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
Primary Purpose
Oral Lichen Planus
Status
Completed
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
PDT Therapy
Triamcinolone (Substance) therapy side
Sponsored by
About this trial
This is an interventional treatment trial for Oral Lichen Planus focused on measuring photodynamic 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
Sites / Locations
- Wroclaw Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
photodynamic therapy side
Triamcinolone (Substance) therapy side
Arm 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
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
Outcomes
Primary Outcome Measures
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
height of oral lichen planus
The measurement was made with a periodontal probe PCP UNC 15 in millimeters
we measured the height
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04991012
First Posted
June 17, 2021
Last Updated
July 26, 2021
Sponsor
Wroclaw Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04991012
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
February 8, 2020 (Actual)
Primary Completion Date
March 8, 2021 (Actual)
Study Completion Date
June 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wroclaw Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Lichen Planus
Keywords
photodynamic therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
full contralateral split-mouth
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
photodynamic therapy side
Arm Type
Experimental
Arm 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
Arm Title
Triamcinolone (Substance) therapy side
Arm Type
Active Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
PDT Therapy
Other Intervention Name(s)
Photodynamic Therapy
Intervention Description
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
Drug
Intervention Name(s)
Triamcinolone (Substance) therapy side
Other Intervention Name(s)
Steroid therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
length of oral lichen planus
Description
The measurement was made with a periodontal probe PCP UNC 15 in millimeters
we measured the length of the lesions
Time Frame
12 weeks
Title
height of oral lichen planus
Description
The measurement was made with a periodontal probe PCP UNC 15 in millimeters
we measured the height
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
computer analysis of autofluorescence of lesions
Description
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
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
kamil jurczyszyn, prof
Organizational Affiliation
Wroclaw Medical University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
tomasz konopka, prof
Organizational Affiliation
Wroclaw Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Wroclaw Medical University
City
Wrocław
State/Province
Dolnoslaskie
ZIP/Postal Code
50-425
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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