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Oral Lichen Planus Treatment

Sponsor
Universidad de Murcia (Other)
Overall Status
Completed
CT.gov ID
NCT05127083
Collaborator
(none)
60
Enrollment
1
Location
3
Arms
40.5
Actual Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Radiation: Patients will be treated with localized PBM with a diode laser
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Oral Lichen Planus Photodynamic Treatment
Actual Study Start Date :
Jun 4, 2018
Actual Primary Completion Date :
Oct 3, 2020
Actual Study Completion Date :
Oct 18, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change Assessment of Pain of OLP [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.

  2. Change Thongprasom sign scoring [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lopez-Jornet Pia Murcia N/A = Not Applicable Spain 30008

Sponsors and Collaborators

  • Universidad de Murcia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Pia Lopez Jornet, Investigador principal Head Oral Medicine, Universidad de Murcia
ClinicalTrials.gov Identifier:
NCT05127083
Other Study ID Numbers:
  • 2227/2018
First Posted:
Nov 19, 2021
Last Update Posted:
Nov 19, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pia Lopez Jornet, Investigador principal Head Oral Medicine, Universidad de Murcia
pain, oral lichen planus ; photodynamic therapy
Additional relevant MeSH terms:
Lichen Planus, Oral
Lichen Planus

Study Results

No Results Posted as of Nov 19, 2021