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

Hospital de Clinicas de Porto Alegre

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Oral Erosive Lichen Planus

Treatments

Drug: tacrolimus ointment 0.1%

Drug: Tacrolimus modified-release

Study type

Interventional

Funder types

Other

Identifiers

NCT06591884

76823524.3.1001.5327 (Other Identifier)

2023-0566

Details and patient eligibility

About

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.

Enrollment

46 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.