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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Oral Erosive Lichen Planus
• Intervention / Treatment: Drug: Tacrolimus modified-release; Drug: tacrolimus ointment 0.1%

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Fernanda Visioli, DDS, PhD; Phone Number: +55 51 3308-5011; Email: fvisioli@hcpa.edu.br
• Study Contact Backup: Name: Erick S Pedraça, DDS, MsC; Email: erickspedraca@gmail.com

Study Locations

• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
      • Recruiting
      • Hospital de Clinicas de Porto Alegre
      • Contact: Fernanda Visioli, DDS, PhD; Phone Number: +55 51 3308-5011; Email: fvisioli@hcpa.edu.br
      • Contact: Erick S Pedraça, DDS, MsC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.08% tacrolimus nanoencapsulated aqueous solution spray; tacrolimus modified-release	Drug: Tacrolimus modified-release; 0.08% tacrolimus nanoencapsulated aqueous solution spray
Active Comparator: 0.1% free tacrolimus commercial ointment	Drug: tacrolimus ointment 0.1%; 0.1% free tacrolimus commercial ointment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral Disease Severity Score (ODSS) - 50%	Number of patients achieving a reduction of at least 50% in ODSS score compared to baseline and the percentage and absolute reduction in ODSS score in both groups at the end of treatment (30 days). ODSS score ranges from 0 to 106, lower score mean a better outcome.	30 days
VAS (visual analogical score) pain score - 50%	number of patients achieving a reduction of at least 50% in VAS score of reported pain compared to baseline and the percentage and absolute reduction in VAS score in both groups at the end of treatment (30 days). VAS score ranges from 0 to 10, lower score mean a better outcome.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OHIP-14 quality of life score	the percentage and absolute reduction in OHIP-14 scale score in both groups at mid-treatment and end of treatment (15 and 30 days) and at the 30 and 60-day follow-ups after treatment completion (follow-up 1 and follow-up 2). OHIP-14 score ranges from 0 to 56, lower score mean a better outcome.	15-90 days
Beck scale scores (anxiety levels)	The percentage and absolute reduction in Beck scale score in both groups at mid-treatment and end of treatment (15 and 30 days) and at the 30 and 60-day follow-ups after treatment completion (follow-up 1 and follow-up 2). OHIP-14 score ranges from 0 to 63, lower score mean a better outcome.	15-90 days
hedonic scale satisfaction scores	Comparison of hedonic scale scores of satisfaction reported by the participants in regards of treatment received in both groups at the end of treatment (30 days) and at the 30 and 60-day follow-ups after treatment completion (follow-up 1 and follow-up 2). Hedonic scale satisfaction score ranges from 0 to 9, higher score mean a better outcome.	30-90 days

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Fernanda Visioli, DDS, PhD, Hospital de Clinicas de Porto Alegre

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: September 9, 2024
• First Submitted That Met QC Criteria: September 9, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): October 2, 2024
• Last Update Submitted That Met QC Criteria: September 30, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Tacrolimus; Oral Lichen Planus
• Additional Relevant MeSH Terms: Skin Diseases; Stomatognathic Diseases; Mouth Diseases; Skin Diseases, Papulosquamous; Lichenoid Eruptions; Lichen Planus, Oral; Lichen Planus; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: 2023-0566; 76823524.3.1001.5327 (Other Identifier: Hospital de Clinicas de Porto Alegre)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No