Status:
RECRUITING
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
Lead Sponsor:
Hospital de Clinicas de Porto Alegre
Conditions:
Oral Erosive Lichen Planus
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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: * Do...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06591884
Start Date
September 3 2024
End Date
December 1 2028
Last Update
October 2 2024
Active Locations (1)
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1
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903