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

NCT06752343 | Completed Phase 2 DMC

• 1 other identifier: wroclaw medical university
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Oral Lichen Planus

Keywords

olp, pdt

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pain rating

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

Experimental: photodynamic therapy side

EXPERIMENTAL

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

Active Comparator: Steroid side

ACTIVE COMPARATOR

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

Interventions

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

Experimental: photodynamic therapy side

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

Active Comparator: Steroid side

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (1)

Wroclaw Medical Univeristy, Departament of Periodontology

Wroclaw, 50-367, Poland

Location

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Photochemotherapy; Clobetasol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy; Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: double
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: full contralateral split-mouth

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 30, 2024
• Study Start: June 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: December 30, 2024

Record last verified: 2024-12

Locations

PL (1)