Comparing two forms of tacrolimus for treating oral lichen planus
Official title: 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
Run by Hospital de Clinicas de Porto Alegre · NCT06591884 · Data updated 2026-11-12
This study is testing whether a new spray form of tacrolimus works better than the regular ointment for treating oral lichen planus.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 46 (estimated) |
| Sponsor | Hospital de Clinicas de Porto Alegre Academic / other |
| Locations | 1 site (Porto Alegre, Rio Grande do Sul) |
| Status | Recruiting |
| Started | September 3, 2024 |
| Main results expected | December 2027 |
| Study ends | December 2028 |
| Registry record updated | October 2, 2024 |
| Trial ID | NCT06591884 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals diagnosed with erosive or ulcerative oral lichen planus.
✕Probably not a fit
Patients with a history of oral cancer, allergic reactions to tacrolimus, or significant immunosuppression may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness of a 0.08% tacrolimus nanoencapsulated aqueous solution spray versus a 0.1% free tacrolimus commercial ointment in treating oral lichen planus. Participants will apply one of the formulations twice daily for one month and attend clinic visits every two weeks for assessments. The study aims to determine which formulation leads to longer periods without lesions. The trial is designed to provide insights into the efficacy of different drug delivery methods for this condition.
Why it matters
Potential benefit: If successful, this study could offer a more effective treatment option for patients suffering from oral lichen planus.
How similar studies have gone: Other studies have explored tacrolimus for oral lichen planus, but the nanoencapsulation approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil Recruiting
Study contacts
- Principal investigator: Fernanda Visioli, DDS, PhD — Hospital de Clinicas de Porto Alegre
- Study coordinator: Fernanda Visioli, DDS, PhD
- Email: fvisioli@hcpa.edu.br
- Phone: +55 51 3308-5011
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.