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Evaluation of the Efficacy of 0.08% Tacrolimus Nanoencapsulated Aqueous Solution Spray Vs. 0.1% Free Tacrolimus Commercial Ointment in the Treatment of Oral Lichen Planus - a Randomized Clinical Trial
The goal of this clinical trial is to assess the efficacy of different formulations of the drug tacrolimus in treating patients with oral lichen planus. The main questions it aims to answer are: * Does the nanoencapsulation of tacrolimus in an aqueous solution, used as a spray, improve the effectiveness of treating oral lichen planus lesions compared to the commercially available tacrolimus ointment? * Which tacrolimus formulation can keep participants free of lesions for longer periods? Researchers will compare a spray of 0.08% tacrolimus nanoencapsulated aqueous solution against a 0.1% free tacrolimus commercial ointment to determine which formulation is more effective. Participants will: * Apply one of the proposed tacrolimus formulations twice a day for 1 month. * Visit the clinic once every 2 weeks for checkups and tests, with follow-ups extending up to 3 months.
Details
| Lead sponsor | Hospital de Clinicas de Porto Alegre |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | RECRUITING |
| Enrolment | 46 |
| Start date | 2024-09-03 |
| Completion | 2028-12 |
Conditions
- Oral Erosive Lichen Planus
Interventions
- Tacrolimus modified-release
- tacrolimus ointment 0.1%
Primary outcomes
- Oral Disease Severity Score (ODSS) - 50% — 30 days
Number of patients achieving a reduction of at least 50% in ODSS score compared to baseline and the percentage and absolute reduction in ODSS score in both groups at the end of treatment (30 days). ODSS score ranges from 0 to 106, lower score mean a better outcome. - VAS (visual analogical score) pain score - 50% — 30 days
number of patients achieving a reduction of at least 50% in VAS score of reported pain compared to baseline and the percentage and absolute reduction in VAS score in both groups at the end of treatment (30 days). VAS score ranges from 0 to 10, lower score mean a better outcome.
Countries
Brazil