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
Recruiting now · Phase 1/Phase 2
Conditions studied: Oral Erosive Lichen Planus
In brief
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.
Key facts
- Study ID
- NCT06591884
- Run by
- Hospital de Clinicas de Porto Alegre
- People needed
- 46
- Starts
- 2024-09-03
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2024-10-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- individuals with a clinical and histopathological diagnosis of erosive/ulcerative/atrophic and symptomatic oral lichen planus, according to the criteria established by the American Academy of Oral and Maxillofacial Pathology
You may not qualify if…
- History of oral cancer;
- history of allergic reactions to tacrolimus or any other component of the formulas;
- history of organ transplant or have a systemic condition that induces significant immunosuppression;
- be pregnant or lactating.
Where it is running
- Hospital de Clínicas de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil (enrolling)
Full record on ClinicalTrials.gov
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