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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-03

Study Completion Date

2028-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Tacrolimus Ointment in Oral Lichen Planus

NCT01544842

Oral Lichen Planus

TERMINATED NA

Comparison of Tacrolimus 0.1% and Clobetasol 0.05% in the Management of Symptomatic Oral Lichen Planus

NCT02744378

Oral Lichen Planus

COMPLETED PHASE2

Efficacy of Topical Rapamycin to Treat Chronic Erosive Oral Lichen

NCT01061853

Oral Lichen Planus

TERMINATED PHASE3

Study on Treatment for Patients With Symptomatic Oral Lichen Planus

NCT04718311

Lichen Planus, Oral

COMPLETED NA

A Randomized Clinical Trial of the Effect of Pimecrolimus Cream 1% Compared With Topical Corticosteroid in Treatment of Erosive Oral Lichen Planus

NCT01524744

Oral Lichen Planus

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oral Erosive Lichen Planus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

0.08% tacrolimus nanoencapsulated aqueous solution spray

tacrolimus modified-release

Group Type EXPERIMENTAL

Tacrolimus modified-release

Intervention Type DRUG

0.08% tacrolimus nanoencapsulated aqueous solution spray

0.1% free tacrolimus commercial ointment

Group Type ACTIVE_COMPARATOR

tacrolimus ointment 0.1%

Intervention Type DRUG

0.1% free tacrolimus commercial ointment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tacrolimus modified-release

0.08% tacrolimus nanoencapsulated aqueous solution spray

Intervention Type DRUG

tacrolimus ointment 0.1%

0.1% free tacrolimus commercial ointment

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No