MedTrace Logo

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

NCT06591884 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2024-10-02

No results posted yet for this study

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.

Conditions

  • Oral Erosive Lichen Planus

Interventions

DRUG

Tacrolimus modified-release

0.08% tacrolimus nanoencapsulated aqueous solution spray

DRUG

tacrolimus ointment 0.1%

0.1% free tacrolimus commercial ointment

Sponsors & Collaborators

  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Principal Investigators

  • Fernanda Visioli, DDS, PhD · Hospital de Clínicas de Porto Alegre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-03
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • Brazil

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06591884 on ClinicalTrials.gov