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Study identifier: NCT06591884 Synced from ClinicalTrials.gov · July 28, 2026
● 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

Condition: Oral Erosive Lichen Planus  ·  Sponsor: Hospital de Clinicas de Porto Alegre

PhasePhase 1/Phase 2
Planned participants46
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Fernanda Visioli, DDS, PhD  ·  +55 51 3308-5011  ·  fvisioli@hcpa.edu.br

Erick S Pedraça, DDS, MsC  ·  erickspedraca@gmail.com

Always discuss trial participation with your own doctor first.

Locations (1)

Hospital de Clínicas de Porto AlegrePorto Alegre, Rio Grande do Sul, BrazilRecruiting

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Source record: clinicaltrials.gov/study/NCT06591884