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

Last updated: September 30, 2024
Sponsor: Hospital de Clinicas de Porto Alegre
Overall Status: Active - Recruiting

Phase

1/2

Condition

Warts

Rash

Treatment

tacrolimus ointment 0.1%

Tacrolimus modified-release

Clinical Study ID

NCT06591884
2023-0566
76823524.3.1001.5327
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • individuals with a clinical and histopathological diagnosis oferosive/ulcerative/atrophic and symptomatic oral lichen planus, according to thecriteria established by the American Academy of Oral and Maxillofacial Pathology

Exclusion

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 significantimmunosuppression;

  • be pregnant or lactating.

Study Design

Total Participants: 46
Treatment Group(s): 2
Primary Treatment: tacrolimus ointment 0.1%
Phase: 1/2
Study Start date:
September 03, 2024
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul 90035-903
    Brazil

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.