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 - a Randomized Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Brazil
Hospital de Clínicas de Porto Alegre
RECRUITING
Porto Alegre
Contact Information
Primary
Fernanda Visioli, DDS, PhD
fvisioli@hcpa.edu.br
+55 51 3308-5011
Backup
Erick S Pedraça, DDS, MsC
erickspedraca@gmail.com
Time Frame
Start Date: 2024-09-03
Estimated Completion Date: 2028-12
Participants
Target number of participants: 46
Treatments
Experimental: 0.08% tacrolimus nanoencapsulated aqueous solution spray
tacrolimus modified-release
Active_comparator: 0.1% free tacrolimus commercial ointment
Related Therapeutic Areas
Sponsors
Leads: Hospital de Clinicas de Porto Alegre

This content was sourced from clinicaltrials.gov