Clinical trial NCT04991012: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Oral Lichen Planus
Keywords: photodynamic therapy
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: full contralateral split-mouth
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: length of oral lichen planus
timeFrame: 12 weeks
measure: height of oral lichen planus
timeFrame: 12 weeks
Secondary outcomes:
measure: computer analysis of autofluorescence of lesions
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Wrocław
country: Poland
facility: Wroclaw Medical University
state: Dolnoslaskie
Study officials:
affiliation: Wroclaw Medical University
name: kamil jurczyszyn, prof
role: STUDY_DIRECTOR
affiliation: Wroclaw Medical University
name: tomasz konopka, prof
role: STUDY_CHAIR
References: