Skip to content

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.

To evaluate expression of CDK4, P16, IL-6 in oral lichen planus patients for changes in malignant potential, inflammatory response with various treatment modalities.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/04/008344
Enrollment
60
Registered
2017-04-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patients having oral Lichen planus lesions and without any severe debilitating medical illness

Interventions

Intervention1: â?¢ Topical Pimecrolimus, Oral Mycophenolate mofetil alongwith topical Pimecrolimus, Patients on oral Methotrexate alongwith topical Pimecrolimus. : pimecrolimus: was prescribed as 1%

Sponsors

Maulana Azad Institute of Dental Science
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients older than 8 years with histologically proven Lichen Planus cases, were included in the study.

Exclusion criteria

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

Design outcomes

Secondary

MeasureTime frame
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

Primary

MeasureTime frame
To compare therapeutic potential of Pimecrolimus, Mycophenolate mofetil and Methotrexate in oral lichen planus(OLP)using IL-6 as a marker of infllammatory Response and Cdk4 & p16 as markers of malignant potential. Timepoint: 3 months 6 months and 9th month

Countries

India

Contacts

Public ContactSinny Goel

Head of Dept. OMDR, Maulana Azad Institute of Dental Sciences, Delhi

drsunitagupta@yahoo.com9460534217

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026