Comparison of Clinical Efficiency of Photodynamic Therapy and Topical Corticosteroid in Treatment of Oral Lichen Planus
Primary Purpose
Lichen Planus, Oral
Status
Completed
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
Triamcinolone Acetonide
Photodynamic Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Lichen Planus, Oral
Eligibility Criteria
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
Sites / Locations
- Wroclaw Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
photodynamic therapy side
Steroid side
Arm Description
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
on the other side The OLP on the other side was treated by daily sticking a cut-to-size carrier with 0.05% triamcinolone acetonide for 8 days
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04976673
First Posted
June 15, 2021
Last Updated
July 26, 2021
Sponsor
Wroclaw Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04976673
Brief Title
Comparison of Clinical Efficiency of Photodynamic Therapy and Topical Corticosteroid in Treatment of Oral Lichen Planus
Official Title
A Comparison of Clinical Efficiency of Photodynamic Therapy and Topical Corticosteroid in Treatment of Oral Lichen Planus- Split-Mouth Randomised
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
December 10, 2020 (Actual)
Primary Completion Date
January 14, 2021 (Actual)
Study Completion Date
May 22, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wroclaw Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
Detailed Description
Oral lichen planus 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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lichen Planus, Oral
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
full contralateral split-mouth
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
photodynamic therapy side
Arm Type
Experimental
Arm Description
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
Arm Title
Steroid side
Arm Type
Active Comparator
Arm Description
on the other side The OLP on the other side was treated by daily sticking a cut-to-size carrier with 0.05% triamcinolone acetonide for 8 days
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide
Other Intervention Name(s)
topical steroid administration
Intervention Description
The OLP on the other side was treated by daily sticking a cut-to-size carrier with 0.05% triamcinolone acetonide for 8 days
Intervention Type
Procedure
Intervention Name(s)
Photodynamic Therapy
Other Intervention Name(s)
PDT
Intervention Description
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 density
Primary Outcome Measure Information:
Title
Size of Oral lichen planus
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Pain rating
Description
Pain ailments were assessed with the use of VAS (visual analog scale)
Scale from 0 to 10 0 =no pain 10= maximal pain
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
tomasz konopka, prof
Organizational Affiliation
Wroclaw Medical University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
kamil jurczyszyn
Organizational Affiliation
Wroclaw Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Wroclaw Medical University
City
Wrocław
State/Province
Dolnoslaskie
ZIP/Postal Code
50-425
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Clinical Efficiency of Photodynamic Therapy and Topical Corticosteroid in Treatment of Oral Lichen Planus
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