A Study of Tacrolimus Ointment of Intas Pharmaceuticals Limited, India in Patients having Inflammatory Condition with ulcer affecting mucous membranes inside the mouth
- Conditions
- Health Condition 1: L438- Other lichen planus
- Registration Number
- CTRI/2018/05/013796
- Lead Sponsor
- Intas Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 154
1. Male or female participants between 18 and 65 years of age (both inclusive) and willing to sign and provide a written informed consent form for participation in the study and agree to comply with study requirements.
2. Confirmed diagnosis of oral lichen planus based on history in combination with a compatible clinical appearance of lesional tissues.
3. Symptomatic OLP (Spontaneous or meal related oral pain) with a score of at least 35 mm on a visual analog scale for pain.
4. Male patients of child begetting potential and female patients of child bearing potential must be practicing either adequate contraception or abstinence from sex. Such female patients must not be pregnant or lactating and must have a negative serum pregnancy test at screening and negative urine pregnancy test at the start of the study.
1. Patients with active extra oral lichen planus lesions requiring management.
2. Patients with asymptomatic oral lichen planus.
3. Subjects who have received systemic immunosuppressants, oral retinoids or any other systemic therapies known or suspected to have an effect on oral lichen planus within 4 weeks prior to randomization in the study.
4. Subjects who have been treated with any topical therapy known or suspected to have an effect on lichen planus within the last one week prior to randomization in the study.
5. Subjects who have severe or recurrent systemic or generalized infections (bacterial, viral or fungal).
6. Subjects who have a clinically relevant liver disorder or renal disorder.
7. Subjects who have unstable or uncontrolled diabetes or hypertension.
8. Subjects must not have taken any potent CYP3A4 inhibitors within 14 days prior to randomization.
9. Subjects who are intended to be treated with any potent inhibitor of the co enzyme CYP450 3A4 during the course of study. Treatment with substrates or moderately potent inhibitors of CYP450 3A4 is permitted during the study, under close monitoring for adverse events during that period.
10. Hypersensitivity to tacrolimus or any of the ointment excipients, pimecrolimus, any macrolides such as clindamycin, erythromycin, azithromycin, clarithyromycin, etc.
11. Patient in need of concomitant treatments (while on study) that can be potentially effective on lichen planus lesions such as antimalarials, oral retinoids, steroids or immunosuppressive drugs
12. History or active presence of HIV and or hepatitis B and or hepatitis C infection.
13. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study.
14. Subjects who are uncooperative, known to miss appointments and are unlikely to follow medical instructions or are not willing to attend regular visits.
15. Patients with history or a known case of Netherton syndrome.
16. Patients with history or a known case of Cushing syndrome.
17. Patients with lymphadenopathy
18. Participation at another clinical trial within the last 30 days or intend to use other investigational drugs during the course of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method