Back to resultsMatrix Metalloproteinases Neutralizing Agents in Oral Lichen Planus
Primary Purpose
Oral Lichen Planus
Status
Unknown status
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Matrix Metalloproteinase Inhibitors (Orochem)
Kenacort A,
Sponsored by
About this trial
This is an interventional treatment trial for Oral Lichen Planus focused on measuring matrix metalloproteinase inhibitors, orochem, OLP
Eligibility Criteria
Inclusion Criteria:
- patients diagnosed with erosive OLP confirmed with a biopsy.
- patients should have symptomatic lesions
Exclusion Criteria:
- Patients who were under anticoagulant medications, suffering from any systemic diseases or having any physical or mental abnormality, pregnant and lactating women, smokers.
Sites / Locations
- periodontology department, Faculty of dentistry, Alexandria University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Orochem (Test)
Conventional (Control)
Arm Description
fifteen patients with lichen planus will be treated with MMPs neutralizing agent 3 times daily for 3 weeks. then pain, discomfort and disease severity will be assessed at 1 and 3 weeks periods.
fifteen patients with oral lichen planus confirmed with a biopsy will be treated with topical corticosteroids, topical antifungal 3 timed daily for 3 weeks. then pain, discomfort and disease severity will be assessed at 1 and 3 weeks periods.
Outcomes
Primary Outcome Measures
change in disease severity score
Thongprasom disease severity score (5-0)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04336488
Brief Title
Matrix Metalloproteinases Neutralizing Agents in Oral Lichen Planus
Official Title
Effectiveness of Matrix Metalloproteinase Neutralizing Agent in Treatment of Oral Lichen Planus: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
July 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jaylane kadry Ghonima
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The current study will be conducted to evaluate the effectiveness of matrix metalloproteinases inhibitors on erosive oral lichen planus.
Detailed Description
Matrix metalloproteinases inhibitor (Orochem) will be given to patients with Oral erosive lichen planus three times daily for 3 weeks. Then the subjective discomfort and pain severity as well as the objective disease severity scores will be collected.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Lichen Planus
Keywords
matrix metalloproteinase inhibitors, orochem, OLP
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
double equal arms
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
participant, investigator as well as outcome assessor are blinded
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Orochem (Test)
Arm Type
Experimental
Arm Description
fifteen patients with lichen planus will be treated with MMPs neutralizing agent 3 times daily for 3 weeks. then pain, discomfort and disease severity will be assessed at 1 and 3 weeks periods.
Arm Title
Conventional (Control)
Arm Type
Active Comparator
Arm Description
fifteen patients with oral lichen planus confirmed with a biopsy will be treated with topical corticosteroids, topical antifungal 3 timed daily for 3 weeks. then pain, discomfort and disease severity will be assessed at 1 and 3 weeks periods.
Intervention Type
Drug
Intervention Name(s)
Matrix Metalloproteinase Inhibitors (Orochem)
Intervention Description
topical application of MMP inhibitors for 3 weeks to evaluate its effectiveness in treating oral lichen planus
Intervention Type
Drug
Intervention Name(s)
Kenacort A,
Other Intervention Name(s)
miconaz gel
Intervention Description
topical application of both drugs 3 times daily for 3 weeks as an active control
Primary Outcome Measure Information:
Title
change in disease severity score
Description
Thongprasom disease severity score (5-0)
Time Frame
change in disease severity score from baseline to 3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients diagnosed with erosive OLP confirmed with a biopsy.
patients should have symptomatic lesions
Exclusion Criteria:
Patients who were under anticoagulant medications, suffering from any systemic diseases or having any physical or mental abnormality, pregnant and lactating women, smokers.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hossam H. AlSabbagh, As. lecturer
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
periodontology department, Faculty of dentistry, Alexandria University
City
Alexandria
ZIP/Postal Code
21500
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
participants data are not to be shared
Learn more about this trial
Matrix Metalloproteinases Neutralizing Agents in Oral Lichen Planus
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