A Comparison of Photodynamic Therapy and Topical Clobetasol in Treatment of Oral Lichen Planus: a Split-Mouth Randomised Controlled Study

Lichen planus is a chronic inflammatory dermatosis. It most often affects the skin and mucous membranes. Sometimes lesions may appear in the area of nails (estimated at 10% of patients) or genital organs and anus.

The most dangerous form of lichen planus is lichen that develops on the oral mucosa. It is believed to be the cause of the development of oral cancer.

The vast majority of people suffering from lichen planus - 90%, experience spontaneous resolution of symptoms within a maximum of two years from the moment of their onset.

In about half of the patients, the changes disappear within about 6 months. People who have a problem that their ailments do not want to go away on their own must take into account the fact that treating lichen is not the easiest one.

Treatment of lichen is mainly based on alleviating its symptoms and accelerating the resolution of symptoms. Topical ointments containing strong glucocorticosteroids are usually applied to skin lesions or we can use Photodynamic Therapy

Study Overview

• Status: Completed
• Conditions: Oral Lichen Planus
• Intervention / Treatment: Drug: Photodynamic Therapy; Drug: Clobetasol

Detailed Description

Oral lichen planus ( OLP) is most often characterized by lesions resembling a painless white mesh, which is usually located on the inside of the cheeks and the sides of the tongue. Lumps, erosions or erythematous changes are less often noticeable.

Symptoms in oral lichen planus are often:

reddening, dry mouth baking, swelling and minor bleeding.

Sometimes the gum mucosa exfoliates. When erosions occur, patients complain of pain and problems with drinking and swallowing food. Oral lesions necessarily require treatment.

Since lichen planus comes in many forms, some of them require histopathological examination to identify some of them. These tests involve taking a slice of the affected skin and examining it under a microscope.

Some causes of lichen planus are thought to involve several components.

Medications: lichen planus can occur as a reaction to certain medications, including:

beta-blockers, which are common drugs used to treat cardiovascular problems; anti-inflammatory drugs; injections to treat arthritis; antimalarial drugs; thiazide diuretics; phenothiazines, a group of tranquilizers with antipsychotic effects.

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 toluidine blue in four sessions every 2 days.

olp on the other side was treated with the administration of the clobetasol 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 week

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 2

Contacts and Locations

Study Locations

• Poland
  • Wroclaw, Poland, 50-367
    • Wroclaw Medical Univeristy, Departament of Periodontology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• having a histological diagnosis of OLP
• non smoker
• without diabetes melitus
• without hepatitis

Exclusion Criteria:

• diabetes melitus
• hepatitis
• occurrence dysplasia in the histopathological specimen;
• use of lichenoid reaction inducing medications 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: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Photodynamic Therapy; Procedure: Photodynamic 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 de
Active Comparator: Active Comparator: Steroid side; on the other side The OLP on the other side was treated by daily sticking a cut-to-size carrier with 0.025 clobetasol for 8 days	Drug: Clobetasol; The OLP on the other side was treated by daily sticking a cut-to-size carrier with 0.025 CLO for 8 days Other Names: topical steroid administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Size of Oral lichen planus	the size of the oral lichen planus on oral mucosa in millimeters was assessed using a periodontal probe PCPUNC 15 we measured the height and length of the lesions	From enrollment to the end of treatment at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain rating	Pain ailments were assessed with the use of VAS (visual analog scale) Scale from 0 to 10 0 =no pain 10= maximal pain	From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

• Sponsor: Wroclaw Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: December 20, 2024
• First Submitted That Met QC Criteria: December 20, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 20, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: olp, pdt
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Lichen Planus, Oral; Lichen Planus; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Clobetasol
• Other Study ID Numbers: wroclaw medical university

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: It is not yet known if there will be a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No