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NCT Number: NCT06591884

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hospital de Clínicas de Porto Alegre

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

Location status: Recruiting

Location contact

Erick S Pedraça, DDS, MsC

CONTACT

Fernanda Visioli, DDS, PhD

CONTACT

[email protected]

+55 51 3308-5011

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tacrolimus modified-release

Drug

0.08% tacrolimus nanoencapsulated aqueous solution spray

Tacrolimus Ointment 0.1%

Drug

0.1% free tacrolimus commercial ointment

Primary outcomes

  1. Oral Disease Severity Score (ODSS) - 50%

    Time frame: 30 days

    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.

  2. VAS (visual analogical score) pain score - 50%

    Time frame: 30 days

    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.

Secondary outcomes

  1. OHIP-14 quality of life score

    Time frame: 15-90 days

    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.

  2. Beck scale scores (anxiety levels)

    Time frame: 15-90 days

    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.

  3. hedonic scale satisfaction scores

    Time frame: 30-90 days

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Erick S Pedraça, DDS, MsC

CONTACT

[email protected]

Fernanda Visioli, DDS, PhD

CONTACT

[email protected]

+55 51 3308-5011

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Sep 19, 2024
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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