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NCT Number: NCT06752343

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Wroclaw Medical Univeristy, Departament of Periodontology

Wroclaw, 50-367, Poland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

photodynamic therapy

Drug

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

Clobetasol

Drug

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

Primary outcomes

  1. Size of Oral lichen planus

    Time frame: From enrollment to the end of treatment at 12 weeks

    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

Secondary outcomes

  1. Pain rating

    Time frame: From enrollment to the end of treatment at 12 weeks

    Pain ailments were assessed with the use of VAS (visual analog scale)

    Scale from 0 to 10 0 =no pain 10= maximal pain

Sponsors and collaborators

Lead sponsor

Wroclaw Medical University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 30, 2024
Registry last updated
Dec 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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