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 | Recruiting Phase 1

• 2 other identifiers: 2023-056676823524.3.1001.5327
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Oral Lichen Planus; Tacrolimus

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• OHIP-14 quality of life score

  15-90 days

• Beck scale scores (anxiety levels)

  15-90 days

• hedonic scale satisfaction scores

  30-90 days

Study Arms (2)

0.08% tacrolimus nanoencapsulated aqueous solution spray

EXPERIMENTAL

tacrolimus modified-release

Drug: Tacrolimus modified-release

0.1% free tacrolimus commercial ointment

ACTIVE COMPARATOR

Drug: tacrolimus ointment 0.1%

Interventions

Tacrolimus modified-release DRUG

0.08% tacrolimus nanoencapsulated aqueous solution spray

0.08% tacrolimus nanoencapsulated aqueous solution spray

tacrolimus ointment 0.1% DRUG

0.1% free tacrolimus commercial ointment

0.1% free tacrolimus commercial ointment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

MeSH Terms

Conditions

Lichen Planus, Oral

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Fernanda Visioli, DDS, PhD

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernanda Visioli, DDS, PhD

CONTACT

+55 51 3308-5011; fvisioli@hcpa.edu.br

Erick S Pedraça, DDS, MsC

CONTACT

erickspedraca@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: September 3, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 2, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)