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

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

Study Overview

• Status: Completed
• Conditions: Oral Lichen Planus
• Intervention / Treatment: Device: PDT Therapy; Drug: Triamcinolone (Substance) therapy side

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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Poland
  • Dolnoslaskie
    • Wrocław, Dolnoslaskie, Poland, 50-425
      • Wroclaw Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: 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; Other Names: Photodynamic Therapy
Active Comparator: 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	Drug: 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; Other Names: Steroid therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of oral lichen planus	The measurement was made with a periodontal probe PCP UNC 15 in millimeters we measured the length of the lesions	12 weeks
height of oral lichen planus	The measurement was made with a periodontal probe PCP UNC 15 in millimeters we measured the height	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
computer analysis of autofluorescence of lesions	Based on photos taken in various light spectrum and fractal analysis of changes In this study, we used two wavelengths: 405, 450 and 405+450 nm together for the autofluorescence of lesions All fractal analysis was performed in ImageJ version 1.53e (Image Processing and Analysis in Java) Applied the intensity difference fractal dimension counting method. We measured the size of oral lichen planus on photos taken with different light wave using computer program as mentioned above	12 weeks

Collaborators and Investigators

• Sponsor: Wroclaw Medical University
• Investigators: Study Director: kamil jurczyszyn, prof, Wroclaw Medical University; Study Chair: tomasz konopka, prof, Wroclaw Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2020
• Primary Completion (Actual): March 8, 2021
• Study Completion (Actual): June 10, 2021

Study Registration Dates

• First Submitted: June 17, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): August 5, 2021

Study Record Updates

• Last Update Posted (Actual): August 5, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: photodynamic therapy
• 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; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: kb845/2020

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