Evaluation of the Effectiveness of Photodynamic Therapy in the Treatment of Lesions of the Lichen Planus Type in the Oral Mucosa and Its Diagnostics With the Use of Autofluorescence, in Various Wavelength Ranges, in Combination With the Use of Texture Analysis and Fractal Dimension

Wroclaw Medical University

Status and phase: Completed; Phase 2

Conditions: Oral Lichen Planus

Treatments: Device: PDT Therapy; Drug: Triamcinolone (Substance) therapy side

Study type: Interventional

Funder types: Other

Identifiers

NCT04991012

kb845/2020

Details and patient eligibility

About

Lesions of the lichen planus type within the oral mucosa are now considered a potentially cancerous condition. One of the minimally invasive methods of treating these lesions is photodynamic therapy, and the gold standard in therapy is topical steroid administration

Full description

Lichen planus shows an irregular shape, which is quite difficult to measure objectively, which is important in assessing the effectiveness of treatment.

Patients will be treated in protocol split mouth with the treatment of lesions on one cheek with a steroid (on an adhesive plaster) and on the other - photodynamic therapy with a foot sensitizer in the form of a methylene blue also on an adhesive plaster The treatment evaluation procedure will consist of taking a series of intraoral photographs. These photos will be taken at each visit. This procedure will involve taking pictures traditionally in "white" light and in the spectrum of 405 nm, 460 nm and 405 + 460 nm (using the unique feature of the prototype laser - emission of two wavelengths simultaneously) in order to induce autofluorescence of the mucosa and treated lesions to better visualize them

A prospective, randomized, single-blind 12-week clinical trial of full contralateral split-mouth in patients with bilateral erythematous or erosive lichen planus in the mouth.On one side, the OLP lesion eligible for treatment was subjected to photodynamic therapy using methylene blue in four sessions every 2 days.

olp on the other side was treated with the administration of the steroid triamcinolone for 8 days

The clinical evaluation of the evolution of OLP eruptions was performed within 12 weeks of qualifying for treatment: at baseline, at the end of both treatments (day 8) and after the next 11 weeks

Enrollment: 30 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• histological diagnosis of OLP
• non smoker
• no diabetes melitus
• no hepatitis

Exclusion criteria

• diabetes melitus
• hepatitis
• occurrence dysplasia in the histopathological specimen;
• use of lichenoid reaction inducing medication and presence of amalgam fillings nearby the lesions;
• interventions for OLP in the previous 12 weeks;
• pregnant or breastfeeding women;
• proved or suspected hypersensitivity to any of the chemicals used in the treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

photodynamic therapy side

Experimental group

Description:

On one side, the OLP lesion eligible for treatment was subjected to photodynamic therapy in four sessions every 2 days.Using as photosensitizer Methylen blue for 10min the lesion was irradiated with a 650 nm semiconductor laser at a dose of 120 J / cm2

Treatment:

Device: PDT Therapy

Triamcinolone (Substance) therapy side

Active Comparator group

Description:

on the other side The OLP on the other side was treated by daily sticking a cut-to-size carrier with 0.05% triamcinolone acetonide for 8 days

Treatment:

Drug: Triamcinolone (Substance) therapy side