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

NCT04991012 | Completed Phase 2

• 1 other identifier: kb845/2020
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Oral Lichen Planus

Keywords

photodynamic therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• computer analysis of autofluorescence of lesions

  12 weeks

Study Arms (2)

photodynamic therapy side

EXPERIMENTAL

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

Triamcinolone (Substance) therapy side

ACTIVE COMPARATOR

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

Interventions

PDT Therapy 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

Also known as: Photodynamic Therapy

photodynamic therapy side

Triamcinolone (Substance) therapy side 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

Also known as: Steroid therapy

Triamcinolone (Substance) therapy side

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (1)

Wroclaw Medical University

Wroclaw, Lower Silesian Voivodeship, 50-425, Poland

Location

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Photochemotherapy; Triamcinolone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• kamil jurczyszyn, prof

  Wroclaw Medical University

  STUDY DIRECTOR

• tomasz konopka, prof

  Wroclaw Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: full contralateral split-mouth

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: August 5, 2021
• Study Start: February 8, 2020
• Primary Completion: March 8, 2021
• Study Completion: June 10, 2021
• Last Updated: August 5, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)