To study markers of cancer and effects of various medicines, Mycophenolate Mofetil, Methotrexate and Pimecrolimus in patients with ulcers in mouth causing burning sensation with spicy food.
Phase 4
Completed
- Conditions
- Health Condition 1: null- Patients having oral Lichen planus lesions and without any severe debilitating medical illness
- Registration Number
- CTRI/2017/04/008344
- Lead Sponsor
- Maulana Azad Institute of Dental Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
1. Patients older than 8 years with histologically proven Lichen Planus cases, were included in the study.
Exclusion Criteria
1. Lichenoid contact reaction due to any medication, mouthrinse, toothpaste or any other agent.
2. Patients who had received any therapy for Lichen Planus within past 8 weeks.
3. Any malignant or viral involvement in mouth .
4. Pregnant or nursing women also excluded.
5. Patients not willing to participate in the study
6. Patients whose complete follow up is lacking
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare therapeutic potential of <br/ ><br>Pimecrolimus, Mycophenolate mofetil and <br/ ><br>Methotrexate in oral lichen planus(OLP)using IL-6 as a marker of infllammatory <br/ ><br>Response and Cdk4 & p16 as markers of malignant potential. <br/ ><br>Timepoint: 3 months 6 months and 9th month
- Secondary Outcome Measures
Name Time Method As serum IL-6 levels significantly decreased in MMF group, correspondingly no resistance to treatment was noted. However with MTX there was no significant decrease in IL-6 and resistance to treatment was noted in some, especially plaque type lesions. Thus IL-6 can be a possible biomarker in deciding the best possible therapy for treatment resistant OLP.Timepoint: after 6 months period