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

Phase 2RecruitingNCT06591884

Hospital de Clinicas de Porto Alegre46 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Oral Erosive Lichen Planus

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Oral Disease Severity Score (ODSS) - 50%

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.

Time frame: 30 days

VAS (visual analogical score) pain score - 50%

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.

Time frame: 30 days

Secondary Outcomes

OHIP-14 quality of life score

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.

Time frame: 15-90 days

Beck scale scores (anxiety levels)

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.

Time frame: 15-90 days

hedonic scale satisfaction scores

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.

Time frame: 30-90 days