Comparing two forms of tacrolimus for treating oral lichen planus
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
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 |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital de Clinicas de Porto Alegre Academic / other |
| Locations | 1 site (Porto Alegre, Rio Grande do Sul) |
| Trial ID | NCT06591884 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with erosive or ulcerative oral lichen planus.
Not a fit: Patients with a history of oral cancer, allergic reactions to tacrolimus, or significant immunosuppression may not benefit from this study.
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 performed: Other studies have explored tacrolimus for oral lichen planus, but the nanoencapsulation approach is relatively novel.
Eligibility criteria
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 this trial is running
Porto Alegre, Rio Grande do Sul
- Hospital de Clínicas de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil (Recruiting)
Study contacts
- Principal investigator: Fernanda Visioli, DDS, PhD — Hospital de Clínicas de Porto Alegre
- Study coordinator: Fernanda Visioli, DDS, PhD
- Email: fvisioli@hcpa.edu.br
- Phone: +55 51 3308-5011
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.