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

NCT ID: NCT04991012

Last Updated: 2021-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-08
• Study Completion Date: 2021-06-10

Brief Summary

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

Detailed 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

Conditions

Oral Lichen Planus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

photodynamic therapy side

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

Group Type: EXPERIMENTAL

PDT Therapy

Intervention Type: DEVICE

the olp was photosensitized with methylen blue and was irradiated with a semiconductor laser with a wavelength of 650 nm, using a dose of 120 J / cm2 and power density

Triamcinolone (Substance) therapy side

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

Group Type: ACTIVE_COMPARATOR

Triamcinolone (Substance) therapy side

Intervention Type: DRUG

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

Interventions

PDT Therapy

the olp was photosensitized with methylen blue and was irradiated with a semiconductor laser with a wavelength of 650 nm, using a dose of 120 J / cm2 and power density

Intervention Type: DEVICE

Triamcinolone (Substance) therapy side

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

Intervention Type: DRUG

Other Intervention Names

Photodynamic Therapy; Steroid therapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wroclaw Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

kamil jurczyszyn, prof

Role: STUDY_DIRECTOR

Wroclaw Medical University

tomasz konopka, prof

Role: STUDY_CHAIR

Wroclaw Medical University

Locations

Wroclaw Medical University

Wroclaw, Lower Silesian Voivodeship, Poland

Countries

Poland

Other Identifiers

kb845/2020

Identifier Type: -

Identifier Source: org_study_id