NCT06591884 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
| NCT ID | NCT06591884 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Hospital de Clinicas de Porto Alegre |
| Condition | Oral Erosive Lichen Planus |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2024-09-03 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 46 participants in total. It began in 2024-09-03 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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: * 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.
Eligibility 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.
Contact & Investigator
Fernanda Visioli, DDS, PhD
PRINCIPAL INVESTIGATOR
Hospital de Clínicas de Porto Alegre
Frequently Asked Questions
Who can join the NCT06591884 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Oral Erosive Lichen Planus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06591884 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06591884 currently recruiting?
Yes, NCT06591884 is actively recruiting participants. Contact the research team at fvisioli@hcpa.edu.br for enrollment information.
Where is the NCT06591884 trial being conducted?
This trial is being conducted at Porto Alegre, Brazil.
Who is sponsoring the NCT06591884 clinical trial?
NCT06591884 is sponsored by Hospital de Clinicas de Porto Alegre. The principal investigator is Fernanda Visioli, DDS, PhD at Hospital de Clínicas de Porto Alegre. The trial plans to enroll 46 participants.