Health Condition 1: L438- Other lichen planus
Conditions
Interventions
Intervention1: Lipid based tacrolimus ointment 0.1%: Dose: 1 cm ribbon spread is recommended, Frequency: Four times in a day, Mode of Administration: Topical, Duration of treatment: 6 weeks / complete
Sponsors
Intas Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female participants between 18 and 65 years of age 2.Confirmed diagnosis of symptomatic oral lichen planus 3.Symptomatic OLP (Spontaneous or meal related oral pain).
Exclusion criteria
Exclusion criteria: 1.Asymptomatic lichen planus with no ulcerated or erythematous oral lesions. 2.Who have received systemic immunosuppressants, oral retinoids or any other systemic therapies known or suspected to have an effect on lichen planus within 4 weeks prior to participation in the study. 3.Who have been treated with topical therapy 4.Severe or recurrent systemic or generalized infections (bacterial, viral or fungal). 5.Who have unstable or uncontrolled diabetes or hypertension. 6.Hypersensitivity to tacrolimus or any of the ointment excipients, pimecrolimus, any macrolides such as clindamycin, erythromycin, azithromycin, clarithyromycin, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the Physicians Global Assessment of Clinical Condition from baseline to week 6 / complete healing of all baseline lesions whichever comes first.Timepoint: Baseline to week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢Patientâ??s pain experience measured by means of the Visual Analogue Scale (VAS). â?¢Patientâ??s quality of life measured by means of the Oral Health Impact Profile (OHIP - 14). Timepoint: Baseline to week 6 | — |
Countries
India
Contacts
Public ContactHitesh Maheshwari
Lambda Therapeutic Research Ltd
Outcome results
None listed