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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

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllHospital de Clinicas de Porto Alegre
NCT06591884 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
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What it tests

  • Tacrolimus modified-release
  • tacrolimus ointment 0.1%
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Where

1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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