen Planus focused on measuring Oral Lichen Planus, Metronidazole, Doxycycline
Eligibility Criteria
Inclusion Criteria:
- a biopsy-proven untreated OLP of every type with no symptom.
Exclusion Criteria:
- 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.
Sites / Locations
- Mashhad University Of Medical Sciences(Dentistry School)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00484250
First Posted
June 7, 2007
Last Updated
June 8, 2007
Sponsor
Mashhad University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00484250
Brief Title
Study of Metronidazole and Doxycycline to Treat Oral Lichen Planus and to Compare Their Efficacy With Each Other
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mashhad University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Lichen Planus
Keywords
Oral Lichen Planus, Metronidazole, Doxycycline
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
metronidazole,doxycycline
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
a biopsy-proven untreated OLP of every type with no symptom.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arash Mansourian, DDS,MS
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Majid Sanatkhani, DDS,MS
Organizational Affiliation
Mashhad University of Medical Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fatemeh Momen Heravi
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mashhad University Of Medical Sciences(Dentistry School)
City
Mashhad
State/Province
Khorasan
ZIP/Postal Code
91375345
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Links:
URL
http://www.emedicine.com/derm/topic663.htm
Description
Related Info
Learn more about this trial
Study of Metronidazole and Doxycycline to Treat Oral Lichen Planus and to Compare Their Efficacy With Each Other
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