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
- Conditions
- Oral Erosive Lichen Planus
- Interventions
- Registration Number
- NCT06591884
- Lead Sponsor
- Hospital de Clinicas de Porto Alegre
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 46
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 0.08% tacrolimus nanoencapsulated aqueous solution spray Tacrolimus modified-release tacrolimus modified-release 0.1% free tacrolimus commercial ointment tacrolimus ointment 0.1% -
- Primary Outcome Measures
Name Time Method Oral Disease Severity Score (ODSS) - 50% 30 days Number of patients achieving a reduction of at least 50% in ODSS score compared to baseline and the percentage and absolute reduction in ODSS score in both groups at the end of treatment (30 days).
ODSS score ranges from 0 to 106, lower score mean a better outcome.VAS (visual analogical score) pain score - 50% 30 days number of patients achieving a reduction of at least 50% in VAS score of reported pain compared to baseline and the percentage and absolute reduction in VAS score in both groups at the end of treatment (30 days).
VAS score ranges from 0 to 10, lower score mean a better outcome.
- Secondary Outcome Measures
Name Time Method OHIP-14 quality of life score 15-90 days the percentage and absolute reduction in OHIP-14 scale score in both groups at mid-treatment and end of treatment (15 and 30 days) and at the 30 and 60-day follow-ups after treatment completion (follow-up 1 and follow-up 2).
OHIP-14 score ranges from 0 to 56, lower score mean a better outcome.Beck scale scores (anxiety levels) 15-90 days The percentage and absolute reduction in Beck scale score in both groups at mid-treatment and end of treatment (15 and 30 days) and at the 30 and 60-day follow-ups after treatment completion (follow-up 1 and follow-up 2).
OHIP-14 score ranges from 0 to 63, lower score mean a better outcome.hedonic scale satisfaction scores 30-90 days Comparison of hedonic scale scores of satisfaction reported by the participants in regards of treatment received in both groups at the end of treatment (30 days) and at the 30 and 60-day follow-ups after treatment completion (follow-up 1 and follow-up 2).
Hedonic scale satisfaction score ranges from 0 to 9, higher score mean a better outcome.
Trial Locations
- Locations (1)
Hospital de Clínicas de Porto Alegre
🇧🇷Porto Alegre, Rio Grande do Sul, Brazil