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

Oral Lichen Planus Clinical Trial

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

Status Completed

Clinical Trial 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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04991012
Study type	Interventional
Source	Wroclaw Medical University
Contact
Status	Completed
Phase	Phase 2
Start date	February 8, 2020
Completion date	June 10, 2021

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05997173` - The Regulatory Role of Immune Response in Oral Lichen Planus
Completed	`NCT02443311` - Clinical and Immunohistochemical Effect of Topical Pimecrolimus in Treatment of Oral Lichen Planus	Phase 4
Completed	`NCT00484250` - Study of Metronidazole and Doxycycline to Treat Oral Lichen Planus and to Compare Their Efficacy With Each Other	Phase 2
Completed	`NCT03682562` - Diagnostic Accuracy of Salivary DNA Integrity Index in Oral Malignant and Premalignant Lesions
Not yet recruiting	`NCT06428630` - Systemic Absorption of Dexamethasone Oral Rinse in Patients With Oral Lichen Planus	Early Phase 1
Completed	`NCT04193748` - Evaluation of Topical Pomegranate Extracts in Management of Oral Lichen Planus (A Randomized Clinical Trial)	Phase 4
Completed	`NCT04153266` - Oral Epithelial Dysplasia Informational Needs Questionnaire
Recruiting	`NCT06135805` - Impact of Fluocinonide 0,05% in Oral Lichen Planus	N/A
Completed	`NCT04289233` - Molecular & Cellular Characterisation of Oral Lichen Planus
Completed	`NCT04293718` - Acquired Chronic Erosive Gingivitis: Clinical Relevance of Papillary Gingival Biopsy
Completed	`NCT00525421` - A Clinical Study of Curcuminoids in the Treatment of Oral Lichen Planus	Phase 2
Not yet recruiting	`NCT04091698` - Clinical and Biochemical Assessment of the Effect of Topical Use of Coenzyme Q10 Versus Topical Corticosteroid in Management of Symptomatic Oral Lichen Planus: Randomized Controlled Clinical Trial	Phase 1
Completed	`NCT03386643` - Effect of Bifidobacterium Animalis Subsp. Lactis HN019 on Oral Lichen Planus	Phase 2
Withdrawn	`NCT03836885` - Apremilast - Oral Lichen Planus Trial	Phase 2
Completed	`NCT05730855` - Diagnostic Accuracy of lncRNA DQ786243 and miRNA146a in Saliva of Oral Potentially Malignant Lesions
Completed	`NCT03257228` - The Association Between Diabetes Mellitus, Oral Lichen Planus and Insulin-like Growth Factors 1 and 2 (IGF1 and IGF2)	N/A
Recruiting	`NCT03026478` - Topical Betamethasone and Clobetasol in Orabase in Oral Lichen Planus	Phase 2
Completed	`NCT02858297` - Glucosamine as a Novel Adjunctive Therapy in Oral Lichen Planus	Phase 4
Completed	`NCT02834520` - Expression of miRNa-138 and Cyclin D1 in Oral Mucosa of Patients With Oral Lichen Planus	N/A
Completed	`NCT02106468` - The Efficacy of Omega-3 in Treatment of Atrophic/Erosive Lichen Planus	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.