Effectiveness of topical triamcinolone combined with oral apremilast versus topical triamcinolone alone in oral lichen planus
Not Applicable
- Conditions
- Health Condition 1: L438- Other lichen planus
- Registration Number
- CTRI/2023/03/051002
- Lead Sponsor
- All India Institute of Medical Sciences, Jodhpur
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
a) Patients with clinical diagnoses of oral lichen planus or biopsy proven oral lichen planus.
b) Age more than 16 years
c) Treatment wash off period of 2 weeks for topical drugs and 4 weeks for immunosuppressive drugs.
Exclusion Criteria
a) Pregnant and lactating women
b) Hypersensitivity to oral apremilast
c) Known case of renal and hepatic impairment
d) Known case of psychiatric disease
e) Patients with extensive cutaneous involvement secondary to lichen planus.
f) Patients with dental restoration in situ
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in clinical severity score (CSS)Timepoint: At 3 weeks, 6 weeks, 9 weeks and 12 <br/ ><br>weeks.
- Secondary Outcome Measures
Name Time Method Change in pain on visual analog scaleTimepoint: At 3 weeks, 6 weeks, 9 weeks and 12 <br/ ><br>weeks.;Change in patientâ??s quality of life.Timepoint: At 3 weeks, 6 weeks, 9 weeks and 12 <br/ ><br>weeks.;Change in serum interleukin 6 & 8 (IL-6,IL-8)Timepoint: Baseline, at the end of treatment and in cases of relapse;Patient satisfaction with treatment using percentage gradingTimepoint: At 3 weeks, 6 weeks, 9 weeks and 12 <br/ ><br>weeks.;Side effects of drugTimepoint: At 3 weeks, 6 weeks, 9 weeks and 12 <br/ ><br>weeks.