A study to evaluate the efficacy, safety and tolerability of tacrolimus ointment 0.1% in patients of oral lichen planus
- Conditions
- Health Condition 1: L438- Other lichen planus
- Registration Number
- CTRI/2015/09/006211
- Lead Sponsor
- Intas Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
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).
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method â?¢Patientâ??s pain experience measured by means of the Visual Analogue Scale (VAS). <br/ ><br>â?¢Patientâ??s quality of life measured by means of the Oral Health Impact Profile (OHIP - 14). <br/ ><br>Timepoint: Baseline to week 6