Oral Lichen Planus Treatment

November 8, 2021 updated by: Pia Lopez Jornet, Universidad de Murcia

Oral Lichen Planus Photodynamic Treatment

Oral lichen planus (OLP) is a chronic inflammatory and immune-mediated disease affecting the oral mucosa. OLP presents with asymptomatic, lacelike white stripes and/or symptomatic red, ulcerated mucous membranes. Eating, drinking and oral hygiene procedures may be painful resulting in reduced quality of life (QOL). Photodynamic therapy (PDT) is a new suggestion for OLP treatment PDT is a successful treatment mo- dality for premalignant and malignant diseases of head and neck,gastrointestinal tract, lung, and skin

In this study, the effect of photodynamic therapy with topical corticosteroid in oral lichen planus patients was compared

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study, the efficacy of toluidine blue-mediated photodynamic therapy and topical triamcinolone acetonide 0.2% on decreasing pain and size of OLP lesions was compared.

This randomized, clinical trial compared the therapeutic effect of photodynamic therapy on symptomatic OLP (atrophic/ erosive/ulcerative forms) with triamcinolone acetonide 0.2%. The protocol of the clinical trial, which was conducted according to the ethical principles of Helsinki Group I toluidine blue-mediated photodynamic therapy Group II photodynamic therapy GroupIII laser sham + triamcinolone acetonide 0.2%

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • N/A = Not Applicable
      • Murcia, N/A = Not Applicable, Spain, 30008
        • Lopez-Jornet Pia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • . The patients with clinical or histopathological diagnosis of bilateral atrophic or erosive OLP (symptomatic OLP) who signed the written consent form were recruited.

Exclusion Criteria:

  • Patients with drug-induced or contact lichenoid reactions, patients receiving any treatment for OLP in 2 months prior to the study, pregnant or lactating women, patients with uncontrolled systemic disease, and patients with photosensitivity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: toluidine blue-mediated photodynamic therapy
The number of points will be variable according to the lesion size. Patients will be treated with localized PBM with a diode laser with continuous wave +toluidine blue
Radiation: Patients will be treated with localized PBM with a diode laser
Toluidine blue was applied on the lesions.The tissue were irradiated with a 660-nm diode laser InGaAlP
Active Comparator: photodynamic therapy + gel
The number of points will be variable according to the lesion size.atients will be treated with localized PBM with a diode laser with continuous wave
Radiation: Patients will be treated with localized PBM with a diode laser
Toluidine blue was applied on the lesions.The tissue were irradiated with a 660-nm diode laser InGaAlP
Sham Comparator: acetonide triamcinolone 0.2%+sham
Patients will be treated with acetonide triamcinolone 0.2% for 30 consecutive days. Laser device will be positioned over the lesion but will be switched off to mask the treatment. Patients will be instructed to apply the gel in the entire lesion three times/days.The number of points will be variable according to the lesion size.
Radiation: Patients will be treated with localized PBM with a diode laser
Toluidine blue was applied on the lesions.The tissue were irradiated with a 660-nm diode laser InGaAlP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change Assessment of Pain of OLP
Time Frame: Participants will be evaluated at baseline (Day 0) ; day 7: day 14 day and 28 day
The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation.
Participants will be evaluated at baseline (Day 0) ; day 7: day 14 day and 28 day
Change Thongprasom sign scoring
Time Frame: Participants will be evaluated at baseline (Day 0) ; day 7: day 14 day and 28 day
a score of 0 for normal healthy mucosa, 1 for lesions with only white striae, 2 for mixed keratotic and atrophic or erythematous lesions < 1 cm2 in size, 3 for keratotic and atrophic or erythematous lesions more than 1 cm2 in size, 4 for erosive/ulcerative lesions smaller than 1 cm2 , and 5 for erosive/ulcerative lesions larger than 1 cm2
Participants will be evaluated at baseline (Day 0) ; day 7: day 14 day and 28 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Murcia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2018

Primary Completion (Actual)

October 3, 2020

Study Completion (Actual)

October 18, 2021

Study Registration Dates

First Submitted

October 18, 2021

First Submitted That Met QC Criteria

November 8, 2021

First Posted (Actual)

November 19, 2021

Study Record Updates

Last Update Posted (Actual)

November 19, 2021

Last Update Submitted That Met QC Criteria

November 8, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2227/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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